linjc16/ctgov huggingface dataset:
The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve

Study Overview
=================
Brief Summary
-----------------
The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy. The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery

Official Title
-----------------
The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve : A Prospective Study

Conditions
-----------------
Antimullerian Hormone, Ovarian Cysts, Antral Follicle Count

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non endometriosis ovarian cysts Age between 15-40 years Regulars menses Signed informed consent Exclusion Criteria: Patients with Previous surgery, Patients with infertility, Patients with endometriosis or Patients with suspicious of malignance

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| differences in the ovarian reserve before and after surgery by Antimullerian Hormone |  | 3 months | 
| differences in the ovarian reserve before and after surgery by Antral Follicle Count |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian Size (mm) |  | 3 months | 
| Time of surgery (minutes) |  | 3 months | 
| Age (years) |  | 3 months | 
| BMI in kg/m2 |  | 3 months |
3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

Study Overview
=================
Brief Summary
-----------------
• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

Detailed Description
-----------------
The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).

Official Title
-----------------
3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas

Conditions
-----------------
Fibroid

Intervention / Treatment
-----------------
* Diagnostic Test: 3D Ultrasound
* Diagnostic Test: Hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids. Absence of STD, PID, active vaginal bleeding. Exclusion Criteria: Presence of general cause of abnormal uterine bleeding History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT) History of recent hormonal treatment High risk of undergoing hysteroscopy Vaginal, Vulval causes of bleeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3D ultrasound for diagnosis of submucous myomas<br> | Diagnostic Test: 3D Ultrasound<br>* Doing 3D ultrasound for diagnosis of submucous myoma<br>|
| Hysteroscopy for diagnosis of submucous myoma<br> | Diagnostic Test: Hysteroscopy<br>* Doing hysteroscopy for diagnosis of submucous myoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy | How many women will be diagnosed by 3D US to have submucous myoma | one week |
The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Study Overview
=================
Brief Summary
-----------------
Moderate alcohol may be beneficial for diabetics

Official Title
-----------------
Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes

Conditions
-----------------
Diabetes, Prediabetes

Intervention / Treatment
-----------------
* Dietary Supplement: alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of type 2 diabetes Male or female alcohol abstainers (not more than 1 drink/week) Age between 40-75 yrs Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months Exclusion Criteria: The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion Triglycerides > 500 mg/dL HbA1c<7 or > 10% Serum creatinine > 2 mg/dl Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST) Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy) Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness Patients with chronic hepatitis (C,B) Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants Presence of active cancer, or chemotherapy within the past 3 years Major illness that may require hospitalization A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse Pregnant or lactating woman Participation in another trial with active intervention

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alcohol 1<br> | Dietary Supplement: alcohol<br>* 150 cc<br>|
| Experimental: alcohol 2<br> | Dietary Supplement: alcohol<br>* 150 cc<br>|
| Placebo Comparator: control<br> | Dietary Supplement: alcohol<br>* 150 cc<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVD status |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol diabetes CVD
An Optional Two Year Follow Up Study to Study CP005A

Study Overview
=================
Brief Summary
-----------------
Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.

Detailed Description
-----------------
Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.

Official Title
-----------------
An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Conditions
-----------------
Cat Allergy, Rhinoconjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Previously randomised into study CP005 and completed all visits in the follow-on study CP005A Exclusion Criteria: Partly controlled and uncontrolled asthma History of anaphylaxis to cat allergen Subjects with an FEV1 < 70% of predicted Subjects who cannot tolerate baseline challenge in the EEC Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo<br>Subjects previously randomized to receive placebo in study CP005 and completed CP005A. | |
| Cat-PAD Group 1<br>Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A. | |
| Cat-Pad Group 2<br>Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Rhinoconjunctivitis Symptom Score |  | 102-106 weeks after the start of treatment in CP005 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Symptom scores for ocular and nasal symptoms |  | 102-106 weeks after the start of treatment in CP005 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cat Allergy, Rhinoconjunctivitis
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.

Official Title
-----------------
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

Conditions
-----------------
Colonoscopy, Adenomatous Polyp, Neoplastic

Intervention / Treatment
-----------------
* Other: Narrow Band Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referral for screening or surveillance colonoscopy the ability to provide informed consent Exclusion Criteria: prior surgical resection of any portion of colon prior history of colon cancer history of inflammatory bowel disease use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure poor general condition or any other reason to avoid prolonged procedure time history of polyposis syndrome or Hereditary Non-polyposis colon cancer inability to give informed consent

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: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Narrow Band Imaging|Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narrow Band Imaging
Induction of Migraine Aura With Cilostazol

Study Overview
=================
Brief Summary
-----------------
In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.

Detailed Description
-----------------
Migraine with aura is associated to an increased risk of stroke. The mechanism behind such increased risk is not fully understood. Cilostazol induce headache and migraine in migraine patients and is used as secondary prevention of stroke. The effect on aura induction is not known. We investigate the aura inducing potential of cilostazol and associated changes in endothelial function.

Official Title
-----------------
The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.

Conditions
-----------------
Migraine With Aura, Stroke

Intervention / Treatment
-----------------
* Drug: Cilostazol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine with aura Minimum of 2 attacks/year Exclusion Criteria: Chronic tension type headache Cardiac arrhythmias

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Cilostazol 200 mg single dose | Drug: Cilostazol<br>* Single oral administration of active or placebo one week apart<br>* Other names: Pletal;|
| Placebo Comparator: Placebo<br>Placebo capsule | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aura | Induction of aura reported by an aura diary for 24 hours post medication | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine | Induction of headache resembling usual migraine attacks | 24 hours | 
| Endothelial response | Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol | 3 hours |
Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Melanoma Setting

Study Overview
=================
Brief Summary
-----------------
To generate meaningful data regarding ctDNA that would infer risk of recurrence in stage III melanoma patients.

Detailed Description
-----------------
Cancer cells harbor and can acquire potentially hundreds of mutations, many of whom are found in the ctDNA. Circulating tumor DNA (ctDNA) holds the promise for the 50% of participants who do not need adjuvant therapies - participants could be monitored to ensure no increase in ctDNA. Participants treated could then be followed for the earliest possible blood level signs of recurrence (incr. ctDNA) and more quickly be switched to more effective therapies. Further, the treating physician could hold therapy until the first signs of ctDNA based recurrence for those participants that would benefit. Blood sample from a biobank will be used to identify to monitor ctDNA. These blood samples were drawn at baseline, 3 months, 6 months and 18 months.

Official Title
-----------------
Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Adjuvant Melanoma Setting

Conditions
-----------------
Stage III Melanoma, Stage IV Cutaneous Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 Confirmed fully resected Stage IIIb-IV cutaneous melanoma; including patients treated neoadjuvantly within three months prior to resection. Exclusion Criteria: • Treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 Study Design

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 |
| --- | --- | --- |
| Identify a pattern for gene recognition of cancer recurrence earlier than standard of care. | Genomic sequencing of 40+ ctDNA genes will be analyzed to identify genetic alterations correlating with the development of recurrence in melanoma. | samples taken at baseline, 3 months, 6 months and 18 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the genetic pathway associated with cancer recurrence and biologic information. | The sequencing data will be analyzed against established determinants of cancer biology in clinically relevant melanoma variants identified via analysis of The Cancer Genome Atlas database. | samples taken at baseline, 3 months, 6 months and 18 months. |
Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre

Study Overview
=================
Brief Summary
-----------------
The first goal of this study is to map all the subtherapeutic, therapeutic and supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second objective is to optimize and validate guidelines for dose modifications in patients with too low or high plasma concentrations and to investigate if the same guidelines can be used in different patient populations.

Official Title
-----------------
Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.

Conditions
-----------------
Patients Treated With Voriconazole

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with voriconazole at least 1 voriconazole plasma level measured during therapy Exclusion Criteria: none
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 |
| --- | --- | --- |
| Voriconazole plasma levels during routine intravenous and oral therapy |  | trough levels every 4 days after start or dose adjustment of voriconazole | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voriconazole, therapeutic drug monitoring, plasma levels, dose adjustment
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and digital cutaneous ulcers. Patients receive oral iloprost or placebo twice daily for 6 weeks. Thrombolytic drugs, oral anticoagulants, and heparin are prohibited on study. Concurrent therapy with angiotensin-converting enzyme inhibitors for Raynaud's is prohibited; calcium channel blockers for severe digital ischemia are allowed as needed. Patients are followed at 2 and 6 weeks.

Conditions
-----------------
Systemic Sclerosis, Raynaud Disease

Intervention / Treatment
-----------------
* Drug: iloprost


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Raynaud's phenomenon secondary to systemic sclerosis (SS) SS meets American College of Rheumatology diagnostic criteria At least 6 Raynaud's attacks per week --Prior/Concurrent Therapy-- No prior participation in oral iloprost study At least 4 weeks since participation in other investigational drug studies At least 2 months since prostanoid therapy At least 12 months since sympathectomy of upper limb Ongoing therapy for systemic sclerosis may continue on study Raynaud's therapy discontinued at entry --Patient Characteristics-- Hematopoietic: No platelet disorder Hepatic: No bleeding diathesis Renal: Creatinine clearance (estimated) at least 30 mL/min Cardiovascular: No unstable angina pectoris None of the following within 3 months: Stroke Transient ischemic attack Myocardial infarction Other: No active cancer or other uncontrolled disease No current history of alcohol or drug abuse No mental disorder precluding compliance No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile women

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
Masking: Double


Arms and Interventions

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

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
-----------------
Raynaud's syndrome, arthritis & connective tissue diseases, cardiovascular and respiratory diseases, rare disease, systemic sclerosis