linjc16/ctgov huggingface dataset:
TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.

Official Title
-----------------
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: TLK286, cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Histologically confirmed non-small cell lung cancer Stage IV or IIIB Measurable disease by RECIST ECOG performance status of 0-1 Adequate liver and renal function Adequate bone marrow reserve Exclusion Criteria: History of bone marrow transplantation or stem cell support Pregnant or lactating women

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: TLK286, cisplatin|TLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objectives of the Study | To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) | Every 3 weeks |
The Effects of Thymopentin on HIV Infectivity of Blood Cells and Semen in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

Official Title
-----------------
Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

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

Intervention / Treatment
-----------------
* Drug: Thymopentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine. Patients must have the following: Seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' peripheral blood monocytes (PBMC) on two separate occasions. Voluntarily sign consent. Patients with HIV wasting syndrome are allowed. Prior Medication: Allowed: Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: AIDS as defined by the CDC. Significant hepatic disease. Thrombocytopenia. Hypersensitivity to thymopentin. Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry. Patients with the following are excluded: AIDS as defined by the CDC. Significant hepatic disease. Thrombocytopenia. Hypersensitivity to thymopentin. Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products. Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry. Prior Medication: Excluded within 30 days of study entry: Immunomodulatory or experimental therapy. Excluded within 90 days of study entry: Zidovudine (AZT). Intravenous drug abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymopentin|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
-----------------
Semen, Thymopentin, Leukocytes, Mononuclear, HIV Seropositivity, AIDS-Related Complex
Observational Study of Dydrogesterone in Cycle Regularization

Study Overview
=================
Brief Summary
-----------------
Dydrogesterone has been widely used worldwide for various gynecological and obstetric indications: Dydrogesterone is effective in cycle regulation treatment. Dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (HPO) axis in the recommended dosage. Dydrogesterone might have non-negative effect on glucose and lipid metabolic.

Detailed Description
-----------------
The current study is designed as a prospective, non-interventional, observational study. Patients with irregular cycle diagnosed as AUB-O will be prescribed dydrogesterone as per physician's clinical practice.

Official Title
-----------------
Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study

Conditions
-----------------
Observational Study, Dydrogesterone, Irregular Menstrual Cycle, Abnormal Uterine Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 16 years or above with menses Patient who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O (irregular cycle is defined as cycle duration < 21days or >35 days) Physicians have decided to prescribe dydrogesterone 10mg for cycle regulation treatment, orally taking dydrogesterone 10mg twice daily, from day16 to day 25 of each cycle, being consecutive at least 3 cycles Patient who is willing to sign written authorization Exclusion Criteria: Hyperprolactinemia and thyroid dysfunction. Patient took cycle regulation treatment including oral contraceptives, sex hormone or glucocorticoid in the past 1 month Women with estrogen deficiency related symptom Patient who meets the contraindications listed in Chinese label of dydrogesterone Pregnant and lactating patients Patient who is not suitable for the study according to physician's discretion

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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 |
| --- | --- | --- |
| percentage of patients reporting a regular cycle (defined as cycle duration≥21 and ≤ 35 days) at the end of cycle 3 |  | 12 months |
How to Study Ventilatory Physiology With the Help of Surface Electromyography (EMG) Recordings

Study Overview
=================
Brief Summary
-----------------
Respiratory muscles seem to be activating differently in critically ill patients than in healthy persons. Needle electrodes would provide artefact-free signal information about muscle activation. However, needle recordings are an invasive technique which limits its feasibility in clinical setting. Intention of this study is to investigate if surface electromyography could be used to measure recruitment patterns of ventilatory muscles.

Conditions
-----------------
Ventilatory Physiology

Intervention / Treatment
-----------------
* Device: Ventilatory therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age Exclusion Criteria: brain death of injury high spinal cord injury severe ARDS (static compliance below 40, PFI below 150)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br>Patients that are treated in intensive care unit and given ventilatory therapy. | Device: Ventilatory therapy<br> <br> |
| Interventional volunteer group<br>Healthy volunteers | |

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
-----------------
Ventilatory physiology
Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

Study Overview
=================
Brief Summary
-----------------
The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start

Official Title
-----------------
Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.

Conditions
-----------------
Duodenal Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data. Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT) Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd Written informed consent provided prior the start of participation in the study. Exclusion Criteria: Subjects who are unwilling or unable to provide informed consent Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion Two or more previous attempts to eradicate H. Pylori

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 |
| --- | --- |
| 1<br>patients with Helicobacter-positive duodenal ulcer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of H. pylori at the end routine triple eradication therapy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage) |  | 2 years | 
| Frequency of duodenal ulcer relapses | Frequency of duodenal ulcer relapses based on gastroscopy data and recurrence rate of H.Pylori infection based on breath test data after 52 weeks from the start of the therapy. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter-positive duodenal ulcer
PET-CT Based Radiotherapy in Esophageal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients.

Detailed Description
-----------------
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients

Official Title
-----------------
Consequences of Positron-Emission-Tomography/Computed Tomography (PET/CT) Based Radiotherapy Treatment Planning for Clinical Outcome in Esophageal Cancer Patients

Conditions
-----------------
Esophageal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus Local curable disease able to undergo Chemoradiotherapy. Exclusion Criteria: Metastasized disease. Previous or concurrent malignancies.

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 |
| --- | --- | --- |
| Locoregional control |  | 2 years and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2 years and 5 years | 
| Disease Free survival |  | 2 years and 5 years | 
| Tumor regression grade | Tumor regression grade at time of surgery evaluated by pathologist. | At the time of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal cancer, PET-CT planning
Dynamics of the Capillary Lactate Levels in OHCA

Study Overview
=================
Brief Summary
-----------------
Serial capillary lactate measurements during cardiopulmonary resuscitation (CPR) in patients with out-of-hospital cardiac arrest (OHCA).

Detailed Description
-----------------
Capillary lactate measurements will be measured every ten minutes during CPR in OHCA.

Official Title
-----------------
Dynamics of the Capillary Lactate Levels in Patients With Out-of-hospital Cardiac Arrest

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Diagnostic Test: capillary lactate measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with OHCA Exclusion Criteria: children with OHCA trauma hypothermia

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 |
| --- |
|Diagnostic Test: capillary lactate measurements|In this study capillary lactate will be measured every 10 minute during CPR.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROSC | In patients with ROSC the capillary lactate level will be lower compare to the non ROSC group. | 2 years | 
| Comparison between primary and secondary cardiac arrest | Initial and serial values of capillary lactate will be lower in patients with primary out-of- hospital cardiac arrest (OHCA) | 2 years | 
| No ROSC | Serial values of capillary lactate will be higher in patients without ROSC | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Out-Of-Hospital Cardiac Arrest, lactic acid, Cardiopulmonary resuscitation, Survival
An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

Study Overview
=================
Brief Summary
-----------------
A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma

Official Title
-----------------
A Multicentre, Retrospective, Observational Study to Analyse the Efficacy of High Dose Isofosfamide Administered Through Elastomer in Patients With Relapsed/ Refractory Osteosarcoma

Conditions
-----------------
Osteosarcoma Recurrent

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of high risk relapsed/ refractory osteosarcoma Aged <= 40 years at the beginning of treatment at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days disease evaluation according to RECIST criteria v.1.1 Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|none, Observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Disease remission or disease progression | Evaluated during the first 4 months at the end of treatment | 
| growth modulation index - GMI | ratio of time to progression (TTP) with nth line of therapy (TTPn) to the most recent prior line of therapy (TTPn-1) | Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI) | 
| toxicity according to CTCAE v.5.0 | Disease evaluation | Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI) |
Tooth Autotransplantation and Bone Dimension Changes

Study Overview
=================
Brief Summary
-----------------
Tooth autotransplantation is a treatment option to replace tooth with imposible prognosis. In several cases the receipt site has a reduced bone dimension. This situation may be imposible the treatment with dental implants without bone reconstruction. Autotransplantation seem to improve the anatomic characteristic of the receipt site without any reconstruction approach. The aim of this study is to evaluate the bone dimension changes followed autotransplantation treatment.

Official Title
-----------------
Tooth Autotransplantation and Bone Dimension Changes. Randomized Clinical Trial.

Conditions
-----------------
Bone Loss, Alveolar, Tooth Loss, Bone Atrophy, Alveolar

Intervention / Treatment
-----------------
* Procedure: AUTOTRANSPLANTATION TOOTH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tooth with imposible prognosis Plaque index score less than 30% No relevant systemic disease Smokers (Less than 20 cigars/day) Exclusion Criteria: Pregnancy-Lactation Relevant systemic disease
Sexes Eligible for Study
-----------------
All

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

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: AUTOTRANSPLANTATION TOOTH<br> | Procedure: AUTOTRANSPLANTATION TOOTH<br>* Tooth with imposible prognosis is replace with a healthy tooth from the same patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alveolar bone 12 months after tooth autotransplantation | CT-scan evaluation before surgery and 1 year after, measuring the difference in millimeters | 1 year |
An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)

Study Overview
=================
Brief Summary
-----------------
This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.

Official Title
-----------------
IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months Previously treated with an erythropoietin stimulating agent (ESA) Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL Exclusion Criteria: Current participation in a clinical trial on renal anemia

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Hb value within the range of 10 - 12 g/dL |  | 6 months | 
| Change in Hb level |  | from baseline to Month 6 | 
| Monthly dose of Mircera |  | 6 months | 
| Safety: Incidence of adverse events |  | 6 months |