linjc16/ctgov huggingface dataset:
Case Fatalities in Hospitalised COVID-19 Patients in the UK

Study Overview
=================
Brief Summary
-----------------
This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. This analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.

Official Title
-----------------
Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Patient Characteristics
* Other: COVID-19 treatments
* Other: Differences in triage
* Other: Surge capacity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted with a proven or high likelihood of COVID-19
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalisations<br>All hospitalised COVID patients | Other: Patient Characteristics<br>* Characteristics of the patients<br>Other: COVID-19 treatments<br>* Specific treatments used on COVID-19 patients<br>Other: Differences in triage<br>* Triage criteria for treating COVID-19 patients<br>Other: Surge capacity<br>* Capacity of hospitals<br>|
| Critical care<br>All hospitalised COVID patients in critical care | Other: Patient Characteristics<br>* Characteristics of the patients<br>Other: COVID-19 treatments<br>* Specific treatments used on COVID-19 patients<br>Other: Differences in triage<br>* Triage criteria for treating COVID-19 patients<br>Other: Surge capacity<br>* Capacity of hospitals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Case fatality | The proportion of new admissions with COVID-19 who died over time | 23 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, ISARIC, Hospitalisations, Mortality, Case fatality, United Kingdom
Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the intraocular stability and safety of secondary iris-fixated IOLs in aphakic patients.

Detailed Description
-----------------
18 eyes of 16 patients received secondary anteriorly iris-fixated intraocular lenses (IOLs) to correct for aphakia without capsular support, partly combined with anterior or complete pars plana vitrectomy. Primary outcome measurements included visual acuity (6m Snellen charts), central endothelium cell count (cECC) and postoperative intraocular position of the IOL assessed with anterior segment optical coherence tomography (OCT).

Official Title
-----------------
Intraocular Architecture of Secondary Implanted Anterior Chamber Iris-Fixated Lenses in Aphakic Eyes Evaluated With Anterior Segment Optical Coherence Tomography

Conditions
-----------------
Aphakia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with aphakia due to complicated cataract surgery, weakness in lens support (capsula, zonulae) Marfans´s syndrome Exclusion Criteria: Aphakia due to preexisting corneal, retinal o uveal disease, low endothelial cell count

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 84 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 |
| --- | --- | --- |
| Intraocular IOL position |  | 12-35 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aphakia, Secondary IOL-Implantation, Iris-Fixated IOL, Artisan, Anterior Segment OCT, Aphakia - secondary iris-fixated IOL position
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring

Study Overview
=================
Brief Summary
-----------------
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation. The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.

Detailed Description
-----------------
The study consisted of 2 phases: a pilot phase and a pivotal phase. The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study. The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.

Official Title
-----------------
A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring

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

Intervention / Treatment
-----------------
* Device: Bloomlife MFM-Pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman ≥ 18 years old Gestational age ≥ 32 weeks and 0 days Singleton pregnancy Ability to read and understand English or Spanish Willingness to participate in the study Exclusion Criteria: Implanted pacemaker or any other implanted electrical device Plurality higher than 1 History of allergies to skin adhesives Irritated or lesioned skin at the Bloomlife MFM-Pro electrodes locations Contraindication to the use of CTG

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 |
| --- | --- |
| Other: Bloomlife MFM-Pro<br> | Device: Bloomlife MFM-Pro<br>* Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy. The system acquires 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 MFM-Pro and CTG in Fetal Heart Rate |  | 5 minutes | 
| Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate |  | 5 minutes |
Heart Rate Variability in Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients

Detailed Description
-----------------
24hr Holter examination is a non-invasive tool in detecting and diagnosing cardiac arrhythmia. Moreover, Heart rate variability has been proven to been an important prognostic factor in many cardiovascular diseases. The traditional linear analysis of heart rate variability proved to predict clinical outcome in myocardial infarction patients. The more delicate non-linear analysis in heart rate variability is one of the hot topics in the world. Despite some biochemical values like WBC counts, platelet counts, BUN, creatinine, lactate, clinical vital parameters like blood pressure, heart rate, and oxygenation have been used to predict clinical outcome in chronic renal disease(CKD) patients, the application is still limited. It is an international interest to find a more safe and simple technique to identify important prognostic factors in CKD patients. Our project aimed to recruit these CKD patients from our hospital and conduct a cross-sectional study. Cardiac ultrasonography and 24hrs Holter will be arranged. Linear and non-linear analysis of heart rate variability will be performed and serum marker that influence prognosis like WBC count, platelet count, lactate, BUN, creatinine, fibrosis marker and adiponectin will be checked. Short term and long term outcome was followed and identify important prognostic factors to improve and detect clinical prognosis.

Official Title
-----------------
Heart Rate Variability in Chronic Kidney Disease Patients

Conditions
-----------------
Chronic Kidney Disease, Heart Rate Variability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: peritoneal dialysis more than 3 months Exclusion Criteria: pregnancy 2. received CT in recent 3 months

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 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 |
| --- | --- |
| 250 300 patients<br>heart rate variability, heart function and Kt/V | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability, heart function, PET, Kt/V |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart rate variability, autonomic function, heart function
Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment

Study Overview
=================
Brief Summary
-----------------
We have just completed a randomized, clinical trial of 100,000 IU Vitamin D3 given as a single dose at the beginning of winter. We found a wide range of responses to the dose. This study proposes that genetic differences account for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Detailed Description
-----------------
We suspect that the wide range of response is effected by other factors such as variation in Vitamin D binding protein (the major transporter of Vitamin D metabolites). Gc, also known as Vitamin D binding protein (DBP), group specific component, or Gc globulin, is a 52-58 kDa multifunctional plasma protein, synthesized in the liver. The gene encoding for Gc is located on chromosome 4, and three common co-dominant alleles give rise to three phenotypes (Gc1s, Gc1f, and Gc2). Gc binds actin, recruits neutrophil leukocytes and converts into a macrophage- and osteoclast- activating factor. It also is the major transporter of Vitamin D and its' metabolites. Lauridsen et al. showed that Gc phenotype correlates with 25(OH)D levels in a group of postmenopausal women. This study proposes that Gc phenotype accounts for some of the variation in response of 25(OH)D levels after treatment with oral Vitamin D.

Official Title
-----------------
Vitamin D Binding Protein (Gc) Allele Variation Effects Response to Vitamin D Treatment

Conditions
-----------------
Vitamin D Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be willing to participate with an additional blood draw. Must have been in the previous study. Exclusion Criteria: Will not be eligible if not a part of the previous study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 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 |
| --- | --- |
| 1<br>All of the subjects will have measurements of Gc concentration and phenotype | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gc concentration and phenotype |  | at 1st visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viatmin D, 25-hydroxyvitamin D, Vitamin D binding protein
An Observational Study of Patients Treated With Bimatoprost 0.03% (Latisse®) for Hypotrichosis of the Eyelashes

Study Overview
=================
Brief Summary
-----------------
This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at least 12 months for hypotrichosis of the eyelashes.

Conditions
-----------------
Eyelash Hypotrichosis

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.03%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypotrichosis of the eyelashes Using bimatoprost ophthalmic solution 0.03% (Latisse®) for at least 12 months Exclusion Criteria: Use of any over-the-counter medication(s) for eyelash growth

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 |
| --- | --- |
| Hypotrichosis of the Eyelashes<br>Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months | Drug: bimatoprost 0.03%<br>* Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months<br>* Other names: Latisse®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Satisfied With Latisse® | Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Applications of Latisse® Per Week | Number of applications of Latisse® per week as reported by the subjects. | Day 1 | 
| Percentage of Subjects Satisfied Wtih Their Eyelashes | Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported. | Day 1 |
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling

Detailed Description
-----------------
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.

Official Title
-----------------
A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: PHA-794428


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Male and female children with a minimum age of 6 years 2. Prepubertal as defined by Tanner staging 3. Growth hormone deficiency Exclusion Criteria: 1. PGHD patients with uncontrolled pituitary tumor growth 2. Tumors within 3 mm of the optic chiasm 3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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: PHA-794428|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK, IGF-1 and safety measurements up to 2 weeks after dosing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody and IGFBP-3 measurements |  |  |
Investigation of GLP-2 Mechanism of Action (GA-8)

Study Overview
=================
Brief Summary
-----------------
Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit the bone resorption. However, the mechanism is unknown. In the present study we will investigate the mechanism of action using a receptor specific inhibitor.

Official Title
-----------------
Investigation of GLP-2 Mechanism of Action (GA-8)

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

Intervention / Treatment
-----------------
* Other: Inhibitor + GLP-2
* Other: Placebo + GLP-2
* Other: Placebo + GIP
* Other: Placebo + Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, 20 to 40 years old, caucasian, BMI 18,5 to 24,9 kg/m2 Exclusion Criteria: Chronic disease, smoking, medication, weight change more than 3 kg whitin the last 3 months, overweight surgery, intestinal surgery, Hgb<8,0 mmol/L, decreased renal function.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhibitor + GLP-2<br> | Other: Inhibitor + GLP-2<br>* Inhibitor and GLP-2 are used as study tools.<br>|
| Experimental: Placebo + GLP-2<br> | Other: Placebo + GLP-2<br>* Placebo and GLP-2 are used as study tools.<br>|
| Active Comparator: Placebo + GIP<br> | Other: Placebo + GIP<br>* Placebo and GIP are used as study tools.<br>|
| Placebo Comparator: Placebo + Saline<br> | Other: Placebo + Saline<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-terminal telopeptide (CTX) | Marker of bone resorption | -30 to 240 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-terminal propeptide of type 1 procollagen (P1NP) | Marker of bone formation | -30 to 240 min. | 
| Osteocalcin (OC) | Bone marker | -30 to 240 min. | 
| Parathyroid hormone (PTH) | Bone marker | -30 to 240 min. | 
| Osteoprotegerin (OPG) | Bone marker | -30 to 240 min. | 
| Glucose-dependent insulinotropic polypeptide (GIP) | GIP total and intact | -30 to 240 min. | 
| Glukagon-like peptide-1 (GLP-1) and glukagon-like peptide-2 (GLP-2) |  | -30 to 240 min. | 
| Glukagon and pancreatic polypeptide (PP) |  | -30 to 240 min. | 
| Glucose |  | -30 to 240 min. | 
| Insulin/c-pep. |  | -30 to 240 min. |
Verapamil for Neuroprotection in Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.

Official Title
-----------------
Intraarterial Verapamil for Neuroprotection in Ischemic Stroke

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: Verapamil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent 18 years of age and over Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia Candidate for mechanical thrombectomy procedure Onset of symptoms less than 8 hours Measurable neurologic deficit (NIHSS >1) Willingness to follow up with rehabilitation therapy Anticipated life expectancy of at least 3 months Exclusion Criteria: Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential) Hepatic and/or renal insufficiency (LFT's>3× upper limit of normal; CrCl < 30ml/min) Thrombocytopenia (platelet count <75,000/mm3) History of intolerance to verapamil Previous functional disability (modified Rankin > 1) Stuporous or comatose Unlikely to be available for 90 day follow-up Severe stroke (NIHSS>22)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Verapamil|Intra-arterial delivery of verapamil following mechanical thrombectomy procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Event | Death | 3 months | 
| Serious Adverse Event | Hemorrhagic conversion | 3 months |