linjc16/ctgov huggingface dataset:
Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

Study Overview
=================
Brief Summary
-----------------
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse. The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.

Official Title
-----------------
Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

Conditions
-----------------
AML

Intervention / Treatment
-----------------
* Biological: immunomodulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myeloid leukemia Allogeneic stem cell transplantation (related or unrelated) Exclusion Criteria: Age under 18 years Cord blood transplantation

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 |
| --- |
|Biological: immunomodulation|Immunomodulation depending on chimerism|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of recipient chimerism | whole blood chimerism | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of relapse at 1 year |  | Relapse rate at 1 year |
The Effect of Oxycodone to the Placental Circulation at Early Labour

Study Overview
=================
Brief Summary
-----------------
Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor pain in the early phase. The aim of the randomised, double blinded, placebo controlled study was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of oxycodone and the effects to the newborn.

Official Title
-----------------
The Effect of Oxycodone to the Placental Circulation at Early Labour

Conditions
-----------------
Labor Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oxycodone planned for pain relief age 18 years or more Informed consent obtained Full term pregnancy Exclusion Criteria: No oxycodone planned age less than 18 years No informed consent not full term pregnancy Other contraindication to oxycodone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed | Drug: Placebo<br>* The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more<br>|
| Experimental: Oxycodone<br>The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more | Drug: Oxycodone<br>* The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| placental blood flow | Placental blood flow is measured with doppler ultrasound | from zero hours to two hours after the first study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine arterial flow | uterine arterial flow is measured with doppler ultrasound | from zero hours to two hours after the first study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor, pain, oxycodone, placenta
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

Study Overview
=================
Brief Summary
-----------------
Multicentric interventional prospective study with collection of biological samples as part of a routine care research

Official Title
-----------------
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Procedure: Tissue sampling
* Procedure: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years. Male and female sex. Any patient with cancer (see list in the body of the protocol) requiring treatment by surgical resection and / or who will start treatment with mAb or BiTE. Patient information and signed informed consent. Subjects affiliated (or beneficiary) to a social security scheme Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.). Exclusion Criteria: History of severe systemic autoimmune disease. Pregnant or breastfeeding patient Impossibility or refusal to sign informed consent Patient under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with cancer<br> | Procedure: Tissue sampling<br>* Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room<br>Procedure: Blood sampling<br>* Collection of a 30mL peripheral blood sample in heparin at several times: during surgical and medical treatment (before surgery, before the start of mAbs and after mAbs)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunophenotyping of immune infiltrates by flow cytometry | Immunophenotyping analysis by flow cytometry (Cyan, Beckman Coulter): identification of several immune sub-populations (T-B-NK lymphocytes, myeloid and tumor cells); identifications of several receptors and ligands (PD1 / PDL1, Tim-3 / HAVCR2,, CTLA-4, 4-1BB / 4-1BBL, Fas / FasL, TRAIL, OX40 / OX40L, ICOS / ICOSL, CD69, CD25 / CD127, NKp46 / NKp30, NKG2D / NKG2DL, galectin-9, MHC class I and II, B7H3 / B7H6); identification of memory subpopulations (CD45RA / CD27 / CCR7) and, if available, intra-cytoplasmic labeling (CXCR3, CCR6, Granzyme B, KI67, TNFα IFNg, IL-17 and IL-21). | Up yo one year |
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

Study Overview
=================
Brief Summary
-----------------
AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem organ failure and death. The prognosis for AL amyloidosis with conventional treatment remains poor, Autologous stem cell transplantation (ASCT) for AL amyloidosis produces high hematologic and organ responses. However, treatment-related mortality remains high and reported series are subject to selection bias.

Detailed Description
-----------------
A prospective randomized trial was conducted to compare in AL amyloidosis ASCT (melphalan 140 or 200 mg/m2 depending on age and clinical status supported with ASCT collected with G-CSF alone) and the oral regimen M-Dex (melphalan 10 mg/m2 and dexamethasone 40 mg for 4 days each months up to 18 months). The objectives were to compare survival and hematologic and clinical responses.

Official Title
-----------------
Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .

Conditions
-----------------
Primary Systemic Amyloidosis (AL)

Intervention / Treatment
-----------------
* Drug: Melphalan
* Drug: Dexamethasone
* Procedure: Autologous stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: below 70 years of age biopsy proven systemic AL amyloidosis no more than 2 prior courses of chemotherapy ECOG performance status < 3 Informed written consent Exclusion Criteria: localized amyloidosis HIV seropositivity previous myelodysplasia concomitant serious disease

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Melphalan|nan|
|Drug: Dexamethasone|nan|
|Procedure: Autologous stem cell transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematologic responses |  |  | 
| clinical responses |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AL amyloidosis, Autologous stem cell transplantation, Melphalan, Dexamethasone
Voriconazole as Prophylactic Therapy in Lung Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation.

Detailed Description
-----------------
All participants will receive itraconazole during their inpatient post transplant stay. As an outpatient, ten subjects will be randomized to receive itraconazole 200mg orally once daily for 6 month and ten patients to receive voriconazole 200mg orally twice daily for 6 months . All subjects will be followed in the clinic as per the standard transplant treatment

Official Title
-----------------
Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Voriconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral-lung or single-lung transplant recipients between the ages of 18- 65 years old. Patients must be able to give informed consent prior to and again after transplantation Exclusion Criteria: Lung transplant patients unable to give informed consent. Prior adverse reaction to the drug itraconazole or voriconazole

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Voriconazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject will be monitored for any fungal infection throughout the duration of the study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fungal infection prophylaxis, Lung transplant, Fungal infection post lung transplant
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)

Official Title
-----------------
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Conditions
-----------------
Mechanically Ventilated Patients, Sedation, Dexmedetomidine, Midazolam

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult mechanically ventilated, critically ill patients Exclusion Criteria: pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEXMEDETOMIDINE, SEDATION<br> | Drug: Dexmedetomidine<br> <br> |
| Active Comparator: Midazolam, sedation,<br> | Drug: Midazolam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERCENTAGE OF TIME WITHIN THE TARGET SEDATION |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, Midazolam, Sedation, Mechanical ventilation, Critically ill patients
Human Phototoxicity Test (823/2016)

Study Overview
=================
Brief Summary
-----------------
To determine the phototoxic potential of a topically applied article in human subjects

Official Title
-----------------
Human Phototoxicity Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517
* Other: Untreated Skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>All subjects are patched with the same product. | Drug: BAY987517<br>* 50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. (Formulation: Z43-078)<br>Other: Untreated Skin<br>* This site is patched without treatment as irradiated control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions will be evaluated using the 5 point grading scale |  | Up to 48 hours |
Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

Study Overview
=================
Brief Summary
-----------------
Post-craniotomy emergence hypertension is a common phenomenon that may predispose to development of intracranial hematoma and cerebral edema.The aim of this study is to compare the safety and efficacy of Mgso4 versus lidocaine infusion for control of emergence hypertension after craniotomy.

Official Title
-----------------
Control of Emergence Hypertension After Craniotomy: Comparison Between the Efficacy of Magnesium Sulphate and Lidocaine Infusion (Randomized Controlled Study)

Conditions
-----------------
Craniotomy, Hypertension

Intervention / Treatment
-----------------
* Drug: Magnesium sulphate
* Drug: Lidocaine Hydrochloride
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status Ι or Π. scheduled patients for brain tumor excision. Exclusion Criteria: Hepatic, renal, cardiac, pulmonary, or endocrine impairment. Signs of increased intracranial pressure or allergy to any of the used drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium sulphate<br>50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion | Drug: Magnesium sulphate<br>* Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion. .<br>|
| Active Comparator: lidocaine hydrochloride<br>1.5mg/kg loading followed by 2mg/kg/hr infusion | Drug: Lidocaine Hydrochloride<br>* lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion<br>* Other names: Xylocaine;|
| Placebo Comparator: NaCl 0.9% normal saline<br>Normal saline infusion with the same rate as the study drugs | Drug: Normal saline<br>* Normal saline infusion with the same rate of infusion as the study drugs<br>* Other names: Nacl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postcraniotomy emergence hypertension response to the study drugs | The number of the patients who have systolic blood pressure below 140 mmH during emergence of anesthesia after craniotomy for brain tumors in each group | 4hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time | Time till discharge from PACU | 2 hours | 
| Incidence of side effects of the used drugs | measure of safety | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
craniotomy- Emergence- hypertension