linjc16/ctgov huggingface dataset:
Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?

Study Overview
=================
Brief Summary
-----------------
While there may be a decrease in the total number of bleeding days women experience with continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an increased number of breakthrough or non-scheduled bleeding days. Breakthrough bleeding is among the main reasons cited for discontinuation of combined COCs dosed traditionally (3 weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception are unknown and may be related to the pill formulation. This study is to determine whether progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction with combined oral contraceptives (COC) dosed continuously.

Conditions
-----------------
Breakthrough Bleeding

Intervention / Treatment
-----------------
* Drug: Birth control pills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 to 49 years old Good general health No medical contraindications to combined COC therapy. In addition, all participants were required to have taken cyclic COCs for at least three months at the time of enrollment, in order to avoid common transition bleeding with the initiation of COCs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Birth control pills|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding patterns |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction, menstrual-associated symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breakthrough bleeding while taking continuously dosed oral contraceptives
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death.

Official Title
-----------------
A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects With Stage V Chronic Kidney Disease on Hemodialysis

Conditions
-----------------
End-Stage Kidney Disease

Intervention / Treatment
-----------------
* Drug: Zemplar (paricalcitol injection)
* Drug: Calcijex


Participation Criteria
=================
Eligibility Criteria
-----------------
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Drug: Zemplar (paricalcitol injection)|nan|
|Drug: Calcijex|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death attributable to cardiovascular disease |  |  | 
| Number of hospitalizations for any cause |  |  | 
| Number of hospitalizations due to cardiovascular disease |  |  | 
| Number of days hospitalized for any cause |  |  | 
| Number of days hospitalized due to cardiovascular disease |  |  |
Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study

Study Overview
=================
Brief Summary
-----------------
The study will be conducted to investigate the efficacy of posterior nasal neurectomy in control of recurrence and improvment of allergic symptoms in patients with allergic rhinitis combined with nasal polyposis

Detailed Description
-----------------
Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate

Official Title
-----------------
Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis :A Comparative Study

Conditions
-----------------
Nasal Polyps

Intervention / Treatment
-----------------
* Procedure: Posterior neurectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis Exclusion Criteria: refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>We will do posterior nasal neurectomy in patients with allergic rhinitis after FESS in one side of the nose | Procedure: Posterior neurectomy<br>* Cut of posterior nasal nerve<br>|
| Experimental: Control group<br>We will do FESS only in the other side of the nose | Procedure: Posterior neurectomy<br>* Cut of posterior nasal nerve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis | Surgical procedure to evaluate the recurrence of nasal polyposis | 1 year |
Cardiomyopathy Tissue Bank in a Cancer Population

Study Overview
=================
Brief Summary
-----------------
Any time the words you, your, I, or me appear, it is meant to apply to the potential participant. The goal of this laboratory research study is to collect and store blood and tissue from patients who have a diagnosis of heart disease and may be at a high risk for the development of heart failure. This blood may be used in the future to identify genes that may play a role in developing congestive heart failure (CHF) from chemotherapy or other sources. This is an investigational study. All will be enrolled at MD Anderson.

Detailed Description
-----------------
You will have a one time blood draw of 2 teaspoons of blood for use in future research. This blood may be studied in the future to try to find possible genetic or biochemical markers that may be the cause of CHF. Your blood will be drawn either on an outpatient basis or during a routine visit to the hospital. If you already have a central line or an IV placed, the blood will be drawn at these sites to decrease the pain and discomfort of the blood draw. The information obtained in this study will not be put into your medical records.

Official Title
-----------------
Cardiomyopathy Tissue Bank in a Cancer Population

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Procedure: Blood Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are at high risk for developing Cardiomyopathy or Congestive Heart Failure. Patients two months of age and older. Exclusion Criteria: Those that are not willing to sign an informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Disease Patients<br> | Procedure: Blood Sample<br>* One time blood draw of 2 teaspoons.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Patient Demographic Information (age, sex, race) |  | One time visit. | 
| Identification biological markers predisposing cancer patients to development of chemotherapy-induced congestive heart failure |  | One time visit for collection of blood and tissue samples. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiomyopathy, Tissue Bank, Heart Disease, Heart Failure, Congestive Heart Failure
Special Drug Use Investigation for LAMICTAL® (Long Term)

Study Overview
=================
Brief Summary
-----------------
The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.

Official Title
-----------------
Special Drug Use Investigation for LAMICTAL (Long Term)

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Lamotrigine tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome Subjects who are treated with lamotrigine tablets Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed lamotrigine tablets<br>Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered. | Drug: Lamotrigine tablets<br>* Administered for long-term according to the prescribing information in the locally approved label by the authorities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions |  | 1 year | 
| Occurrence of skin disorder after the start of treatment | Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall improvement of subjects' symptoms | Investigators will assess the overall improvement as remarkably improved. improved, slightly improved, unchanged or worsened on the basis of the degree of change in frequency of seizures, strength, span and other related symptoms. | 1 year |
Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

Study Overview
=================
Brief Summary
-----------------
Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)

Detailed Description
-----------------
Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an activated cell phone. ICD therapy will have been temporarily inactivated before exposure to cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. The cell phones will be held over the ICD generator, as well as in the parasternar region (close to the ICD lead, which senses the signals). Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interference of the ICD when exposed to cell phones. The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

Official Title
-----------------
Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

Conditions
-----------------
Electromagnetic Interference

Intervention / Treatment
-----------------
* Other: Study group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implantation with a wireless-enabled ICD Exclusion Criteria: Age <18yrs inability to sign an informed consent pacemaker dependancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Study group<br>Evaluation of interference | Other: Study group<br>* Exposure to cell phone interference of the ICD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have electromagnetic interference of the ICD when exposed to cell phones. | Detection of electromagnetic interference | 5-10minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implantable cardioverter defibrillator, Electromagnetic interference, Cell phone
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet

Study Overview
=================
Brief Summary
-----------------
All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done. No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.

Official Title
-----------------
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet

Conditions
-----------------
Minor Traumatic Brain Injury, Treatment by Antiplatelet

Intervention / Treatment
-----------------
* Biological: S100B protein dosing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Years old Minor traumatic brain injury measured by a Glasgow score between 13 and 15 Antiplatelet agent therapy Free subject without tutorship or curatorship Exclusion Criteria: Age < 18 years old Glasgow score <13 Traumatic brain injury older than 6 hours Patient without any social security system Patient with renforced protection (tutorship, curatorship, …)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S100B protein dosing<br> | Biological: S100B protein dosing<br>* Patients under antiplatelet therapy and who have a minor traumatic brain injury will have a blood samples with protein S100B dosage on arrival to the emergency room and after they will have a brain scanner between 4 and 8 hours after the trauma to analyse the negative predictive value with a treshold of 0.105 μg/L<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L |  | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
S100B protein, minor traumatic brain injuries, antiplatelet therapy
Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS) in patients of the investigators previous study who received either placebo or sertraline and have not responded.

Official Title
-----------------
An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Procedure: transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients from a previous study (ID:USP-HU-001) who: received sertraline and did not respond. received placebo and did not respond. Exclusion criteria: Patients from a previous study who: received active tDCS. responded.

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active stimulation<br>In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes. | Procedure: transcranial direct current stimulation<br>* Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response | Response is defined as MADRS <=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score). | Week 1 | 
| Treatment response | Response defined as above. | Week 2 |
Effect and Prognosis of Immunohistochemical Biomarkers Changes in Patients With Bladder Cancer After Neoadjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Clinical trial to investigate the relationship between the expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67 in bladder cancer and pathological complete response after neoadjuvant chemotherapy.

Detailed Description
-----------------
This is a retrospective study included bladder cancer patients treated with neoadjuvant chemotherapy. We analyzed the changes in the expression of GATA-3, CK20, P53 and Ki67 before and after NAC. Evaluating the sensitivity factor for predicting pathological complete response.

Official Title
-----------------
Effect and Prognosis of Immunohistochemical Biomarkers Changes in Patients With Bladder Cancer After Neoadjuvant Chemotherapy

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

Intervention / Treatment
-----------------
* Other: neoadjuvant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any male or female patient aged 18 or older. Histologically confirmed bladder cancer, cystectomy was performed after NAC. Complete clinical data. Exclusion Criteria: Patients with severe organic disease who can not tolerate chemotherapy or surgery Patients received previous treatment (chemotherapy, radiation, or molecular targeted therapy). Patients with distant metastasis or other cancer history.

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 |
| --- | --- |
| Histologically confirmed bladder cancer treated with NAC<br> | Other: neoadjuvant chemotherapy<br>* The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of immunohistochemical biomarkers GATA-3, CK20, P53 and Ki67 |  | 1 year | 
| Tumor regression grade |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder cancer, neoadjuvant chemotherapy, immunohistochemical biomarkers