linjc16/ctgov huggingface dataset:
Cryoplasty CLIMB-registry

Study Overview
=================
Brief Summary
-----------------
In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly according the Instructions For Use of the CE-approved device (PolarCath Peripheral Dilatation System, Boston Scientific) and only data are collected that have been made available conform the Standard the Standards of Care for these patients.

Official Title
-----------------
CLIMB Prospective Multicenter Registry Evaluating the Use of the PolarCath Peripheral Dilatation System (Boston Scientific) in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia (Rutherford 4 and 5).

Conditions
-----------------
Critical Limb Ischemia, Peripheral Arterial Occlusive Disease

Intervention / Treatment
-----------------
* Device: PolarCath Peripheral Dilatation System (Boston Scientific)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic CLI male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. If patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the PolarCath Peripheral Dilatation System (Boston Scientific) and analysed for registry purposes. Patients will be considered eligible for inclusion into the registry if satisfying the product DFU specifications.
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 |
| --- |
|Device: PolarCath Peripheral Dilatation System (Boston Scientific)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical patency |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | procedure | 
| angiographic outcomes for the subgroup of patients in which made available. |  | 12 months | 
| Primary patency rate |  | 12 months | 
| Limb-salvage rate |  | 12 months | 
| Serious adverse events |  | 12 months | 
| Clinical success (improvement of Rutherford classification) |  | 12 months | 
| Health Economics assessment |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLI, Critical Limb Ischemia, Infrapopliteal, Cryoplasty
Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.

Detailed Description
-----------------
Previous studies have shown the feasibility of detecting mutation status by circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no clinical standard method has been established, and most previous studies were lack of prospective clinical data and aimed at advanced NSCLC. We plan to perform a prospective study including consecutive cases of NSCLC patients who underwent surgical treatments. Primary tumor and plasma samples were collected in each patients and gene mutation analysis were performed immediately after surgery. We utilized the targeted DNA sequencing with a next-generation sequencing (NGS) platform to detect driver somatic mutations in matched tumor DNA (tDNA) and plasma ctDNA samples with matched white blood cell (WBC) DNA as a control. A panel of genes were identified.

Official Title
-----------------
A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who is confirmed primary lung cancer by frozen pathologic histology Both the fresh tissue tumor and plasma samples are collected for analysis Exclusion Criteria: Patients who received any treatment prior to resection Patients who have a history of malignancy Paraffin embedded section confirmed small cell lung cancer or unclassified carcinoma Tumor specimens where insufficient DNA

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample |  | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer |  | 2-3months | 
| Correlation of ctDNA concentration with clinical features |  | 2-3months | 
| Comparison of positive predictive value between ctDNA and tumor markers |  | 2-3months | 
| The relationship between ctDNA concentration and disease free survival(DFS） |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating Tumor DNA, Lung cancer, Targeted sequencing
Single Versus Double Dose Intra-vaginal Prostaglandin E2 Misoprostol Prior Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 Misoprostol, 400 microgram during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.

Official Title
-----------------
Single Versus Double Dose Intra-vaginal Prostaglandin E2 Misoprostol Prior Abdominal Myomectomy: A Randomized Controlled Study

Conditions
-----------------
Prostaglandin E2 Misoprostol Prior Abdominal Myomectomy

Intervention / Treatment
-----------------
* Drug: 2 doses 400 microgram misoprostol
* Drug: single dose misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion) Exclusion Criteria: hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index >30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: double dose misoprostol<br>2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). | Drug: 2 doses 400 microgram misoprostol<br>* 2 doses 400 microgram misoprostol, 3 and 1 hours<br>|
| Active Comparator: single dose Misoprostol<br>intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) | Drug: single dose misoprostol<br>* 1 dose, 1 hours, prior surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the operative time | The time from start till end of surgery | from skin to skin in minutes | 
| intra and post-operative blood loss | collected soaked towels and sucked blood | during and 6 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myomectomy, Misoprostol
Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint

Study Overview
=================
Brief Summary
-----------------
Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon. Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use. There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.

Official Title
-----------------
Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint

Conditions
-----------------
Arthritis, Septic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021 clinical finding of persistent synovitis, defined by the presence of pain, effusion or joint stiffness despite well-conducted treatment having had a diagnosis of joint infection proven by a positive culture of the joint fluid to a pathogenic germ having had treatment with local or systemic corticosteroids. Exclusion criteria: Patient who has expressed his opposition to the reuse of his data for scientific research purposes. Absence of corticosteroid treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Complete regression of the pain in a fast way |  | 6 months after treatment with corticosteroids | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Septic, synovitis, Corticosteroid therapy, Inflammatory response, Native joint
Simvastatin for Treating Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.

Official Title
-----------------
The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial

Conditions
-----------------
Erectile Dysfunction, Vascular Disease Detected, C Reactive Protein

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile dysfunction Elevated C reactive protein Able to adhere the protocol Exclusion Criteria: Diabetes mellitus Cardiac disease Cerebral vascular disease Hypogonadism Any contraindication to simvastatin

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: Placebo<br> <br> |
| Experimental: Simvastatin<br>Treatment arm. | Drug: Simvastatin<br>* simvastatin 20 daily for six months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile erection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simvastatin, endothelial dysfunction, erectile dysfunction
Exercise and Neural Response to Food Cues in Children

Study Overview
=================
Brief Summary
-----------------
Physical exercise has been shown to significantly reduce subsequent energy intake in obese adolescents but not in lean, without altering their appetite feelings. Although previous studies have pointed out the role of gastric peptides in this post exercise nutritional response, some recent work question the role of the neural system in the post exercise drive to eat. This study tends to explore whether or not an acute bout of exercise can affect the neural response to food cues in adolescents, obese or lean.

Detailed Description
-----------------
After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities. They will have then to enter the laboratory on 2 different occasions in a randomized order from 8am to 330pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) a cycling exercise or 2) remaining sitting fpr one hour. after the one hour sitting station or the exercise bout, they will be asked to complete a computer task while and electroencephalogram will be recorded. This computer task consists in visual recognition of rare pictures compared to frequent ones (oddball method). at 1215 they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales. Ad libitum energy consumption will be assessed by investigators and recorded for each participants.

Official Title
-----------------
Effect of Exercise on the Neural Response to Food Cues and Energy Intake in Lean and Obese Adolescents

Conditions
-----------------
Exercise Condition (EX), Control Session (CON)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 12-15 years old BMI defining obesity (Cole et al., 2000) Not being under diet restriction Information and consent forms have to be signed by the adolescent and his legal representative being registered to the national social security system Exclusion Criteria: Being under medication contraindication to exercise smokers dieting

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lean adolescents<br> | |
| Obese adolescents<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural response to food cues | The electroencephalogram signals amplitude in response to visual food cues will be the primary outcome, after the exercise (during the exercise condition) and after the sitting position (during the control session) | up to 2 months |
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding

Conditions
-----------------
Non-variceal Upper Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Drug: Surgicel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy Patients with active bleeding (Forrest classification Ia or Ib or IIa) Exclusion Criteria: Patients with upper gastrointestinal tract malignancy Patients with acute severe illness Coagulopathy: liver cirrhosis, thrombocytopenia Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgicel add therapy<br> | Drug: Surgicel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate at the second look endoscopy |  | 2 year |
Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the percentage of patients with depression who are treated with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®) who are Poor Metabolizers (based on the levels of the drug in the blood) at 2D6 (a system in the liver that breaks down some medications and other chemicals).

Official Title
-----------------
An Open-Label Study To Evaluate The Prevalence Of Phenotypic Poor Metabolizers At CYP2D6 Among Venlafaxine-Treated Outpatients With Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women subjects aged 18 years or older. Current outpatient treatment with extended-release venlafaxine HCl (U.S. marketed brand Effexor XR®), within the US Food and Drug Administration (FDA)-approved dosage range for depression (37.5 mg/day to 225 mg/day), for 8 weeks or less. Ability to have a blood draw within 4 to 12 hours of the most recent dose of Effexor XR®. Exclusion Criteria: Determination by the investigator that a blood draw is contraindicated. Participation in an investigational study within the past 30 days where the study medication is not known. Previous treatment with Effexor XR® or extended-release venlafaxine HCl (generic) in the 6 months prior to current treatment regimen. Treatment with DVS SR within the last 30 days.

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Procedure: blood draw<br>* Test Article was not provided to subjects for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood) |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers. |  | 1 day |
Cone Beam CT Scanning in Lung and Bladder Cancer.

Study Overview
=================
Brief Summary
-----------------
To study changes in tumor and normal organ size and/or position which occur during a course of radiation treatments.

Official Title
-----------------
Improving the Accuracy of Radiotherapy Planning and Delivery Using Kilovoltage Cone Beam CT Imaging

Conditions
-----------------
Lung Neoplasm, Small Cell Carcinoma, Bladder Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has biopsy proven limited stage SCLC receiving radical concurrent chemoradiotherapy no prior chest RT no prior surgical resection of lung tumor no prior chemotherapy patients' lung tumors should be centrally-located to minimize the effect of respiratory motion patient has biopsy proven TCC bladder receiving radical concurrent chemoradiotherapy or RT alone no prior chemotherapy patient signs study-specific consent form Exclusion Criteria: mixed small cell and non small cell histology patient not being treated with concurrent chemoradiotherapy chemoradiotherapy given sequentially previous chest RT previous chemotherapy prior surgical resection of lung mass patient ineligible for pelvic RT patient does not sign study 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?
-----------------
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
-----------------
small cell lung cancer, bladder cancer, conformal radiotherapy
LIVInG With chrONic Cancer TrEatments (LONGEVITI) Study

Study Overview
=================
Brief Summary
-----------------
People with advanced chronic cancers are now living for many years as a result of new targeted anti-cancer treatments. Many of these treatments are quite new and people may take them for months, even years, as long as the treatments are helping. The purpose of this study is to help understand how to best support people receiving these treatments.

Official Title
-----------------
LIVInG With chrONic Cancer TrEatments (LONGEVITI) Study

Conditions
-----------------
Cancer, Tyrosine Kinase Mutation, Breast Cancer, Melanoma, Multiple Myeloma, Chronic Leukemia, Prostate Cancer, Ovarian Cancer, Colorectal Cancer, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: taking chronic targeted anti-cancer agents - Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview | Single interview to learn the experiences of people and their caregivers living with incurable cancer | Day 1 |