linjc16/ctgov huggingface dataset:
Noradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC

Study Overview
=================
Brief Summary
-----------------
ABG PARAMETERS ARE CHANGED DURING HIPEC, WE TRIED TO FIND COMPARISON BETWEEN NORADRENALINE AND PHENYLEPHRINE IN OPTIMIZING ABG PARAMETERS THAT REFLECTS ORGAN PERFUSIONS ESPECIALLY SERUM LACTATE

Detailed Description
-----------------
Arterial blood gas testing is considered one of the most important and widely used test in the detection of acidosis, alkalosis, electrolytes disturbance and tissue perfusion. in regard to tissue perfusion serum lactate above 4 mmol/L indicates poor tissue perfusion. serum lactate could be measured at ABG or separately. in this study we will test the effect of both noradrenaline and phenylephrine on lactate level at ABG during the stage of HIPAC in managing abdominal cancer patients.

Official Title
-----------------
Effect of Noradrenaline Infusuion Versus Phenyephrine Infusion in Improving Tissue Perfusion in HIPEC

Conditions
-----------------
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Intervention / Treatment
-----------------
* Drug: NORADRENALIN
* Drug: PHENYLEPHRINE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CANCER PATIENTS ENROLLED FOR HIPEC Exclusion Criteria: DRUG SENSITIVITY

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NORADRENALIN<br>NORADRENALINE INFUSION | Drug: NORADRENALIN<br>* DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION<br>* Other names: PERFUSION;|
| Active Comparator: PHENYLEPHRINE<br>PHENYLEPHRINE INFUSION | Drug: PHENYLEPHRINE<br>* DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SERUM LACTATE IN ABG | LANDMARK FOR TISSUE AND ORGAN PERFUSION | IMMEDIATELY POSTOPERATIVELY |
Preoperative Hyperthermia in Major Abdominal Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Detailed Description
-----------------
The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Official Title
-----------------
Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: Normothermia
* Procedure: Hyperthermia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients, age 18 - 75 Open abdominal, curative cancer surgery > 2 h Exclusion Criteria: Pregnancy Chronic cortisone treatment Ongoing chemotherapy Acute infections, septic surgery Palliative surgery (e.g. debulking only)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Warming without increase in core temperature | Procedure: Normothermia<br>* Warming without increase in core temperature<br>|
| Active Comparator: Hyperthermia<br>Hyperthermia for 2,5 hours (39 °C core temperature) | Procedure: Hyperthermia<br>* Core hyperthermia (39 °C) for 2,5 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Status | LPS induced TNF-alpha | 24 hours after surgery |
Stem Cells for Treatment of Bronchopleural Fistula

Study Overview
=================
Brief Summary
-----------------
Bronchopleural fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity. The investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to investigate the application of umbilical cord mesenchymal stem cells in the treatment of bronchopleural fistula.

Official Title
-----------------
Umbilical Cord Mesenchymal Stem Cells for Treatment of Bronchopleural Fistula

Conditions
-----------------
Bronchopleural Fistula

Intervention / Treatment
-----------------
* Biological: UCMSC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with bronchopleural fistula by imaging or bronchoscopic examination typical symptom of bronchopleural fistula, such as fever, cough, purulent sputum, weight loss… patients present compromised conditions, who can only accept a conservative treatment. Exclusion Criteria: absolute contraindication of bronchoscopic examination and treatment with previous treatment of cell therapy, including stem cells.

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: UCMSC treatment<br>UCMSC: umbilical cord mesenchymal stem cells | Biological: UCMSC<br>* UCMSC: umbilical cord mesenchymal stem cells 3-5*10^7/5 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| closure of the fistula | median time for fistula closure | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | fever, coughing up blood, infection... | 1 year |
A Retrospective Review of Gemcitabine, Methylprednisolone Cisplatin (GEM-P) With or Without Rituximab in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Study Overview
=================
Brief Summary
-----------------
There has been considerable international /national interest in the GEM-P regimen for treatment of patients with relapsed/refractory lymphoma. Currently, there is no accepted standard therapy for these patients. Since the publication of our experience with this regimen (Study with CCR ethics number 1857 closed to recruitment in July 2003:Ng M, Waters J, Cunningham D et al, Br J Cancer 2005;92:1352-7), we have treated relapsed/refractory lymphoma patients with this regimen and would like to undertake a retrospective review of a sub-group of these patients with diffuse large B cell lymphoma (DLBCL). Patients treated with GEM-P with or without Rituximab prior to March 2005 for refractory/relapsed DLBCL will be included in the analysis. Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. All eligible patients identified from the pharmacy database, and will be consented at the time of the next clinic appointment, if they are agreeable for the retrospective case note review.

Conditions
-----------------
Non-Hodgkins Lymphoma

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Cisplatinum
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - a) Age over 18 b) Histological diagnosis of diffuse large B cell lymphoma c) Patients who have received Gemcitabine-cisplatin, methylprednisolone (GEM-P) as per standard unit guidelines with or without Rituximab for relapsed/refractory DLBCL. d) Informed written consent Exclusion Criteria: a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma

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 |
| --- |
|Drug: Gemcitabine|nan|
|Drug: Cisplatinum|nan|
|Drug: Rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Official Title
-----------------
An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan
* Drug: capecitabine [Xeloda]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=18 years of age; locally advanced and/or metastatic colorectal cancer; >=1 target lesion. Exclusion Criteria: previous treatment with Xeloda or irinotecan; previous systemic therapy for metastatic disease; progressive disease during previous adjuvant therapy or within 6 months of completion.

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> | Drug: Irinotecan<br>* 250mg/m2 iv on day 1 of each 3 week cycle<br>Drug: capecitabine [Xeloda]<br>* 1000mg/m2 po bid on days 1-15 of each 3 week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor measurement (RECIST criteria) |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival. |  | Event driven |
Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia

Study Overview
=================
Brief Summary
-----------------
Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia

Official Title
-----------------
Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Procedure: onlay mesh hernioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incisional hernia Acceptance of the trial Exclusion Criteria: BMI>40 ASA score of 4 Severe pulmonary or cardiac disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onlay<br>Onlay mesh repair group | Procedure: onlay mesh hernioplasty<br> <br> |
| Experimental: sublay<br>Sublay mesh repair group | Procedure: onlay mesh hernioplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence |  | 3 years |
Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward

Study Overview
=================
Brief Summary
-----------------
The proposed cohort study collected within a 5-month observation period adverse drug reaction (Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of Zurich. ADE have been recorded using prospective monitoring and assessed using standardized algorithms regarding causality and severity. Data sources included information from the medical records, laboratory values and internal rounds. Additional information has been collected using a standardized patient questionnaire. The primary endpoints of this study are to determine the frequency of ADE, the comparison of the quality of data sources and collection methods for the detection of ADE in regard to patient characteristics, size, number of medications, the category of ADE, severity, causation, diagnosis, hospitalization, cause of hospitalization and medication cause. Secondary endpoint is the assessment of the ADE causality, severity and predictability.

Official Title
-----------------
Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward

Conditions
-----------------
Adverse Drug Reactions

Intervention / Treatment
-----------------
* Procedure: Collection of adverse drug events


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: German-speaking patients, At least 18 years old. Exclusion criteria: Patients who could not give her consent, or have given, and any minor patient.

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 |
| --- | --- |
| Patients on the ward<br> | Procedure: Collection of adverse drug events<br> <br> |

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
-----------------
Adverse drug reactions in patients on the oncology ward
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.

Official Title
-----------------
A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099

Conditions
-----------------
HIV Infections, AIDS

Intervention / Treatment
-----------------
* Drug: stavudine, efavirenz, lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed d4T studies AI455-096 or AI455-099 Have demonstrated compliance with the study medication and treatment visits Provide written informed consent Agree to use a barrier method of birth control (such as condoms) during the study Have a negative pregnancy test within 72 hours prior to start of study medication Exclusion Criteria: Are pregnant or breast-feeding Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis Have certain other conditions or prior treatments that might interfere with study continuation Need to take certain medications that should not be taken with EFV
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

| Intervention/Treatment |
| --- |
|Drug: stavudine, efavirenz, lamivudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Changes in CD4 cell counts |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antivirals, HIV
Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation

Study Overview
=================
Brief Summary
-----------------
Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related macular degeneration (AMD) after one year of oral supplementation with AREDS-like formulation.

Detailed Description
-----------------
Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study, and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon 3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed in all patients, at baseline and 12 months after. Automated delineation of macular drusen was modified by the investigators when evident segmentation errors occurred.

Official Title
-----------------
Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation: One-year Results.

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Dietary Supplement: Antioxidant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AREDS category 2 and 3 AMD Exclusion Criteria: AREDS category 4 AMD other ophthalmological diseases currently on antioxidant supplementation

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>Patients with AREDS category 2 and 3 AMD are observed during 1 year | |
| Active Comparator: Antioxidant<br>Patients with AREDS category 2 and 3 AMD are enrolled to take daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg) during 1 year. | Dietary Supplement: Antioxidant<br>* Oral supplemmentation with antioxidants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drusen volume change |  | 12 months |