linjc16/ctgov huggingface dataset:
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.

Official Title
-----------------
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers

Conditions
-----------------
Foot Ulcer, Diabetic

Intervention / Treatment
-----------------
* Device: Daily use of podimetrics smart-foot mat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female, 18 years or older Diagnosis of type 1 or type 2 Diabetes Mellitus, controlled or uncontrolled Ankle Brachial Index (ABI) >0.5 Patient with history of previous foot ulcer. Exclusion Criteria: Active Charcot foot disease One or more plantar foot ulcers (UT Grade 1A-C, 2A-C & 3A-C) Active Infection/Gangrene Active malignancy Immunosuppressive disease History of alcohol or drug abuse Pregnant women (verbal confirmation or confirmation obtained within current medical records) Cognitive deficit 2+ or great lower extremity edema End stage renal disease History of major lower extremity amputation (below knee or above knee amputation) Other issue that, at the discretion of the investigator, renders the subject ineligible for participation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant cohort<br>Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. | Device: Daily use of podimetrics smart-foot mat<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Plantar Diabetic Foot Ulcer |  | Through study completion or subject withdrawal (34 weeks per-protocol) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Adherence in Daily Use of the Study Device |  | Through study completion or subject withdrawal (34 weeks per-protocol) | 
| Device-related Trips/Falls |  | Through study completion or subject withdrawal (34 weeks per-protocol) | 
| Device-related Injuries |  | Through study completion or subject withdrawal (34 weeks per-protocol) |
Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

Study Overview
=================
Brief Summary
-----------------
To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients

Detailed Description
-----------------
To determine the revascularization rate, clinical efficacy and safety in a real-world setting of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Official Title
-----------------
Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Procedure: Mechanical thrombectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy Exclusion Criteria: Intracranial hemorrhage
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Group<br>Subjects in whom a MindFrame Device was employed for restoration of flow and clot removal | Procedure: Mechanical thrombectomy<br>* Mechanical thrombectomy using a MindFrame device<br>* Other names: Flow;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Efficacy | The ability of the MindFrame System to restore blood flow by removing thrombus and establishing final Thrombolysis in Cerebral Infarction (TICI) 2b or 3 perfusion | Immediate postprocedure | 
| Safety | The rate of device-related serious adverse events | 90 days postprocedure | 
| Clinical Efficacy | The rate of modified Rankin Scale (mRS) score 0-2 at 90 days | 90 days postprocedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Ischemic Stroke, Revascularization, Mechanical thrombectomy, Neurothrombectomy
B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)

Study Overview
=================
Brief Summary
-----------------
The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of AML Cell Vaccine given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.

Official Title
-----------------
A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant

Conditions
-----------------
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Biological: AML Cell Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse. Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor). Key Exclusion Criteria: Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12 21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD). Patients unsuitable for standard induction chemotherapy. Patients who have previously undergone or will be able to undergo allogeneic transplantation. Patients who have had previous or current treatment with any form of investigational immunotherapy.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AML Cell Vaccine<br> | Biological: AML Cell Vaccine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine-related toxicity based on the NCI criteria V4.0 |  | 52 weeks | 
| Frequency, severity of adverse events to the AML cell vaccine |  | 52 weeks |
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

Study Overview
=================
Brief Summary
-----------------
This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. The duration of the study for each patient will be approximately two years.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a 91-Day Extended-Cycle Combination Oral Contraceptive (Seasonale) for the Treatment of Low Bone Mineral Density in Adolescent Females With Secondary Amenorrhea and Osteopenia

Conditions
-----------------
Osteopenia

Intervention / Treatment
-----------------
* Drug: Seasonale (levonorgestrel and ethinyl estradiol)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not sexually active and agree to remain sexually inactive throughout the course of the study First menstrual period at least one year ago No menstrual period in the last 6 months Exclusion Criteria: Undiagnosed abnormal genital bleeding Known or suspected pregnancy Medical history of any disorder that contraindicates the use of oral contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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: Seasonale (levonorgestrel and ethinyl estradiol)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change in the lumbar spine bone mineral density at month 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interim and 24 month mean percent change in lumbar spine bone mineral density |  |  | 
| Mean percent change in the proximal femur (hip) bone mineral density |  |  | 
| Mean percent change in total body bone mineral density |  |  | 
| Mean change in biochemical markers of bone resorption and bone formation |  |  | 
| Change in body weight |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amenorrhea, osteopenia, bone mineral density, adolescents
The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.

Conditions
-----------------
Cryopreservation of Embryos

Intervention / Treatment
-----------------
* Other: cryopreservation technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (with female age < 40 years) Patients undergoing a 1st oocyte retrieval for an IVF/Intracytoplasmatic Sperm Injection (ICSI) treatment Patients planned for an embryo transfer on day 3. Patients with supernumerary embryos of sufficient quality for freezing/vitrifying on day 3. Fresh personal (own oocytes) One inclusion in the study per patient. Exclusion Criteria: Patients undergoing a 2nd or higher ranked oocyte retrieval after a fresh cycle with failed pregnancy. Female age ≥ 40 year Patients with Preimplantation Genetic Diagnosis (PGD) Patients with donor oocytes Patients with positive serology whose embryos may not be frozen. Patients planned for a transfer on day 2 or day 5. Patients receiving assisted hatching in the embryo transfer in the frozen cycles. Patients who have been included in the study before.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: cryopreservation technique<br>slow freezing cryopreservation technique | Other: cryopreservation technique<br> <br> |
| Active Comparator: vitrification cryopreservation technique<br>vitrification cryopreservation technique | Other: cryopreservation technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life birth rate per embryo thawed |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate per embryo transferred |  | 3 | 
| survival rate |  | 3 year | 
| implantation rate per embryo transferred |  | 3 years | 
| implantation rate per embryo thawed |  | 3 years | 
| abortion rate |  | 3 years |
Anatomical Classifications of Inferior Mesenteric Artery

Study Overview
=================
Brief Summary
-----------------
The vascular branches of inferior mesenteric artery (IMA) involve superior rectal artery(SRA),Sigmoid artery(SA) and the left colic artery(LCA). Different levels of ligation of the (IMA) are applied in rectal cancer surgery, including retain or not retain the left colic artery(LCA). Retained the LCA would facilitate the vascularity. The variations of vessels are more frequent in the combinations of branches, while LCA, SA and SRA may vary from people to people. Which contribute to the difficulty of surgery to retain the LCA.. As a result, a better understanding of the anatomical branches classification of IMA is a must during operation. However, existing studies of IMA's branches combination are very rare and often single-centered with minimal samples. In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of IMA and the surgical outcome of each type

Official Title
-----------------
Clinical Trial of Anatomical Classifications of Inferior Mesenteric Artery in Laparoscopic Rectal Resection Surgery

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergoing laparoscopic rectal cancer surgery. Pathology: adenocarcinoma or huge adenomas proven by colonoscopic biopsy. Localization: tumor located between distal sigmoid colon and anal canal. Patients have to be aware of the aim of the trial, and have signed the informed consent. Exclusion Criteria: History of any gastrointestinal surgery. Patients with emergent surgery.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| classifications vascular branches of IMA | based on the positon of LCA that conjoin the IMA | 3years |
Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.

Official Title
-----------------
Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

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

Intervention / Treatment
-----------------
* Radiation: radiation therapy
* Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified rectal carcinoma Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging) the distance from anal verge <= 12cm with or without metastasis Age 18-75 years old ECOG PS 0-2 No previous chemotherapy or radiotherapy for rectal carcinoma Written informed consent Exclusion Criteria: no histologically verified rectal carcinoma rectal cancer with stage I distance from verge >12cm age <=18 or >=75 years old performed previously chemotherapy or radiotherapy infection diseases within three months serious other diseases no written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| rectal cancer with stage II-IV<br>rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin | Radiation: radiation therapy<br>* 45-55Gy<br>Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)<br>* radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)<br>* Other names: Xeloda;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circulating tumor cells level changes after radiotherapy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 
| disease-free survival |  | 3 years | 
| serum carcinoembryonic antigen (CEA) level |  | 3 years | 
| pathological response (tumor regression grade)if surgery |  | 3 years | 
| RECIST-based tumor response at 10 week after radiotherapy |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, circulating tumor cells, predict responses
Design the Home Care Platform for the Monitoring of A Hemodialysis Arteriovenous Graft by Intelligent Physiological Signal

Study Overview
=================
Brief Summary
-----------------
Most patients with end-stage renal disease require hemodialysis. An arteriovenous fistula (AVF) or a prosthetic arteriovenous graft (AVG) is the preferred accesses for this. After its surgical creation, the fistular vein immediately faces a tremendous blood flow and the venous lumen is gradually dilated and the wall thickened, producing an access that can be routinely needled and deliver sufficient blood flow for dialysis. However, many hemodialysis patients will experience access stenosis, dysfunction, and even thrombosis, which are the most common complications of a hemodialysis access. Most physicians, in-charge nurses of the hemodialysis unit, patient, and/or the family use traditional stethoscope as a convenient method to evaluate the patency and function of a hemodialysis access before, during, and after each session of dialysis. The acoustic signal of an access is always affected by environmental noises, non-specific in nature, and the sensitivity to detect stenosis is very low. With the development and use of electronic stethoscope, the proprietary ambient noise acoustically cancels out an average of 75% of distracting room noise, greatly enhancing overall utility. However, the output acoustic signals are still apprehended by the ear, which is the main source of bias and errors of detection. Our study purpose is to apply the signal processing technology to transfer the acoustic signals into simple visual signals that provide an easy way to read. It can be used by a professional medical staff, a non-professional person responsible for taking care, or even the patient himself, disability or not, as an early screening detector of stenosis or dysfunction of a hemodialysis access.

Conditions
-----------------
Renal Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prosthetic grafts with clinical signs of dysfunctions or malfunctions and were referred for angiographic evaluations. Exclusion Criteria: autologous arteriovenous accesses or known thrombosed accesses.

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 |
| --- | --- | --- |