linjc16/ctgov huggingface dataset:
The Effect of COVID-19 Patients' Serum Phosphate Level on Mortality in ICU

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate the relationship between phosphate level and mortality using the 4C Mortality Score in COVID-19 patients who were followed up in the intensive care unit.

Official Title
-----------------
Phosphate Levels of COVID-19 Patients and Mortality

Conditions
-----------------
Covid19, Phosphate Deficiency, Mortality

Intervention / Treatment
-----------------
* Diagnostic Test: 4C mortality score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study Exclusion Criteria: there is no exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 4C mortality score|4C mortality score and phosphate levels|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4C mortality score | 4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters | 6 months | 
| serum phosphate levels | mg/dl | 6 months | 
| mortality | mortality percentage of patients in 28 days | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID19, phosphate deficiency, 4C mortality score
Quality Project to Evaluate and Validate the FAST-O Rating Scale

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients at acute wards or psychiatric intensive care units.

Official Title
-----------------
Quality Project to Evaluate and Validate the FAST-O Rating Scale (Fast ASessment in Acute Treatment of Psychosis-Observation)

Conditions
-----------------
Acute Psychotic Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| psychotic patients<br>psychotic patients, acute ward, symptom rating scale. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability test of the FAST-O rating scale based on observational symptom ratings of patients with acute psychotic diseases |  | Each patients symtoms will be rated on 2 occasions, by 2-3 raters, each. First is made within 24 hrs of admission to acute psychiatric care, secondis made 14 +/- 2 days after admittance, or earlier if the patient is discharged. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychotic symptom assessments, Observational assessments of patients with acute psychotic symptoms
Study of Risk Factors and Clinical Characterization of Rapidly Growing Melanoma

Study Overview
=================
Brief Summary
-----------------
State of the question Over the past decade, the incidence of melanoma (MM) has steadily increased in France and in most developed countries. This increased incidence was concerned mainly MM thin while the incidence of MM thick that represent the true killers, and mortality from MM remained stable or increased slightly over the same period. These epidemiological data and observations from everyday medical practice dermatologists suggest the existence of different growth patterns within MM. Indeed, some MM progressing slowly sometimes for decades before diagnosis but are thin at the time of resection. Conversely, others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the relative mortality in MM, as improved screening failed to influence to this day. Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to calculate the growth rate, an Australian team recently studied the growth rate in a population of patients suffering from MM. In this population 1/3 of MM had a growth of more than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The European and Australian people are very different in particular regarding the prevention policy, these results can not be extrapolated to the French population.The main objective is to identify risk factors for FGMM in French propulation

Conditions
-----------------
Melanoma Cancer

Intervention / Treatment
-----------------
* Behavioral: Melanoma scale questionnair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Breslow primitive melanoma for over 1 mm skin affected Exclusion Criteria: Patient unable to answer questionnair concerning its melanoma history desease

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 |
| --- | --- |
| Patient with melanoma<br> | Behavioral: Melanoma scale questionnair<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed growth of melanoma size |  | 1 year |
The Hormonal and Behavioral Impact of Eating Breakfast

Study Overview
=================
Brief Summary
-----------------
This study is exploring the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who regularly eat breakfast.

Detailed Description
-----------------
Healthy women will be studies in a cross-sectional fashion to examine the metabolic, hormonal and behavioral factors associated with breakfast skipping.

Official Title
-----------------
CCRC: The Hormonal and Behavioral Impact of Eating Breakfast

Conditions
-----------------
Eating Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH) 20 to 45 years old, BMI less than 40 kg/m2 Stable body weight (fluctuation of less than ± 3%) for past 3 months. Breakfast eaters: defined as eating at least 15% of total daily energy intake at a meal between 0400-1000 h at least 6 days/week. Breakfast skippers: defined as eating no foods or beverages between 0400-1000h at least 4 days/week or only taking beverages (no solid food) containing less than  100 kcal. Exclusion Criteria: Erratic/intermittent breakfast eating Currently pregnant or lactating Shift workers/diagnosed sleep disorders Use of tobacco products Use of non-prescription drugs/hormone replacement/steroid-based medications Diagnosed endocrine, metabolic, or digestive disorder Hemoglobin <11 g/dl Plasma Glucose >120 mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breakfast Eaters<br>Women who self-report eating breakfast regularly. | |
| Non-Breakfast Eaters<br>Women who self-report skipping breakfast regularly. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake Behavior | The goal is to explore the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in a group of women who regularly skip breakfast and in another group of women who regularly eat breakfast. | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of nutrient metabolism | Blood glucose, insulin, lipids, and metabolic hormones will be measured. | week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food intake, Breakfast eating
Rosiglitazone on Microalbuminuria in Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
Following a 4-week single-blind placebo run-in period, eligible subjects were randomized in a 1:1 ratio to receive 32 weeks of double-blind study medication: Rosiglitazone (starting dose 4mg od) or Glyburide (starting dose 5mg od), both in combination with open-label Metformin > or = (1g/day). Subjects were stratified for use of ACEI, nondihydropyridine calcium channel blockers (NDP CCB), or angiotensin II receptor blockers (ARB) to provide equal representation of these subjects in each treatment group.

Official Title
-----------------
A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, aged 40-80 with T2DM and Microalbuminuria previously treated by diet and exercise alone, a single oral antidiabetic agent, or combination oral antidiabetic therapy. Exclusion Criteria: Pregnancy or lactation, use of any TZD (pioglitazone or Rosiglitazone) or insulin, renal disease or renal dysfunction , any degree of congestive heart failure, clinically significant hepatic disease or anemia, presence of unstable or severe angina or coronary insufficiency, high blood pressure

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment. |  | 32 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy endpoints included change from baseline (visit 3) at week 32 (visit 7) in the following: serum TGF, creatinine clearance (calculated), PAI-1, CRP, IL-6, vWF, sVCAM, fibrinogen, TNF alpha, ET-1, heart rate and blood pressure |  | 32 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microalbuminuria,, Type 2 Diabetes, rosiglitazone,
Therapeutic Endometrial Biopsy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth. Further it is planned to aspirate secretions from the uterus and take blood samples during the treatment, which presumably can provide information about the mechanisms underlying the possible effect of the treatment.

Detailed Description
-----------------
Randomized controlled prospective clinical study.

Conditions
-----------------
ART, Infertility, Endometrium, Endometrial Biopsy

Intervention / Treatment
-----------------
* Other: Endometrial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or more previous failed implantation despite transfer of good quality embryons/blastocyst in a fresh IVF/ICSI treatment Planned Antagonist treatment Planned Standardized hormone treatment FSH: 2-12 IU/L Age: 18-40 years BMI: 18-32 Regular menstrual cycles Written consent Exclusion Criteria: Patients in need for a interpreter Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges) Planned use og Assisted hatching or use of specialized media Previous inclusion in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard treatment | |
| Experimental: Intervention<br>Endometrial biopsy before standard treatment | Other: Endometrial biopsy<br>* The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)<br>* Other names: Local injury to the endometrium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical pregnancy |  | Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of biochemical pregnancy |  | Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years. | 
| Rate of implantation |  | Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. | 
| Rate of live birth |  | Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. |
Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.

Official Title
-----------------
Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea

Conditions
-----------------
Hypothalamic Amenorrhea

Intervention / Treatment
-----------------
* Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypotalamic Amenorrhea Exclusion Criteria: diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) hypertension significant liver or renal impairment other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal) neoplasms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hormonal Replace Therapy<br>1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months | Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Anti-oxidant Capacity |  | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | 6 Months | 
| Osteocalcin |  | 6 Months | 
| Estrogen levels |  | 6 Months | 
| number of Cycles in 6 months | n° of menstrual cycle | 6 Months | 
| beta crosslaps |  | 6 months |
A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.

Official Title
-----------------
A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy

Intervention / Treatment
-----------------
* Biological: CVX-045


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed advanced solid tumors unresponsive to currently available therapies, or for which there is no standard therapy. Adequate coagulation, liver and renal function. Candidate for DCE-MRI evaluation. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. Exclusion Criteria: Evidence of bleeding problems. Uncontrolled hypertension. Certain gastrointestinal problems including fistula and abscess. Patients with primary brain 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?
-----------------

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: 1<br> | Biological: CVX-045<br>* Weekly, intravenous dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors |  | Throughout duration of study | 
| To identify and characterize CVX-045-related adverse events (AEs) |  | Throughout duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the plasma pharmacokinetics (PK) of CVX-045 |  | Days 1, 4, 8, 15, 29 | 
| To determine a recommended Phase 2 dose of CVX-045 |  | End of study | 
| To evaluate the potential for immunogenicity of CVX-045 |  | Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU | 
| To document any preliminary evidence of antitumor activity |  | Every 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1, Solid Tumors, CVX-045
Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis

Study Overview
=================
Brief Summary
-----------------
Since the beginning of COVID-19 pandemic, a safe and effective vaccine against infection and development of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is needed control of the wide spread of COVID-19 and reduce death rates throughout the world. Many clinical trials investigated the immunogenicity of different proposed vaccine including the first distributed vaccine; the ChAdOx1 nCoV-19 vaccine and there is a need to analyze the results of published clinical trials.

Official Title
-----------------
Safety, Efficacy and Immunogenicity of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis

Conditions
-----------------
ChAdOx1 nCoV-19 Vaccine

Intervention / Treatment
-----------------
* Other: ChAdOx1 nCoV-19 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant who received 2 doses of ChAdOx1 nCoV-19 vaccine Exclusion Criteria: non vaccinated person

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ChAdOx1 nCoV-19 vaccine|covid-19 vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis | the frequency of breakthrough COVID-19 infection | up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, efficacy, immunogenicity, COVID-19 vaccine