linjc16/ctgov huggingface dataset:
Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease

Study Overview
=================
Brief Summary
-----------------
Determination of IRTI (infrared thermal imaging) can be used to evaluate PAD patients with critical limb ischemia with different degrees of lesion. IRTI can be used to evaluate the foot blood perfusion after percutaneous transluminal angioplasty (PTA) treatment and determine the success rate of surgery. IRTI can be used as an effective follow-up tool for patients after surgery.

Official Title
-----------------
Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease

Conditions
-----------------
Peripheral Artery Disease (PAD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Rutherford grade 3, 4, 5, or 6. Patients with indications for lower extremity arterial PTA: severe intermittent claudication, rest pain, ulceration or gangrene. Patients who required PTA of only one limb (left versus right). Exclusion Criteria: Patients with body temperature above 37 ° C. Patients with indications for open surgery. Patients requiring major amputation (above the ankle). Patients with acute occlusive or embolic limb ischemia. Patients with deep venous thrombosis of the lower extremity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment. | The different levels of pseudocodes (white, red, pink, yellow, green, blue, and black) represent the corresponding IRTI, corresponding to the color bar from low to high temperature. We will measure the average temperature of the dorsum and sole of the foot before and after PTA treatment in the operated and non-operated limbs. Ankle-brachial index (ABI) of the operated and non-operated limbs before and after PTA treatment will also be measured. We will analyze the agreement between ABI and foot temperature in the operated and non-operated limbs, as well as the agreement between the change in ABI and foot temperature. | up to 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral artery disease (PAD), infrared thermal imaging (IRTI), percutaneous transluminal angioplasty (PTA)
A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Background: The aim of this study is to develop a prediction model for radiation-induced trismus (maximal interincisal distance equal to or less than 35 mm) based on a multivariable analysis of dosimetric and clinical factors.

Detailed Description
-----------------
The maximum inter-incisal opening (MIO) of hean and neck cancer (HNC) patients who undergo radiotherapy (RT) ± concurrent chemotherapy with radical intent, will be prospectively measured prior to RT (baseline) and 6 months post-RT. The potential risk factors (clinical and dosimetric) will be first screened by univariate analysis and then by multivariate analysis. At the end of this process, the features identified as relevant, will be used to fit a logistic regression model and calculate the probability of observed trismus during the 6-month follow-up after RT

Official Title
-----------------
A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer

Conditions
-----------------
Trismus

Intervention / Treatment
-----------------
* Radiation: Volumetric modulated radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HNC treatment definitive or postoperative external beam radiotherapy, either alone or in -combination with chemotherapy or cetuximab at least 6 months follow-up Exclusion Criteria: primary tumor out-side the head and neck region, intracranially, or if it originated from the nasal vestibule patient death during RT or within the first 6 months after the start of RT, no outcome data available
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Head and neck cancer patients undergoing radiotherapy<br> | Radiation: Volumetric modulated radiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trismus | maximal interincisal distance equal to or less than 35 mm | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation induced trismus, head and neck radiotherapy
A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure

Study Overview
=================
Brief Summary
-----------------
Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.

Official Title
-----------------
A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure

Conditions
-----------------
AML

Intervention / Treatment
-----------------
* Combination Product: CLAG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myeloid leukemia patients with first-induction failure Exclusion Criteria: Acute myeloid leukemia patients with serious infection and organ dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 65 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 |
| --- | --- |
| Group<br>Acute myeloid leukemia patients with first-induction failure | Combination Product: CLAG<br>* Acute myeloid leukemia patients are re-induced by CLAG Regimen after first-induction failure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure | CLAG Regimen improves CR rate in acute myeloid leukemia patients with first-induction failure | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLAG, acute myeloid leukemia, First-induction failure
PET Study of Acetylcholine Esterase Activity in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to understand regional variations in acetylcholine esterase activity in Alzheimer's disease. In this study the aim is to identify by PET the physiological values of the regional activity of acetylcholine esterase using the 11C PM4 tracer and to study by PET and 11C PM4 the brain activity of acetylcholine esterase in a group of patients with Alzheimer's disease, enrolled according to the inclusion and exclusion criteria. The PET data will be correlated with the clinical, neuropsychological and morphological data acquired by MRI and with the clinical-cognitive outcome.

Official Title
-----------------
PET Study of Acetylcholine Esterase Activity in Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Diagnostic Test: PET with 11C MP4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with Alzheimer's disease; patients must have undergone an instrumental morphological examination to exclude other neurological pathologies. Exclusion Criteria: positive history of major head trauma; clinically active somatic diseases.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET with 11C MP4|Each subject will undergo a PET exam using 11C MP4 as a tracer. This is a specific ligand for the acetyl-choline esterase enzyme already used abroad both in healthy volunteers and in various patient groups.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET with 11C MP4 as a tracer to identify acetylcholine esterase values in patients with neurodegenerative diseases. | Development of a new PET method for the in vivo measurement of acetylcholine esterase activity at the cortical level to be used as an indicator of the presence of disease. | 4 years |
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy

Study Overview
=================
Brief Summary
-----------------
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D660 Monotherapy in Essential Hypertension Patients

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: D064, D702, placebo of D660
* Drug: D660, placebo of D064, placebo of D702


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are 19 years old or older. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF. Exclusion Criteria: Subjects with a history of secondary hypertension or suspected secondary hypertension Subjects with hypersensitivity or history of clinical trial drugs and similar drugs Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening Subjects who received other clinical trial drugs within 4 weeks of screening visit. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br> | Drug: D064, D702, placebo of D660<br>* Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660<br>* Other names: D064, D702 are consisted of antihypertensive agent.;|
| Experimental: Comparator Group<br> | Drug: D660, placebo of D064, placebo of D702<br>* Experimental Group Subjects assigned to this group are treated with D660, placebo of D064, placebo of D702<br>* Other names: D660 is consisted of antihypertensive agent.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSSBP |  | 8 weeks after drug administrations |
Vitamin D Status Among Infertile Women in Sweden

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective cohort study is to learn about the overall and seasonal prevalence of vitamin D insufficiency and its determinants in a population of women with infertility who will go through in vitro fertilization in Sweden. The main questions it aims to answer are: What is the prevalence of vitamin D insufficiency? What are the determinants of this insufficiency? Participants will be asked to complete a questionnaire validated for dietary assessment of vitamin D intake and sun exposure habits and they will leave a blood sample for measurement of 25(OH)D concentration. Researchers will compare the in vitro fertilization outcomes between women with vitamin D insufficiency and sufficiency to see if there is any difference.

Official Title
-----------------
Vitamin D Status, Its Determinants and IVF Outcomes Among Infertile Women in South-Western Sweden.

Conditions
-----------------
Infertility, Female, Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged 18-38 years, who will go through in vitro fertilization for infertility. Exclusion Criteria: women who will go through pre-implantation genetic testing women who will go through sperm- or oocyte donation treatment Fertility preservation cycles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of vitamin D insufficiency | Overall and seasonal prevalence of vitamin D insufficiency | September 2020 - August 2021 | 
| Determinants of vitamin D insufficiency | Determinants (dietary, sun exposure habits) of vitamin D insufficiency | September 2020 - August 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vitro fertilization outcomes | Pregnancy outcomes (biochemical pregnancy, clinical pregnancy, miscarriage, live birth) after in vitro fertilization between women with and without vitamin D insufficiency. | September 2020 - August 2021 |
5-Day Preoperative Radiation for Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.

Official Title
-----------------
Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Radiation: External Beam Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum. Has been offered preoperative radiation and surgery as part of standard-of-care treatment Age ≥ 18 KPS ≥ 70 or ECOG 0 to 2 Life expectancy ≥ 6 months If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented. Ability to understand and the willingness to personally sign the written IRB approved informed consent document. Exclusion Criteria: History of prior radiation to the area to be treated. Active use of other anti-cancer investigational agents. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery). Pregnancy.

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: External beam radiotherapy<br>Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily. | Radiation: External Beam Radiotherapy<br>* Radiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Complication Rate | Rate of post-operative complications. | 120 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Recurrence Rate | Rate of local recurrence, including in-field, borderline and out-field recurrences | 2 years and 5 years after surgical resection |
Assessment of Complications in Patients Who Underwent LPN According to the CCI

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the strength of the classical Clavien-Dindo classification system (CDC), which is a Likert scale analysis versus the comprehensive complication index (CCI), a new quantitative evaluation system, in patients undergoing laparoscopic partial nephrectomy (LPN).

Detailed Description
-----------------
Prospectively collected data of sixty-two patients undergoing LPN with postoperative complications from November 2009 to August 2020 were evaluated retrospectively. Postoperative complications were classified according to the CDCs and calculated using the CCI calculator (https://www.assessurgery.com) quantitatively. Major complications were determined as ≥ grade 3 complications according to the CDC. The complexity of the renal mass was defined according to the RENAL nephrometry score. The cut-off value for CCI was analyzed by the ROC analysis technique. The significance level was taken as p<0.05.

Official Title
-----------------
Which is Better to Assess Postoperative Complications in Patients Undergoing Laparoscopic Partial Nephrectomy?: Clavien-Dindo Classification Versus Comprehensive Complication Index.

Conditions
-----------------
Renal Cancer, Surgery-Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with complete data patients with consent Patients > 18 year-old The surgeries performed by the surgeon EO Exclusion Criteria: Missing data patients without consent patients who underwent open or retroperitoneoscopic laparoscopic partial nephrectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Postoperative complication | Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up | up to 3 months, postoperatively | 
| Opertaion time | From first trocar incision to closure of all incisions | during the surgery (minute) | 
| Estimeted blood loss | perioperative estimated blood loss | during the surgery (mL) | 
| warm ischemia time | Its starts when the renal artery and vein are controlled and it ends when reperfusion of the graft kidney starts on the back table | during the surgery (minute) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, partial nephrectomy, complication, CCI, urology
The Association Between the Intraoperative Blood Pressure Changes and Whole Exome Genome

Study Overview
=================
Brief Summary
-----------------
The intraoperative blood pressure changes have been important for postoperative morbidity and mortality. However, some patients did not occur intraoperative hypotension but some patients would have severe intraoperative hypotension. It may be associated with genome related. In this hypothesis, we aim to elucidate the association between the whole exome genome and intraoperaive blood pressure changes.

Detailed Description
-----------------
We aim to elucidate the association between the whole exome genome and intraoperative blood pressure changes. We will enroll patients older than 20 years old and undergo elective general anesthesia. Before anesthesia, we will obtain blood sample for whole exome genome test and give arterial line for intraoperative monitor. After completing surgery, we will follow the patients' all postoperative major organ function. We hope this study to be able to give us the more information about the specific genetic effect on the arterial stiffness and intraoperative blood pressure changes.

Official Title
-----------------
Association Between Whole Exon Sequencing and Arterial Stiffness in Patients With Intraoperative Hypotension)

Conditions
-----------------
the Association Between the Arterial Stiffness, Intraoperative Blood Pressure Changes and Genetic Effect

Intervention / Treatment
-----------------
* Other: this study did not involve interventions; it only observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective general surgery Exclusion Criteria: coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients undergoing general anesthesia<br>patients undergoing general anesthesia | Other: this study did not involve interventions; it only observational study<br>* this study did not involve interventions. This study is an observational study for elucidating the intraoperative blood pressure changes, artierial stiffness, and whole exome genome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between the arterial stiffness and whole exome genome | using pearson correlation to describe the association | 15 minutes |