linjc16/ctgov huggingface dataset:
Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

Study Overview
=================
Brief Summary
-----------------
The use of intravitreal corticosteroids in the management ocular inflammatory diseases has recently gained widespread acceptance. The purpose of this study is to determine if the use of intravitreal triamcinolone is associated with suppression of endogenous cortisol production, as generally admitted for patients treated with oral or parenteral corticosteroid therapy.

Detailed Description
-----------------
The normalcy of hypothalamic- pituitary- adrenal axis (HPA axis) of enrolled subjects will will be assessed before intravitreal injection of 4mg of triamcinolone and again after one day, one week and two weeks. Patients with abnormal HPA axis will be re-tested after four weeks and later until the HPA axis function return to normal. The HPA axis will be assessed with low dose (1mcg) intravenous corticotropin(ACTH) stimulation test, in which cortisol levels will be sampled before , 30 minutes and 60 minutes after 1mcg ACTH IV injection.

Official Title
-----------------
Low Dose (1mcg ) ACTH Stimulation Test for Assessment of the Hypothalamo- Pituitary- Adrenal Axis in Patients Treated With Intravitreal Injection of Triamcinolone Acetonide

Conditions
-----------------
Secondary Adrenal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving intravitreous injection of triamcinolone 4mg Exclusion Criteria: patients receiving steroids in any form, except by intravitreous administration

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.

Detailed Description
-----------------
PROTOCOL OUTLINE: This project involves 2 clinical studies. Members of known kindreds participate in Study I; members of kindreds who have not been surveyed, genotyped, or phenotyped participate in Study II. In Study I, participants undergo clinical, hormonal, radiologic, and biochemical studies. Assessment on unrestricted fluid intake includes body weight, urine volume, osmolality, creatinine, sodium, potassium, urea, glucose, arginine-vasopressin (AVP), oxytocin, and aquaporin-II. Participants with diabetes insipidus (DI) undergo a standard fluid deprivation test; those without DI undergo standard water load and hypertonic saline testing. Previously untreated DI patients may be given intranasal or subcutaneous desmopressin or oral chlorpropamide (adults only) for 2 or 3 days. Magnetic resonance imaging of the pituitary-hypothalamic area is performed on all patients with and without gadolinium. Infants and children are studied annually for the first 5 years or until they develop DI. Affected adults are studied every 2-5 years. Unaffected adults are re-tested only if they subsequently report de novo symptoms suggestive of DI. In Study II, participants undergo similar genotype and phenotype testing. Kindreds demonstrating the familial neurohypophyseal diabetes insipidus phenotype and genotype are added to Study I. Kindreds found to have a different type of DI are directed into a companion protocol.

Conditions
-----------------
Diabetes Insipidus, Diabetes Insipidus, Neurohypophyseal

Intervention / Treatment
-----------------
* Drug: chlorpropamide
* Drug: desmopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Verified or suspected familial neurohypophyseal diabetes insipidus with or without an identified mutation of the vasopressin-neurophysin II gene Affected and unaffected members of kindreds entered

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chlorpropamide|nan|
|Drug: desmopressin|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
-----------------
diabetes insipidus, endocrine disorders, rare disease
Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy

Study Overview
=================
Brief Summary
-----------------
The investigators have devised a simple method to continuously measure the CP using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. The investigators have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery and also measure the oxygen concentration in the oropharynx to determine the potential risk of an airway fire.

Official Title
-----------------
Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy

Conditions
-----------------
Otolaryngological Surgery

Intervention / Treatment
-----------------
* Device: Cuff ETT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation Exclusion Criteria: Patient who is intubated with an uncuffed endotracheal tube Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Cuff ETT<br> | Device: Cuff ETT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in intracuff pressure | Changes in intracuff pressure of cuffed ETT related to the position of the patient's head and retractor placement. | during time of surgery |
Prospective Memory in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The investigators tested whether prospective memory is impaired in individuals with Parkinson's Disease compared to controls using reliable and validated experimental measures. Also, the investigators assessed the impact of Parkinson's medication on prospective memory performance in PD to better estimate prospective memory function in PD patients' everyday (chronically treated) life.

Official Title
-----------------
Prospective Memory in Parkinson's Disease

Conditions
-----------------
Memory, Prospective Memory, Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PD Group: Clinically definite PD 40-70 years old Hoehn and Yahr stage I,II,III Currently treated with Levodopa/carbidopa Control Group: 40-70 years old Spouses of PD Group preferred Exclusion Criteria: PD Group and Control Group: Significant neurological problems Significant current psychiatric diagnoses Mini Mental Status Exam score < 24 (MMSE) Any significant abnormality on brain imaging MPTP exposure Control Participants met the same exclusion criteria described above as well as a biological family history of PD

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD Group<br> | |
| Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virtual Week | Prospective Memory Task; Score range is 0-100%, with higher scores being better performance. | One session at baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prospective Memory Performance, Prospective Memory Outcome, Parkinson's Disease
Urell and Pregnancy

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).

Official Title
-----------------
Effect of URELL(Cranberry Vaccinium Macrocarpon)Consumption on the Prevalence of Recurrent Urinary Tract Infection and Asymptomatic Bacteriuria During Pregnancy.

Conditions
-----------------
Urinary Tract Infection (UTI)

Intervention / Treatment
-----------------
* Dietary Supplement: URELL
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pregnant woman in her 4th gestational month or more, having urinary tract infection. Exclusion Criteria: Pregnant woman with organic or functional urinary tract malformations Diabetic patients HIV positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urell<br> | Dietary Supplement: URELL<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Urinary tract infections |  | From the 4th gestational month till the end of pregnancy (about the 40th gestational week) |
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.

Official Title
-----------------
A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis

Conditions
-----------------
Germ Cell Tumor

Intervention / Treatment
-----------------
* Drug: gemcitabine, ifosfamide, cisplatin, G-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 16 years Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP) Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria: Testicular primary site Prior treatment limited to one program (or 6 or fewer cycles of cisplatin) Either a complete response or a partial response with normal serum AFP and HCG Relapse documented by rising AFP and/or HCG or by a biopsy No previous carcinoma, except basal-cell carcinoma of the skin Adequate renal function: measured or calculated creatinine clearance> 60 ml/min Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubin < 1.5 fold the upper normal value Signed informed consent. Exclusion Criteria: Patients infected by the human immunodeficiency virus (HIV) Patients who do not fit inclusion criteria

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

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

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: gemcitabine, ifosfamide, cisplatin, G-CSF|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Progression free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)
DARK STUDY DysbetalipoproteinemiA and atheRoma Risk

Study Overview
=================
Brief Summary
-----------------
Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides. As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis. However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually. The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.

Official Title
-----------------
Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients

Conditions
-----------------
Dysbetalipoproteinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - apo E gene sequencing in CBE (Centre de Biologie Est / Hospices Civils de Lyon / France) laboratory in Lyon until December 2012 Exclusion Criteria: age < 40 years refused participation

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Computed tomographic measurements for coronary-artery calcium | Comparison with eventual previous examinations. | Day one : the coronary calcium score is assessed on the date of measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of carotid intima-media by ultrasonography | Comparison with eventual previous examinations. | Day one : on the date of measurement | 
| Measurement of ankle brachial index | Comparison with eventual previous examinations | Day one : on the date of measurement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dysbetalipoproteinemia, artery calcium score, carotid intima media, ankle brachial index, dysbetalipoproteinemic patients
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

Conditions
-----------------
Pain, Bone Neoplasm, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bondronat]
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with malignant bone disease; patients with moderate to severe pain. Exclusion Criteria: patients who have received a bisphosphonate within 3 weeks from the signing of informed consent; patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing; untreated esophagitis or gastric ulcers; recent or pre-scheduled radiotherapy to bone; patients who are pregnant or breast-feeding.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ibandronate [Bondronat]<br>* 6mg iv on days 1-3, and 50mg po from day 22 to week 24<br>|
| Active Comparator: 2<br> | Drug: zoledronic acid<br>* 4mg iv on day 1, and every 3-4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, as measured by Brief Pain Inventory and analgesic use |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance score and QoL measures |  | Week 24 | 
| AEs and laboratory parameters |  | Throughout study | 
| Opioid side effects |  | Throughout study | 
| Skeletal-related events |  | Throughout study |
Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?

Study Overview
=================
Brief Summary
-----------------
The Swiss company mementor has recently developed an interactive self-help intervention for the treatment of insomnia entitled mementor somnium. This programme is based on the guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online sessions. An animated personal sleep coach provides relevant audio-information and asks questions to which the patient is invited to respond. The components of the programme flexibly adapt to the patient's responses. Aside from psycho-education, exercises and an instruction for sleep restriction, mementor somnium includes a cognitive restructuring intervention in terms of a Socratic dialogue. This Socratic dialogue, implemented by the animated sleep coach, is based on a complex algorithm in the shape of an decision tree. University of Zurich's Department of Psychology in Switzerland will test the effectiveness of mementor somnium in a randomised controlled trial with three assessment times (pre, 6-weeks post and 3-months follow-up). Patients suffering from insomnia will be allocated randomly to either the active intervention group or the waitlist control group. Participants will have access to the programme mementor somnium for six weeks. Primary outcome measure is the Insomnia Severity Index, secondary outcome measures are Beck Depressions-Inventory revised (BDI-II), Brief Symptom Inventory 18, and the SF-12 Health Survey. Additionally, sleep diary data will be collected.

Conditions
-----------------
Insomnia Disorder

Intervention / Treatment
-----------------
* Device: mementor somnium
* Other: wait list


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnia Disorder (DSM-5) German language comprehension Internet-access Exclusion Criteria: Other sleep disorder Suicidality Current psychotherapy Drug abuse or recent change in medication

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>mementor somnium | Device: mementor somnium<br> <br> |
| Other: Waitlist<br> | Other: wait list<br>* delayed access to mementor somnium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index |  | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | Six weeks | 
| Brief Symptom Inventory 18 |  | Six weeks | 
| SF-12 Health Survey |  | Six weeks |