linjc16/ctgov huggingface dataset:
Evaluation by HR-pQCT of Bone Microarchitecture Changes in Patients With Rheumatoid Arthritis Under Anti-TNF Therapy.

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease in adults and is characterized by chronic inflammation of the joints leading to their destruction, resulting in a major loss of function. The investigators propose a pilot study for studying changes in bone microarchitecture with High Resolution peripheral micro Computerized Tomography (HR-pQCT) in patients with RA treated with anti-TNF(Tumor Necrosis Factor), with the measurement of micro-architectural parameters in subchondral area near an inflammatory joint during the first 12 months of initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).

Official Title
-----------------
Evaluation by HR-pQCT of Bone Microarchitecture Changes in Patients With Rheumatoid Arthritis Under Anti-TNF Therapy.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: HR-pQCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men from 18 to 65 years old Women from 18 years old to menopause Patient with a polyarthritis rheumatoid no controlled by the usual treatment (DAS28>3) Patient affiliated or beneficiary of a national insurance system Patient with signed consent Exclusion Criteria: Concomitant osseous disease (Paget's disease, osteomalacia...) Endocrinopathy defined on biological criteria (Cushing's disease, hyperthyroidism, hypogonadism...) Patients under protection of justice Refusal consent

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with anti-TNF therapy<br>patients with rheumatoid polyarthritis inadequately controlled by a conventional treatment, occurring during the first 12 months of initiation of an anti-TNF therapy | Device: HR-pQCT<br>* HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at radius levels in humans.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trabecular volume (bone volume / tissue volume) in percent for bone microarchitecture measured by HR-pQCT | Describe changes to trabecular volume of the distal radius in subchondral area in patients with rheumatoid polyarthritis inadequately controlled by a conventional treatment, occurring during the first 12 months of initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®). | 12 months after intitiation of anti-TNF treatment |
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC

Study Overview
=================
Brief Summary
-----------------
There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.

Official Title
-----------------
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

Conditions
-----------------
Oral Cancer, Oropharynx Cancer

Intervention / Treatment
-----------------
* Procedure: Radiotherapy 50 Gy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oral and oropharynx (exclusion vallecula) squamous cell carcinoma T1 or T2 unique, untreated tumor N0 or nodes <3cm complete pathological resection no perineural spread, vascular emboli <5 pN0 or <=2N+R- signed inform consent Exclusion Criteria: Vallecula carcinoma

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 |
| --- |
|Procedure: Radiotherapy 50 Gy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| loco-regional control |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, oral and oropharynx carcinoma, postoperative radiotherapy, molecular analysis, microsatellite instability
Oxytocin and Emotion Processing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether oxytocin influences emotional processing and learning of emotional and social stimuli.

Detailed Description
-----------------
An effect of OXT on emotion processing and anxiety has been broadly investigated in animal studies. However, in humans, effects seem more complex. The rationale of the study is to examine direct effects of OXT to processing and learning of emotional and social values in humans.

Conditions
-----------------
Healthy Males

Intervention / Treatment
-----------------
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers Exclusion Criteria: Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers MRI contraindication

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

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>Oxytocin: Syntocinon-Spray, Novartis intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT | Drug: Oxytocin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo nasal spray | Drug: Oxytocin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity | fMRI | During emotion processing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychophysiological response | Skin conductance response | During stimuli presentation |
Modified Providence Pedi Cast-Sling vs.Cast and Sling

Study Overview
=================
Brief Summary
-----------------
Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.

Official Title
-----------------
Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial

Conditions
-----------------
Fractures, Bone, Pediatric ALL

Intervention / Treatment
-----------------
* Device: Providence Pedi Cast-Sling
* Device: Regular sling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 0-18 years old who were evaluated in the pediatric emergency department (ED) by the orthopaedic resident on call patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast. Exclusion Criteria: open fractures fractures at multiple levels (e.g. wrist AND elbow fracture) fractures requiring immediate/urgent surgery patients requiring admission for any reason bivalved LAC's for any reason

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Active Comparator: Regular sling<br> | Device: Regular sling<br> <br> |
| Experimental: Cast-sling<br> | Device: Providence Pedi Cast-Sling<br>* Custom made sling with readily available casting materials<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction scores |  | 1 week |
Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

Study Overview
=================
Brief Summary
-----------------
Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.

Detailed Description
-----------------
The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.

Official Title
-----------------
Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5

Conditions
-----------------
Pain, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal hysterectomy (LAVH) under general anesthesia Patients who want to use intravenous patient controlled analgesia (PCA) after surgery ASA physical status class I, II Exclusion Criteria: history of drug addiction opioid medication within 12 hours before surgery previous history of opioid medication for 3 months neurologic disorder cardiac disorder hepatic disease renal disease respiratory disease such as COPD, asthma sleep apnea BMI > 30 psycotic disorder

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
| Postoperative Cumulative Fentanyl Consumption |  | 24 hr after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Cumulative Fentanyl Consumption |  | 48hr after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacogenetics
Predictive Value of Dynamic Combination of BNP and NGAL for the Prognosis of Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
Objective: to clarify the predictive value of brain natriuretic peptide (BNP) in combination with neutrophil gelatinase associated lipocalin (NGAL) for the prognosis of patients with sepsis.

Official Title
-----------------
Predictive Value of Dynamic Combination of B-type Natriuretic Peptide and Neutrophil Gelatinase-associated Lipocalin for the Prognosis of Patients With Sepsis

Conditions
-----------------
28-day Mortality, Sepsis

Intervention / Treatment
-----------------
* Other: BNP and NGAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years and <85 years; presence of severe sepsis according to Survival Sepsis Campaign 10; all patients voluntarily joined this study with informed consents. Exclusion Criteria: participated in other trials within 30 days before the criteria for this trial were met; expected to die within 24 hours; pregnant; advanced malignancy with life expectancy <6 months; history of congestive heart failure; chronic renal dysfunction (baseline creatinine >176.8μmol/L); and relatives were unwilling to agree to the use of full life support.

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: Screening
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Low BNP and Low NGAL Group<br>BNP≤100pg/ml and NGAL≤153pg/ml | Other: BNP and NGAL<br> <br> |
| Active Comparator: High BNP and Low NGAL Group<br>BNP>100pg/ml and NGAL≤153pg/ml | Other: BNP and NGAL<br> <br> |
| Active Comparator: Low BNP and High NGAL Group<br>BNP≤100pg/ml and NGAL>153pg/ml | Other: BNP and NGAL<br> <br> |
| Active Comparator: High BNP and High NGAL Group<br>BNP>100pg/ml and NGAL>153pg/ml | Other: BNP and NGAL<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-ventilator synchrony for 30mins |  | 30mins after the patients involved | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the numbers of days in the ICU between day 1 and day 28 |  | the numbers of days in the ICU until day 28 | 
| Mechanical ventilation duration between day 1 and day 28 |  | days of mechanical ventilation between day 1 and day 28 | 
| 28-day mortality |  | 28 days after the patients involved | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BNP, NGAL, Sepsis, Mortality
Hypertensive Treatment and Epidemiological Analyses

Study Overview
=================
Brief Summary
-----------------
To determine the impact of the treatment of hypertension on the epidemiological analyses of blood pressure from observational studies.

Detailed Description
-----------------
BACKGROUND: With the use of antihypertensive medication increasing steadily over the last 25 years, treatment for hypertension is now common. Given the high prevalence of treatment for hypertension, researchers can no longer assume that participants in epidemiologic studies represent natural blood pressure measures, as opposed to treated blood pressure measures. The effect of this high prevalence of treatment, however, has not been fully investigated. Although it might seem that studies of natural history are no longer relevant, great interest currently exists in establishing both environmental and genetic determinants of blood pressure. Additionally, there currently is a renewed interest in refining treatment guidelines. For example, the need to account for absolute as well as relative risk has been hotly debated in recent years. The need will continue to exist, therefore, to analyze observational data sets to meet the evolving interest in the determinants of blood pressure and to meet the requirements for more refined risk estimates. DESIGN NARRATIVE: To investigate the effect of blood pressure treatment on the analysis of epidemiologic studies, the investigators conducted two interrelated analyses using simulation studies and data from five observational studies: The Framingham Heart Study; the NHANES I, II, and III cohorts; and The International Collaborative Study of Hypertension in Blacks (ICSHIB). They first conducted simulation studies to examine the behavior of different methodologies in each of two common analytic settings: relating body mass index to level of systolic blood pressure and relating level of systolic blood pressure to coronary heart disease mortality. They planned to use the data from the five studies to derive the parameters for use in the simulation studies. In these studies they quantified the level of bias that results from ignoring the presence of blood pressure treatment in observational data. After conducting their simulations studies, they repeated the analysis of the relationship between body mass index and systolic blood pressure using available empirical data. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Hypertension, Heart Diseases, Coronary Disease

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 |
| --- | --- | --- |
Prehospital Screening to Prevent Injury and Illness

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to prevent injuries and diseases among older adults through the development and evaluation of a novel emergency medical services (EMS)-based screening program to identify preventable injuries and diseases and refer the identified injuries and diseases for intervention. To prevent injuries and diseases among older adults, this study specifically aims to: Evaluate the feasibility of an EMS-based primary prevention program that screens older adults for need of the influenza and pneumococcal vaccine and for risk of falling during emergency medical responses in a rural setting; Evaluate the outcome of the EMT-implemented screening and education program by performing a 14-day telephone follow-up on older adults cared for by EMTs. At the conclusion of this award, we will determine if an EMT-implemented primary prevention program for older adults is feasible and benefits the community.

Official Title
-----------------
Prehospital Screening to Prevent Injury and Illness

Conditions
-----------------
All Conditions

Intervention / Treatment
-----------------
* Procedure: Education and referral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 or older; Request assistance from intervention group EMS agency Request assistance from control group EMS agency Request assistance between February 2003 and June 2005 Exclusion Criteria: Institutionalized Previous inclusion in study Unable to communicate in English

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Education and referral|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of immunizations |  |  | 
| Changes to home to prevent falls |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discussion with physician regarding preventable diseases |  |  | 
| Recollection of receiving educational materials |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention, Emergency Medical Services, Emergency Medical Technicians
Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study

Study Overview
=================
Brief Summary
-----------------
This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.

Detailed Description
-----------------
This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting. Will be enrolled all patients who have been part of the Italian Compassionate Use Program (CUP) prior to participating in this study. Once the CUP will be closed the trial will continue with th prospective collection of data of patients treated with Niraparib according to the label for 2 years.

Official Title
-----------------
Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study by MITO Group

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that received niraparib as monotherapy for the maintenance treatment of platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after response (complete or partial) to platinum-based chemotherapy as part of the CUP, regardless of whether the patient is receiving niraparib at the time of enrolment; patients with high grade serous ovarian cancer treated with Niraparib according to the label will be included; patients able to understand the study procedures and that agree to participate in the study by providing written informed consent Exclusion Criteria: No exclusion criteria

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

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

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 |
| --- | --- | --- |
| Progression free survival (PFS) | To compare PFS of patients with advanced, platinum sensitive ovarian cancer treated with Niraparib as maintenance treatment | up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TFST | Time to first subsequent therapy | up to two years | 
| TSST | Time to second subsequent therapy | up to two years | 
| OS | Overall Survival | up to two years | 
| ORR | Overall Response Rate | up to two years | 
| Incidence of treatment-emergent adverse events | Toxicity will be evaluated by NCI CTCAE V 4.03 | up to two years |