linjc16/ctgov huggingface dataset:
Veracity Surgical: A Time/Motion and Quality of Care Study

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the time required for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

Detailed Description
-----------------
This study aims to compare the time commitment for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

Official Title
-----------------
Veracity Surgical: A Time/Motion and Quality of Care Study

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Standard of Care4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years of age with upcoming cataract surgery. At least 25% of enrolled eyes must be post-refractive, and 25% must require astigmatic planning (arcuate incision or toric IOL) Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence refractive outcome or interfere with postoperative refraction accuracy. Exclusion Criteria: Patients with visually significant comorbidities (corneal, retina, optic nerve disease, not including prior refractive surgery) that could significantly affect their ability to have accurate preoperative biometry or postoperative refraction. Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would interfere with postoperative refraction. Patients with > grade 2 or greater posterior capsule opacity

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Standard of Care4|The current standard of care for surgical planning for the participating investigator surgeon is to use Zeiss Veracity Surgical, so this same method will be used for the surgery actually performed on participating patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of minutes:seconds to plan surgery for a single eye |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| By each method the number of total data points where a human is required manually to transcribe data from one place to another. |  | 1 day |
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery

Detailed Description
-----------------
The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery and we compare this with other acute phase reactants

Official Title
-----------------
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease

Conditions
-----------------
Sepsis Newborn

Intervention / Treatment
-----------------
* Diagnostic Test: Neutrophil to lymphosit ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn to be operated with the diagnosis of congenital heart disease Exclusion Criteria: age older than 1 month not to be operated
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Neutrophil to lymphosit ratio|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil to Lymphocyte Ratio | We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes | 1 day | 
| Neutrophil to Lymphocyte Ratio | We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes | 2 week |
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
One important part of individual nursing care is that that nurses teach and apply breathing exercises, which are vital and increase the patient's quality of life, in the light of their current knowledge and skills. The purpose of this study was therefore to determine the effect of postoperative breathing exercises on pain and anxiety in patients hospitalized in the general surgery clinic and who had undergone laparoscopic cholecystectomy.

Detailed Description
-----------------
Introduction: Several methods are employed for overcoming pain and anxiety that are frequently experienced in the postoperative period. This study was planned to determine the effect of a breathing exercise on patient pain and anxiety after laparoscopic cholecystectomy. Methods: The sample determined using power analysis in this randomized, controlled, semi-experimental research performed in two hospitals in the west of Turkey between January and November 2019 consisted of 74 individuals (37 experimental and 37 controls). An information form involving descriptive characteristics, a visual analogue scale (VAS), and the State-Trait Anxiety Inventory (STAI I/II) were used for data collection. Descriptive statistical methods and parametric tests were employed in the data analysis.

Official Title
-----------------
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy: A Randomized Controlled Study

Conditions
-----------------
Anxiety, Pain

Intervention / Treatment
-----------------
* Other: Educational and Research Hospital


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Hospitalized in the general surgery clinics, with histories of laparoscopic cholecystectomy, consenting to take part. Exclusion Criteria: - Have a psychiatric disorders.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP 1<br>BREATHING EXERCISE GROUP | Other: Educational and Research Hospital<br>* breathing exercise<br>|
| No Intervention: GROUP 2<br>CONTROL GROUP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative anxiety scores would be lower in the experimental group than in the control group. | Postoperative anxiety scores | six months | 
| Postoperative pain score would be lower in the experimental group than in the control group. | Postoperative pain score | six months |
Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: dapsone gel
* Drug: dapsone gel vehicle
* Drug: sodium lauryl sulfate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Healthy adults. Exclusion Criteria: Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application Sensitivity to adhesive bandages or tape.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapsone Gel Subset 1<br>Dapsone gel, dapsone gel vehicle and controls applied to the skin by separate occlusive patches every 24 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. | Drug: dapsone gel<br>* Patches containing dapsone gel will be applied to the skin.<br>Drug: dapsone gel vehicle<br>* Patches containing dapsone gel vehicle will be applied to the skin.<br>Drug: sodium lauryl sulfate<br>* Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.<br>Drug: Normal saline<br>* Patches containing normal saline (Negative Control) will be applied to the skin.<br>|
| Experimental: Dapsone Gel Subset 2<br>Dapsone gel, dapsone gel vehicle and negative control applied to the skin by separate occlusive patches every 48 to 72 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. | Drug: dapsone gel<br>* Patches containing dapsone gel will be applied to the skin.<br>Drug: dapsone gel vehicle<br>* Patches containing dapsone gel vehicle will be applied to the skin.<br>Drug: Normal saline<br>* Patches containing normal saline (Negative Control) will be applied to the skin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Cumulative Irritation Index During Induction Phase |  | 21 Days | 
| Incidence of Sensitization Reactions During Challenge Phase |  | 6 Weeks |
Predicting Treatment and Care Difficulties Among HIV Infected Patients

Study Overview
=================
Brief Summary
-----------------
Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use various psychometric tools to determine if these scores have a predictive value on late testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The expected outcomes would be to be able to stratify patients using a behavioural risk score and allocate targeted ressources to improve the quality of care for the most at risk patients.

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Other: Observationnal (no intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV Infected outpatient Exclusion Criteria: Refusal to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observationnal (no intervention)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 Count | CD4 count at diagnosis and last recorded measure | 1 year after interview | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| viral load |  | 1 year after interview | 
| hiv disclosure to partner |  | at the time of interview | 
| loss to follow up |  | one year after interview | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Behavior
Peripheral Metabolic Effects of Somatostatin

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate peripheral effects of Somatostatin on glucose metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by GH.

Official Title
-----------------
Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls

Conditions
-----------------
Acromegaly, Growth Hormone Deficiency, Diabetes

Intervention / Treatment
-----------------
* Drug: Somatostatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI < 27 kg/m2 Written informed consent Healthy Exclusion Criteria: Any disease Any use of medications Present or previous malignancy Alcohol dependency Allergy to trial medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somatostatin<br> | Drug: Somatostatin<br>* 4 h of 150 microgram infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of glucose |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GH signalling |  | one year | 
| Serum levels of free fatty acids (FFA) |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GH signalling, insulin resistance, somatostatin, acromegaly
Efficacy and Safety of Grazax in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season

Official Title
-----------------
A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: Grazax-R
* Biological: Grazax Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls 5-16 years of age A clinical history of grass pollen induced hayfever Positive Skin Prick Test to Phleum pratense Positive specific IgE against Phleum pratense Exclusion Criteria: History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed History of severe asthma Current severe atopic dermatitis

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Grazax treatment | Biological: Grazax-R<br>* Grass tablet, 75.000 SQ per day for one year<br>|
| Placebo Comparator: 2<br>Grazax Placebo | Biological: Grazax Placebo<br>* Grazax Placebo, 0 SQ tablet per day for one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hayfever symptoms |  | Grass pollen season 2007 | 
| Intake of hayfever symptom relieving medication |  | Grass pollen season 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined hayfever symptom and medication scores |  | Grass pollen season 2007 | 
| Asthma symptoms and medication |  | Grass pollen season 2007 | 
| Global Evaluation of treatment efficacy |  | Grass pollen season 2007 | 
| Adverse Events |  | 9 months | 
| Pharmacoeconomic Assessment |  | 9 months | 
| Immunological Assessment |  | 9 months |
Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

Study Overview
=================
Brief Summary
-----------------
This retrospective study aims to evaluate the fate of children born by cesarean section under spinal anesthesia with or without norepinephrine as vasopressor support for anesthesia. The main objective is to compare the initial Apgar score. The records of patients who received norepinephrine are compared to those without norepinephrine. To limit the biases of this type of study, the investigators will apply a propensity score that will include as a variable: age, ASA score, comorbidity, urgency. The patients analysed correspond to the period 2016-2017.

Official Title
-----------------
Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section

Conditions
-----------------
Caesarean Section;Stillbirth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 Spinal Anesthesia for Cesarean Section Exclusion Criteria: sub epidural cesarean section contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>boli of ephedrine phenylephrine (45μg/mL-3mg/mL) if the variation of MAP < 20% of baseline (MAP before spinal anaesthesia). | |
| Protocol group<br>continuous infusion of norepinepineprhine at 20 μg/mL, started at 0.05 μg/kg/min. The dosage of norepinephrine was then adjusted to maintain a variation in MAP < 20% of baseline. In case of failure, the use of a control group boli injection was possible. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate level | The primary endpoint is the Umbilical Cord Lactate levels | Just after the birth of the newborn baby | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR Score | APGAR Score | 1, 5 and 10 minutes after birth | 
| Umbilical Cord arterial PH | Umbilical Cord arterial PH | Just after the birth | 
| Umbilical Cord venous PH | Umbilical Cord venous PH | Just after the birth | 
| maternal arterial tension during cesarean section | maternal arterial tension during cesarean section | 0, 5,10,15, 20 25, 30,35,40 minutes after spinal anesthesia | 
| incidences of mother nausea and vomiting | incidences of mother nausea and vomiting | from beginning to cesarean section end | 
| use of vasopressors | use of vasopressors | from beginning to cesarean section end |
Sleep Disorders and the Onset and Progression of ALS

Study Overview
=================
Brief Summary
-----------------
200 cases of ALS patients were collected to explore whether sleep disorders are related to earlier onset age, and whether sleep disorders accelerate the progress of ALS and shorten the survival time of ALS patients.

Detailed Description
-----------------
200 patients with ALS were collected. 1) sleep disorders were assessed by Pittsburgh sleep quality index (PSQI) and Epworth Sleepiness Scale (epworth) at baseline Sleeping Scale，ESS）； 2) Name, age, gender and onset site were collected to explore whether sleep disorders were associated with earlier onset age; 3) The patients' function (ALSFRS-R) at baseline and every 3 months within 2 years were collected, and the end-point time (death and invasive breathing) was recorded to evaluate whether sleep disturbance accelerated the decline of patients' function and shortened their short-term survival.

Official Title
-----------------
Effect of Sleep Disorder on Onset and Progression of Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Behavioral: sleep disorder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been diagnosed in the Department of Neurology of the Third Hospital of Beijing Medical University since August 2020. The clinical diagnosis of patients with amyotrophic lateral sclerosis includes: probable and define; Informed consent has been signed. Exclusion Criteria: Those who can not cooperate to complete the scale and receive follow-up.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALS patients with sleep disorder<br> | Behavioral: sleep disorder<br>* ALS patients with or without sleep disorder<br>|
| ALS patients without sleep disorder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALSFERS-R | ALS functional score | 2 years | 
| end point event | death or invasive breathing | 2 years |