linjc16/ctgov huggingface dataset:
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
Additional testosterone undecanoate can improve female sexual function in postmenopausal women which one aspects of quality of life. The dose adjustment can reduce incidence of adverse effects and low cost of treatment with effective outcome.

Detailed Description
-----------------
Research Question:  Does oral testosterone undecanoate improve sexual problem in postmenopausal women?  Type Research:Clinical research Study design: Randomized double-blinded placebo controlled trial

Official Title
-----------------
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Conditions
-----------------
Female Sexual Dysfunction

Intervention / Treatment
-----------------
* Drug: Testosterone undecanoate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal women with age between 40-60 years Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5 Exclusion Criteria: women with previous use of hormonal replacement or anti-psychiatric drugs within 3 months women with history of or present premalignancies/malignancies women present with liver disease or abnormal liver enzyme women with active cardiovascular, cerebrovascular or thromboembolic disorders women with Present psychiatric disease Partner have sexual dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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: Testosterone undecanoate<br>testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily | Drug: Testosterone undecanoate<br>* testosterone undecanoate 40 mg orally twice a week<br>* Other names: Andriol;|
| Placebo Comparator: placebo<br>placebo twice a week with progynova 1 mg oral daily | Drug: placebo<br>* placebo orally twice a week with progynova 1 mg oral daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| female sexual function index score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects of the drug | weight gain acne hirsutism. vaginal bleeding | 8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female sexual function, postmenopause, testosterone
Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

Study Overview
=================
Brief Summary
-----------------
In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.

Official Title
-----------------
Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients

Conditions
-----------------
Infertility, PCOS

Intervention / Treatment
-----------------
* Drug: GnRh agonist +1500E hCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICSI patients below 38 years 1, 2 and 3e IVF cycle Body Mass Index (BMI) less than 32 PCOS patients Exclusion Criteria: endocrinal diseases or problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: humaan chorion gonadotropine<br>ovulation induction with 5000E hCG | |
| Active Comparator: GnRH agonist + 1500E hCG<br>ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval | Drug: GnRh agonist +1500E hCG<br>* ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MII oocytes | The number of mature oocytes retrieved after stimulation without creating OHSS | patients will be followed during the stimulation with an average of 10 days | 
| 2 Pro Nuclei (2PN) fertilization | laboratory follow up of the fertilized egg during the first 24h | 24h after ICSI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | The number of pregnancies obtained wich still is the most important issue for the patients | 12 weeks | 
| OHSS | patient follow up according to subjective complaints and objective measures | one month with oocyte retrieval in the middle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OHSS, mataphase II oocytes (MII), good quality embryo's, pregnancy
miRNA Profile in Aneurysmal Subarachnoid Haemorrhage

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate and understand the circulating miRNA profiles after acute aneurysmal subarachnoid haemorrhage and underlying pathological significance.

Detailed Description
-----------------
The investigators aim to investigate the miRNA classifier for delayed cerebral infarction after aneurysmal subarachnoid haemorrhage; The investigators aim to investigate the corresponding circulating and CSF miRNA profiles.

Official Title
-----------------
Circulating and CSF miRNA Profile in Patients With Acute Aneurysmal Subarachnoid Haemorrhage

Conditions
-----------------
Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aneurysmal subarachnoid hemorrhage patients within the first 72 hours or Healthy volunteers Exclusion Criteria: Previous neurological diseases such as stroke or dementia

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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 |
| --- | --- |
| SAH with DCI<br>Aneurysmal subarachnoid haemorrhage patients with delayed cerebral infarction | |
| SAH nonDCI<br>Aneurysmal subarachnoid haemorrhage patients without delayed cerebral infarction | |
| Control<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating micro RNA concentrations | Serum micro RNA concentrations | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating micro RNA change | Changes of serum micro RNA concentrations between days 1,2,3,7 | Days 1,2,3,7 | 
| Cerebrospinal fluid micro RNA concentrations | Cerebrospinal fluid micro RNA concentrations | Day 1,2,3,7 | 
| Cerebrospinal fluid micro RNA change | Changes of cerebrospinal fluid micro RNA concentrations between days 1,2,3,7 | Days 1,2,3,7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subarachnoid Haemorrhage
Antagonistic Interaction CB1-paracetamol

Study Overview
=================
Brief Summary
-----------------
Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of Paracetamol in healthy volunteers

Detailed Description
-----------------
Double Blind, cross-over, randomized and controlled versus placebo, study in healthy volunteers.

Official Title
-----------------
Evaluation of the Interaction of Rimonabant (Antagonist of CB1 Receptor) on the Analgesic Effect of Paracetamol in Intravenous Administration

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Rimonabant and Paracetamol and placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between 18 and 40 years old written consent given Exclusion Criteria: Rimonabant or paracetamol hypersensibility Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania Concomitant medication Chronical diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rimonabant and Paracetamol and placebo|evaluation of an possible inhibiting effect of rimonabant on the analgesic effect of paracetamol in healthy volunteers|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain's threshold with electrical stimulation (Pain Matcher). Pain's threshold with mechanical stimulation (electronical Von Frey). |  | during electrical stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic concentration of paracetamol or his metabolite with or without Rimonabant |  | with or without rimonabant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain,, analgesia, Healthy volunteers
A Study of Physiologic Changes in a Telemetry Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the physiological changes associated with health deterioration, as well as different types, doses, and routes of administration of medications and fluids in acutely ill patients.

Official Title
-----------------
Physiologic Changes Associated With Health Deterioration, Medications and Fluids Used in the Telemetry Unit

Conditions
-----------------
Acute Illness Requiring to Hospital Telemetry Admission

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mayo Clinic patients who: Admitted to telemetry unit With acute illness Received any type of medication via any route of administration (oral, sublingual, intranasal, inhalational, intramuscular, intravenous, subcutaneous, transdermal) Received any amount of any type of intravenous fluids Cognitively and/or physically be able to sign consent Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Change in Heart Rate | Number of beats per minute | Baseline, through telemetry unit stay (approximately 1-3 days) | 
| Change in Blood Pressure | Measured in millimeters of mercury (mmHg) | Baseline, through telemetry unit stay (approximately 1-3 days) | 
| Change in Respiratory Rate | Number of breaths per minute | Baseline, through telemetry unit stay (approximately 1-3 days) | 
| Change in Oxygen Saturation Levels | Measured by a pulse oximeter reading reported as a percentage | Baseline, through telemetry unit stay (approximately 1-3 days) | 
| Change in ECG morphology | Changes in ECG waveform appearance measured from the digital ECG waveform interpretation | Baseline, through telemetry unit stay (approximately 1-3 days) |
Study to Evaluate the Performance of a Sustained Vacuum System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.

Official Title
-----------------
A Non-Randomized, Prospective Study to Evaluate the Performance of a Sustained Vacuum System

Conditions
-----------------
Seroma as Procedural Complication, Hematoma Postoperative

Intervention / Treatment
-----------------
* Device: SOMAVAC® 100 Sustained Vacuum System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 21 years or older; Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection; Capable of providing informed consent. Exclusion Criteria: Pregnant or lactating females; Patients on steroids or other immune modulators known to impact healing; Patients who are likely to not complete the study; Patients who, in the opinion of the investigator, are unlikely to comply with the protocol; Patients who have participated in this trial previously and who were withdrawn; Patients with known allergies to contacting materials (i.e. latex, metal, etc.); Patients who received neoadjuvant chemotherapy or radiotherapy within the last 3 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All participants receive the SOMAVAC® 100.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>All participants receive the SOMAVAC® 100 Sustained Vacuum System | Device: SOMAVAC® 100 Sustained Vacuum System<br>* The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time with drains | Determine the length of time drains were used | 1 - 6 weeks | 
| Surgical site related complications | Evaluate the number of surgical site related complication | 1 week - 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported usability of the suction device | Determine patient reported usability of the suction device with the system usability scale | 1week - 1year | 
| Amount of fluid collected | Determine the total amount of fluid collected | 1week - 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seroma Following Procedure, Healing Delayed, Dehiscence
Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis

Study Overview
=================
Brief Summary
-----------------
This project aims to investigate cardiac function in patients with cirrhosis in the acute setting. Acute decompensation and acute-on-chronic liver failure are major events in the life of a patient as they herald disease progression and negative prognosis. Cardiocirculatory function will be assessed by serial assessments in patients admitted for acute decompensation of cirrhosis.

Detailed Description
-----------------
In this project we aim to investigate the dynamic role of cardiac function in the short-term evolution of patients with AD of cirrhosis through noninvasive and accessible tests and validate prognostic imaging and serum biomarkers. The main objectives are: To describe changes and evolution of cardiac function in AD of cirrhosis To investigate associations between echocardiographic parameters and serum biomarkers To investigate the association between ACLF and cardiac dysfunction To assess the short-term prognostic impact of cardiac function in AD and ACLF; To evaluate the added predictive value of cardiac markers to current scores (CLIF-C).

Official Title
-----------------
Dynamic Assessment of Cardiac Function in Acutely Decompensated Cirrhosis

Conditions
-----------------
Cirrhosis, Acute Liver Failure, Cardiomyopathies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven cirrhosis with acute decompensation Exclusion Criteria: screening after > 72 hours from admission previous severe cardiac conditions (e.g. ischemic heart disease, atrial fibrillation, congestive heart failure, ICD) concomitant severe disease (e.g. active neoplasia, severe COPD, etc) lack of informed consent intubated/ comatose patient

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 |
| --- | --- | --- |
| cardiac dysfunction | rate of onset and evolution of systolic/ diastolic dysfunction in acute decompensation | 90 days | 
| composite outcome | risk of developing ACLF, disease worsening, or death during follow-up | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarkers | detecting biomarkers predictive for cardiac dysfunction and disease severity | 30 days |
Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures

Study Overview
=================
Brief Summary
-----------------
The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is performed prior to operation. Blood samples and CSF samples are collected at surgery and blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at , 3 months and >1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

Detailed Description
-----------------
The hypotheses explored in this investigation is that patients being pre-AD or having AD have worse prognosis following an acute hip fracture. This has been demonstrated in retrospective studies. In this study we admit all patients with a hip fracture planned tro receive a spinal anesthesia. Our golden standard of anesthesia in this patient cohort. Preoperatively Clinical Dementia Score is assessed after study inclosure. At the performance of the spinal dosage is standardized. Prior to giving this 5 ml of CSF is collected and blood is collected. Blood is then collected at intervals up until day 3 postoperatively. We plan to analyze beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at, 3 months and >1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

Official Title
-----------------
The Presence of Pre-Alzheimers/Alzheimers Disease (AD) and Neuromarkers Related to Morbidity/Mortality in Patients With Acute Hip Fractures

Conditions
-----------------
Alzheimers Disease, Inflammation, Hip Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip fracture with a planed spinal anesthesia Exclusion Criteria: Not receiving a spinal anesthesia i.e. no CSF is available
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 |
| --- | --- | --- |
| Mortality and morbidity | interview by phone and death registration | 1year |
Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in patients with open-angle glaucoma or ocular hypertension

Official Title
-----------------
Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Xalatan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open-angle glaucoma ocular hypertension Exclusion Criteria: - VA worse than 0.60

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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IP Change from Baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open-angle glaucoma, ocular hypertension