linjc16/ctgov huggingface dataset:
Study of Postoperative Cognitive Decline in Aged Patients

Study Overview
=================
Brief Summary
-----------------
postoperative cognitive decline is a common and deleterious complication in aged patients.The link between inflammation and postoperative cognitive decline has also been reported.However,the link between SOD1，SOD2，Osteopontin， Kallikrein-6，and Contactin-1 and postoperative cognitive decline is unknown. In this project ,investigators examine the relationship between 5 cytokines measured at there timepoints (preoperative [PREOP], postoperative day 1 [POD1] , and postoperative day 3[POD2]) and postoperative cognitive decline among older adults undergoing orthopedic surgery.

Official Title
-----------------
Relationship Between Postoperative Cognitive Decline and Cytokines in Elderly Patients

Conditions
-----------------
Cognitive Decline

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are more than 65 years old patients who undergo orthopedic surgery(trauma ,especially fracture of lower limb) patients with ASA physical status I-III patients who have a consent Exclusion Criteria: patients who are more than 85 years old patients with ASA physical status >III patients who have neurological disorders, stroke or other affective central nervous system diseases patients who have a history of serious psychiatric illness patients with long-term use of psychoactive substances patients who undergo multiple trauma and the presence of head injury

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POCD group<br>patients occur cognitive decline after surgery according to scores in this group. | |
| NO POCD group<br>patients do not occur cognitive decline after surgery according to scores in this group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in cytokines levels between the two groups | Compare differences in cytokines levels between the two groups | preoperation | 
| Differences in cytokines levels between the two groups | Compare differences in cytokines levels between the two groups | 24h after operation | 
| Differences in cytokines levels between the two groups | Compare differences in cytokines levels between the two groups | 72h after operation |
Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation

Study Overview
=================
Brief Summary
-----------------
The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Detailed Description
-----------------
The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy. Secondary objectives are to investigate associations between intralymphocyte concentrations and whole-blood concentrations of CsA, renal tissue concentrations and nephrotoxicity, heart tissue concentrations and cardiotoxicity with CsA based immunosuppressive therapy in transplanted patients. In addition, this study aims to validate the use of quinine as a probe for determination of CYP3A4 activity in transplanted patients as well as proteomic-based urine analyses as a screening tool for acute rejection episodes in transplanted patients.

Conditions
-----------------
Renal Transplantation, Heart Transplantation

Intervention / Treatment
-----------------
* Drug: Cyclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation. 18 years of age or older. Signed informed consent. Exclusion Criteria: Known contraindications for renal or heart biopsies, respectively, at the time of inclusion. Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclosporine A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rejection |  |  | 
| pharmacokinetics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  |  | 
| genotypes |  |  | 
| metabolites |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracellular concentration, cyclosporine A, renal biopsies, heart biopsies, Renal transplant recipients
Effect of Portion-control Training on Food Intake

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether food intake in response to large portion sizes differs between women who have received portion-control training and women who have not received such training. In a crossover design, women come to the laboratory on four occasions to eat a lunch of seven foods varying in energy density. Across meals, all foods are varied in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy intake is determined for each meal. Participants are from two groups: women who completed a one-year weight-loss trial in which they were trained in portion-control strategies, and women who had not received such training (community controls).

Conditions
-----------------
Feeding Behaviors

Intervention / Treatment
-----------------
* Other: Meal portion size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in the Portion-Control Strategies Trial (NCT01474759) OR Community control who regularly eats three meals per day Exclusion Criteria: Score on the Eating Attitudes Test indicating symptoms of disordered eating Score on the Zung or Beck questionnaires indicating symptoms of depression Food allergies or restrictions Dislike for foods served in the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 66 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100% Portions<br>Meal portion size: 100% | Other: Meal portion size<br> <br> |
| Experimental: 125% Portions<br>Meal portion size: 125% | Other: Meal portion size<br> <br> |
| Experimental: 150% Portions<br>Meal portion size: 150% | Other: Meal portion size<br> <br> |
| Experimental: 175% Portions<br>Meal portion size: 175% | Other: Meal portion size<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in energy intake across subject groups | Calculated energy intake (kcal) based on weight and energy density of food consumed | Weeks 1, 2, 3, and 4 | 
| Difference in intake by weight across subject groups | Weights (grams) of all food consumed | Weeks 1, 2, 3, and 4 | 
| Difference in energy density consumed across subject groups | Energy density (kcal/gram) of all food consumed | Weeks 1, 2, 3, and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings of hunger and satiety across subject groups | 100-point visual analog scales | Weeks 1, 2, 3, and 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Portion Size
A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

Study Overview
=================
Brief Summary
-----------------
Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes. In this study, Bloomlife Lovelace FT is used to collect the dataset needed for the development of a future product (Bloomlife Lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.

Official Title
-----------------
A Cross-sectional, Interventional, Exploratory Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

Conditions
-----------------
Fetal Monitoring

Intervention / Treatment
-----------------
* Device: Bloomlife Lovelace FT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman ≥ 18 years old Gestational age greater or equal to 24 weeks and 0 days Singleton pregnancy Ability to read and understand Dutch Willingness to participate in the study Exclusion Criteria: Implanted pacemaker or any other implanted electrical device History of allergies to skin adhesives Irritated or lesioned skin at the Bloomlife Lovelace FT electrodes locations Contraindication to the use of CTG based on physician's decision (e.g. due to preterm contractions)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bloomlife Lovelace FT<br> | Device: Bloomlife Lovelace FT<br>* Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate | Bland-Altman analysis, based on a 95% limits of agreement. | 1 hour | 
| Extent of agreement between Bloomlife Lovelace FT and CTG in maternal heart rate | Bland-Altman analysis, based on a 95% limits of agreement. | 1 hour | 
| Performance metrics of Contraction Detection with Bloomlife Lovelace FT | Sensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement. | 1 hour |
Molecular Tumor Board at the Center for Personalized Medicine Tübingen

Study Overview
=================
Brief Summary
-----------------
Molecular Tumor Board at the Center for Personalized Medicine

Detailed Description
-----------------
Molecular Tumor Board at the Center for Personalized Medicine The study objectives are To ensure a prospective documentation of all patients who are referred to the Molecular Tumor Board in routine clinical care To prospectively ensure the documentation of MTB patients with an emphasis to clinical outcome parameters progression-free survival (PFS), overall survival (OS) and further response assessments (e.g. peripheral immunmonitoring, imaging parameters) To prospectively assess patient-reported outcome of MTB patients To evaluate compliance to MTB suggestions in routine clinical care

Official Title
-----------------
Molecular Tumor Board at the Center for Personalized Medicine Tübingen: a Prospective Observational Study

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Given informed consent (broad consent of the University Hospital Tübingen) ≥ 18 years of age Clinical indication for a referral to Molecular Tumor Board by the treating physician Exclusion Criteria: The MTB assists the referring physician with the interpretation and the use of tumor molecular profiling data for deciding on a therapeutic strategy. Therefore, this board is confined to cancer patients and cannot provide any service for non-cancer patients
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Progression-free survival | an average of 1 year |
Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.

Official Title
-----------------
Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients

Conditions
-----------------
Postmenopausal Symptoms

Intervention / Treatment
-----------------
* Drug: Divigel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women Have moderate to severe hot flashes Normal Pap Smear Exclusion Criteria: Abnormal mammogram Abnormal clinical breast exam BMI >35

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Divigel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily frequency and severity of moderate to severe vasomotor symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vulvar and vaginal atrophy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasomotor symptoms, estrogen, estradiol, hot flashes
High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury

Study Overview
=================
Brief Summary
-----------------
Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.

Conditions
-----------------
Severe Head Injury

Intervention / Treatment
-----------------
* Drug: human serum albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe head injury (GCS < 9) Next of kin informed consent Exclusion Criteria: Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2< 300 mmHg) Blood loss > 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: human serum albumin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the daily median value of intracranial pressure |  |  |
Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities

Study Overview
=================
Brief Summary
-----------------
Single institution case series review with a histological diagnosis of mixofibrosarcoma of the extremities from 01 Jan 1993 to 01 Dec 2017. The study will exam all the clinical, radiological, histological and immunohistochemical features of this tumour in all samples and in a limited serie of cases the presence of mutation of 50 genes cancer related.

Official Title
-----------------
Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities: Diagnostic and Prognostic Impact

Conditions
-----------------
Sarcoma,Soft Tissue

Intervention / Treatment
-----------------
* Other: case series review of clinical and histological data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients treated at Rizzoli Institute from 01 Jan 1993 to 01 Dec 2017 Diagnosis of mixofibrosarcoma of extremities Histological slides/formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis and molecular analysis Enough tumor biobanked material available for molecular analysis Presence of the biobank signed informed consent Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: 1) Patients with histological diagnosis different from mixofibrosarcoma of extremities

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 |
| --- |
|Other: case series review of clinical and histological data|We will review all the medical records, radiological imaging, and histological data of these cases. The immunohistochemical analysis of the principal alterated genes identified in this tumor will be performed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | identify patients with different risk classes in terms of disease-free survival (local and systemic recurrence). | at baseline (Day0) | 
| overall survival | identify patients with different risk classes in terms of overall survival. | at baseline (Day0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixofibrosarcoma
Feasibility Study of Take-Home LAAM Medication - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test therapeutic benefits of take-home LAAM. (1) Do subjects with take-home LAAM availability show increased clinical responsibility over subjects without; (2) Do subjects with take-home LAAM attempt diversion when random recall and other diversion safeguards are used; (3) Does treatment response correlate with background or drug use variables at intake, discharge, or during treatment?

Detailed Description
-----------------
1-Year study, participant will be randomly assigned to one of two groups: One will have the opportunity to earn take-home doses by turning in a designated number of clean urines. Two will not have the opportunity to earn take-home doses. Clinic visits three times per week. Urine sample given at each visit.

Official Title
-----------------
Feasibility Study of Take-Home LAAM Medication

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: LAAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: meets DSM-IV criteria for opiate dependence. M/F, 18 years or older. Certified for LAAm treatment by a physician. Able to understand english. Willing to provide names, addresses, and numbers of 3 relatives who can aid in patient location for follow-up visits. Exclusion Criteria: Hypertensive to LAAM. Pregnant or nursing women. Female of childbearing potential who refuses to use an acceptable form of birth control. Clinically significant abnormality in hematology, blood work, or UA, ETOH and/or sedative/hypnotic dependence according to DSM-IV criteria. Medical or psychiatric illness which would jeopardize safe study participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LAAM|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Increased prosocial behaviors |  |  | 
| Decreased frequency of HIV related behavior |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opiate, dependence