linjc16/ctgov huggingface dataset:
A Focused Registry on Anterior Cervical Interbody Spacer ACIS

Study Overview
=================
Brief Summary
-----------------
Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment may require anterior decompression and fusion, which usually is established with a cage implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.

Official Title
-----------------
A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration

Conditions
-----------------
Degenerative Cervical Spine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21 years or older Degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels Degenerative cervical disc disease C3 through Th1 or Ruptured and herniated discs C3 through Th1 Ability to understand the content of the patient information / informed consent form Willingness and ability to participate in the registry according to the registry plan (RP) Signed and dated IRB / EC-approved written informed consent Exclusion Criteria: Spinal tumor Osteoporosis Cervical trauma and instability Any not medically managed severe systemic disease (ie. infection) Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment Pregnancy or women planning to conceive within the registry period Prisoner Participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry Intraoperative exclusion criteria: Intraoperative decision to use implants other than the device under investigation

Ages Eligible for Study
-----------------
Minimum Age: 21 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<br>Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of neck pain on everyday life measured by the Neck Disability Index (NDI). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Numeric Rating Scale | Baseline; 1-2days; 6 weeks; 6 months | 
| Handling details | easiness of using ACIS, overall satisfaction with ACIS, time of surgery | Intraoperative | 
| Length of Hospital Stay | From the day of the surgery until the day of discharge | Expected average of 5 days | 
| Adverse Events |  | Intra and post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical, interbody, spacer, degenerative, pain, neck, decompression, fusion, implant
Quality of Life in Patients With Nonmelanoma Skin Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to learn more about the physical discomfort, sensory impairment, depression, anxiety, and interference with relationships, family, and work associated with NMSC via survey questions.

Detailed Description
-----------------
The purpose of this study is to learn more about the physical discomfort, sensory impairment, depression, anxiety, and interference with relationships, family, and work associated with NMSC via survey questions.

Official Title
-----------------
Quality of Life in Patients With Nonmelanoma Skin Cancer

Conditions
-----------------
Nonmelanoma Skin Cancer

Intervention / Treatment
-----------------
* Behavioral: surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with nonmelanoma skin cancer 18 years of age Exclusion Criteria: non-English speakers minors
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 |
| --- | --- |
| 1<br>nonmelanoma skin cancer patients | Behavioral: surveys<br>* anxiety surveys<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| statistics from results of Skindex survey |  | 1 hour to complete survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| statistics from time-tradeoff utility survey |  | 1 hour to complete survey |
Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%.

Official Title
-----------------
A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin

Conditions
-----------------
Diabetes Type 2

Intervention / Treatment
-----------------
* Drug: Technosphere Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 2 years since diagnosis of type 2 diabetes mellitus Received subcutaneous (sc) insulin for at least 3 months Body Mass Index <44 kg/m2 HbA1c>7.0% and <11.5% Serum creatinine <2.0 mg/dL for males and <1.8 mg/dL for females Baseline FVC and FEV1>70% and < 125% of predicted normal Exclusion Criteria: Significant hepatic disease (AST/ALT3 x ULN) Diagnosis of Type 1 diabetes Severe complications of diabetes History of moderate to severe ketoacidosis within the past 3 months Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days Diagnosis of HIV Positive serology for hepatitis B or C COPD, emphysema, or asthma Current smokers or smoking history within the past 6 months Major psychiatric disorder precluding satisfactory completion of protocol Clinically significant heart disease disease, stroke or heart attack within the past 6 months Treatment with an investigational drug within 30 days Previous treatment with Technosphere/Insulin History of malignancy in the past 5 years except basal cell carcinoma Anemia (hemoglobin <10.5 g/dL for females and <11.5 g/dL (for males) Women who were pregnant of lactating History of hypersensitivity to drugs resembling FDKP carrier products Treatment with another inhaled insulin product during the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Drug: Technosphere Insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in HbA1c from baseline to treatment week 24 |  | 24 weeks |
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

Study Overview
=================
Brief Summary
-----------------
The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser opportunistic infections and/or other conditions associated with ARC.

Official Title
-----------------
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

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

Intervention / Treatment
-----------------
* Drug: Inosine pranobex


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Concurrent Medication: Excluded: Cardiac glycosides. Patients with the following are excluded: AIDS. Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or > 3 months who have not responded to therapy. Critical illness. Hemophilia. Prior Medication: Excluded within 1 month of study entry: Steroids. Cytotoxic immunosuppressive agents. Radiotherapy and/or systemic antiviral medication. Immunomodulators (including Isoprinosine). Prior Treatment: Excluded within 1 month of study entry: Radiotherapy. History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction. Lymphoid malignancy. Homosexual male patients with AIDS related complex (ARC). Current IV drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inosine pranobex|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
-----------------
AIDS-Related Opportunistic Infections, Inosine Pranobex, Homosexuality, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response

Study Overview
=================
Brief Summary
-----------------
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.

Official Title
-----------------
Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Genetic: collection of blood, urine, tumor and ascite samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old. Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study. Patient to be managed by surgery (laparoscopy and / or laparotomy). Exclusion Criteria: Pregnant woman Persons deprived of liberty or guardianship (including curatorship) History of any other clinically active malignancy in the last 5 years prior to inclusion

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: collection of blood, urine, tumor and ascite samples|collection of blood, urine, tumor and ascite samples during ovarian surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests | Number and quality of tumor, blood and urine samples that can be used to perform predictive tests of the response to treatment | Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
predictive tests, ex vivo, tumor models
Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
On the basis of a questionnaire the participation at sports activities of children and adolescents with type 1 diabetes mellitus will be studied. The occurrence of hypoglycemia and hyperglycemia will be evaluated, as well as the measures to prevent these complications.

Official Title
-----------------
A Study on Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- | --- |
| Participation at sports | Detailed description of participation at daily sports in school and outside school | August 2017 | 
| Occurence of hypoglycemia or hyperglycemia |  | August 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures taken to prevent hypoglycemia or hyperglycemia | The ingestion of extra carbohydrates to prevent hypoglycemia and/or the administration of extra insulin to prevent hyperglycemia. | August 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes mellitus, sports, child, adolescent
Dietary Treatment of Hyperlipidemia in Women vs. Men

Study Overview
=================
Brief Summary
-----------------
To conduct a dietary intervention trial to test the lipid lowering response to the National Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and men and to compare the response between them.

Detailed Description
-----------------
BACKGROUND: Women experience as much illness from hardening of the arteries including stroke and heart disease as do men, but because women experience them later in life, the importance of heart disease, cholesterol, and diet for women has been under appreciated. DESIGN NARRATIVE: Half of the subjects were randomized to diet instruction with two years of follow-up and half to six months of no intervention followed by the same diet instruction and followup. Control subjects had a fasting blood drawn at three months of the nonintervention period. Having parallel intervention and control groups was necessary to test the efficacy of the NCEP Step Two Diet: The diet was taught to study subjects during eight weekly two hour classes. Follow-up included four individual visits, at three, six, nine, and twelve months, with a dietitian and two group sessions, at 4.5 and 10.5 months, in the first year and two individual visits, at 18 and 24 months, in the second year. Fasting blood samples for lipoprotein lipid analysis and 4-day food diaries were collected at all individual visits. Additionally, medical history, lifestyle characteristics, vital signs, other adherence measures, behavioral factors related to adherence, and serum nutrients for monitoring nutrient sufficiency were collected. Dietitians provided adherence and dietary modification counseling as necessary to help participants maximize their adherence. The primary questions to be answered were: 1) Did the NCEP Step Two Diet effectively lower plasma lipids in hypercholesterolemic (HC) and combined hyperlipidemic (CHL) women and men over six months? 2) Did HC and CHL women have a different response than HC and CHL men? 3) Was response in women influenced by menstrual status and sex hormone exposure?, and 4) Were the behavioral adaptations to dietary modification different between women and men?

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Falls Prevention in Acute Care Hospital

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of a multifactorial falls prevention program in an acute internal medicine ward.

Official Title
-----------------
Falls Prevention Program in Acute Care Hospital

Conditions
-----------------
Falls

Intervention / Treatment
-----------------
* Other: Multifactorial falls prevention program
* Other: No falls prevention intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to internal medicine ward Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Falls prevention<br> | Other: Multifactorial falls prevention program<br> <br> |
| Placebo Comparator: Usual care<br> | Other: No falls prevention intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| falls rate |  | 2 years |
Genetic Study of Sitosterolemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Identify the genetic defect and fine map the gene that causes sitosterolemia.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients, family members, and normal volunteers provide blood samples for genetic studies and may fill out a general health and medication history. Linkage analysis and microsatellite screening is performed on genomic DNA, especially chromosome 2p21, between microsatellite markers D2S1788 and D2S1352. Positive results may be reported to the patient and may influence future treatment.

Conditions
-----------------
Lipid Metabolism, Inborn Errors, Sitosterolemia

Intervention / Treatment
-----------------
* Procedure: genetic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of sitosterolemia Presence of tendon and tuberous xanthomas Premature atherosclerotic disease No family history of premature coronary artery disease Normal or elevated plasma cholesterol levels OR Family member of patient with sitosterolemia OR Normal volunteer

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: genetic testing|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
-----------------
endocrine disorders, inborn errors of metabolism, rare disease, sitosterolemia
Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.

Official Title
-----------------
Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects

Conditions
-----------------
Respiratory Muscle Function

Intervention / Treatment
-----------------
* Drug: Levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent Exclusion Criteria: use of any prescript medication chronic hiccups pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including diabetes and auto-immune diseases. pre-existent lung disease pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography) pregnancy, breast feeding upper airway / esophageal pathology phrenic nerve lesions any metals in body (pacemaker, splinters, metal stiches)

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levosimendan<br> | Drug: Levosimendan<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Levosimendan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves |  | Multiple measurements within 4 hours after administration of study medication | 
| Fatiguability of the diaphragm |  | Multiple measurements within 4 hours after administration of study medication |