linjc16/ctgov huggingface dataset:
4 Versus 6 cm Active Phase of Labour

Study Overview
=================
Brief Summary
-----------------
A study to compare maternal and perinatal outcome between 4 and 6 cm cervical dilatation at amniotomy.

Detailed Description
-----------------
Low risk women with singleton pregnancy are recruited. There are two groups which are 4 and 6 cm cervical os dilatation. The intrapartum management and labour outcomes are documented.

Official Title
-----------------
4 Versus 6 cm Cervical os Dilatation to Demarcate Active Phase of Labour: Comparative Cross Ectional Study

Conditions
-----------------
Cervix; Open, Labor Complication

Intervention / Treatment
-----------------
* Other: oxytocin augmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy no medical disorders no antenatal complications such as hypertension and diabetes Exclusion Criteria: fetal anomaly one previous caesarean section other uterine scars

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 4 cm cervical os dilatation<br>Low risk women with cervical os dilatation of 4 cm at amniotomy and whether they need oxytocin augmentation and analgesia. | Other: oxytocin augmentation<br>* Only observation of the outcome<br>|
| 6 cm cervical os dilatation<br>Low risk women with cervical os dilatation of 6 cm at amniotomy and whether they need oxytocin augmentation and analgesia. | Other: oxytocin augmentation<br>* Only observation of the outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean section rate | in percentage | from recruitment up to birth of neonate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration from amniotomy until delivery | duration in minutes from recruitment until delivery | from recruitment until up to delivery of neonate | 
| oxytocin augmentation | percentage of those who required | from recruitment until up to delivery of neonate | 
| Percentage of women with complications | complications such as postpartum haemorrhage and extended perineal tear | from recruitment until up to 6 weeks post delivery | 
| Percentage of neonates with complications | neonatal intensive care unit admission, Apgar score less than 7 at 5 minutes and cord pH <7.24 | from birth of neonate up tom 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
active labour, 4 and 6 cm, low risk women
Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

Study Overview
=================
Brief Summary
-----------------
In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis). More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM. However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.

Official Title
-----------------
Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

Conditions
-----------------
Menstrual Cup, Intrauterine Device Migration

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 or over Consultant for one of the following reasons: IUD control IUD expulsion Pregnancy on IUD Other reason that required an ultrasound for the IUD Consent to participate in the study Exclusion Criteria: Patient benefiting from a legal protection measure

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 |
| --- | --- |
| CAS<br> | Other: Questionnaire<br>* questionnaire for the patients and the volontaire<br>|
| TEMOIN<br> | Other: Questionnaire<br>* questionnaire for the patients and the volontaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the risk of IUD displacement in patients using menstrual cup | Transvaginal ultrasounds will be used to monitor the position of the intrauterine device in patients using a menstrual cup. | 1 DAY |
Latanoprost Versus Fotil

Study Overview
=================
Brief Summary
-----------------
To compare the intraocular pressure effect and safety of latanoprost 0.005% given every evening versus PTFC given twice daily.

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

Intervention / Treatment
-----------------
* Drug: latanoprost 0.005%
* Drug: Fotil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with primary open-angle or pigment dispersion glaucoma, or ocular hypertension untreated intraocular pressure should be between 24-36 mm Hg inclusive visual acuity should be 5/50 or better in both eyes Exclusion Criteria: presence of exfoliation syndrome or exfoliation glaucoma contraindications to study medications any anticipated change in systemic hypotensive therapy

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: latanoprost 0.005%|nan|
|Drug: Fotil|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Survival Study in Patients Undergoing On-line Hemodiafiltration

Study Overview
=================
Brief Summary
-----------------
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.

Official Title
-----------------
A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Procedure: Hemodialysis
* Procedure: On-line hemodiafiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Currently undergoing hemodialysis Clinical stability Stable vascular access Exclusion Criteria: Chronic inflammatory diseases Liver cirrhosis Malignancies Chronic immunosuppressant or antiinflammatory use Dialysis through temporary catheter or single puncture

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Hemodialysis | Procedure: Hemodialysis<br>* 3 times per week<br>|
| Experimental: B<br>On-line hemodiafiltration | Procedure: On-line hemodiafiltration<br>* 3 times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mortality, Convective therapies, On-line Hemodiafiltration, Dialysis Adequacy, Age 18 or older, Undergoing hemodialysis
Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential

Study Overview
=================
Brief Summary
-----------------
A single centre randomised controlled trial investigating the influence of a novel prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of oocytes

Official Title
-----------------
Influence of a Prematuration Culture With a PDE3-I on Embryonic Aneuploidy Rate and Developmental Potential

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: prematuration culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers, either with PCOS/PCOS-like ovaries, or with normal ovaries, who undergo oocyte donation for research AFC at least 10 AMH: > 5 μg/L Female age < 36 years Exclusion Criteria: major uterine or ovarian abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: in-vitro maturation of oocytes<br> | Procedure: prematuration culture<br>* The aneuploidy rate and the developmental potential of embryos obtained from PDE3 inhibitor-treated oocytes (a prolonged IVM (PMC)) in comparison to conventional IVM will be analysed. It is intended to assess the nuclear and cytogenetic constitution of the obtained embryos.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of aneuploidy rate by fluorescence in situ hybridisation (FISH) technique in 6 to 8 cell embryos from prolonged (PMC) IVM compared to conventional IVM on sibling oocytes. |  | 3 days after egg retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation potential of embryos from conventional IVM performed on Type II COC. Efficiency of both maturation systems in obtaining blastocysts. Endometrium quality in IVM cycles. |  | 7 days after egg retrieval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS and normal ovulatory patients, aneuploidy, in-vitro maturation of oocytes
IMPlementation of gUideLines for the Management of Arterial hypertenSION. The IMPULSION Study

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to improve awareness, treatment, and control of arterial hypertension, within primary prevention of target organ damage, by implementing guidelines, after training of the participating physicians.

Detailed Description
-----------------
Physicians from 20 hospitals and 40 health centres (primary health care settings) were trained to implement guidelines in treating arterial hypertension. There will be a baseline recording of patients with arterial hypertension and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of arterial hypertension. After a six month effort, physicians will have to complete the same form at study completion. Previous training of physicians and the fact that they will have to report their success in treating hypertension will hopefully contribute to an increase in number of hypertensive patients at blood pressure target, and will minimise the target organ damage. The estimated reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at study completion with that of baseline.

Official Title
-----------------
IMPlementation of gUideLines for the Management of Arterial hypertenSION. The IMPULSION Study

Conditions
-----------------
High Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: Implementation of guidelines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arterial hypertension as defined by the JNC 7 report Exclusion Criteria: Pregnancy Lactation Malignancies with small life expectancy Unwillingness to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Implementation of guidelines|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in arterial hypertension control |  | 6 months | 
| Efficacy in reducing estimated risk of coronary heart disease |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness of arterial hypertension control |  | 6 months | 
| Differences between primary and secondary health care settings as well as teaching hospitals |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High blood pressure, Awareness, Treatment, Effective Control, Coronary heart disease risk reduction, Hypertension
PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1,2). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and investigate its effectiveness for lower extremity rehabilitation.

Official Title
-----------------
Long-term Paired Associative Stimulation for Rehabilitation of Lower Extremities in Persons With Incomplete Tetraplegia

Conditions
-----------------
Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
-----------------
* Device: Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical incomplete SCI Exclusion Criteria: epilepsy metal inclusion in the head area pacemaker hearing device high intracranial pressure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAS<br>The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator. | Device: Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)<br>* Paired associative stimulation (PAS) administered several times per week for 8 weeks to lower limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daniels and Worthingham's Muscle Testing | Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal) | 2 days after the last stimulation session | 
| Daniels and Worthingham's Muscle Testing | leg muscles are evaluated on 0-5 scale | 1 month after the last stimulation session |
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

Study Overview
=================
Brief Summary
-----------------
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Comparator: Rizatriptan
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month Exclusion Criteria: Heart disease, high blood pressure

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate | Drug: Comparator: Rizatriptan<br>* One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.<br>|
| Placebo Comparator: 2<br>matching placebo | Drug: Comparator: Placebo<br>* One dose matching placebo to Rizatriptan to treat one migraine attack.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Elimination of Nausea at 2 Hours Postdose | Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment. | At 2 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Pain Relief at 2 Hours Postdose | Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment. | 2 hours after treatment |
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Study Overview
=================
Brief Summary
-----------------
The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an active control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).

Official Title
-----------------
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate

Conditions
-----------------
Dental Pain, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: benzocaine
* Drug: TAC alternate gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers 18 years or older Ability to consent to participate in the research Ability to communicate a VAS score Generally healthy, ASA I and ASA II No known drug allergies Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence Exclusion Criteria: Allergy or other contraindications to the topical anesthetics Inability to consent to participation in the study Use of analgesics prior to the procedure Vulnerable populations
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Benzocaine<br>serves as active control | Drug: benzocaine<br>* 20% benzocaine., topical placement onto site, minimal amount, for 1 minute<br>* Other names: Hurricaine;|
| Experimental: TAC<br>serves as comparator | Drug: TAC alternate gel<br>* use 1 pump, place topically onto site, leave for 1-3 minutes<br>* Other names: 20% TAC alternate gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale score |  | pre-op, insertion, every minute post-op for 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | three times pre-op, insertion, ten times post-op | 
| oxygen saturation |  | three times pre-op, insertion, ten times post-op | 
| heart rate |  | three times pre-op, insertion, ten times post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topical anesthetics, topical anesthesia, 20% benzocaine, TAC alternate gel, combination topical anesthetics, dental anesthesia