linjc16/ctgov huggingface dataset:
ATG-F VS ATG for the Prevention of GVHD

Study Overview
=================
Brief Summary
-----------------
Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.

Official Title
-----------------
Comparing ATG-Fresenius vs Thymoglobulin for the Prevention of Graft-versus-host Disease in the Setting of Haplo-identical Hematopoietic Stem Cell Transplantation

Conditions
-----------------
GVHD in the Setting of Haplo-HSCT

Intervention / Treatment
-----------------
* Drug: Immunosuppressive Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged <65 years Patients undergoing Haplo-identical hematopoietic stem cell transplantation. Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females. Any co-morbidity precluding the administration of ATG or ATG-F.

Ages Eligible for Study
-----------------
Maximum Age: 65 Years

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

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: Arm 1<br>ATG-F treated | Drug: Immunosuppressive Agent<br>* ATG-Fresenius versus ATG<br>|
| Active Comparator: Arm 2<br>ATG treated | Drug: Immunosuppressive Agent<br>* ATG-Fresenius versus ATG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of GVHD |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leukemia-free survival |  | 1 year | 
| treatment-related mortality |  | 1 year |
Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the efficacy and safety of matrifen in patients with severe and chronic pain who can only be sufficiently treated with opioid analgesics (WHO class 3).

Official Title
-----------------
Matrifen for Therapy of Severe, Chronic Pain.

Conditions
-----------------
Severe, Chronic Pain

Intervention / Treatment
-----------------
* Drug: Matrifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: Patients with severe, chronic pain Main exclusion criteria: Hypersensitivity of fentanyl Co-administration of monoaminooxidase-inhibitors Pregnancy Respiratory depression Chronic obstructive pulmonary disease (COPD) Drug abuse Impairment of CNS functions Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

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 |
| --- | --- |
| Matrix II<br> | Drug: Matrifen<br>* as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.2)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success, efficacy of Matrifen |  | within 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of fentanyl and the transdermal system, quality of life |  | within 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, fentanyl, transdermal patch
Platelet Transfusion in Sepsis Trial

Study Overview
=================
Brief Summary
-----------------
Platelets are important mediators of an inflammatory response and a key component of the innate immune system to defend the human body against invading pathogens. However, little evidence exists regarding the number of platelets that should be used als transfusion threshold in septic patients. In this trial platelet transfusion will be performed with either <50000/µl or <20000/µl as a trigger.

Official Title
-----------------
Platelet Transfusion in Sepsis Trial (PlaTiSep)

Conditions
-----------------
Sepsis, Thrombocytopenia

Intervention / Treatment
-----------------
* Biological: platelet transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sepsis defined as alteration of SOFA score (Sepsis-related organ failure assessment score) >2 points (Sepsis-3 definition) platelet count <50.000/µl Exclusion Criteria: Age less than 18 years patients with immune thrombocytopenia major bleeding in the last 72 hours or ongoing major bleeding patient, surrogate or physician not committed to full intensive care support pregnancy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: <50.000/µl<br>Transfusion of platelets starting with a platelet count <50.000/µl | Biological: platelet transfusion<br>* Transfusion of platelets<br>|
| Experimental: <20.000/µl<br>Transfusion of platelets starting with a platelet count <20.000/µl | Biological: platelet transfusion<br>* Transfusion of platelets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in 90 day follow-up period | overall survival at 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality at 6 months | overall survival at 6 months | 6 months | 
| resolution of shock | time to normalization of lactate levels and end of vasopressor therapy | 5 days | 
| ICU length of stay | length of stay on ICU ward | 28 days | 
| duration of mechanical ventilation support | time to extubation | 28 days | 
| renal replacement therapy | frequency and duration of renal replacement therapy | 28 days | 
| bleeding events | bleeding events requiring transfusion during ICU stay | 28 days | 
| SOFA score | Sepsis-related organ failure assessment score | 28 days | 
| discharge location | discharge to home, ward, rehabilitation unit, nursing home | 90 days |
Effect of Selective iNOS Inhibition During Human Endotoxemia

Study Overview
=================
Brief Summary
-----------------
Sepsis or endotoxemia is manifested by hypotension, resistance to vasopressors, myocardial depression,and altered organ blood flow distribution. The mechanisms underlying the cardiovascular dysfunction during sepsis are complex; however, they are partially mediated by an uncontrolled production of NO by inducible NO synthase (iNOS).Control subjects received 2 ng/kg E. coli endotoxin, whereas the active intervention group received endotoxin in the presence of selective iNOS-inhibitor aminoguanidine. Hemodynamics, vascular responses to norepinephrine, acetylcholine and sodium nitroprusside, as well as circulating cytokines and other mediators of inflammation were measured. We tested the hypothesis that inhibition of NO-synthesis prevented the LPS-mediated insensitivity to noradrenalin and endothelial-dependent vasorelaxation. Furthermore, we tested whether NO participates in occurrence of the endotoxin tolerance in humans by using the iNOS inhibitor aminoguanidine on healthy volunteers with endotoxemia. At 0; 2 and 4 hours after the LPS challenge whole blood was stimulated with five TLR agonists in vitro and pro- and anti-inflammatory cytokines were measured.

Official Title
-----------------
Effect of Selective iNOS Inhibition During Human Endotoxemia

Conditions
-----------------
Endotoxemia

Intervention / Treatment
-----------------
* Drug: Aminoguanidine
* Drug: endotoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: tendency towards fainting alcohol abuse nicotine abuse drugs abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aminoguanidine|nan|
|Drug: endotoxin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamics |  | 24 hrs after LPS administration | 
| Markers of Inflammation |  | 24 hrs after LPS administration | 
| Cytokines |  | 24 hrs after LPS administration | 
| Markers of Renal Injury |  | 24 hrs after LPS administration | 
| Inducible NO synthase expression |  | 24 hrs after LPS administration | 
| NO-metabolites |  | 24 hrs after LPS administration | 
| Mediators of Vascular reactivity |  | 24 hrs after LPS administration | 
| Sensitivity to norepinephrine |  | 24 hrs after LPS administration | 
| Endothelial-dependent vasorelaxation |  | 24 hrs after LPS administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endotoxemia, Aminoguanidine
A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.

Official Title
-----------------
A Prospective, Multicenter, Open, Randomized, Comparative Study to Evaluate the Safety and Efficacy of Ertapenem Versus it's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults

Conditions
-----------------
Complicated Intra-abdominal Infection

Intervention / Treatment
-----------------
* Drug: MK0826; ertapenem sodium
* Drug: Comparator: ceftriaxone + metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0826; ertapenem sodium|nan|
|Drug: Comparator: ceftriaxone + metronidazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable clinical response at 7-14 days after treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable microbiologic response at 7-14 days after treatment |  |  |
Prevention of Chest Pain in Chemo-treated Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.

Official Title
-----------------
Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil

Conditions
-----------------
Solid Carcinoma, 5-Fluorouracil Toxicity, Cardiotoxicity, Chemotherapeutic Toxicity, Acute Coronary Syndrome, Coronary Artery Calcification, Chest Pain

Intervention / Treatment
-----------------
* Procedure: Cardiologic assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified cancer First-time treatment with 5-FU/Capecitabine Expected remaining lifetime > 6 months Informed consent Exclusion Criteria: Known ischemic heart disease Ischemia-suspicious symptoms prior to 5-FU treatment Ischemia-suspicious ECG-changes prior to 5-FU treatment

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiological assessment<br>a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment | Procedure: Cardiologic assessment<br>* Aggressive ischemic risk factor management<br>|
| No Intervention: Standard treatment<br>Standard chemotherapeutic treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute coronary syndrome | Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest pain | Incidence of chest pain | 6 months |
Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes

Study Overview
=================
Brief Summary
-----------------
The primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life.

Detailed Description
-----------------
Patients will be randomly assigned to one of two groups. One group will be offered an Internet assisted home-based symptom reporting system Cancer Symptom Monitor (CSM) for a twelve-month study period. Patient and care team evaluations will be measured using quantitative and qualitative methods (via focus groups). The second group will receive standard care without home-based symptom monitoring. Both groups will be evaluated at baseline, 1, 2, 3, 6, 9, & 12 months, for symptom levels and overall quality of life during the twelve-month study period.

Official Title
-----------------
Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes

Conditions
-----------------
Cancer, Solid Tumor, Hematologic Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older Diagnosis of solid tumor or hematologic malignancy Starting active treatment (chemotherapy or hormonal therapy) Must be able to give informed consent & consent to use the Cancer Symptom Monitor - Exclusion Criteria: Inability to give informed consent Life expectancy of less than 3 months Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

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
-----------------
Cancer, Symptom Management, Supportive Symptom Interventions, Symptom Severity, quality of life, Home-based symptom monitoring
Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas

Study Overview
=================
Brief Summary
-----------------
The pupose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.

Conditions
-----------------
Refractory Neoplasms

Intervention / Treatment
-----------------
* Procedure: Electroporation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery. Patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery. Exclusion Criteria: Patients with: Metal in the body ChildPugh ≥ 3 Long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate Poor cardiac or renal function with intolerant surgery or anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: IRE for refractory neoplasms in liver and pancreas<br>To evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions. | Procedure: Electroporation<br>* Effectivity and safety of irreversible electroporation for refractory neoplasms in liver and pancreas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60 patients of refractory neoplasms in liver and pancreas with irreversible electroporation-related effectivity as assessed by MRI |  | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Effectivity, safety, irreversible electroporation, liver, pancreas
Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This study investigates effects of a multidisciplinary rehabilitation program or physical therapy in patients with chronic low back pain on emotion regulation and coping behaviour. Hypothesis: Significant differences of negative emotions pre and post treatment and between groups after intervention. Standardised questionnaires are used for investigation

Detailed Description
-----------------
Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative Affect Schedule PANAS Brief Symptom Inventory BSI-18

Official Title
-----------------
Emotionsregulation Und Bewältigungsverhalten in Zusammenhang Mit Ambulanter Rehabilitation Oder Physikalischer Therapie Bei Chronischem Rückenschmerz

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Procedure: outpatient rehabilitation program
* Procedure: physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic low back pain > 3 months VAS >= 2 understanding of german language Exclusion Criteria: retired psychiatric disorders dementia sick headache chronic pain disease other than chronic low back pain patients with general contraindications of the therapy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: outpatient rehabilitation program<br>whole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation | Procedure: outpatient rehabilitation program<br> <br> |
| Active Comparator: physical therapy<br>prescribed physical therapy | Procedure: physical therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion regulation before and after treatment | Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI | 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric muscle strenght before and after treatment | The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed | 6-8 months | 
| Pain in the spine before and after treatment | Pain will be assessed with Visual Analogue Scale | 6-8 months | 
| Emotion regulation before and after treatment | Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ | 6-8 months |