linjc16/ctgov huggingface dataset:
N-Acetylcysteine and L-carnitine in Pcos

Study Overview
=================
Brief Summary
-----------------
N-Acetylcysteine and L-carnitine were used in pcos patients

Detailed Description
-----------------
N-Acetylcysteine was compared to L-carnitine in clomiphene citrate in Pcos women to detect the hormonal and metabolic effect

Official Title
-----------------
N-Acetylcysteine Versus L-carnitine in Clomiphene Citrate Resistant Pcos Women. a Randomized Controlled Trial

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Drug: N-Acetylcysteine
* Drug: L-carnitine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pco infertile Exclusion Criteria: no medical disorders no hormonal treatment in the previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-Acetylcysteine<br>N-Acetylcysteine used by clomiphene resistant pcos women | Drug: N-Acetylcysteine<br>* N-Acetylcysteine in clomiphene resistant pcos women<br>|
| Active Comparator: L-carnitine<br>L-carnitine used by clomiphene resistant pcos women | Drug: L-carnitine<br>* L-carnitine in clomiphene resistant pcos women<br>* Other names: motova plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | number of women with clinical pregnancy | 3 momths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation rate | number of women with follicle >18mm. | 3 momths | 
| abortion rate | number of women with abortions | 3 momths |
Effect of Turner Syndrome on Number Sense

Study Overview
=================
Brief Summary
-----------------
This study evaluates approximate number sense (ANS) in children, adolescents, and adult women with Turner syndrome compared to age-matched healthy peers. One primary aim of this project is to assess the effectiveness of an online ANS training tool in enhancing complex mathematics ability. Participants will undergo weekly training sessions in their own home. Half of the participants will complete 2 training sessions a week for 8 weeks, and the second half will complete 1 training session for 8 weeks.

Official Title
-----------------
Investigation of the Role of Turner Syndrome on Approximate Number Sense

Conditions
-----------------
Turner Syndrome

Intervention / Treatment
-----------------
* Behavioral: ANS training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children, adolescents, and adult women with Turner syndrome. Healthy controls. Normal or corrected to normal vision. Exclusion Criteria: Major psychiatric or developmental disorder (e.g., bipolar disorder, major depression, psychotic disorders, intellectual disability, autism spectrum disorder). Chemical dependency Currently taking the following medications: antidepressant, antipsychotic, and anti-seizures drugs.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 40 Years

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

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

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: ANS training<br> | Behavioral: ANS training<br>* In-home computer-based ANS training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single and multiple-operand addition and subtraction accuracy | Task accuracy calculated as the percentage of trials answered correctly. | 8 weeks | 
| Single and multiple-operand addition and subtraction response time | Average amount of time, in seconds, required to answer each question on the task. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
numeracy, number sense
Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).

Official Title
-----------------
An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.

Conditions
-----------------
Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate 15 mg sterile suspension
* Other: Anecortave Acetate Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 50 years. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anecortave Acetate<br>Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) | Drug: Anecortave Acetate 15 mg sterile suspension<br>* 0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection<br>|
| Placebo Comparator: Anecortave Acetate Vehicle<br>Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) | Other: Anecortave Acetate Vehicle<br>* Administered as a posterior juxtascleral injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in logMAR visual acuity score at 12 months |  | Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, anecortave acetate, wet AMD, age-related macular degeneration, Macular Degeneration, Maculopathy, Age-Related, Age-Related Maculopathies, Age-Related Maculopathy, Maculopathies, Age-Related
Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be focused.

Detailed Description
-----------------
At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data will be correlated to sedation depth, as assessed using a validated score. Three Age Groups (infants, children and adolescents) will be evaluated considering the physiologic properties during pediatric development.

Official Title
-----------------
Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation.

Conditions
-----------------
Deep Sedation, Intensive Care Pediatric

Intervention / Treatment
-----------------
* Other: PK analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients between 28 days and 17 years of age mechanical ventilation more than 3 days analgosedation with midazolam and fentanyl Exclusion Criteria: missing informed consent

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 17 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 |
| --- | --- |
| Midazolam/fentanyl: PK analysis<br>Pediatric intensive care patients under analgosedation with midazolam and fentanyl. | Other: PK analysis<br>* Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters |  | Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation |  | Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days | 
| Sedation depth |  | Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days | 
| Length of stay at the intensive care unit (ICU) |  | Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks |
Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe

Study Overview
=================
Brief Summary
-----------------
The conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). The purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments (surgery, injection, rehabilitation, etc.). Women requiring pelvic MRI may participate in the study. The pelvic dynamic MRI will be done with an intravaginal probe which will be inserted by the patient herself as well as gel in the anus and vagina which will allow to obtain the data on the characteristics of the pelvic tissues of each woman with a 3D reconstruction.

Official Title
-----------------
Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe

Conditions
-----------------
Pelvic Floor Disorders

Intervention / Treatment
-----------------
* Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All: Understanding of the French language Signature of informed consent Insured social patient For pregnant women: Primiparous women with no severe maternal-fetal pathology with no scheduled caesarean section at the time of the MRI For women with prolapse: - Requires pelvic MRI Exclusion Criteria: Minor Person who does not have social security Person with ongoing vaginal infection Pregnant woman during the first or third trimester of pregnancy Pregnant woman with broken water pocket Bi-cicatricial uterus IVF Person wearing a pace maker or any intra-body metal implant (if tube MRI) Claustrophobic person (if tube MRI)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic pelvic MRI<br> | Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor<br>* Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D reconstruction of the pelvic cavity | Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe. | at 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Geometrical reconstruction, Pelvic Floor Disorders, FE models, Pelvic system
The Impact of Late Effects After Treatment for Bladder Cancer on Quality of Life

Study Overview
=================
Brief Summary
-----------------
Bladder Cancer prognosis, treatment, and subsequent morbidity and mortality vary between the different stages, thus resulting in a different impact on patients' lives. There are some well known late effects of the treatments for bladder cancer, but the knowledge of their impact on patients Quality of Life is sparse. This study aims to determine the prevalence of late effects impact on Quality of Life and potential risk factors for impairment.

Official Title
-----------------
The Impact of Late Effects After Treatment for Bladder Cancer on Quality of Life - What is the Cost of the Cure?

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible if they are referred to a hospital in the Central Region Denmark, due to hematuria between 01/01/2022 and 01/01/2023 Ability to understand written and oral Danish Exclusion Criteria: Known Alzheimers disease Diagnosed other causes explaining the hematuria

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life | Changes in Quality of Life measured using validated instruments | 5 years from baseline inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of late effects | Based on Patient Reported Outcomes and medical records | 5 years from baseline inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Bladder Cancer, Late effects
Clinical Study for AL-CM

Study Overview
=================
Brief Summary
-----------------
In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up.

Official Title
-----------------
Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy

Conditions
-----------------
Immunoglobulin Light Amyloidosis Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: current treatment of AL-CM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-90 years, regardless of gender, diagnosed with Al-CM at the Second Affiliated Hospital of Zhejiang University School of Medicine; Patients have the ability to understand the test, can cooperate with investigators. Exclusion Criteria: Unable to understand or unwilling to fill in informed consent forms or follow visitors

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AL-CM<br> | Drug: current treatment of AL-CM<br>* current treatment of AL-CM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina) | 10 year |
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Conditions
-----------------
Menopause, Postmenopausal Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: estradiol, 10 mcg
* Drug: estradiol, 25 mcg
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy Postmenopausal Hysterectomized or non-hysterectomized Moderate or severe vaginal dryness and soreness Exclusion Criteria: Known, suspected, or past history of breast cancer Known, suspected, or past history of hormone-dependent tumor Genital bleeding of unknown etiology Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use Vaginal infection Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study History of treatment with diethylstilbestrol

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: estradiol, 10 mcg|nan|
|Drug: estradiol, 25 mcg|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of vaginal symptoms |  | following 12 weeks of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Hematology and chemisty tests, and endometrial biopsy |  |  | 
| Vaginal and urethral cytology, and grading of vaginal health |  |  |
Waitlist-controlled Trial of a Psychological Education Program for Nurses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. The investigators will explore efficacy of the intervention for reducing psychological stress and medical errors.

Official Title
-----------------
Waitlist-controlled Trial of a Psychological Education Program for Nurses

Conditions
-----------------
Psychological Stress

Intervention / Treatment
-----------------
* Behavioral: Psychological education program for nurses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have RN degree Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit Exclusion Criteria: Participation in earlier pilot trial of the intervention

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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological education program<br>Patients receive the psychological education program upon study enrollment. | Behavioral: Psychological education program for nurses<br>* Approximately 4 weekly one-hour group sessions led by study clinicians and 1 optional individual session with a single study clinician.<br>|
| No Intervention: Waitlist<br>Participants are assigned to a 16-week wait-list period upon enrollment. Participants are invited to receive the psychological education program following the waitlist period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory |  | At approximately 16 and 32 weeks post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in from baseline in medical errors as measured by the Medical Errors Questionnaire |  | At approximately 16 and 32 weeks post-baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncology service, Nursing staff, Psychosocial intervention, Coping skills
Risk Factors of Minor Head Injury

Study Overview
=================
Brief Summary
-----------------
Introduction and Aims: The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.

Detailed Description
-----------------
Minor head injury (MHI)is one of the most common diagnoses in emergency rooms and traumatological outpatient departments. The aim of this study is to find clear evidence which risk factors are the most important in MHI patients to develop intracranial bleeding. We hypothetize that anticoagulation is one of the main risk factors for intracranial bleeding.

Official Title
-----------------
Risk Factors of Minor Head Injury in Traumatological Patients

Conditions
-----------------
Minor Head Injury, Intracranial Bleeding, Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minor head injury, dizziness, nausea, vomiting Exclusion Criteria: no injury to the head
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minor head injury, iintracranial bleeding, traumatic brain injury, Cranial computed tomography, anticoagulatory drugs