linjc16/ctgov huggingface dataset:
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl

Study Overview
=================
Brief Summary
-----------------
evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia

Detailed Description
-----------------
Hypokalemia is frequently encountered in hospitalized patients. Intravenous (IV) potassium repletion with saline is preferred used for initial therapy. However, administration of normal saline (0.9%NaCl) usually provokes sodium and potassium diuresis, thus, it might delay reversal of the hypokalemia. Object of this study : to evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia.

Official Title
-----------------
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients

Conditions
-----------------
Hypokalemia

Intervention / Treatment
-----------------
* Other: KCl plus 0.9%NaCl
* Other: KCl plus 0.45%NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum K+ 2.5-3.49 mmol/L No life threatening condition from hypokalemia Exclusion Criteria: Pregnancy Volume overload, heart failure Hypotension Acute kidney injury Dysnatremia K+ shift Salt wasting nephropathy

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: 0.9%NaCl<br>KCl plus 0.9%NaCl | Other: KCl plus 0.9%NaCl<br>* comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia<br>|
| Active Comparator: 0.45%NaCl<br>KCl plus 0.45%NaCl | Other: KCl plus 0.45%NaCl<br>* comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with normal serum K as assessed by serum electrolyte |  | 24 hours |
Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.

Detailed Description
-----------------
Type 2 diabetic people will be screened by clinical symptoms of neuropathy and DN4 questionnaire. Among those who did not have neuropathic symptoms or who have DN4 score below 4 will be considered for the study.Then aerobic capacity will be measured by a cycle ergometer and VO2max will be obtained. Weight, body mass index and muscle mass will be measured by bioimpedance analysis. Physical activity status will be determined by International Physical Activity Score (IPAQ). Cognitive function will be evaluated by Mini Mental test. HbA1c and fasting blood glucose will be measured in venous blood after overnight fasting. Blood pressure will be measured in the sitting position after resting from the left arm. Speed of gait will be measured by an accelerometer.Then, the effect of above mentioned factors on speed of gait will be studied.

Official Title
-----------------
Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

Conditions
-----------------
Gait Disorder, Sensorimotor, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: measurement of gait speed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with Diabetes Mellitus less than 10 years but longer than 1 year Absence of neuropathic symptoms DN4 questionnaire sore less than 4 Exclusion Criteria: Individuals who had insulin therapy, poor glycemic control, manifesting cardiovascular disease, retinopathy or other visual problems, diabetic neuropathy, nephropathy, cerebrovascular disease, cognitive impairment, heart failure, alcohol or cigarette dependence, cancer, chemo/radiotherapy, foot ulcer, orthopedical or surgical problems wheel-chair or any assistive devices for ambulation prominent knee or hip arthritis, prosthesis

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: measurement of gait speed|Cross sectional, cohort|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait speed | gait speed measured by wearable accelerometer | The gait speed will be measured once within a month after the participants enrolled. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mini-Mental State Examination, gait, aerobic capacity, HbA1c, muscle, hypertension, glucose
Memantine in Adult Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).

Official Title
-----------------
Memantine in Adult Autism Spectrum Disorder

Conditions
-----------------
Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS

Intervention / Treatment
-----------------
* Drug: memantine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC) Participant has a diagnosis of: Autistic Disorder Asperger's Disorder Pervasive Developmental Disorder (PDD) NOS Participant meets one of the following criteria: CGI-S >= 4 (CGI-S: ________) Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine: _____________________________________________ _____________________________________________ _____________________________________________ Exclusion criteria The patient meets none of the following criteria (mark if absent): Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible). Rett's Syndrome or Childhood Disintegrative Disorder Active treatment with an acetylcholinesterase inhibitor Prior or current treatment with memantine Current treatment with lamotrigine Genetic, metabolic or degenerative disorder (excepting Fragile X). Brain malformation or known severe brain trauma Pregnancy or breastfeeding Glomerular Filtration Rate (GFR) < 30 mL/min

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Treatment as usual plus placebo | Drug: Placebo<br>* Look-alike placebo<br>|
| Active Comparator: memantine<br>Treatment as usual plus memantine | Drug: memantine<br>* memantine 5-20 mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Scale(CGI-S) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS, Adult, Memantine
Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown. Data gathered from previous research studies suggest that genetics may play a role in the development of PF in patients with rheumatoid arthritis. However, the actual genetic factors involved in the disease process have not been identified. The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis and rheumatoid arthritis.

Detailed Description
-----------------
Pulmonary fibrosis that develops within a subpopulation of patients with rheumatoid arthritis is a disorder of unknown etiology. Although previous reports suggest that some individuals with rheumatoid arthritis have a genetic predisposition to the development of fibrotic lung disease, genetic factors have not been clearly identified. It is the intent of this clinical protocol to identify genetic polymorphisms in individuals with pulmonary fibrosis and rheumatoid arthritis.

Official Title
-----------------
Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Identification of Genetic Polymorphisms

Conditions
-----------------
Healthy, Pulmonary Fibrosis, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Individuals 21 years of age or older with any of the following: RA (based on 1987 American College of Rheumatology Revised Criteria for the Classification of RA) with PF (biopsy-proven), or RA-only, or Biopsy-proven idiopathic PF-only, or Healthy research volunteers. EXCLUSION CRITERIA: Individuals with any of the following: Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium). Chronic pulmonary disorders other than pulmonary fibrosis. Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease). Non-rheumatoid arthritis. Viral infections associated with PF (e.g., hepatitis B, hepatitis C, human immunodeficiency virus). Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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
-----------------
Interstitial Lung Disease, Inherited Disease, Genetic Markers, Alpha 1 Protease Inhibitor, DNA Mutations, Rheumatoid Arthritis, Pulmonary Fibrosis, Normal Volunteer
Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.

Official Title
-----------------
A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III Non-Small-Cell-Lung Cancer

Conditions
-----------------
Non-Small-Cell-Lung Cancer

Intervention / Treatment
-----------------
* Drug: carboplatin/gemcitabine
* Procedure: cisplatin/radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cytological or histologically proven NSCLC unresectable stage III NSCLC presence of at least one measurable lesion (RECIST criteria) adequate haematological, renal and hepatic function adequate lung function reserve good condition, weight loss <10% over previous 6 months, life expectancy > 3 months Exclusion Criteria: previous chemotherapy for NSCLC distant metastasis or a pleural or pericardial effusion treatment for malignant disease in the past or serious concomitant medical or psychiatric disease active uncontrolled infection at time of inclusion interstitial lung disease auto-immune systemic disease with potential involvement of the lungs concomitant use of amiodarone

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: carboplatin/gemcitabine|nan|
|Procedure: cisplatin/radiation therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year survival rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Time to intrathoracic failure |  |  | 
| Overall survival |  |  | 
| Toxicity of induction chemotherapy |  |  | 
| Toxicity of chemo-radiotherapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, lung cancer, induction chemotherapy, chemo-radiotherapy
Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand

Study Overview
=================
Brief Summary
-----------------
Ultrasound-guided infiltration is a common procedure and is known to be locally painful. This care-induced pain leads to strong apprehension in patients who need to benefit from this procedure. The practice of hypnosis to improve the patient's comfort during a treatment has appeared progressively in hospital departments. Among the various existing conversational hypnosis techniques, there is the magic glove technique. This is the technique that will be used in this study. The investigators wish to evaluate the interest of hypnosis on the pain felt by the patient when performing an echo-guided infiltration of the hand, one of the most painful extremities during infiltrations.

Official Title
-----------------
Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand

Conditions
-----------------
Hand Injuries

Intervention / Treatment
-----------------
* Procedure: Hypnosis
* Procedure: Infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an indication of a first hand infiltration under ultrasound examination Major patient Patient with capacity to understand the protocol and has given oral consent to participate in the research, Patient with social security coverage. Exclusion Criteria: Patient having preventively applied a pain patch to the area to be infiltrated Contraindication to infiltrations ( imbalanced diabetes, imbalanced,hypertension, ongoing infections). Hearing impaired patient Patient under guardianship/curtel Minor Pregnant woman Patient participating in another intervention research protocol Patient unable to follow the protocol as judged by the investigator.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infiltration<br>Ultrasound-guided hand infiltration | Procedure: Infiltration<br>* Ultrasound-guided hand infiltration<br>|
| Experimental: Hypnosis<br>Hypnosis before Ultrasound-guided hand infiltration | Procedure: Hypnosis<br>* conversational hypnosis technique call the magic glove<br>Procedure: Infiltration<br>* Ultrasound-guided hand infiltration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pain felt in patients who have benefited from a hypnosis session before a hand infiltration versus hand infiltration without hypnosis | Analogical visual scale of pain (VAS) To 0mm (no pain) form 10 mm (maximum pain imaginable) | 5 minutes after ultrasound-guided infiltration of hand |
Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia

Study Overview
=================
Brief Summary
-----------------
Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.

Detailed Description
-----------------
This is a mechanistic study evaluating in a cross-over design the effects of Itopride hydrochloride. The primary objective of this study is to evaluate the acute effects of itopride hydrochloride (200 mg three times daily) on gastric emptying of solid and liquid meal components in patients with type 1 and type 2 diabetes mellitus. Secondary objectives are to evaluate the effects of itopride hydrochloride on the glycaemic response to a meal, meal-related upper gastrointestinal symptoms and intragastric meal distribution.

Official Title
-----------------
Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and Meal-related Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Drug: Itopride
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type-1 and Type-2 diabetic patients 18 to 65 years old Glycated haemoglobin level (HbA1c) below 9% Body mass index (BMI) between 18 and 35 kg/m2 Exclusion Criteria: Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics) Exposure to radiation for research purposes during the previous 12 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* oral, three times daily<br>|
| Experimental: Itopride<br> | Drug: Itopride<br>* oral, three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying assessment |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution |  | weekly |
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)

Study Overview
=================
Brief Summary
-----------------
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers. Trial with medical device

Detailed Description
-----------------
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy (medical device). The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain (questionnaire), size of the calcinosis (ultrasound and CT), new ulcers and intake of painkillers.

Official Title
-----------------
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)

Conditions
-----------------
Calcinosis Cutis in Connective Tissue Disease

Intervention / Treatment
-----------------
* Device: shock wave therapy with Modulith SLK (Storz)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age of 18 Calcinosis cutis due to connective tissue disease information about ESWT given Patient understands the study and signs the informed consent Exclusion criteria: No ESWT done cuagulopathy sepsis pregnancy pace maker severe disease in the opinion of the investigator cardiac risk with NYHA III-IV Ehlers-Danlos-Syndrome

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shock wave therapy<br>intervention: shock wave therapy with Modulith SLK (Storz) | Device: shock wave therapy with Modulith SLK (Storz)<br>* Three sessions with shock wave therapy, interval of one week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain |  | after 6 weeks |