linjc16/ctgov huggingface dataset:
Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles

Detailed Description
-----------------
compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen

Official Title
-----------------
Comparison of Coagulation Profiles in Oral Contraceptive Pills Users Between 1.5 mg Estradiol/2.5 mg Nomegestrol Acetate (Zoely) and 15 mcg Ethinylestradiol/60 mcg Gestodene (Minidoz): A Randomized Control Trial

Conditions
-----------------
Contraception, Hypercoagulability

Intervention / Treatment
-----------------
* Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate
* Drug: 15 µg ethinylestradiol and 60 µg gestodene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman age 19-40 yr Normal uterus and both adnexae BMI < 28.5 kg/m2 Require contraception with COCs Exclusion Criteria: Pregnancy Postartum period within 6 wk Smoking BP ≥ 140/90 mmHg Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system Use contraceptive steroids within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zoely<br>Monophasic combined oral contraceptive pills 24 white active tablets and 4 yellow inactive tablets each active tablet contains 1.5 mg estradiol and 2.5 mg nomegestrol acetate 3 cycles | Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate<br> <br> * Other names: Zoely®;|
| Active Comparator: Minidoz<br>Monophasic combined oral contraceptive pills 24 active tablets and 4 inactive tablets each active tablet contains ethinylestradiol 15 µg and gestodene 60 µg 3 cycles | Drug: 15 µg ethinylestradiol and 60 µg gestodene<br> <br> * Other names: Minidoz®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-dimer | µg/L | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibrinogen | mg/dL | 12 weeks | 
| antithrombin III | percent | 12 weeks | 
| to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz® |  | 12 weeks |
Insulin, Neurogenetics and Memory in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This study examines the use of insulin-sensitizing compounds, as therapeutic agents for cognitive impairment in Alzheimer's disease.

Official Title
-----------------
Insulin, Neurogenetics and Memory in Alzheimer's Disease: A Novel Therapeutic Approach

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women with mild Alzheimer's Disease without serious medical or psychiatric comorbid conditions.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 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: rosiglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina

Study Overview
=================
Brief Summary
-----------------
This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina. The effect of moderate amounts of physical activity on the spread will be evaluated, and compared to no physical activity.

Official Title
-----------------
Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE

Conditions
-----------------
Health, Vulvovaginal Candidiasis

Intervention / Treatment
-----------------
* Drug: Miconazole nitrate
* Procedure: Magnetic resonance imaging
* Behavioral: Moderate levels of exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not at risk for pregnancy Willing to abstain from intercourse 24 hours prior to MRI Regular menstrual cycles (every 23-38 days) At least 10 weeks from most recent pregnancy outcome and had 2 spontaneous menstrual cycles since Normal pap smear within previous 12 months Negative test for yeast, bacterial vaginosis and trichomonas Not allergic to any component of the formulation No contraindications to MRI Not participated in another investigational trial within 30 days No history of condition, or finding on exam, that, in the opinion of the investigator, would make participation unsafe for the volunteer or complicate interpretation of the data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Miconazole nitrate|nan|
|Procedure: Magnetic resonance imaging|nan|
|Behavioral: Moderate levels of exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare between exercise and no exercise: |  |  | 
| Time needed for the capsule to dissolve; |  |  | 
| Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion; |  |  | 
| Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion; |  |  | 
| Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product distribution will be assessed by: |  |  | 
| Linear spread from the cervix covered by the product; |  |  | 
| Percent of maximal linear spread from the cervix; |  |  | 
| Surface area covered by the product; |  |  | 
| Percent of maximal surface contact; |  |  | 
| Presence bare spots in coating; |  |  | 
| Presence of product outside the introitus |  |  |
Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, two-way, non-intervention study. the main purpose: Understand the current status of diagnosis and treatment of cholangiocarcinoma patients in China and observe the effect of different treatment options on patient recurrence and long-term survival Secondary purpose: Exploring the actual clinical treatment situation and its compliance with the existing diagnosis and treatment of bile duct cancer Exploring the establishment of clinical research standard fields and standards for diagnosis and treatment of bile duct cancer

Official Title
-----------------
Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study

Conditions
-----------------
Cholangiocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above the age of 18 years old, male or female clinical diagnosis of patients with cholangiocarcinoma Child-Pugh classification of A, B Eastern Cooperative Oncology Group scoring system (ECOG) score of 0-2 points Exclusion Criteria: None

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFSR | RFSR-Recurrence Free Survival Rate | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | OS-Overall Survival | 3 years | 
| RFS | RFS-Recurrence Free Survival | 3 years |
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.

Official Title
-----------------
An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between Two 5-mg Tablets and a New 10-mg Tablet Formulation of Lecozotan SR in Healthy Subjects.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: lecozotan SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Generally healthy, man and women, aged 18 to 50 years. Exclusion criteria: History or active presence of clinically important medical disease.

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lecozotan SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) analyses |  |  |
Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Study Overview
=================
Brief Summary
-----------------
Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.

Official Title
-----------------
Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)

Conditions
-----------------
Chronic Pancreatitis

Intervention / Treatment
-----------------
* Drug: CREON


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical history of chronic pancreatitis (CP). Diagnosis of Exocrine Pancreatic Insufficiency (EPI). Exclusion Criteria: --History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants on CREON<br> | Drug: CREON<br>* Oral Capsules<br>* Other names: ABT-SLV245;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire |  | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue |  | Up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pancreatitis, Exocrine Pancreatic Insufficiency, CREON, pancrelipase, ABT-SLV245
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.

Official Title
-----------------
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux

Conditions
-----------------
HNSCC

Intervention / Treatment
-----------------
* Drug: cetuximab
* Drug: Carboplatin, 5FU concomitant
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx Stage III - IV (T0-T4, N0-N2b, M0) Not resected Karnofsky PS>=80 Informed consent signed Exclusion Criteria: Contra indication to chemotherapy or cetuximab

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Radiotherapy 70Gy, Erbitux, Carboplatin-5FU | Drug: cetuximab<br>* D-7, D1, D8, D15, D22, D29, D43, D50<br>Drug: Carboplatin, 5FU concomitant<br>* Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46<br>Radiation: Radiotherapy<br>* 70 Gy in 7 weeks<br>|
| Active Comparator: 2<br>Radiotherapy 70Gy, Erbitux | Drug: cetuximab<br>* D-7, D1, D8, D15, D22, D29, D43, D50<br>Radiation: Radiotherapy<br>* 70 Gy in 7 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco-regional control |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage III, Stage IV, locally advanced
Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess whether a computer-assisted prescription allows a reduction of the overall number of inappropriate PAR in emergency departments.

Official Title
-----------------
Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department

Conditions
-----------------
Plain Abdominal Radiography

Intervention / Treatment
-----------------
* Other: Computer-assisted prescription


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 16 or more with a PAR. Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Before after. During the before period, standard of care. During the after period, computer-assisted prescription for plain abdominal radiography (reminding the indication for this procedure).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Before<br>Standard of care for informatic prescription. | |
| Active Comparator: After<br>Computer-assisted prescription for radiological procedure | Other: Computer-assisted prescription<br>* The intervention is based on a computer-assisted prescription: when a PAR will be ordered, an alert will arise and explain the recognized indications for this examination and ask a confirmation for the prescription. This is a non-blocking system: physicians will be able to prescribe PAR even if the PAR is not appropriate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of plain abdominal radiopraphy (PAR) with an inappropriate indication | 4 indications are considered as appropriate : (1) foreign body suspicion, (2) checking after contrast injection, (3) catheter checking and (4) follow-up of urolithiasis. Order for PAR will be independantly reviewed by blinded assessors. | Same ED consultation (or max 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of additional radiological examination (CT, US, IRM) after the PAR |  | Same ED consultation (or max 24 hours) |
Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening

Study Overview
=================
Brief Summary
-----------------
20% of deliveries take place following an artificial induction of labor. The latter sometimes requires prior cervical ripening, of which the two most widely used methods in France are oral misoprostol and the balloon catheter, left to the discretion of clinicians. The objective of this study is to observe which cervical maturation method patients choose when an artificial induction of labor with an unfavorable cervical status must be carried out, and to observe the patient's criteria as to the choice made, as well as their experience and their satisfaction with artificial induction of labor, in order to improve our clinical practices, the experience of childbirth, and promote patient autonomy.

Official Title
-----------------
Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening

Conditions
-----------------
Cervical Ripening

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult woman (≥18 years old) Patient who underwent induction of labor between February 1, 2020 and February 29, 2021 Patient not having expressed her opposition, after information, to the reuse of her data for the purposes of this research. Exclusion Criteria: Patient who expressed her opposition to participating in the study Absence of prior cervical maturation (Bishop score greater than or equal to 6 on the day of initiation) Gestational age less than 37 weeks, multiple pregnancy, scarred uterus, non-cephalic presentation, death in utero and severe fetal malformation (requiring neonatal resuscitation or with a palliative care plan) Patient for whom the triggering method was chosen by the practitioner Patient under guardianship, curatorship or safeguard of justice

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of the cervical ripening method that patients choose when artificial induction of labor with unfavorable cervical status must be performed |  | Files analysed retrospectively from JFebruary 01, 2020 to February 29, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Ripening, PREGNANCY, LABOR INDUCED, Artificial induction
Pain in Traumatic Brain Injury - Basile, MD

Study Overview
=================
Brief Summary
-----------------
The observation through a chart review of persistent pain on neuro psychological functioning and how it applies to the community integration with patients that had suffered traumatic brain injury.

Detailed Description
-----------------
This pilot study is designed and conducted over a one year period by the PI, who then solely carried out this study from recruitment, to patient testing, to data entry. Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.

Official Title
-----------------
The Role of Persistent Pain on Neuro Psychological Functioning and Community Integration in Traumatic Brain Injury

Conditions
-----------------
Head Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented history of traumatic brain injury 18 years or older Exclusion Criteria: younger than 18 years old cannot read and write English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Assessment of Pain Severity | Pain was assessed on a scale for 1 (no pain) to 10 (severe) pain. This is observational study so participants were only seen at one time point, when they were referred to the neuropsychology service. | Referral | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head trauma; traumatic brain injury