linjc16/ctgov huggingface dataset:
Colour Coded Duplex Ultrasound of Native Arterio-venous Fistula for Haemodialysis With Venous Pressure Measurement Using Controlled Compression Ultrasound as a Predictor for Shunt Maturation in the Early Postoperative Phase

Study Overview
=================
Brief Summary
-----------------
Prospective observational ultrasound study of native arterio-venous fistula for haemodialysis with venous pressure measurement using controlled compression ultrasound.

Conditions
-----------------
Renal Insufficiency

Intervention / Treatment
-----------------
* Procedure: Ultrasound (Pressure measurement)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients after creation of a native arterio-venous fistula at the cephalic vein for hemodialysis access; Informed consent. Exclusion criteria: Former creation of a native arterio-venous fistula at the same arm; Known upper extremity occlusive arterial disease; Situation when ultrasound examination is not suitable: extreme swelling of the arm, post-operative pain, hematoma, local infections.

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

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound (Pressure measurement)|cut-off value for non maturationg fistulas|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Assessment of Pubertal Growth Spurt in Growing Girls Using Middle Phalynx Finger and Correlate With Mandibular Second Molar

Study Overview
=================
Brief Summary
-----------------
Assessment of Pubertal Growth Spurt in Growing Egyptian Females Using Modified Middle Phalanx of The Middle Finger Stages and Its Correlation With Development Stage of Mandibular Second Molar

Detailed Description
-----------------
The sample will be selected randomly from different schools in the government. Digital periapical radiograph for the middle finger for each participants will be taken using Digital x-ray portable machine. Radiographical images will be stored in a digital sensor to be transferred to computer then we asses growth spurt in girls and correlate it with devlopemt stage of mandibular second molar

Official Title
-----------------
Assessment of Pubertal Growth Spurt in Growing Egyptian Females Using Modified Middle Phalanx of The Middle Finger Stages and Its Correlation With Development Stage of Mandibular Second Molar in Al Sharkia Governorate

Conditions
-----------------
Growth Alteration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian citizen Exclusion Criteria: Systemic disease and syndromes Severe crowding

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the time of pubertal growth spurt in growing Egyptian | Taking xray of middle phalynx finger and then asses age of growth spurt through stages of middle phalynx finger | 3month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| females. Assessment the correlation between the modified middle phalanx of the middle finger and development stage of mandibular second molar | By taking xray mandibular second molar then make correlation between stages of both to estimate age for pubertal growth spurt for females | 3month |
Observation of Initial Procalcitonin and the Clinical Course of Patients With Acute Respiratory Tract Infections

Study Overview
=================
Brief Summary
-----------------
Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.

Detailed Description
-----------------
Primary endpoint: initial Procalcitonin values of patients with Acute Respiratory Tract Infections Secondary endpoints: correlation of initial Procalcitonin values to classify Acute Respiratory Tract Infections correlation of initial Procalcitonin values to subjective severity of Acute Respiratory Tract Infections correlation of initial Procalcitonin values to antibiotic- prescriptions correlation of initial Procalcitonin values to frequency of admission to hospital correlation of initial Procalcitonin values to frequency of referrals (radiology, pneumology)

Official Title
-----------------
Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover

Conditions
-----------------
Respiratory Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent all types of respiratory tract infection according to investigator´s diagnosis Exclusion Criteria: pretreatment with antibiotics in the past 2 weeks portal hypertension Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease) Peritoneal dialysis Acute treated or recently operated medullary c-cell-carcinoma, SCLC, carcinoid Other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary care, procalcitonin, acute respiratory tract infection
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture

Study Overview
=================
Brief Summary
-----------------
a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.

Detailed Description
-----------------
this study aimed to compare the adhesion of microorganisms to the non metallic denture base of PEEK and metallic denture base of cobalt chromium alloy in patients with class III modification 1

Official Title
-----------------
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture

Conditions
-----------------
Polyetheretherketone

Intervention / Treatment
-----------------
* Device: PEEK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients are medically free Exclusion Criteria: patients with badly broken abutments

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non metallic<br>PEEK denture base, | Device: PEEK<br>* a metallic denture base<br>* Other names: cobalt chromium alloy denture base;|
| Placebo Comparator: metallic denture base<br>cobalt chromium alloy denture base | Device: PEEK<br>* a metallic denture base<br>* Other names: cobalt chromium alloy denture base;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbial culture using number of clonies after insertion by 3 months | microbial adhesion will be measured using continous cultures to assess number of colonies | one year |
OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

Study Overview
=================
Brief Summary
-----------------
Prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.

Official Title
-----------------
Randomized Evaluation of Vascular Healing After Implantation of Sirolimus Eluting Stent Inspiron™ Versus Its Own Bare Metal Version- An OCT Evaluation After 3 Months Follow-up

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Sirolimus Eluting Stent Inspiron
* Device: Bare Metal Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or two de novo lesions (> 50% visual estimation) lesion diameter between 2.5 and 3.5 mm lesion length up to 33 mm. Exclusion Criteria: MI within the last 72 hours restenotic lesion.

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: Inspiron<br>Sirolimus Eluting Stent Inspiron | Device: Sirolimus Eluting Stent Inspiron<br>* Angioplasty with Sirolimus Eluting Stent Inspiron implantation<br>|
| Active Comparator: Cronus<br>Bare Metal Stent | Device: Bare Metal Stent<br>* Angioplasty with Bare Metal Stent Cronus implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Percentage of strut coverage by OCT | 3 months |
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.

Official Title
-----------------
A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: CT-388
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 18-65 years old, inclusive BMI 27.0-40.0, inclusive Stable body weight for 2 months Exclusion Criteria: Significant medical history Uncontrolled hypertension History of malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-388<br>SC dose of CT-388 | Drug: CT-388<br>* Synthetic Peptide<br>|
| Placebo Comparator: Placebo<br>SC dose of placebo matching CT-388 dose | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events as assessed by self-report | Safety and tolerability | Baseline up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration versus time curve (AUC) | PK AUC | Baseline up to 6 weeks | 
| Maximum observe drug concentration (Cmax) | PK Cmax | Baseline up to 6 weeks | 
| Elimination half-life | PK t1/2 | Baseline up to 6 weeks | 
| Change in mean body weight | PD body weight | Baseline up to 6 weeks | 
| Change in mean glucose levels | PD glucose | Baseline up to 6 weeks | 
| Change in mean insulin levels | PD insulin | Baseline up to 6 weeks |
A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment

Study Overview
=================
Brief Summary
-----------------
This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be divided into 4 groups, with normal renal function, or mild, moderate or severe renal impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The anticipated time on study treatment is <3 months (single dose study)and the target sample size is <100 individuals.

Official Title
-----------------
Effect of Renal Impairment on Pharmacodynamics and Pharmacokinetics of RO4998452: A Multiple-center, Open-label, Parallel Group Study Following Single Oral Dosing of RO4998452 to Type 2 Diabetes Patients With Varying Degrees of Renal Impairment.

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

Intervention / Treatment
-----------------
* Drug: RO4998452


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 40-80 years of age; type 2 diabetes; normal renal function, or impaired but stable renal function; stable with regard to medication or treatment regimen taken for renal impairment or diabetes. Exclusion Criteria: patients with a renal transplant; end-stage renal disease, requiring dialysis; nephrotic syndrome, or a history of nephrectomy; type 1 diabetes mellitus.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 (normal)<br> | Drug: RO4998452<br>* 20mg po single dose<br>|
| Experimental: 2 (mild)<br> | Drug: RO4998452<br>* 20mg po single dose<br>|
| Experimental: 3 (moderate)<br> | Drug: RO4998452<br>* 20mg po single dose<br>|
| Experimental: 4 (severe)<br> | Drug: RO4998452<br>* 20mg po single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance; Pk parameters; adverse events |  | Days 1-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose; meal tolerance test |  | Days 1-3 |
Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction

Official Title
-----------------
Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

Conditions
-----------------
Esophagogastric Junction Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytological proved locally advanced esophagogastric junction cancer ECOG performance status ≦2 Stage IIa-IIIc No distant metastasis (M0) Sign in Informed Consent Form Exclusion Criteria: History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product Pregnancy or lactation women, Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3 Inadequate organ function which is defined as below: Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation); Symptomatic peripheral neuropathy Receiving a concomitant treatment with other fluoropyrimidines Fluoropyrimidines (DPD) congenital absence

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 |
| --- | --- |
| neoadjuvant therapy group<br>Preoperation chemotherapy treatment for patients up to four cycles | |
| adjuvant therapy<br>Postoperation chemotherapy treatment for patients up to six cycles | |
| Perioperative therapy<br>Preoperation chemotherapy treatment for patients up to four cycles and postoperation chemotherapy up to six cycles | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival(DFS) | time from surgery to disease recurrence or death | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | time to death | up to 5 years | 
| Adverse events(AE) | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 4.03. | through study completion, up to 1 year |
Dermacyd Silver Floral (Lactic Acid) - Acceptability.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To prove the safety of the gynaecological formulation in normal conditions of use.

Official Title
-----------------
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral vaginal mucosa in the product analysis region Use the same category of cosmetics products Willingness in following the study procedures and to be present in the clinic at the days and scheduled time Exclusion criteria: Use of Anti-inflammatory, immunossupression or antihistaminics drugs Allergic or atopic history to cosmetics products Cutaneous active disease (local and/or general) in the evaluated area Disease which can cause immunosuppresion, such as diabetes, HIV Endocrinology pathology such as thyroid gland, ovary and adrenal gland Intensive solar exposure until 15 days before evaluation Gynecological treatment until four weeks before the study Other reason considered by the investigator as a reason for not being included. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd Silver Floral (Lactic Acid)<br>Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days | Drug: LACTIC ACID(ND)<br>* treatment period: 21 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction. |  | From the treatment start to the end of the study (treatment period 21 days) |
Use of Fitbits During Breathing Meditation

Study Overview
=================
Brief Summary
-----------------
This study will examine short breathing meditations paired with Fitbit technology in order to assess mindfulness and track physical activity. Measures including heart rate, physical activity, sleep patterns, as well as assessments of well-being and anxiety levels, will be examined.

Official Title
-----------------
Use of Fitbits During Breathing Meditation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Breathing meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years. Currently a student, faculty, or staff member at university where research is being completed. Able to wear a Fitbit close to 24 hours a day for two weeks. Exclusion Criteria: Younger than 18 years. Has previously practiced meditation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Uses Fitbit, does not participate in breathing meditation. | |
| Experimental: Meditation<br>Uses Fitbit and participates in brief, daily breathing meditation. | Behavioral: Breathing meditation<br>* Daily, 5-minute breathing meditation for one week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mindfulness | Mindful Attention Awareness Scale (MAAS) | Baseline and 2 weeks post | 
| Change in Anxiety and Depression | Hospital Anxiety and Depression Scale (HADS) | Baseline and 2 weeks post | 
| Change in Well-being | Mental Health Continuum Short Form (MHC-SF) | Baseline and 2 weeks post | 
| Change in Worry | UMC Penn State Worry Questionnaire | Baseline and 2 weeks post | 
| Change in Program Feasibility and Acceptability | Surveys created by researcher | Baseline and 2 weeks post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep | Duration and type of sleep measured using Fitbit | Throughout 2 week study | 
| Change in Heart Rate | Fitbit | Throughout 2 week study | 
| Change in Steps | Fitbit | Throughout 2 week study | 
| Change in Calories | Fitbit | Throughout 2 week study | 
| Change in Exercise | Types of exercise and duration | Throughout 2 week study |