linjc16/ctgov huggingface dataset:
Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

Study Overview
=================
Brief Summary
-----------------
The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.

Detailed Description
-----------------
Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle

Official Title
-----------------
Toripalimab Combined With S1 and Albumin Paclitaxel as First Line in Patients With Advanced Biliary Tract Cancer: a Single-arm,One Center， Phase II Clinical Study

Conditions
-----------------
Advanced Biliary Tract Cancer

Intervention / Treatment
-----------------
* Drug: Toripalimab Combined With S1 and Albumin Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points) ECOG score 0 or 1 point At least one measurable lesion no previous treatment Exclusion Criteria: organs failure ,including liver ,heart ,kidney Have received a liver transplant in the past Active brain metastasis or spinal cord compression ECOG score 3 or 4 point Symptomatic peripheral neuropathy (CTCAE ≥ 2)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toripalimab Combined With S1 and Albumin Paclitaxel<br> | Drug: Toripalimab Combined With S1 and Albumin Paclitaxel<br>* Toripalimab 240 mg ，every 2-3 weeks S1：80-120mg，bid；oral，d1-14； Albumin Paclitaxel：120mg/m2，D 1 \8<br>* Other names: TSA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | ORR | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | PFS | 1 year | 
| disease response rate | DCR | 1 year | 
| overall survival | OS | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced biliary tract cancer, Albumin Paclitaxel, s1, Toripalimab
Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test

Study Overview
=================
Brief Summary
-----------------
Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of sedation based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing

Official Title
-----------------
Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test)

Conditions
-----------------
Seizure

Intervention / Treatment
-----------------
* Device: Masimo Sedline brain function monitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older scheduled for Wada testing at MUSC Exclusion Criteria: No exclusions

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

| Intervention/Treatment |
| --- |
|Device: Masimo Sedline brain function monitors|Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of sedation based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Masimo Sedline brain function monitor- based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing |  | 1 year |
Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if collecting information and blood from a group of people who never smoked but who have lung cancer, is possible across the US. The investigators will collect information on each patient's diagnosis and treatments. If the collection is successful, blood samples will be used to try to identify new genes (which are the basic elements of heredity, passed from parents to their offspring), which may explain and predict why certain patients develop lung cancer without having smoked tobacco.

Official Title
-----------------
Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: blood sample and questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older histologically and/or cytologically proven diagnosis of non-small cell lung cancer never smoker, defined as having smoked less than 100 cigarettes over one's life-time completed survey and inclusion form signed informed consent Exclusion Criteria: previous history of cancer (other than lung cancer) living outside the United States patients who cannot read English (as website and questionnaires will only be written in English) unable to understand the protocol or to give informed consent

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 |
| --- | --- |
| 1<br>Never-smokers with lung cancer | Other: blood sample and questionnaire<br>* After giving informed consent, all patients will be asked to complete questionnaire and will be asked to provide a blood sample for DNA analysis. The questionnaire will consist of a detailed smoking questionnaire, based on the most recent Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System Survey Questionnaire.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of an internet-based protocol to collect clinical information and biological specimens from 2,000 never smokers with lung cancer. |  | conclusion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Questionaires
Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria

Study Overview
=================
Brief Summary
-----------------
acidosis, acute renal failure and acute pulmonary oedema are common, and frequently fatal, manifestations of severe P. falciparum malaria. The course of all three might be ameliorated by optimising a patient's intravenous fluid therapy. The fluid treatment of severe malaria is presently empirical, by defining cardiovascular responses to volume replacement we would provide a physiological basis for resuscitation strategies. We will use pulse contour cardiac output monitoring (PiCCOTM) to guide the fluid resuscitation of patients admitted to intensive care with severe malaria. With data collected during the patients' admission we hope to: Assess the degree of hypovolaemia in adults with severe malaria and its contribution to microcirculatory dysfunction and acidosis. To assess the relationships between volume status, haemodynamic parameters and the renal and pulmonary manifestations of severe malaria. To assess the utility of central venous pressure measurement as a guide for fluid administration in patients with severe malaria To investigate the prognostic and clinical utility of central venous oxygen saturation in severe malaria In this way we hope to develop a greater understanding of the pathophysiology of haemodynamic derangement in severe malaria. By comparing the PiCCO derived data with simpler clinical parameters, we hope to determine potential fluid resuscitation strategies - relevant for a resource poor setting - whose efficacy could be confirmed in future trials.

Official Title
-----------------
Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria

Conditions
-----------------
Severe Falciparum Malaria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Severe malaria, defined by the modified criteria of Hien et al and the presence of asexual forms of P. falciparum in the peripheral blood smear. The patients or their attending relative able and willing to give fully informed written consent. Age ≥ 16 years Exclusion Criteria 1. Patients or relatives unable or unwilling to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Metabolic Acidosis |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute renal failure |  | By discharge | 
| Acute pulmonary oedema |  | By discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Falciparum, malaria, volume, haemodynamics
Comparison of Low and High Ligation in the Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the defecatory function when nerve fibers around the inferior mesenteric artery(IMA) and left colic artery(LCA) are preserved(so called low ligation ) or not(high ligation) in the rectosigmoid and rectal cancer surgery.

Detailed Description
-----------------
Fecal incontinence after anterior resection are often observed. Whether or not postoperative bowel function is influenced by the preservation of nerve fibers around the root of IMA and LCA (low ligation) is still unknown. So in this randomized controlled trial, we evaluate the efficacy of low ligation in terms of the bowel function.

Official Title
-----------------
Comparison of Functional Results of High Ligation and Low Ligation After Anterior Resection for Rectal Cancer - Randomized Controlled Trial-

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: preservation of nerve fibers around IMA
* Procedure: resection of nerve fibers around IMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On the basis of whether anterior resection was anticipated at WMUH for rectosigmoid and rectal cancer, and appropriate informed consent was obtained. Exclusion Criteria: Patients who could not respond to medical interview for own bowel function Patients without an informed consent
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>low ligation, which the IMA is ligated below the origin of the left colic artery | Procedure: preservation of nerve fibers around IMA<br>* low ligation<br>* Other names: low tie;|
| Active Comparator: 2<br>high ligation, which the IMA is ligated at its origin from the aorta | Procedure: resection of nerve fibers around IMA<br>* high ligation<br>* Other names: high tie;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of bowel function |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of leakage rate |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low or high ligation
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.

Official Title
-----------------
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer

Conditions
-----------------
Ovarian Insufficiency, Radiation Exposure

Intervention / Treatment
-----------------
* Radiation: radioactive iodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient in childbearing period. Female patient with differentiated thyroid carcinoma. Underwent thyroidectomy. Candidate for radioactive iodine therapy. Exclusion Criteria: • Male patients. Postmenopausal female patients. Female patients with undifferentiated thyroid carcinoma. Pregnant female patients. Lactating female patients.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: self controlled case series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br> | Radiation: radioactive iodine<br>* 80-200 mCi of radioactive iodine will be given to thyroid cancer patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of anti-Müllerian (AMH) hormone | Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy. | 6 months |
Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

Detailed Description
-----------------
A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

Official Title
-----------------
A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic of JP-2266 in Healthy Subjects

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: JP-2266
* Drug: JP-2266 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Caucasian subject aged 18 to 50 years inclusive Body Mass Index (BMI) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening Signing a written informed consent prior to selection; Exclusion Criteria: Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JP-2266<br>Drug: JP-2266 | Drug: JP-2266<br>* Single Ascending Dose: Single administration on Day 1 Food effect cohort: Single administration on Day 1 of each period Multiple Ascending Dose: Repeated administrations from D1 to D15<br>|
| Placebo Comparator: JP-2266 Placebo<br>Drug: JP-2266 Placebo | Drug: JP-2266 Placebo<br>* Single Ascending Dose: Single administration on Day 1 Food effect cohort: Single administration on Day 1 of each period Multiple Ascending Dose: Repeated administrations from D1 to D15<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of the number of adverse events and the number and percentage of subjects | Single Ascending Dose | up to Day 10 | 
| Assessment of PK parameter: Maximum plasma concentration (Cmax) | Food effect cohort | up to 72hours of each period | 
| The evaluation of the number of adverse events and the number and percentage of subjects | Multiple Ascending Dose | up to Day 19 |
Improving Outcomes in Underserved Women With GDM

Study Overview
=================
Brief Summary
-----------------
Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.

Detailed Description
-----------------
Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.

Official Title
-----------------
Improving Outcomes in Underserved Women With GDM

Conditions
-----------------
Diabetes Mellitus, Pregnancy

Intervention / Treatment
-----------------
* Other: telemonitoring
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of GDM 33 or less weeks gestation Exclusion Criteria: multiple gestations history of glucose intolerance outside of pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Telemedicine<br>Usual care plus telemonitoring | Other: telemonitoring<br>* Women will transmit their blood glucose levels, fetal movement counts, and insulin doses via the Internet and/or IVR system at least three times per week<br>|
| Active Comparator: 2 Standard of Care<br>Standard of care - women will monitor and record blood glucose levels four times a day. | Other: Standard of care<br>* Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal blood glucose control |  | 3 to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant birthweight |  | at delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GDM, pregnancy, macrosomia