linjc16/ctgov huggingface dataset:
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Study Overview
=================
Brief Summary
-----------------
To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.

Official Title
-----------------
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Conditions
-----------------
HIV Infections, Cytopenias

Intervention / Treatment
-----------------
* Drug: Sargramostim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Serum antibody to HIV with or without evidence of HIV. Antigenemia. Anticipated survival of at least 6 months. Allowed: Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Malignancy other than Kaposi's sarcoma. Excessive diarrhea (more than 5 liquid or non-liquid stools per day). Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection. Primary hematologic or infectious disorders unrelated to AIDS virus infection. Dementia or altered mental status that would prohibit the giving and understanding of informed consent. Patients with the following are excluded: History of malignancy other than Kaposi's sarcoma. Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection. Prior Medication: Excluded within 3 weeks of study entry: Marrow suppressive medication. Excluded within 4 weeks of study entry: Any investigational drug. Prior Treatment: Excluded within 4 weeks of study entry: Systemic cytotoxic chemotherapy. Irradiation. Risk Behavior: Excluded within 3 months of study entry: Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

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

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
-----------------
Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor
Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).

Detailed Description
-----------------
In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children < 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of 141W94 Plus Current Nucleoside Therapy Versus Current Nucleoside Therapy Alone in Protease-Naive, HIV-Infected Children

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Amprenavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Your child may be eligible for this study if he/she: Is 6 months - 18 years of age. Is HIV-positive. Has a viral load (level of HIV in the body) greater than 10,000 copies/ml. Is able to take medications by mouth. Has consent of parent or legal guardian if under 18. Has a negative pregnancy test within 7 days of study entry. Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study. Exclusion Criteria Your child will not be eligible for this study if he/she: Has a serious illness, including any life-threatening infection or other chronic serious medical condition. Has an opportunistic (AIDS-related) infection or a serious bacterial infection. Is allergic to NRTIs. Is breast-feeding. Is unlikely to complete the study. Has received certain medications. Has received radiation therapy within the past 4 months, or will need to receive it during the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

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

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
-----------------
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.

Detailed Description
-----------------
Rivaroxaban is an orally active direct factor Xa inhibitor, that is used for thrombosis prophylaxis for example in the setting of orthopaedic surgery. In the observed situation Rivaroxaban was applied in a dosage of 10mg daily during 5 days after endovenous laser ablation.

Official Title
-----------------
Rivaroxaban for Thrombosis Prophylaxis in Endovenous Laser Ablation With and Without Miniphlebectomy: A Multicenter Experience

Conditions
-----------------
Varicose Veins, Venous Thrombosis, Thromboembolism, Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age greater than 18 years, informed consent was given. Endovenous Laser Ablation (EVLA) of the greater saphenous vein (GSV), autologous saphenous vein (ASV) and/or small saphenous vein (SSV) using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional Endothermal Heat Induced Thrombosis (EHIT) prophylaxis with rivaroxaban. Exclusion Criteria: Patients are ineligible if they had: an endovenous ablation technique other than EVLA, other veins than GSV, ASV or SSV treated with EVLA (i.e. perforators), postinterventional EHIT prophylaxis other than prophylactic dose of rivaroxaban or informed consent was not given.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a EHIT class 3 or class 4 within 6 weeks after endovenous laser ablation |  | within 6 weeks after endovenous laser ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of major or clinically relevant bleedings within 6 weeks after endovenous laser ablation. |  | within 6 weeks after endovenous laser ablation |
Registry for Hirschsprung Disease of the BELAPS

Study Overview
=================
Brief Summary
-----------------
Registry for Hirschsprung disease of the BELAPS (Belgian Association of Pediatric Surgery) Protocol Short Title/Acronym / Sponsor name BELAPS Principal Investigator Prof. Dr. Marc Miserez Medical condition or disease under investigation Hirschsprung's disease Purpose of clinical study To register pre-, intra- and postoperative data in order to improve surgical care to paediatric patients with Hirschsprung's disease in Belgium. Primary objective The primary objective is to evaluate defecation habits at 3.5-5.5 years after surgery. Secondary objective (s) Evaluating the long-term results and evaluate risk factors for constipation / incontinence. Study Design Prospective registry Endpoints Krickenbeck score, urinary, sexual and QoL evaluation

Official Title
-----------------
Registry for Hirschsprung Disease of the BELAPS (Belgian Association of Pediatric Surgery)

Conditions
-----------------
Hirschsprung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hirschsprung Disease, surgery Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| To register pre-, intra- and postoperative data in order to improve surgical care to pediatric patients with Hirschsprung's disease in Belgium. |  | at least 10 years postoperatively |
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.

Official Title
-----------------
A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy

Conditions
-----------------
Recurrent Glioblastoma, Brain Tumor

Intervention / Treatment
-----------------
* Drug: Cediranib
* Drug: Lomustine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis & stage Patients received no more than 2 previous systemic chemotherapy regimes Life Expectancy > 12 weeks Patients must be at least 3 months from the completion of cranial radiation therapy Exclusion Criteria: History of poorly controlled high blood pressure Recent major surgery prior to entry into the study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lomustine + Cediranib (AZD2171) | Drug: Cediranib<br>* oral tablet<br>* Other names: AZD2171;Drug: Lomustine<br>* oral capsule<br>* Other names: CeeNU®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination. |  | Assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the pharmacokinetics of cediranib alone versus when in combination with lomustine as measured by minimum steady state plasma concentration (Css,min) steady-state plasma concentration |  | assessed 2 & 4 hours post dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, tumor, advance solid tumour, glioblastoma, malignant brain tumour
EGFR-targeted Therapy for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.

Detailed Description
-----------------
Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Official Title
-----------------
Anti-EGFR Antibody (GC-1118) in Combination With Weekly Paclitaxel as a Second-line Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas With Amplifications

Conditions
-----------------
Adenocarcinoma of the Stomach

Intervention / Treatment
-----------------
* Drug: Anti-EGFR antibody in combination with weekly paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria Histologically-proven gastric and gastroesophageal junction adenocarcinoma Refractory to first-line chemotherapy for metastatic disease Presence of at least 1 measurable lesion according to RECIST version 1.1 EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining Key exclusion criteria 1.Prior exposure to taxane or EGFR-targeted therapy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-EGFR<br>Participants will receive GC-1118 in combination with weekly paclitaxel. | Drug: Anti-EGFR antibody in combination with weekly paclitaxel<br>* Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy<br>* Other names: GC-1118 in combination with weekly paclitaxel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate will be assessed using CT/MRI according to RECIST v1.1. | Response rate will be assessed at 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed. | From date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed up to 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.

Official Title
-----------------
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.

Conditions
-----------------
Haemophilia B

Intervention / Treatment
-----------------
* Biological: Replenine®-VF (High Purity Factor IX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Replenine®-VF<br> | Biological: Replenine®-VF (High Purity Factor IX)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental recovery for Factor IX | Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG | 90 min post-dose |
Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the observation of the course of the mechanics of the respiratory system the endexpiratory lung volume and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department.

Official Title
-----------------
Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure

Conditions
-----------------
Respiratory Distress Syndrome, Adult, Respiratory Distress Syndrome, Child

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients accepted for extracorporeal life support at our department due to the most severe forms of ARDS/respiratory failure not responding to conventional therapy. Exclusion Criteria: malignant disease with a poor prognosis massive intracranial bleeding

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- | --- |
| Course of inflammatory parameters and lung function |  | end of treatment |
ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0

Study Overview
=================
Brief Summary
-----------------
This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.

Detailed Description
-----------------
ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.

Official Title
-----------------
Evaluation of Left Ventricular Autothreshold

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Cardiac pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead Patients who have an active LV bipolar or unipolar lead Patients who have an active RV defibrillation lead Patients who are willing and capable of participating in all testing associated with this Clinical Investigation Exclusion Criteria: Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining Patients who are pacemaker-dependent as defined as VVI 40 without intrinsic atrial or ventricular activity Patients who will not tolerate a pacing pause of up to 6 seconds Patients with a pre-existing unipolar pacemaker Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes Patients enrolled in any concurrent study, without Boston Scientific CRM written approval Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.

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 |
| --- | --- |
| Pulse Width<br>One group reflecting two different pulse widths. | Device: Cardiac pacing<br>* Cadiac pacing via a pulse generator and implaned intracardiac leads.<br>* Other names: COGNIS PG.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing. | The primary objective of this study is to collect real-time signals during LV pacing and voltage step-down from patients with implanted COGNIS devices. | Minimum of 24 hrs post CRT-D implant. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Autothreshold, Pacing, CRT-D recipients, Left Ventricular evoked response signals
Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of Near-Infrared Technology can guide the laparoscopic resection of hypervascular neoplasms of the pancreas.

Official Title
-----------------
Use of Near Infrared Technology as a Guide in Laparoscopic Resection of Pancreatic Lesions: the COLPAN Colour-and-resect Project

Conditions
-----------------
Pancreatic Neuroendocrine Tumors, Clear Cell Renal Carcinoma, Solid Pseudopapillary Tumors of the Pancreas

Intervention / Treatment
-----------------
* Device: NIR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 80 diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery Exclusion Criteria: allergy to indocyanine green or other vital stains, indium, shellfish chronic kidney insufficiency chronic hepatopathy hyperthyroidism, thyroid adenomas

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

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

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

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: 1<br>Use of NIR | Device: NIR<br>* Laparoscopic use of NIR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR |  | within the time of surgery |