linjc16/ctgov huggingface dataset:
Evaluation of Depression and Sleep Disorders in Endometriosis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the depression and sleep disturbances of operated endometriosis patients before and after the operation. The main objective here is to provide data on how patients' psychological states and sleep patterns are affected by the symptoms of endometriosis and how these effects can be corrected. In this way, it is aimed to determine whether the patients have psychological support needs and to give the planned treatment due to endometriosis in the early period. As a secondary goal, it is planned to keep the patients in follow-up with their improved sleep and psychological conditions, and to improve their adherence to treatment and quality of life.

Official Title
-----------------
Evaluation of Depression and Sleep Disorders in Endometriosis Patients Preoperatively and Postoperatively

Conditions
-----------------
Sleep, Endometriosis, Depression

Intervention / Treatment
-----------------
* Behavioral: Beck Depression Scale and Pittsburgh Sleep Quality Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-49 years of age with no known psychiatric disorder and Endometriosis patients with indications for operation Exclusion Criteria: Patients receiving only medical treatment without any indication for operation, those with a known psychiatric disease, patients with sleep disorders due to another reason, Patients over the age of 49, patients under the age of 18, Patients with malignancy, pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Beck Depression Scale and Pittsburgh Sleep Quality Index|postoperative depression and sleep disorders in patients with endometriosis will be evaluated|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Scale | postoperative depression in endometriosis patients will be evaluated. Consists of 21 questions scored between 0-3. HIGH SCORE SHOWS TO HIGH DEPRESSION. (0-63 POINTS) | 1 week | 
| Pittsburgh Sleep Quality Index | postoperative sleep disorders of endometriosis patients will be evaluated. Consists of 9 questions scored between 0-3. HIGH SCORE SHOWS BAD SLEEP QUALITY. (0-27 POINTS) | 1 week |
Blood Donation and Subjective Well-being

Study Overview
=================
Brief Summary
-----------------
Studies have suggested a positive relationship between prosociality and well-being. attempt to analyze the relationship between blood donation and subjective well-being, and try to figure out the moderators and mediators. Also, the investigators would like to compare difference of subjective well-being between donors who are explicitly presented with information that the participants' blood has saved patient's life and those who are not.

Official Title
-----------------
The Relationship Between Blood Donation and Subjective Well-being

Conditions
-----------------
Blood Donation, Happiness

Intervention / Treatment
-----------------
* Other: Information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Whole blood donors with negative serological results. Exclusion Criteria: Whole blood donors with positive or suspicious serological results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information group<br>In this group, blood donors will receive a questionnaire 15-25 days after their blood donation, i.e., after their blood has been sent to the hospital and be transfused by patients. The questionnaire contains items measuring empathy, altruism, subjective well-being, etc., as well as a clear reminder to inform donors that their blood has saved patient's life. | Other: Information<br>* A reminder to inform donors that their blood has saved patient's life in a questionnaire.<br>|
| No Intervention: Non-information group<br>In this group, blood donors will receive a questionnaire 15-25 days after their blood donation, i.e., after their blood has been sent to the hospital and be transfused by patients. The questionnaire contains items measuring empathy, altruism, subjective well-being, etc., but there will be no reminder to inform donors that their blood has saved patient's life. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The scores of the subjective well-being in the questionnaire | Donors' self-rated average scores of the subjective well-being items, the higher score the better outcome. | 1 day |
Rickets Device - Feasibility Study

Study Overview
=================
Brief Summary
-----------------
On a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. We hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns Objective of the study: Clinical feasibility of the urine collection device, indicated by staff and parents. Study design: The study will be an open label, clinical feasibility study, of the urine collection device. During a period of 6 months, 30 feasibility tests will be performed. Study population: Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics at Rijnstate Hospital Arnhem.

Official Title
-----------------
Rachitis Device Study

Conditions
-----------------
Rickets

Intervention / Treatment
-----------------
* Device: Urinary collecting device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents Exclusion Criteria: No informed consent Defective skin in genital region Three previous tests in the same subject
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Urinary collecting device|Urinary collecting device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents | With concern to feasibility we want to know whether this device is able: easy to apply to the neonate to only collect urine to exclude stool admixture easy to use by the nurses comfortable for te neonates | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reactions | Number of times skin reactions occurs, reported by the responsible nurse | 1 week | 
| Skin irritability | Number of times skin irritability occurs, reported by the responsible nurse | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prematurely born newborns, Urine, Collecting device
Does Premature Luteinization Matter?

Study Overview
=================
Brief Summary
-----------------
Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.

Official Title
-----------------
Does Measurement of Serum Progesterone on the Day of Trigger Matter?

Conditions
-----------------
Premature Progesterone Rise

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned fresh Embryo transfer Exclusion Criteria: Cancelation of the embryo transfer for any reason

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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 |
| --- | --- | --- |
| Clinical pregnacy rate |  | 14 days after the day of embryo transfer (ET) |
A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

Official Title
-----------------
A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: BIIB015


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age 18 years or older at the time of informed consent. Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists. ECOG Performance Status </= 2. Exclusion Criteria History of keratoconjunctivitis, open or closed angle glaucoma, or dry eye disease. New York Heart Association (NYHA) Grade II or greater congestive heart failure. History of myocardial infarction within 6 months prior to Day 1. Presence of >/= Grade 2 peripheral neuropathy. Known presence of central nervous system or brain metastases. Prior therapy with a conjugated or unconjugated maytansine derivative.

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

| Intervention/Treatment |
| --- |
|Drug: BIIB015|IV infusion once every 3 weeks until disease progression or unacceptable toxicity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety |  | ongoing | 
| To determine the maximum-tolerated dose (MTD) |  | ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetics (PK) |  | ongoing | 
| To evaluate clinical activity |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed, Refractory
Prevention Ventilator Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing VAP in a major heart surgery ICU. The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.

Official Title
-----------------
Impact of 4 Sequential Measures on the Prevention of Ventilator Associated Pneumonia in Major Heart Surgery Intensive Care Unit

Conditions
-----------------
Ventilator-associated Pneumonia

Intervention / Treatment
-----------------
* Other: Bundle implementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with heart surgery admitted in critical care unit during the study period Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bundle implementation<br>The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine. | Other: Bundle implementation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP) | Change (reduction) in the incidence density of VAP | Baseline and up to 35 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change(length) in Intensive Care Unit (ICU) stay |  | Baseline and up to 35 months | 
| Change (number of days) in Mechanical Ventilator (MV) per ICU stay |  | Baseline and up to 35 months | 
| Change in mortality rate |  | Baseline and up to 35 months | 
| Change in cost of antimicrobial acquisition during ICU stay |  | Baseline and up to 35 months | 
| Change in compliance with the measures |  | Baseline and up to 35 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bundle, prevention, Disturbance; Heart, Functional, Postoperative, Cardiac Surgery
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

Detailed Description
-----------------
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery. Follow-up period is 2 years.

Official Title
-----------------
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Conditions
-----------------
Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma, Primary Open Angle

Intervention / Treatment
-----------------
* Procedure: XEN® Gel Stent implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate glaucoma patients Have given written informed consent Aged 18 years or older of either sex Exclusion Criteria: Patients not able to understand the character of the study Participation in other clinical research within the last 4 weeks Patients with end-stage glaucoma Patients with glaucoma surgery done before

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
Intervention Model: Single Group Assignment
Interventional Model Description: Intraocular pressure, adverse events, complications, number of medications in mild to moderate glaucoma patients who underwent XEN® Gel Stent implantation were recorded. Data were collected in a 2 years follow-up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Evolution of IOP after XEN® Gel Stent implantation<br>To study the efficacy of the XEN® Gel Stent in lowering the IOP. | Procedure: XEN® Gel Stent implantation<br>* Minimally invasive glaucoma surgery (MIGS) which consists of implanting a XEN® Gel Stent in the irido-corneal angle of the eye to drain the aqueous humour in the sub-conjunctival space to lower the IOP.<br>* Other names: XEN® Gel Stent, Aquesys;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | Change in IOP before and after XEN® Gel Stent implantation | Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of needlings | Number of needlings performed during the follow-up after surgery | 2 years | 
| Number of antiglaucomatous medications | Change in number of antiglaucomatous medications before and after the surgery. | Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2 |
RISE FOR HEALTH Study

Study Overview
=================
Brief Summary
-----------------
The RISE FOR HEALTH study (RISE) is an initiative of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium, which was formed by the NIDDK in 2015 to develop the science to improve bladder health in women and girls. RISE is designed to identify risk and protective factors for bladder health and lower urinary tract symptoms (LUTS) and to estimate the distributions of bladder health and bladder health knowledge, attitudes, and beliefs in women of all ages across the life course. This will be accomplished by conducting a population-based prospective cohort study. A sample of individuals who live within the study base, i.e., the county containing each PLUS clinical research center and each adjacent county, will be invited to complete two baseline surveys and then two follow-up surveys one year later. A subset of participants will be invited to attend an in-person evaluation to collect additional clinical information and biologic specimens.

Official Title
-----------------
RISE FOR HEALTH Study by the PLUS Consortium

Conditions
-----------------
Lower Urinary Tract Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Community dwelling Age ≥18 years Identify or born as female (includes cis- and trans-women, and trans-men) Able to read and understand English or Spanish Able to read and provide informed consent Exclusion Criteria: Physical or mental health conditions that would prohibit self-administration of questionnaires either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis). Residence in a nursing home or other institutionalized living facility.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder Health Scales and Function Indices | Multi-item measurement to assess bladder health comprised of subscales and indices ranging from zero to 100 | Baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge, Attitudes and Beliefs (KAB) | Several questions on knowledge, attitudes, and beliefs regarding bladder health and influences on bladder health | Baseline assessment | 
| Change in Bladder Health Scales and Function Indices | Change in multi-item measurement to assess bladder health comprised of subscales and indices ranging from zero to 100 | 1 year follow-up from baseline assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder Health, LUTS, PLUS, RISE
HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

Study Overview
=================
Brief Summary
-----------------
The principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This data is an essential requirement for the assessment, development and evaluation of cost effectiveness of prophylactic vaccination and screening programmes.

Detailed Description
-----------------
Patients undergoing a tonsillectomy operation for non-cancerous reasons will be recruited for this study. They will be asked to complete two questionnaires (study and sexual practices), provide saliva, urine and a blood sample. Following anaesthesia, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.

Official Title
-----------------
HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

Conditions
-----------------
Chronic Tonsillitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea Age - 0 to 65 years Subject or legal guardian has given informed written consent Exclusion Criteria: Subjects undergoing adenoidectomy alone with no tonsillectomy Subjects with previous oropharyngeal cancer or oral cancer, or any other head and neck cancer such as nasopharyngeal or laryngeal cancer that is currently undergoing or has previously been diagnosed or treated Learning disability preventing an adult over 16 years old from giving their own consent

Ages Eligible for Study
-----------------
Maximum Age: 65 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 |
| --- | --- |
| Tonsillectomy<br>Subjects undergoing tonsillectomy for non-cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of HPV in tonsils and in oral scrape sample | Presence of HPV result | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccination status | vaccination received yes/no and the type of vaccination description | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, oral cancer, oropharyngeal cancer, tonsillectomy