linjc16/ctgov huggingface dataset:
Anlotinib for Esophageal Cancer (AFEC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced esophageal cancer in the real world, and to summarize the treatment experience of a wide range of people.

Official Title
-----------------
A Real World Study on the Effect of Single or Combined Treatment of Anlotinib on Survival and Prognosis of Advanced Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Anlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 18 years old, male or female; Patients with esophageal cancer were diagnosed; Patients assessed by doctors to benefit from single or combined treatment of arotinib; Patients volunteered to join the project. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anlotinib|This is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | From date of admission until the date of death from any cause, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine

Study Overview
=================
Brief Summary
-----------------
A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine

Official Title
-----------------
A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Technosphere Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months BMI <40 kg/m squared HbA1c greater than or equal to 7% and less than or equal to 11.5% Serum creatinine less than 2 for males and less than 1.8 for females Acceptable pulmonary function Exclusion Criteria: Significant hepatic disease Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Technosphere Insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose following a standard meal |  | 0-300 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline HbA1c |  | week 12 |
Follow-up of the Natural Course of the Small EUS-suspected Gastric Gastointestinal Stromal Tumors

Study Overview
=================
Brief Summary
-----------------
Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up conservatively. However, little is known about the natural course of small GISTs. The goal of this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and to determine the size predicting subsequent progression with increased malignant potential.

Conditions
-----------------
Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) a small tumor size, less than 3 cm; (2) patients declined surgical intervention at initial identification of the lesion; (3) at least two EUS follow-up procedures were recorded; (4) the EUS follow-up period was more than 24 months. Exclusion Criteria: (1) a tumor size, larger than 3 cm; (2) less two EUS follow-up procedures were recorded; (3) the EUS follow-up period was less 24 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| EUS-suspected gastric GISTs<br>In this retrospective study, 50 patients with EUS-suspected gastric GISTs, less than 3 cm were enrolled and had EUS follow-up at least two times over a period of more than 24 months. | |

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
-----------------
Gastrointestinal stromal tumor,endoscopic ultrasound,submucosal tumor
Pulse Oximeter Test

Study Overview
=================
Brief Summary
-----------------
Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia

Official Title
-----------------
Accuracy of Pulse Oximeters With Profound Hypoxia

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Device: Spry Loop oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health with no evidence of medical problems Exclusion Criteria: Smoking Anemia

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spry Loop oximeter|Oximetry was performed on the subjects and accuracy was determined based on comparison with blood gas analysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oximetry Accuracy | RMSE of pulse oximeter | 30 minutes |
A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Detailed Description
-----------------
Patients receive intravenous DS-4152 by infusion weekly for 4 weeks, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Official Title
-----------------
A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Tecogalan sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Kaposi's sarcoma plus HIV infection OR metastatic solid tumor. Life expectancy of at least 12 weeks. NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks. Recovered from toxicity of any prior anticancer therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Leukemia or lymphoma. Current gastrointestinal bleeding by stool guaiac. Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors. Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics. Acute intercurrent infection other than genital herpes. Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy. Concurrent Medication: Excluded: Other anticancer therapy. Other investigational agents. Patients with the following prior conditions are excluded: History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease. History of myocardial infarction within past 6 months. Prior Medication: Excluded: Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C). Investigational agents within the past 4 weeks.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tecogalan sodium|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
-----------------
Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, tecogalan
Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer

Study Overview
=================
Brief Summary
-----------------
Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.

Official Title
-----------------
A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction

Conditions
-----------------
Gastroesophageal Adenocarcinoma, Gastric Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: OSI-7904L


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age >= 18 years At least one target lesion Exclusion Criteria: Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OSI-7904L|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to investigate the effect of providing patients access to their electronic medical records Via the IPC Connect Application on their A Survey will be proposed to all outpatients with a solid or hematologic malignancy who will attend an appointement at Institut Paoli Calmettes clinic. Data will be collected during a 1-month period. The auto-questionnaire will be composed of 31 questions addressed to all patients, 17 questions will be specifically addressed to patients using IPC connect application and 7 questions will be addressed to patients who do not use the application.

Official Title
-----------------
An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application

Conditions
-----------------
Solid Tumor, Hematologic Malignancy

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman, age> 18 Years Solid tumor or hematologic malignancy Patient attending an appointment at Institut Paoli Calmettes Non-opposition Exclusion Criteria: emergency, Vulnerable person or unable to provide informed consent First appointment at Institut Paoli Calmettes

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 |
| --- | --- |
| Institut Paoli Calmettes Outpatients<br>Patients with a solid tumor or an hematologic malignancy who will attend an appointement at IPC Outpatients clinic | Other: Survey<br>* Self-completed questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Patients Access to Their Electronic Medical Records Via the IPC Connect Application on patients anxiety level | Anxiety level will be measured by the Hospital Anxiety and Depression scale | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electronic Medical Records, Patients anxiety
To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)

Study Overview
=================
Brief Summary
-----------------
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

Official Title
-----------------
An Open-Label, Single-Arm, Prospective Study to Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet in Patients With Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0733, simvastatin / Duration of Treatment: 12 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient, >18 years of age Patients with hypercholesterolemia who meet the following lipid criteria: primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl secondary cholesterolemia (patients with cad, dm): ldl-c>=130 mg/dl The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study Exclusion Criteria: Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1 Uncontrolled hypertension with systolic blood pressure > 160 mmhg or diastolic > 100 mmhg at visit 1. Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening

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: MK0733, simvastatin / Duration of Treatment: 12 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks |  |  |
Effect of Modulation of TENS in Pain After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.

Detailed Description
-----------------
Mothers were randomly divided into three groups (G100, G4 and placebo (GP) - appliance off) and evaluated by NRS (numeric rating scale) before, immediately after application of TENS, and every 20 minutes until he was one hour after the application of electroanalgesia, to verify its effectiveness over time.

Official Title
-----------------
Hypoalgesic Effect of TENS Modulation in Post-Cesarean Pain: A Clinical Trial Controlled and Randomized.

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

Intervention / Treatment
-----------------
* Device: transcutaneous electrical nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 years present pain at the site of surgical incision less than three according to Category Numerical Scale (NRS) literate oriented as to time and space with spinal anesthesia before surgery incision pfannenstiel type with absence of genitourinary pathology primiparous or multiparous Exclusion Criteria: patients with abnormal sensitivity to clinical examination demyelinating diseases spinal cord injury hemorrhage infection fever anesthetic complications hypertension, mammary, intolerance, irritation or strong discomfort at the injection site caused by TENS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: grupo TENS com frequência de 100 Hz<br>TENS application of high frequency (100 Hz, 100 μs) | Device: transcutaneous electrical nerve stimulation<br> <br> |
| Experimental: grupo TENS com frequência de 4 Hz<br>Application of low-frequency TENS (4 Hz, 100 μs) | Device: transcutaneous electrical nerve stimulation<br> <br> |
| Placebo Comparator: Placebo with TENS off<br>TENS application when off | Device: transcutaneous electrical nerve stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain after cesarean |  | after TENS application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section, pain, transcutaneous electrical nerve stimulation, postpartum period
An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy

Study Overview
=================
Brief Summary
-----------------
This trial is an open, national, multi-centre trial. The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement of related Adverse Events.

Detailed Description
-----------------
The main objective of this trial is to assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica, the measurement rate is the frequency of patients with investigational medicinal product (IMP)-related adverse events (AEs) will be the primary endpoint.

Official Title
-----------------
An Open Trial to Assess the Tolerability of AVANZ® Cupressus Immunotherapy

Conditions
-----------------
Allergic Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Biological: AVANZ Cupressus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry. Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ≥ 3 mm) Exclusion Criteria: History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted). Ongoing treatment with any allergen-specific immunotherapy product. A history of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction). A systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not).

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: AVANZ Cupressus<br>AVANZ Cupressus | Biological: AVANZ Cupressus<br>* AVANZ Cupressus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients with IMP-related AEs |  | 6 treatment weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients with systemic reactions |  | 6 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cupressus arizonica