linjc16/ctgov huggingface dataset:
Platelet-derived Factors for Treatment of Muscular Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.

Official Title
-----------------
Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial

Conditions
-----------------
Muscle Lesions

Intervention / Treatment
-----------------
* Biological: platelet-derived repairing factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old if woman, no pregnancy ongoing muscular lesion grade 2 or 3 in a lower limb muscular group Exclusion Criteria: no hematological conditions no anticoagulation in the two preceding 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-derived repairing factors<br> | Biological: platelet-derived repairing factors<br>* autologous platelet lysate injection within 24 hours from lesion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury. | If the athlete is able, 21 days after the muscular injury, to return to (at least) training activities, the outcome will be coded successful; and unsuccessful otherwise | 21 days from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-return to sport activities |  | within 4 months from lesion | 
| Side effects | Overall frequency of patients with any adverse events (number, proportion and 95%CI) | within 4 months from treatment | 
| time-to-healing at ultrasound |  | within 4 months from treatment | 
| side effects | types of side effects (number, proportion and 95%CI for each type of adverse events) | within 4 months from treatment | 
| side effects | grade of side effects (number, proportion and 95%CI for each grade of adverse events) | within 4 months from treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscular lesions grade 2, muscular lesions grade 3
MAGZEN® Effect on Recent Anxiety Reaction

Study Overview
=================
Brief Summary
-----------------
Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the treatment of recent anxiety reaction.

Detailed Description
-----------------
107 patients suffering from recent anxiety reaction will be included in the study. They will be treated by MAGZEN® during 4 weeks and we will study the effect of this treatment on the evolution of their anxiety after the cure.

Official Title
-----------------
MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Other: Hamilton-anxiety scale (HAM-A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient suffering from recent anxiety reaction Hamilton-anxiety score ≥ 20 at inclusion recent anxiety disorders (less than 3 months) not treated by pharmacological or psychological treatment Exclusion Criteria: major depressive syndrome anxiety disorders more than 3 months anxiety due to death

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| MAGZEN®<br>All patient will be treated with MAGZEN® and will be evaluated with the Hamilton-anxiety scale (HAM-A) | Other: Hamilton-anxiety scale (HAM-A)<br>* Evolution of anxiety disorders is evaluated by the Hamilton-anxiety scale (HAM-A)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of responders patients | number (%) of responders patients with a diminution of the HAM-A score ≥ 50 % | 4 weeks |
Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output

Study Overview
=================
Brief Summary
-----------------
The perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control. Several questions on phenylephrine global and regional hemodynamics effects remain unresolved. The investigators assume that Phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. The investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler. The aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.

Official Title
-----------------
Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output

Conditions
-----------------
Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypotension (SBP <90 mm Hg and / or MAP <60 mm Hg) Injection of a bolus of phenylephrine at the discretion of the anesthesiologist physician in charge of the patient. Exclusion Criteria: Minor or major patient under guardianship Esophageal Diseases supra ventricular rhythm trouble Severe valvular Shunt intracardiac Vt <7ml/kg theoretical weight heart rate / respiratory rate <3.6 Clinical hypepression of intra-abdominal Compliance <30 mL/cmH2O pulmonary hypertension, Right ventricular failure Spontaneous Ventilation Thorax open VG severe dysfunction (LVEF <40%) Prior Injection of ephedrine prior

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 |
| --- | --- | --- |
| cardiac output | Comparing cardiac output values before and after injection of a phenylephrine bolus, based on the existence of a preload dependency, defined by a measure of respiratory variation of pulse pressure greater than or equal to 13%. | one year |
Surgical Treatment of Hepatic Hydatidosis in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. The investigators analyzed the postoperative morbidity and mortality rates of elderly patients who underwent surgery at our unit.

Detailed Description
-----------------
Retrospective observational study from prospective database focused on liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit. The study period spanned from January 2006 to October 2020. The study was approved by the Research Ethics Committee of our hospital. An informed consent from the patient was not required since the study was retrospective and observational, and entailed no risk. Seventy years of age was the cutoff age to consider patients as elderly. Inclusion criteria of patients: liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, and LHC treated by total or partial pericystectomy. Exclusion criteria of patients: emergency surgery and simple drainage of cyst.

Official Title
-----------------
Surgical Treatment of Hepatic Hydatidosis in Elderly Patients

Conditions
-----------------
Cystic Echinococcosis

Intervention / Treatment
-----------------
* Other: Surgical remove


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver hydatid cyst (LHC) pathological diagnosis after surgery LHC treated by total or partial pericystectomy Exclusion Criteria: emergency surgery and simple drainage of cyst

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 |
| --- | --- |
| Young group<br>patients < 70 years of age | Other: Surgical remove<br>* liver hydatid cyst (LHC) treated by total or partial pericystectomy<br>|
| Elderly<br>Patients ≥ 70 years of age) | Other: Surgical remove<br>* liver hydatid cyst (LHC) treated by total or partial pericystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Patients with postoperative morbidity according to the Clavien-Dindo score 19, severe complication (Clavien-Dindo ≥ IIIa) and postoperative mortality | 90 days |
Comparison of Propioceptive Neuromuscular Facilitation Vs Balance Exercise Along With Conventional Therapy for Balance and Gait in Chronic Parkinson's Patient

Study Overview
=================
Brief Summary
-----------------
To determine the effect of Proprioceptive Neuromuscular Facilitation Vs Balance Exercise along with Conventional Therapy for balance and gait in Chronic Parkinson's patients.

Official Title
-----------------
Comparison of Propioceptive Neuromuscular Facilitation Vs Balance Exercise Along With Conventional Therapy for Balance and Gait in Chronic Parkinson's Patient

Conditions
-----------------
Parkinson

Intervention / Treatment
-----------------
* Diagnostic Test: Propioceptive Neuromuscular Facilitation
* Diagnostic Test: Balance Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Parkinson's patients.(34) Patients from both gender around the age of 45-65.(35) Patient with a score of 42 above on the Berg Balance Scale.(29) Patient with good cognitive function minimum score of 20 or more on Mini-mental Status Examination Scale (MMSE).(36) Exclusion Criteria: Patients with a history of recurrent stroke.(37) Patient with peripheral vascular disease.(38) Patient with fracture or dislocation of lower limb.(39) Patient with peripheral nerve injury.(40) Patient with skin discoloration, skin ulcers, and skin allergy.(41)

Ages Eligible for Study
-----------------
Minimum Age: 42 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propioceptive Neuromuscular Facilitation<br>Propioceptive Neuromuscular Facilitation With Conventional Therapy for Balance and Gait | Diagnostic Test: Propioceptive Neuromuscular Facilitation<br>* Propioceptive Neuromuscular Facilitation With Conventional Therapy for Balance and Gait<br>|
| Experimental: Balance Exercise<br>Balance Exercise Along With Conventional Therapy for Balance and Gait | Diagnostic Test: Balance Exercise<br>* Balance Exercise Along With Conventional Therapy for Balance and Gait<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance Exercise Along With Conventional Therapy | 30 participants in Balance Exercise with routine Physical therapy for 45 minutes on lower limb. The interventions will be performed by a trained physiotherapist. Berg Balance Scale, Functional Gait Assessment Tool | 6 Months | 
| Propioceptive Neuromuscular Facilitation | 30 participants in Proprioceptive Neuromuscular Facilitation with routine Physical Therapy for 45 minutes on lower limb. Minimental Status Examination Tool. | 6 Months |
Growth and Tolerance of Young Infants Fed Infant Formulas

Study Overview
=================
Brief Summary
-----------------
This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.

Official Title
-----------------
Growth and Tolerance of Young Infants Fed Infant Formulas

Conditions
-----------------
Infant Newborn

Intervention / Treatment
-----------------
* Other: experimental infant formula with alternate protein source
* Other: Infant formula powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy infant full term birth weight > 2490 g 0 to 8 days of age parent/physician agree to not use medications affecting tolerance/growth parent agrees to sole source feeding of study formula parent agrees to not use vitamin/mineral supplements parent has signed consent/HIPAA authorization Exclusion Criteria: any maternal, fetal, or infant history affecting growth and tolerance participation in any other study not preapproved by Abbott

Ages Eligible for Study
-----------------
Maximum Age: 8 Days

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant formula, alternate protein source<br>Experimental infant formula with alternate protein source | Other: experimental infant formula with alternate protein source<br>* experimental infant formula to be fed ad libitum<br>|
| Active Comparator: Infant formula powder<br>Infant formula powder | Other: Infant formula powder<br>* powdered infant formula to be fed ad libitum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 119 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal tolerance | Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit | 119 days | 
| Anthropometric variables | Length gain per day and head circumference gain per day | 119 days |
Treatment Response Prediction System of mCRC Patients Based on CTC

Study Overview
=================
Brief Summary
-----------------
This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.

Official Title
-----------------
Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells

Conditions
-----------------
Colorectal Cancer Stage IV, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Diagnostic Test: Circulating tumor cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years; histologically proven colorectal liver metastasis With liver-dominant disease (extrahepatic metastases limited to lung metastases) ECOG 0-1 A life expectancy of ≥ 3 months Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl Written informed consent for participation in the trial. Exclusion Criteria: Other previous malignancy within 5 years Have metastases other than liver and lung metastases Receiving any treatment before first blood collection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training Group<br>The training cohort that used to built the response prediction model | Diagnostic Test: Circulating tumor cell<br>* Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)<br>|
| Validation Group<br>The validation cohort that used to validate the response prediction model | Diagnostic Test: Circulating tumor cell<br>* Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The sensitivity of the response prediction model | 1 year | 
| Specificity | The specificity of the response prediction model | 1 year |
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational research study is to follow participants who have been treated with either bel-sar or received alternate treatment (sham, standard of care therapy, etc.) while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care. Additionally, the registry will collect all adverse events, information about pregnancy and symptomatic overdose.

Detailed Description
-----------------
This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma. The Registry will initially be open to subjects who have previously participated in an Aura Biosciences bel-sar sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions. All subjects will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first. No interventions will be required as part of the Registry. Data collection will be based on IL or CM information anticipated to be available based on the standard of care for subjects with CM or IL.

Official Title
-----------------
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Conditions
-----------------
Choroidal Melanoma, Indeterminate Lesions of Eye

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial. Have received AU-011 bel-sar or assigned to a different cohort or treatment arm (sham, SoC, etc.) an observation cohort in a previous Aura sponsored clinical trial. Exclusion Criteria: - None

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 |
| --- | --- |
| Subjects previously participated in an Aura Biosciences bel-sar study<br>Subjects with Choroidal Melanoma or Indeterminate Lesions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar, sham, SoC or alternative treatment. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Choroidal Melanoma, Indeterminate Lesions of Eye
Setting up a Warehouse of Physiological Data and Biomedical Signals in Adult Intensive Care

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the establishment of a warehouse physiological data and biomedical signal in intensive care adult patients in acute situations from particular records from the Philips Intellivue MP70 monitor.

Detailed Description
-----------------
Cardiopulmonary failures are major public health concerns, due to the aging population. Each of these situations is burdened with a poor prognosis in the medium term and a source of prolonged hospitalizations, generating significant health costs. Early detection and prediction of organ failure could reduce health costs and risks for the patient, offering a reaction early and appropriate medical technology. The proposed approach aims to optimize the knowledge of a complex physiological domain and multi-system, while promoting the automatic transfer of knowledge. The approach proposed data-mining and development of algorithms for detecting and / or predicting a strong potential for disruption because it proposes to apply innovative automated analysis procedures to a fragile patient population, and then a transfer to the medical device industry. From communicating tools of recording of the signals, the investigator envisage in a global way: the constitution of a warehouse of physiological data of grown-up patients in acute situation (intensive care unit); the development by data mining of a system of detection of organs failures or adverse events basing itself on the application of innovative algorithms, allowing the decision-making operational, from the fusion of arisen ill-assorted events; the use of intelligent tools of auto-learning and elaboration of complex multimodal models for purposes of prediction of events;

Official Title
-----------------
Setting up a Warehouse of Physiological Data and Biomedical Signals in Adult Intensive Care

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient admitted in Brest University Hospital's intensive care unit for monitoring of vital failure Exclusion Criteria: Refusal to participate

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 |
| --- | --- | --- |
| Number of participants with physiological signal abnormality | Whereas this is a data mining process (non-deterministic approach), no description can be provided | from two to twenty-four hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
data warehousing, data aggregation, data mining