linjc16/ctgov huggingface dataset:
Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

Study Overview
=================
Brief Summary
-----------------
For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507. For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.

Official Title
-----------------
A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

Conditions
-----------------
Lymphoma, Leukemia, Cancer

Intervention / Treatment
-----------------
* Drug: MEDI-507


Participation Criteria
=================
Eligibility Criteria
-----------------
Individuals may be eligible for this study if they are 18 years of age or older and: Have one of the following types of T-Cell Lymphoproliferative disorders such as Cutaneous T-cell Lymphoma (CTCL), Peripheral T-cell Lymphoma (PCTL), Large Cell Lymphoma (LGL), or Adult T-cell Lymphoma (ATL). Patients should have disease that is resistant or refractory to the front-line therapy, except ATL patients for whom there is no standard therapy. At least 30% of tumor cells must be CD2 positive. Karnofsky Performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work). At least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first MEDI-507 administration (except thrombocytopenia). Have no prior treatment with MEDI-507.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MEDI-507|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose (MTD) or the optimal biological dose |  |  | 
| (OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with |  |  | 
| CD-2 positive lymphoproliferative disorders. |  |  |
Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

Study Overview
=================
Brief Summary
-----------------
Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. The overproduction of aldosteron might in some cases be due to unilateral hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these cases the adrenal can be removed and the patient cured of hypertension. The clinical evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective sampling of blood from the adrenal veins to determine lateralization of overproduction. This is executed as an interventional radiological procedure. The adrenal vein sampling is challenging, and success is determined by measuring another adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample. By routine laboratory assays the procedure is evaluated after the patient has been discharged from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the radiologist to draw new samples during the same procedure if the first set of samples is unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.

Official Title
-----------------
Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.

Conditions
-----------------
Primary Hyperaldosteronism

Intervention / Treatment
-----------------
* Other: Intraoperative cortisol measurement.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hyperaldosteronism Motivated for surgery if applicable Able to give informed consent Exclusion Criteria: Not able to give informed consent Severe kidney failure

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: Intraoperative measurement of cortisol<br>Intervention: During a routine procedure intraoperative cortisol is measured. Upon unsuccessful sampling, the sampling will be repeated. | Other: Intraoperative cortisol measurement.<br>* Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Representative blood sample from adrenal veins bilaterally. | Patients where the drawn blood from both adrenal veins is representative is the primary endpoint. | Intraoperatively |
Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

Detailed Description
-----------------
A number of studies have tried to investigate clinical impact of mutations in spliceosomal machinery genes in MDS but they failed to demonstrate a consistent prognostic relevance. Moreover, the clinical impact of these mutations on the outcomes of hypomethylating agent treatment in MDS has never been explored yet. The investigators investigated the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

Official Title
-----------------
Prognostic Molecular Markers Determined by Using Gene Expression Profiling in Patients With Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Genetic: spliceosome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: de novo MDS patients were included in the study who had received 1st line decitabine treatment and had adequate genomic DNA from pretreated bone marrow samples Exclusion Criteria: therapy-related MDS

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 90 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 |
| --- | --- |
| spliceosome<br>patient who have available data for spliceosome mutation status | Genetic: spliceosome<br>* spliceosome mutations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myelodysplastic syndrome, decitabine, spliceosome mutation
Modified SALT Score for Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy.

Official Title
-----------------
Modified SALT Score for Assessment of Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: Triamcinolone Acetonide
* Other: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent. Exclusion Criteria: • pregnant, and lactating females Alopecia totalis or universalis or ophiasis or cicatritial alopecia Usage of systemic treatment of alopecia areata 2 months prior to the study. Any scalp lesion within the treated area Bleeding diathesis, severe anemia or platelet disorders Medical conditions such as autoimmune diseases.

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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intralesional Steroids<br> | Drug: Triamcinolone Acetonide<br>* intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions<br>|
| Placebo Comparator: Control<br> | Other: saline<br>* intralesional injection of saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage involvement | Degree of severity expressed as a percentage | 6months to 1 year | 
| Modified Severity of Alopecia Tool (mSALT) score | New Score calculating severity (hair density) and area as a number minimum value is 0 and maximum value is 105 the higher the number of the score the worse the affection | 6 months to 1 year |
Removal Wichita Fusion Nail After Knee Arthrodesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to make clear how difficult it is to remove osteosynthesis materials afterwards, so surgeons will think twice before inserting intramedullary nails. Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has become.

Conditions
-----------------
Removal Wichita Fusion Nail After Knee Arthrodesis

Intervention / Treatment
-----------------
* Procedure: Proposed technique for removal of the Wichita Fusion Nail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Extraction of Wichita Fusion Nail Exclusion Criteria: All other kinds of intramedullairy nails used to become a solid knee arhrodesis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Conventional<br>Conventional technique for Wichita nail extraction | |
| New<br>Proposed technique for Wichita nail extraction | Procedure: Proposed technique for removal of the Wichita Fusion Nail<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation technique | Was the arthrodesis site left intact? How was the Nail removed? Time for operation? | first 4 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility |  | 1 year postop | 
| Pain measurement following the Visual Analogue Scale |  | 1 year postop | 
| Major complications after removal | Amputation? Infection? Wound problems? | first 2 years postop |
Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study

Study Overview
=================
Brief Summary
-----------------
This pilot study compares the effect of working memory training and neurofeedback in non-medicated children age 7 to 13 years with ADHD. Half of the participants will receive working memory training, while the other half will receive neurofeedback.

Official Title
-----------------
Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Behavioral: Cogmed Robomemo, working memory training
* Behavioral: Othmer, neurofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD/ADD Exclusion Criteria: Positive effect of metylphenidate

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 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 |
| --- | --- |
| Active Comparator: Cogmed Robomemo, working memory training<br>Robomemo working memory training, 25 sessions with 8 verbal and non-verbal tasks per session. | Behavioral: Cogmed Robomemo, working memory training<br> <br> |
| Active Comparator: Othmer, neurofeedback<br>Othmer method neurofeedback, 25 sessions a 30 minutes. | Behavioral: Othmer, neurofeedback<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological tests | Subtests from the NEPSY-II test battery | 3-4 weeks after last training session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantum EEG | Electroencephalography (EEG) is the measurement of electrical patterns at the surface of the scalp which reflect cortical activity, and are commonly referred to as brainwaves. Quantitative EEG (qEEG) is the analysis of the digitized EEG, and in lay terms this sometimes is also called Brain Mapping | 3-4 weeks after last training session | 
| Questionaires | 5-15 (FTF) Parent Questionaire For Evaluation of Development and Behavior of 5 to 15-year-old children. Behavior Rating Inventory of Executive Function (BRIEF) | 3-4 weeks after last training session |
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology

Study Overview
=================
Brief Summary
-----------------
Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.

Official Title
-----------------
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology

Conditions
-----------------
Refractory Malignant Ascites

Intervention / Treatment
-----------------
* Procedure: Paracentesis
* Device: Tunneled Intraperitoneal Drain (IPD)
* Device: Peritoneal-Venous shunts (PVS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR Known malignancy with imaging findings of peritoneal carcinomatosis . Eastern Cooperative Oncology Group (ECOG) performance score 3 Age greater than or equal to 18 Capable of giving informed consent Exclusion Criteria: Life expectancy less than one month Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion Active skin infections at sites where PVS would be inserted Presence of infectious peritonitis or bacteremia Neutropenia American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV) Stage 5 CKD (ie GFR < 15 mL/min) Severe hypoalbuminemia defined as < 2.2 g/dL Loculated or hemorrhagic ascites History of bleeding gastroesophageal varices Inability to provide informed consent Unable to participate in neuropsychological tests / questionnaires Pregnant or nursing women Anasarca

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: Paracentesis|Paracentesis|
|Device: Tunneled Intraperitoneal Drain (IPD)|Tunneled Intraperitoneal Drain (IPD)|
|Device: Peritoneal-Venous shunts (PVS)|Peritoneal-Venous shunts (PVS)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting

Detailed Description
-----------------
Adjuvant chemotherapy is still the standard of care for stage Ⅲ gastric cancer. Till now, oxaliplatin with capecitabine or S1 still the standard chemotherapy regimen. Howerver, the prognosis of diffuse type gastric cancer patients is still poor even after adjuvant chemotherapy of XELOX or S1 regimen. Several retrospective, single institutional studies have shown that the addition of Nab-paclitaxel to S1 can prolong the survival of advanced gastric cancer with diffuse type.However, the effection of Nab-paclitaxel and S1 is unknown in diffuse gastric cancer patients after radical surgery. We assessed the effectiveness of radical surgery following docetaxel, nab-pacitaxel and S1 therapy for gastric cancer with diffuse type.

Official Title
-----------------
Phase I Study: Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer as Adjuvant Setting (NORDICA)

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Nab-paclitaxel combined with S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric cancer patients after radical resection diffuse type gastric cancer stage III Exclusion Criteria: Patients who have metastasis disease Patients who can not tolerate chemotherapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel combined with S-1<br>Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting | Drug: Nab-paclitaxel combined with S-1<br>* Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommended dose for Phase II study |  | through study completion, an average of 2 year |
Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract

Study Overview
=================
Brief Summary
-----------------
A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.

Detailed Description
-----------------
The occurrence of both glaucoma and clinically relevant cataract in the same individual is a frequent condition, especially in the elderly population. Besides age, this might be related to the possible role of antiglaucoma medications in the progression of lens opacity.When both procedures are required, these can be performed separately or in combination. Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment. The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification. This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .

Official Title
-----------------
To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract

Conditions
-----------------
Glaucoma and Ocular Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - age above 18 Exclusion Criteria: - congenital glaucoma

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| glaucoma and ocular hypertension<br>glaucoma and ocular hypertension | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract . | to check the change in intraocular pressure after EX-PRESS shunt implantation | within one to two years post surgery |