linjc16/ctgov huggingface dataset:
Alliance With Therapeutic Entourage in Support of Young Suicidal

Study Overview
=================
Brief Summary
-----------------
Regardless of age, the quality of hospital care, the confidence that the young can have in the health care team, joining parents are pivotal elements and influence followed. Family support is all the more important as 14% of young people realize a new suicidal act within three months of hospitalization for attempted suicide, and that the essential predictors appear to be the young age and quality of intra-family relationships. The main objective of this study is to determine, through the construction of an instrument to quantify the therapeutic alliance, defined by the characteristics of the mobilization of the entourage and the mutual commitments in the care of nursing teams and the entourage, the role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether primosuicidants or repeat offenders, on short and medium term recurrences and early mortality.

Conditions
-----------------
Suicide

Intervention / Treatment
-----------------
* Other: Therapeutic alliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 13-40 years From male or female Supported the waning of a suicidal gesture. speaking and writing fluent French living in Upper or Lower Normandy signed informed consent form, and at least one of his parents after oral and written information about the study for minors. Exclusion Criteria: Age <13 years or > 40 years Do not live in the Upper and Lower Normandy regions Detained patient forced hospitalization Patient under guardianship Patient with severe somatic pathology (cancer, heart failure, kidney or respiratory, central neurological disorder), scalable, or likely to be life-threatening within a period of less than one year Refusal to participate in the study Inability to respond

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Therapetic alliance<br> | Other: Therapeutic alliance<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characteristics of the mobilization of the entourage evaluated with Family Assessment Device |  | baseline |
Hemostatic Activity Following LAAO

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).

Detailed Description
-----------------
This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.

Official Title
-----------------
Hemostatic Activity Following Left Atrial Appendage Occlusion

Conditions
-----------------
Stroke, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Left Atrial Appendage Occlusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Atrial fibrillation (paroxysmal, persistent, or permanent) Admitted and eligible for LAAO Signed written consent Exclusion Criteria: Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease) Platelet count < 75 x 109/ml

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 |
| --- |
|Device: Left Atrial Appendage Occlusion|Interventional left atrial appendage occlusion with the Amulet or Watchman device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coagulation activity | Coagulation activity as measured by prothrombin fragment 1+2 | 7 days, 14 days, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet activity | Incl. platelet count, turnover, and aggregation | 7 days, 14 days, 90 days | 
| Additional measures of changes in coagulation and contact activation | Incl. thrombin generation, fibrinogen, d-dimer and coagulation factors | 7 days, 14 days, 90 days | 
| Change in endothelial activation and response | Incl. changes in soluble thrombomodulin, syndecan-1, selectin and von Willebrand factor | 7 days, 14 days, 90 days | 
| Non-procedural bleeding events | As defined by the Bleeding Academic Research Consortium | 7 days, 14 days, 90 days | 
| Radiographical evidence of device endothelization | On CT indicated by no contrast patency distal to the LAAO device. | 7 days, 14 days, 90 days | 
| Radiographically confirmed device-related thrombosis | Defined as high grade HAT on follow-up cardiac CT or TEE | 7 days, 14 days, 90 days |
Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler® (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children, adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Easyhaler type A
* Device: Easyhaler type B
* Device: Diskus inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent (IC) obtained Documented diagnosis of asthma and/or COPD Age: 4 years and above Exclusion Criteria: Any severe chronic respiratory disease other than asthma or COPD Acute respiratory infection Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Easyhaler type A<br> | Device: Easyhaler type A<br>* Easyhaler type A inhaler, 3 consecutive inhalations<br>* Other names: SF EH (D94-2SF);|
| Other: Easyhaler type B<br> | Device: Easyhaler type B<br>* Easyhaler type B inhaler, 3 consecutive inhalations<br>* Other names: SF EH (D94-2SF-B);|
| Other: Diskus inhaler<br> | Device: Diskus inhaler<br>* Diskus inhaler, 3 consecutive inhalations<br>* Other names: Inhaler for Seretide Diskus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The inspiratory volume through the placebo Easyhaler and Diskus inhalers will be measured at the same time with the peak inspiratory flow rate |  | 1 day |
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Official Title
-----------------
Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

Conditions
-----------------
Parenteral Nutrition Associated Cholestasis

Intervention / Treatment
-----------------
* Drug: Omegaven


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cholestasis defined as either serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis Exclusion Criteria: Age > 1y at time that omegaven is started Not expected to survive at least 30 days Fish allergy in a first degree relative Hemodynamic instability Coagulopathy Not likely to require PN for > 30d Not expected to survive > 30d

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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: Omeagven<br> | Drug: Omegaven<br>* 1 g/kg/d iv infusion over 24h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) |  | approximately for 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Transaminases |  | approximately for 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholestasis, PNAC, Parenteral Nutrition Associated Cholestasis, PNALD, Parenteral Nutrition Associated Liver Disease
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.

Official Title
-----------------
The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

Conditions
-----------------
Peripheral Arterial Occlusion or Emboli

Intervention / Treatment
-----------------
* Device: Mechanical Thrombectomy by the Indigo System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment. Treatment with components of the Penumbra and/or Indigo System. Exclusion Criteria: Participation in another clinical investigation that may confound the results of the study.
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: Mechanical thrombectomy by the Indigo System<br> | Device: Mechanical Thrombectomy by the Indigo System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores | Proportion of patients with a post-procedure TIMI score of 2 to 3. | Immediate post-procedure | 
| Procedural Serious Adverse Events |  | During the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral arterial occlusion, visceral emboli, limb ischemia, adverse events, Indigo System, aspiration, mechanical thrombectomy
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal of their tumor. The study will also look at the safety of paricalcitol prior to surgery.

Official Title
-----------------
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Paricalcitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration. Age greater than or equal to 18 years Medically fit for surgery in the opinion of the treating surgeon Ability to provide written informed consent Exclusion Criteria: - Patients who are currently pregnant, planning to become pregnant, or breast-feeding. Note: women of childbearing potential must agree to use a medically accepted form of birth control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility [tubal ligation or a partner that has undergone a vasectomy], or oral contraceptives). OR must agree to completely abstain from intercourse for two weeks before beginning study treatment, during participation in this study, and for 2 weeks after the final study treatment Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol. Serum creatinine > 2.5 x ULN OR GFR <30 mL/min by Cockroft-Gault formula . Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Arm A: 50mcg IV weekly | Drug: Paricalcitol<br>* Product: Paricalcitol Dose/Route/Regimen: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily<br>|
| Experimental: Arm B<br>Arm B: 12mcg PO daily | Drug: Paricalcitol<br>* Product: Paricalcitol Dose/Route/Regimen: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 18 months |
Integrated Whole-Genome Analysis of Hematologic Disorders

Study Overview
=================
Brief Summary
-----------------
We will use new technologies to look at the DNA, RNA, proteins, and metabolites in the disease-containing blood, bone marrow, or tissue and normal cells from the skin. Our goal is to analyze all of the genes in the diseased and normal skin sample. By comparing the results of the diseased sample and normal skin cells and the results of the two types of genetic information (DNA and RNA), we should be able to identify genetic changes that are important for the initiation, progression, or treatment response of that particular disorder.

Official Title
-----------------
Integrated Whole-Genome Analysis of Hematologic Disorders Using High-Throughput Sequencing and Array Technologies

Conditions
-----------------
Hematologic Diseases

Intervention / Treatment
-----------------
* Procedure: Blood Draw
* Procedure: Skin Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Patient meets the clinical and/or pathologic criteria for the hematologic disorder being examined. Patient is willing to provide a skin biopsy and five 10 mL tubes of peripheral blood. Exclusion Criteria: Less than 18 years of age Patient is not willing to provide a skin biopsy and five 10 mL tubes of peripheral blood.

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

| Intervention/Treatment |
| --- |
|Procedure: Blood Draw|nan|
|Procedure: Skin Biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression |  | sample collection at time of routine visit |
Emergency Capsule Endoscopy in Severe GI-bleeding

Study Overview
=================
Brief Summary
-----------------
Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.

Official Title
-----------------
Emergency Capsule Endoscopy in Severe GI-bleeding

Conditions
-----------------
GI-bleeding

Intervention / Treatment
-----------------
* Device: capsule endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with signs of severe GI-bleeding (with melena or dark bloody stool) and hemodynamic instability (defined as (pre)collapse or MAP < 80 mmHg or HR > 110) and/or drop of hemoglobin > 2g/dl/d and/or need of transfusion of minimum of 2 packed red cells Exclusion Criteria: missing consent form, pregnancy, origin of bleeding found in upper GI-endoscopy (e.g. blood in the stomach, ulcer, varices with signs of bleeding, mallory-weiss-tear, Angiodysplasia (with signs of bleeding), refluxesophagitis LA C or D) fresh bloody stool, known stenosis of the bowel, known site of bleeding, known inflammatory bowel disease

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: capsule endoscopy<br> | Device: capsule endoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures. |  | after complete recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of mid-GI-bleeding in all patients |  |  | 
| diagnostic yield |  | after complete recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GI-bleeding, capsule endoscopy
A Clinical Trial About Treatment of Mild to Moderate Persistent Alergic Rhinnitis With Test or Reference Mometasone (PUMA)

Study Overview
=================
Brief Summary
-----------------
The primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers.

Official Title
-----------------
A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis With Eurofarma Mometasone or Reference Mometasone.

Conditions
-----------------
Mild to Moderate Persistent Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Mometasone furoate
* Drug: Mometasone furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign and date the informed consent form or, in case of subjects younger than 18 years, the document must also be signed by a legal guardian; ≥ 12 years old; Suffer from mild to moderated persistent alergic rhinitis; Total NIS scale score ≥ 4 points at the screening visit and within at least 4 of the 7 days before the randomization visit; Indication for use nasal corticosteroid; Present with alergic rhinitis symptoms for at least 2 years; May undergo a washout period of at least 2 weeks Exclusion Criteria: Patients with severe alergic rhinitis; Patients with severe co-morbidities (at the investigator's criteria); Patients with mild to severe persistent asthma; Clinical history of infection of the airways 30 days before the study entry; Patients with structural changes causing nasal obstruction, such as pronounced nasal septum deviation, nasal polyps or any other type of nasal malformation; For female subjects, be pregnant or breastfeeding or planning to become pregnant or unwilling to use safe birth control methods during the study; subjects in need of other drugs to treat alergic rhinitis, such as anti-immunoglobulin E, immunotherapy, anti-leukotrienes, oral corticosteroids, inhalant corticosteroids, or any administration route other than cutaneous; Active smokers (use of cigarette, pipe, cigar or any other form of tobacco in any amount within the past 3 months before the study entry); Participation in another clinical study within the past 12 months;

Ages Eligible for Study
-----------------
Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone<br> | Drug: Mometasone furoate<br> <br> |
| Active Comparator: Nasonex®<br> | Drug: Mometasone furoate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing |  | 04 weeks |