linjc16/ctgov huggingface dataset:
A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

Study Overview
=================
Brief Summary
-----------------
This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense

Official Title
-----------------
A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma

Conditions
-----------------
Advanced Melanoma

Intervention / Treatment
-----------------
* Drug: Genasense® (G3139, oblimersen sodium)
* Drug: Genasense followed by DTIC; then DTIC alone
* Drug: DTIC alone; then Genasense followed by DTIC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic Stage IV disease, or Stage III disease that is not surgically resectable ECOG Performance Status of 0, 1, or 2 Life expectancy of at least 12 weeks Adequate venous access Agreement to practice effective method of birth control Exclusion Criteria: Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy Significant medical disease Known hypersensitivity to phosphorothioate-containing oligonucleotides Known hypersensitivity to DTIC Pregnancy/Lactation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 | Drug: Genasense® (G3139, oblimersen sodium)<br> <br> Drug: DTIC alone; then Genasense followed by DTIC<br>* Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2<br>|
| Experimental: Group 2<br>Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2 | Drug: Genasense® (G3139, oblimersen sodium)<br> <br> Drug: Genasense followed by DTIC; then DTIC alone<br>* Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2<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
-----------------
CFR, bcl-2, DTIC, ECOG, EMEA, MedDRA, NCI CTC, SAE
N-acetyl Cysteine and Patients With Non-alcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease

Official Title
-----------------
Effect of N-acetyl Cysteine on Markers of Oxidative Stress and Insulin Resistance in Patients With Non-alcoholic Fatty Liver Disease

Conditions
-----------------
Simple Steatosis Non Fatty Liver

Intervention / Treatment
-----------------
* Drug: N acetyl cysteine with weight reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged 18-60 years diagnosed with NAFLD Exclusion Criteria: History of alcohol consumption, drug addiction or the use of medications known to precipitate steatohepatitis. Patients with schistosomiasis, active hepatitis B or C, autoimmune and metabolic diseases. current Consumption of any antioxidant supplements and hepatotoxic drug. Pregnancy or lactation or expecting to get pregnant during the study. Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data. Active Cancer patients. Anyone having hypersensitivity to N-acetylcysteine. Anyone already taking N-acetylcysteine.

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: intervention<br>NAC and weight reduction program | Drug: N acetyl cysteine with weight reduction<br>* high dose 2400mg/day<br>|
| No Intervention: control<br>weight reduction program only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the effect of NAC on leptin | leptin as insulin resistance marker in NAFLD | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the effect of NAC on MDA | MDA as oxidative stress marker in NAFLD | 3 months |
Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.

Detailed Description
-----------------
Vaginal stenosis can occur as a result of treatment for pelvic malignancies. Women receiving pelvic radiation therapy using a vaginal dilator 5-7 times per week will have less vaginal stenosis than women using a vaginal dilator fewer times or not at all.

Official Title
-----------------
Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy

Conditions
-----------------
Malignancies, Stenosis of Vagina

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre and post menopausal women undergoing definitive (not palliative) treatments for a pelvic malignancy, including rectal, endometrial, cervical, or anal canal carcinoma. Treatments include radiation therapy, chemotherapy, surgery, or a combination of therapies. May have early-stage or locally advanced (node positive) disease. Male partners of the female subjects are also consented for this study. Exclusion Criteria: Subject may not have evidence of metastatic disease. Prior pelvic radiation therapy Prior hysterectomy (not for current diagnosis) Diagnosis of prior malignancy, except non-melanoma skin cancer.

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 |
| --- | --- |
| Pelvic Malignancies<br>Women with Vaginal Stenosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator) | Observation of change in vaginal length will be measured at baseline (which for the patients in the radiation group will be prior to any pelvic radiation therapy and for patients in the surgery group this will be at the first post-operative visit), as well as in follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements. | Up to 24 Months | 
| Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ) | The baseline SAQ will be administered prior to radiation therapy for the pelvic malignancy group and it will be administered at the post-operative visit for the surgery only group, and the post-treatment SAQ version will be given at the follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements. | Up to 24 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaginal length, Sexual dysfunction
Is Pentoxifylline Able to Improve Olfactory Sensitivity?

Study Overview
=================
Brief Summary
-----------------
Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis is that pentoxifylline could lead to increased sensitivity to odors.

Detailed Description
-----------------
Olfactory signal processing is conducted by a G-protein linked increase of intracellular concentration of adenosine 3´,5´-cyclic monophosphate (cAMP). In the cilia of olfactory sensory neurons (OSN) cAMP is degraded by phosphodiesterase 1C2 (PDE1C2). Inhibition of PDE1C2 could result in an increased response of OSN to chemical stimuli. Aim of the present prospective post-marketing surveillance study was to investigate the impact of pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.

Official Title
-----------------
Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study

Conditions
-----------------
Olfaction Disorders

Intervention / Treatment
-----------------
* Drug: Pentoxifylline retard 400mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hyposmic or functionally anosmic patients TDI-score <31 age: 18-50 years odor threshold: better than 1 cause of smell loss: post traumatic, postinflammatory, idiopathic Exclusion Criteria: normosmic patients, patients with contraindications for application of pentoxifylline patients that cannot give written agreement to the study patients under 18 years and over 50 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1. | Drug: Pentoxifylline retard 400mg<br>* Agapurin retard 400mg 3/day per os for 3 weeks<br>* Other names: Agapurin retard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TDI-score |  | at day 0 and follow up after 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| odor threshold odor discrimination odor identification |  | at day 0 and at follow up after 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smell, olfaction, olfactory sensitivity, smell loss, chemoreception
Detection of Urinary Stones on ULDCT With Deep-learning Image Reconstruction Algorithm

Study Overview
=================
Brief Summary
-----------------
Urolithiasis has an increasing incidence and prevalence worldwide, and some patients may have multiple recurrences. Because these stone-related episodes may lead to multiple diagnostic examinations requiring ionizing radiation, urolithiasis is a natural target for dose reduction efforts. Abdominopelvic low dose CT, which has the highest sensitivity and specificity among available imaging modalities, is the most appropriate diagnostic exam for this pathology. The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in urolithiasis patients.

Official Title
-----------------
Detection of Urinary Tract Stones on Ultra-low Dose Abdominopelvic CT Imaging With Deep-learning Image Reconstruction Algorithm

Conditions
-----------------
Urolithiasis, Urinary Tract Stones, Renal Colic, Deep Learning Reconstruction

Intervention / Treatment
-----------------
* Diagnostic Test: Abdominopelvic low dose CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old, Patient referred for abdominopelvic CT to confirm urolithiasis or for follow-up, Affiliation to a social security program, Ability of the subject to understand and express opposition Exclusion Criteria: Age <18 years old, Person under guardianship or curators, Pregnant woman, Any contraindications to CT

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Abdominopelvic low dose CT|Patients with urinary stones will undergo multiple computed tomography (CT) examinations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy between low dose CT using DLIR reconstruction and low dose CT without DLIR reconstruction for the detection of urinary tract stones | Accuracy between low dose CT using DLIR reconstruction and low dose CT without DLIR reconstruction for the detection of urinary tract stones. Patients who were referred to the department for abdominopelvic CT exam for urolithiasis diagnostic or follow-up, and had consented to participate in the study, will undergo an additional ultra-low dose acquisition (ULD, <1 mSv) with deep learning-based reconstruction (DLIR). | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urolithiasis, Urinary Tract Stones, Renal Colic, deep learning reconstruction, radiation dose, dose reduction, low dose CT
A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction. The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized. It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will be 2:1 randomization with 9 patients total. Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo. Primary endpoint is death /or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days. 9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.

Official Title
-----------------
Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Myocardial Infarction within 6 hours of symptoms Exclusion Criteria: -

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: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| i) Survival through 12 months ii) Re-hospitalization for CHF through 12 months iii) Improvement in LVEF at days 7 and 12 months iv) Infarct wall thickness at 30 days v) Re-infarction within 30 days v |  | specified above |
Outcome Predictors in Acute Brain Injury

Study Overview
=================
Brief Summary
-----------------
This study will attempt to evaluate clinical, laboratory and radiographic parameters together to assess heir values in outcome prediction from brain injury. Patients will be followed up for a period of 6 months, following admission to ICU, to assess outcome, using the Extended Glasgow Outcome Score (GOSE). We hypothesise that it is possible to reliably predict outcome in brain injury from the current investigations we have at our disposal.

Detailed Description
-----------------
Design- A prospective clinical trial of patients admitted to intensive care with acute brain injury due to trauma. Setting- Intensive Care Unit of the Alfred Hospital Clinical Examination- Day 4 and day 8, ICU consultant to assess prognosis and score patient. Electrophysiology- Day 4 and day 8, SSEP and EEG. Interpretation by person blinded to the patient. CT Brain- Day 1, day 4 and day 8. Interpretation by radiologist blinded to the patient. Blinding- Persons blinded to the patients will make all interpretations of investigations. Mode of brain injury will be made available. Follow up of patients- Structured interviews by telephone will be performed at 6 months post injury with the patient alone, relatives/ friend/ carer alone or patient and relatives/ friend/ carer. These will be performed in relation to the Extended Glasgow Outcome Scale (GOSE). Statistics- The positive and negative predictive values for the tests will be determined.

Official Title
-----------------
Outcome Predictors in Acute Brain Injury, A Pilot Study

Conditions
-----------------
Acute Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glasgow Coma Scale < 9 post resuscitation Intubated and ventilated Traumatic brain injury Exclusion Criteria: Pregnancy

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcome predictors, Acute brain injury
Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of ear acupuncture alone in subjects with a contraindication to anti-inflammatory medications in the reduction of pain and hours lost from work in acute sore throat.

Official Title
-----------------
Ear Acupuncture for Acute Sore Throat in Patients Unable to Take Non-steroidal Anti-inflammatory Agents (NSAIDs)

Conditions
-----------------
Acute Sore Throat

Intervention / Treatment
-----------------
* Device: Ear Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Male and female subjects (DoD beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat. Minimum pain score of 5 points on a 11 point scale (0-10 with 10 being the worst pain) The above with any one of the following: Allergy to Non-Steroidal Anti-inflammatory agents (NSAIDs) History of significant gastrointestinal bleed Previous documented history of stage 2 kidney disease or worse History of gastric bypass surgery Chronic oral steroids use Exclusion: Absence of one or more ears Known Pregnancy Known Peritonsillar abscess (PTA) Throat, mouth or esophageal cancer Active cellulitis of ear Ear anatomy precluding identification of acupuncture landmarks Use of Hearing Aids that preclude the use of ear acupuncture Non-English speaking

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: battlefield auricular acupuncture<br> | Device: Ear Acupuncture<br>* Ear acupuncture utilizes up to 10 needles (see figure 6). If at any point the subject decides not to continue with the placing of the needles, the acupuncture will cease and the number of points will be documented. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero (see figures 1-5).<br>|
| No Intervention: placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain | Does ear acupuncture alone significantly reduce pain in acute sore throat? | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Sore Throat, Ear Acupuncture