linjc16/ctgov huggingface dataset:
A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
To determine the mass balance of PD 0200390

Official Title
-----------------
A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: PD 0200390


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: unhealthy, or concomitant meds

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A425<br>A425 Treated | Drug: PD 0200390<br>* Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F and Total 14C data in blood, urine and feces |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % urinary recovery |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-restorative, sleep
Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck

Study Overview
=================
Brief Summary
-----------------
This is an open-label, exploratory, biomarker study of intravenous temsirolimus given once weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to beginning their standard therapy for their specific disease. The primary objective of this study is to identify biomarkers of temsirolimus activity.

Official Title
-----------------
An Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck

Conditions
-----------------
Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Temsirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma of the oral cavity, oral pharynx, hypopharynx or larynx. Subjects willing to undergo tumor biopsies. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. Age >/= 18 years. Exclusion Criteria: Subjects receiving anticoagulation therapy. Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia. Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or investigational agent for their head and neck cancer.

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 |
| --- |
|Drug: Temsirolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Head, Neck
Hypophosphatemia as a Predictor in Surgical Resuscitation Sepsis

Study Overview
=================
Brief Summary
-----------------
Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.

Official Title
-----------------
Evaluation of Hypophosphatemia as a Predictor of Sepsis in Surgical Resuscitation Units.

Conditions
-----------------
Hypophosphatemia, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Exclusion Criteria: Less than 18 years old Infected at admission

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 |
| --- | --- | --- |
| Number of patients with sepsis within 28 days after ICU admission | Sepsis was defined according to the criteria of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). | 28 days since the ICU admission |
Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Hysterectomy is one of the most commonly performed gynecologic surgeries in the USA. It is used for many benign conditions such as leiomyoma and abnormal uterine bleeding. Surgery may involve the removal of the cervix (total hysterectomy, TH) or its preservation (supracervical or subtotal hysterectomy, SH). Whether TH or SH is the best procedure for benign conditions is a matter of debate. Considering the lack of evidence, this study aims to evaluate long-term sexual dysfunctions, urinary dysfunctions and pelvic organ prolapse in women who underwent laparoscopic subtotal versus total hysterectomy for benign conditions.

Official Title
-----------------
Evaluation of Long-term Sexual Dysfunctions, Urinary Dysfunctions and Pelvic Organ Prolapse in Women Who Underwent Laparoscopic Subtotal Versus Total Hysterectomy for Benign Conditions

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Subtotal Laparoscopic Hysterectomy
* Procedure: Total Laparoscopic Hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who underwent subtotal or total hysterectomy by laparoscopy for benign conditions. Exclusion Criteria: Women with gynecological and non-gynecological cancers.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subtotal Laparoscopic Hysterectomy<br>Women who underwent subtotal laparoscopic hysterectomy | Procedure: Subtotal Laparoscopic Hysterectomy<br>* Subtotal laparoscopic hysterectomy involves removing the main body of the uterus and leaving the cervix in place by laparoscopy.<br>|
| Total Laparoscopic Hysterectomy<br>Women who underwent total laparoscopic hysterectomy | Procedure: Total Laparoscopic Hysterectomy<br>* Total laparoscopic hysterectomy involves removing the whole uterus and cervix by laparoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Dysfunctions | Female Sexual Function Index | 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Dysfunctions | Pelvic Floor Distress Inventory short form | 5 years after surgery | 
| Pelvic Organ Prolapse | Pelvic Organ Prolapse (POP-Q) evaluation | 5 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subtotal Laparoscopic Hysterectomy, Total Laparoscopic Hysterectomy, Hysterectomy
Inflammatory Mediators in Erythema Migrans

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.

Official Title
-----------------
Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans

Conditions
-----------------
Erythema Migrans

Intervention / Treatment
-----------------
* Drug: Doxycycline 7 days
* Drug: Doxycycline 14 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: erythema migrans in patients > 18 years Exclusion Criteria: pregnancy or immunocompromising conditions taking antibiotic with antiborrelial activity within 10 days

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erythema migrans patients treated with doxycycline<br>adult patients with erythema migrans will be treated with oral doxycycline | Drug: Doxycycline 7 days<br>* Patient will be treated with doxycycline orally, 100 mg, bid, 7 days<br>Drug: Doxycycline 14 days<br>* Patient will be treated with doxycycline orally, 100 mg, bid, 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory proteins in erythema migrans patients | The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum and if available, skin, of patients during active infection and after treatment. | up to 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene polymorphisms in erythema migrans patients | ImmunoChip single-nucleotide polymorphism array for dense genotyping of rheumtic disease-relevant genomic variants will be used. | at enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lyme Borreliosis, Inflammation, Outcome
Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat. To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men.

Official Title
-----------------
The Efficacy of a Low Carbohydrate Diet, With and Without Exercise, on Cardiovascular Disease Risk in Obese Men

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: low carbohydrate diet
* Behavioral: low carbohydrate diet and exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 21-65 years body mass index (BMI) 27-40kg/m2 not currently losing weight physically able to exercise at moderate intensity

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low carbohydrate diet<br> | Behavioral: low carbohydrate diet<br> <br> |
| Experimental: diet & exercise<br> | Behavioral: low carbohydrate diet and exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition |  |  | 
| lipid profile |  |  | 
| body weight |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low carbohydrate diet, obesity, moderate exercise, men
Long Term Outcome Study in Patients With Pituitary Disorders

Study Overview
=================
Brief Summary
-----------------
To determine the outcomes of patients with different pituitary disorders whether they are managed medically, surgically or expectantly.

Detailed Description
-----------------
A chart audit of around 1500 patients seen in two specific clinics, the Medical Pituitary Clinic and the combined Endocrine/Neurosurgical Pituitary Clinic at the University of Alberta Hospital, will be performed to determine the effectiveness of various treatment strategies on the long term outcome of specific pituitary disorders. The investigator's will collect retrospective demographic (age, sex, ethnicity), clinical (mode of presentation, hormonal parameters) and therapeutic outcome (surgical, medical, expectant and / or radiation treatment; co-morbidities and complications) of patients seen in these two clinics between January 2000 and December 2020.

Official Title
-----------------
Long Term Outcome Study in Patients With Pituitary Disorders

Conditions
-----------------
Pituitary Diseases, Pituitary Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with confirmed pituitary disease Exclusion Criteria: patients who do not have confirmed pituitary disease
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 |
| --- | --- | --- |
| Progression free survival after pituitary surgery | Using clinical, biochemical and imaging studies of a cohort of surgically operated patients to identify prognostic factors of tumor recurrence | up to 17 years post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pituitary tumor, Acromegaly, Cushing, Prolactinoma
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.

Official Title
-----------------
A Randomized, Double Blind, Parallel Group Study to Evaluate the Effects of Valsartan Versus Placebo in Patients With Early Stage Heart Failure Due to Diastolic Dysfunction Already Evidenced by an Elevated B-type Natriuretic Peptide Level: the VALIDATE Study

Conditions
-----------------
Hypertension, Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 25-85 years of age, inclusive Past diagnosis of hypertension for a min 1 year Patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months BP is considered adequately controlled with DBP < 90mmHg Elevated BNP levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory LV ejection fraction ³ 45% LVH defined as myocardial mass ³ 116 g /m2 in males and 104 g/m2 in females At least one of the following parameters of diastolic dysfunction E/A < 1 for the patients who are younger than 55 years or < 0.8 for the patients whose age is ³ 55 years (full year), or DT > 220 ms, or IVRT > 90 ms Exclusion Criteria: • Present use of ACE inhibitor Other protocol-defined exclusion criteria may apply. -

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in a blood measurement for heart failure after 26 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in a blood measurement for heart failure after 12 weeks |  |  | 
| Change in baseline heart size after 26 weeks |  |  | 
| Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks |  |  | 
| Change from baseline in markers of heart fibrosis after 26 weeks |  |  | 
| Change from baseline quality of life questionnaire after 26 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HYPERTENSION, HEART FAILURE, PEPTIDE, valsartan
Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

Study Overview
=================
Brief Summary
-----------------
The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.

Detailed Description
-----------------
Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.

Official Title
-----------------
Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

Conditions
-----------------
Wound Heal

Intervention / Treatment
-----------------
* Device: vista care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patient able and willing to comply with the requirements of the including hospitalization for up to 15 days. Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh Agreement of the study no-objection form Age greater than or equal to 18 years Patient affiliated to a social security scheme Exclusion Criteria: -Patient with general signs of infection at the time of inclusion (fever, lymphangitis, pus ...). Patient with active smoking Subject under guardianship or deprived of liberty Failure to obtain patient consent

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 |
| --- |
|Device: vista care|Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds. |  | 2 years |
Overnight Post-Exercise Recovery After Protein Ingestion Prior to Sleep

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of post-exercise protein ingestion prior to sleep on overnight protein kinetics and muscle recovery.

Official Title
-----------------
Protein Ingestion Prior to Sleep as a Dietary Strategy to Improve Post-exercise, Overnight Recovery.

Conditions
-----------------
Exercise, Resistance Training

Intervention / Treatment
-----------------
* Dietary Supplement: protein
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age between 20 and 30 years Healthy, recreationally active BMI <25 kg/m2 Exclusion Criteria: Use of medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sweetened beverage<br> | Dietary Supplement: protein<br>* protein<br>|
| Placebo Comparator: placebo control<br>placebo | Dietary Supplement: placebo<br>* placebo control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle protein synthesis |  | 10 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistance, exercise, protein, recovery