linjc16/ctgov huggingface dataset:
Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects

Official Title
-----------------
A Phase-I, Two-Stage, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Trial of Low Doses of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects.

Conditions
-----------------
Opiate Addiction

Intervention / Treatment
-----------------
* Drug: 6β-Naltrexol escalating doses from 0.05-0.5 mg IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Opiate dependent males and females age 21-45 on stable doses of methadone Fluent English speaker Willing and able to give written consent Exclusion Criteria: Pregnancy or lactation FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 6β-Naltrexol escalating doses from 0.05-0.5 mg IV|Drug: Naloxone 0.1 mg IV/5 minutes to all subjects to determine tolerability to precipitated withdrawal during screening. Those that tolerate withdrawal proceed to Stage 1: Drug: Lactulose 10 gm orally plus 3 IV infusions 30 minutes apart of Naloxone 0.1 mg IV and 2 placebo given randomly to all subjects. If tolerated, proceed to 5 additional medication dosing sessions with all subjects receiving oral Lactulose 10 GM plus IV escalating 6β-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 6β-Naltrexol will have 13 hr half-life. Plasma collected |  | -0-24 hrs post dose | 
| - 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected |  | 0-8 hrs post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -6β-Naltrexol will have a lower potency in precipitating withdrawal and be better tolerated than Naloxone assessed by vital signs, objective/subjective ate Withdrawal Scales, Visual Analog Scales, Pupil Size and GI Motility measures |  | 0-8 hrs post dose | 
| 6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests |  | 0-8 hrs post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Naloxone, 6β-Naltrexol, Opioid-dependent, Pharmacokinetics, peripheral effects of withdrawal, central effects of withdrawal
Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory. The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.

Official Title
-----------------
A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma

Conditions
-----------------
Lymphoma, T-Cell

Intervention / Treatment
-----------------
* Drug: Concurrent Radiotherapy (RT)/cisplatin, VIPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed NK/T-cell lymphoma Localized (Ann Arbor stage I/II) disease At least one measurable lesion Age > 18 ECOG performance status 0 - 2 Expected life span of at least 12 weeks Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3) Normal liver function (total bilirubin < 2x upper limit of normal [ULN], transaminase < 3x ULN) Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min) Written informed consent Exclusion Criteria: Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure) Acute or active infection requiring intravenous (IV) antibiotics Pregnant, lactating women Previous history of chemotherapy or radiotherapy Concomitant medication that may influence the study drugs Allergic reaction to study drugs Grade 2 or greater peripheral neuropathy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Concurrent Radiotherapy (RT)/cisplatin, VIPD|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
-----------------
Lymphoma, NK/T-Cell
Management in Intensive Care Unit of Life-threatening Keto-Acidosis

Study Overview
=================
Brief Summary
-----------------
Patients hospitalized in intensive care between January 2014 and September 2021 for ketoacidosis complicated by organ failure in participating departments.

Detailed Description
-----------------
Analysis of patients with International Statistical Classification of Diseases and Related Health Problems coding compatible with inclusion Selection of patients eligible for inclusion based on review of medical records (verification of inclusion and non-inclusion criteria) Telephone contact and sending of the information letter on participation in the study and research of the patient's non-opposition to his participation and the processing of his data. Collection of retrospective data Phone call to collect prospective data

Official Title
-----------------
Management in Intensive Care Unit of Life-threatening Keto-Acidosis

Conditions
-----------------
Ketoacidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major (age ≥ 18 years old) Hospitalized in intensive care between January 2014 and September 2021 for ketoacidosis complicated by organ failure in the participating departments. Diagnosis of ketoacidosis judged to be the main cause of the severity of the clinical condition. Blood potential hydrogen < 7.15 and bicarbonates < 10mmol/L in the first 12 hours of treatment. Presenting at least one of the 3 organ failures during hospitalization among: Use of extra-renal purification for acute renal failure Administration of pressor amines Use of mechanical ventilation Exclusion Criteria: Metabolic acidosis primarily of an origin other than ketonic Refusal to participate or opposition to the processing of their data Patient under guardianship or curators

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 |
| --- | --- | --- |
| evaluate the incidence of mortality in intensive care units of patients hospitalized for severe diabetic ketoacidosis. | Percentage of mortality in intensive care units in patients admitted for ketoacidosis complicated by organ failure. | up to 6 months |
Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Steinert's disease is an orphan disease. The prognosis of patients with this disease is conditioned by cardiac involvement. Search an early stage alterations in contractile function in subjects suffering from dystrophy would detect patients at risk of sudden death. The first stage of work is to validate the tools to detect early stage of infringement systolic function in a population of patients with myotonic dystrophy.

Conditions
-----------------
Steinert's Disease

Intervention / Treatment
-----------------
* Procedure: electrocardiogram
* Procedure: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from muscular dystrophy type 1 followed CHU Poitiers. age ≥ 18 years Exclusion Criteria: duration QRS> 120 ms ECG permanent ventricular stimulation trouble segmental kinetic obvious to echocardiography in visual analysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: electrocardiogram|nan|
|Procedure: Echocardiography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular Ejection Fraction Left 3D |  | Immediately | 
| Global longitudinal systolic Strain |  | Immediately | 
| Strain of the dispersion index |  | Immediately |
Outcome of Radiation Therapy in Urinary Bladder Squampus Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Detection of distribution of clinico-pathological features of squamous cell carcinoma of urinary bladder and their relation to treatment outcome.

Official Title
-----------------
Outcome of Radical Radiation Therapy in Squampus Cell Carcinoma

Conditions
-----------------
Urinary Bladder Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-70 . histologically proved urinary bladder squamous cell carcinoma. non-metastatic disease. all patients who underwent radical treatment or bladder preserving approach. patient with isolated urinary bladder carcinoma (no other or previous primary). Exclusion Criteria: age < 18 , > 70. patient not documented having bladder squamous cell carcinoma by biopsy (cystoscopic or operative). metastatic disease. patient with synchronous or metachronous double primary

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy|Radiotion therapy squamous cell carcinoma in cancer bladder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival | baseline |
5D LB Ultrasound in Determination of Fetal Weight in Normal Pregnancy : A Pilot Study

Study Overview
=================
Brief Summary
-----------------
5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.

Official Title
-----------------
Accuracy of Five Dimensional Ultrasound Long Bones Fetal Biometry (5DUS LB ) for Prediction of Fetal Weight Compared to Two Dimensional Ultrasound: a Pilot Study

Conditions
-----------------
Fetal Weight

Intervention / Treatment
-----------------
* Other: 2D and 5D LB ultrasound comparison for fetal weight estimation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-40years singleton pregnancy normal pregnancy Exclusion Criteria: Intrauterine fetal death multiple pregnancy congenital anomaly nonvisualized fetal parts by ultrasound maternal medical disorders like diabetes and hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal pregnant women<br>Normal pregnant women between 37 and 42 weeks gestation. | Other: 2D and 5D LB ultrasound comparison for fetal weight estimation<br>* 2D and 5DUS LB will be done for term pregnant women and fetal weight will be estimated by the hadlock formula. Accuracy of estimated fetal weight by both techniques will be compared to actual birth weight.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of 5D LB ultrasound in determining fetal weight (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight) |  | 48hours |
A Modernized Approach to Prenatal Care in Low Risk Women

Study Overview
=================
Brief Summary
-----------------
The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.

Official Title
-----------------
A Modernized Approach to Prenatal Care in Low Risk Women

Conditions
-----------------
Pre-eclampsia, Intrauterine Growth Retardation

Intervention / Treatment
-----------------
* Other: Modernized prenatal care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 35 Doesn't live alone Current phone number Previous pregnancy No prior second trimester miscarriage/fetal loss after 13 weeks Previous delivery If yes, all had uncomplicated antepartum course All Deliveries > 37 weeks All birth weight > 2700 grams Maternal BMI between 18.5 and 30 No chronic medical problems No current substance abuse Spontaneous conception No family history of pre-eclampsia Agrees to first trimester aneuploidy screening Exclusion Criteria: Clinically significant abnormalities on routine physical exam or routine laboratory results Multiple pregnancy Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency > 3 mm but not including second trimester markers for aneuploidy or a low lying placenta A risk of fetal aneuploidy on first trimester screening > 1:300 PAPP-A < 5 %ile or HCG < 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome) Elevated blood pressure (> 140/90), Cervical length < 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).

Ages Eligible for Study
-----------------
Maximum Age: 35 Years

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

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: Low risk patients<br>Patients who agreed to 4 telemedicine obstetrical visits | Other: Modernized prenatal care<br>* Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unanticipated pregnancy complications | Any maternal and/or fetal adverse outcome that was not detected, but could have been detected by routine antepartum visits between 18 and 36 weeks | Gestational age 18-36 weeks |
Revival of Stem Cells in Addison's Study

Study Overview
=================
Brief Summary
-----------------
Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune Addison's disease (AAD) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of ACSC activity is a realistic possibility.

Official Title
-----------------
Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease

Conditions
-----------------
Adrenal Failure

Intervention / Treatment
-----------------
* Drug: depot tetracosactide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established autoimmune adrenal failure for >1yr age 16 to 65 Exclusion Criteria: Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy Asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease Pregnancy, breast feeding or plan for pregnancy within 9 months Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.) Known hypersensitivity or allergy to Synacthen

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 66 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: Synacthen<br>active treatment | Drug: depot tetracosactide<br>* 1mg, 3x weekly by sc injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak serum Cortisol following ACTH stimulation |  | Tested at 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QoL |  | 20 weeks |
Causes of Appetite Loss in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The project looks at causes of appetite loss in patients with COPD. It is know that active systemic inflammation can lead to appetite loss and COPD is classified as a disease lead by inflammation. But it has never been investigated if the patient with COPD has other causes of appetite loss such as physical, psychological or social barriers for not reaching a sufficient dietary intake. The study uses a homemade questionnaire, the CAT-scale and the CNAQ-score to evaluate the extent of appetite loss and certain demographic characteristics of the participants. There will be made correlation analysis for CNAQ-score and continuous variables and there will be tested for significant differences between the group who scores as low appetite and the group that scores with a normal appetite via CNAQ. The second part of the study invites patients to participate in a semi-structured interview, that focuses on the patient's experience with appetite loss, meals and food. The interviews will be transcribed and analysed.

Official Title
-----------------
Causes of Appetite Loss in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: Council of Nutrition Appetite Questionnaire - test for applicability in Danish COPD patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD diagnosis Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Council of Nutrition Appetite Questionnaire - test for applicability in Danish COPD patients|Council of Nutrition Appetite Questionnaire - test for applicability in Danish COPD patients and for correlation of scores with lung function, CAT-score and other|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNAQ-score | Appetite questionnaire to divide participants in either normal appetite or loss of appetite | 6 months |