linjc16/ctgov huggingface dataset:
Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion

Study Overview
=================
Brief Summary
-----------------
This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery.

Official Title
-----------------
Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage Management After Second-trimester Abortion: A Randomized Clinical Trial

Conditions
-----------------
Abortion, Induced, Labor Stage, Third/Drug Effects, Pregnancy Trimester, Second, Oxytocin/Administration & Dosage

Intervention / Treatment
-----------------
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks Exclusion Criteria: If fetus and placenta expelled together Obstetrical haemorrhage needs intervention Known prostaglandin allergy

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br> | Drug: Oxytocin<br>* 20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered<br>* Other names: Pitocin;|
| No Intervention: Observation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortion rate | expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus | within 5 minute after placenta delivered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss estimated by gravimetric method | blood loss will be estimated by gravimetric method | within 10 minutes after delivery of placenta | 
| Transfusion rate | number of packed red cell units transfused | Within 7 days of hospitalization | 
| Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion | Difference in hemoglobin before and 24-hour after abortion | 24 hours after delivery of placenta | 
| Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus | The time elapsed until the delivery of the placenta from the delivery of foetus | 5 minute after delivery of placenta |
Taxotere + Cisplatin in Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
Primary objective: To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin. Secondary objective: To assess tumor control and survival

Official Title
-----------------
A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)

Conditions
-----------------
Nasopharyngeal Neoplasms

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: International Union against Cancer stages III and IV newly diagnosed NPC Exclusion Criteria: Inadequate bone marrow reserve Inadequate renal function Other primary malignancy Evidence of distant metastases The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 |
| --- | --- |
| Experimental: 1<br>Neo-adjuvant Taxotere followed by cisplatin and radiotherapy | Drug: Docetaxel<br>* 75 mg/m²<br>|
| Active Comparator: 2<br>Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy | Drug: Cisplatin<br>* 75 mg/m²<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate. |  | From administration of drug to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | From administration of drug to end of study |
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain

Official Title
-----------------
A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Postherpetic Neuralgia

Conditions
-----------------
Postherpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: KAI-1678
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption pain score at least 4 on 11-point numerical rating scale (0-10) stable doses of analgesic medications for at least 1 month Exclusion Criteria: diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption pain score at least 4 on 11-point numerical rating scale (0-10) stable doses of analgesic medications for at least 1 month

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A1: Placebo<br>Placebo | Drug: Placebo<br>* Placebo IV Infusion<br>|
| Experimental: A2: KAI-1678<br>Experimental | Drug: KAI-1678<br>* KAI-1678 IV Infusion<br>|
| Active Comparator: A3: Lidocaine<br>Lidocaine | Drug: Lidocaine<br>* Lidocaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). | Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours |  | Day 1 | 
| The effect of KAI-1678 on patient global response to treatment |  | Day 1 | 
| The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS) |  | Day 1 | 
| The number of adverse events as a measure of safety and tolerability of KAI-1678 | Frequency of adverse events on each study treatment | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lidocaine, Lignocaine, Analgesics. Non-narcotic / therapeutic use, Neuralgia, Postherpetic, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy, PHN
Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages

Study Overview
=================
Brief Summary
-----------------
For implantation of developing conceptus, placental cells need to invade mother's uterus to access maternal blood supply in a control manner. We have found a combination of maternal immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia where placenta does not implant adequately. The aim of this research is to investigate these two genes family in women suffering with recurrent miscarriages and find a possible link between them.

Detailed Description
-----------------
Little is known about reasons for early pregnancy failures. It is believed that some pathology leading to defective implantation of fetus in maternal uterus may lead to recurrent early miscarriages. This project arises from previous work on pre-eclampsia where we found combination of maternal immune genes (KIR) with their ligand (HLA-C) in the fetus was strongly associated with the disease. We will tissue type the fetus, mother and father in cases of unexplained miscarriages. We hope that genetic findings in recurrent miscarriage will lead to new insights, prevention and treatment.

Official Title
-----------------
Combination of Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages

Conditions
-----------------
Recurrent Miscarriages

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Couples with 3 or more unexplained miscarriages Exclusion Criteria: Previous livebirths, parental karyotypic abnormalities, thrombophilic defects, uterine structural abnormalities
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
In this study we try to review the possible effects when using modern hydroxyethylstarch solutions 6 % versus albumin 5% during living donor renal transplantation.

Official Title
-----------------
Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch

Conditions
-----------------
Anesthesia Morbidity

Intervention / Treatment
-----------------
* Other: Albumin resuscitation
* Other: Hydroxyethylstarch resuscitation
* Drug: Albumin 5%
* Drug: Hydroxyethylstarch 6%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end stage renal disease, for living donor renal transplantation Exclusion Criteria: severe cardiac or hepatic dysfunction, re-transplantation, coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albumin group<br>Albumin resuscitation Albumin 5% | Other: Albumin resuscitation<br>* Albumin 5% is used as the intra-operative colloid<br>Drug: Albumin 5%<br>* Infusion of Albumin 5% intra-operatively<br>* Other names: Albumin;|
| Experimental: Hydroxyethylstarch group<br>Hydroxyethylstarch resuscitation Hydroxyethylstarch 6% | Other: Hydroxyethylstarch resuscitation<br>* Hydroxyethyl starch 6% is used as the intra-operative colloid<br>Drug: Hydroxyethylstarch 6%<br>* Infusion of Hydroxyethylstarch 6% intra-operatively<br>* Other names: Tetraspan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of complications | Increased creatinine and/or need for dialysis | 7 days |
HMW-Adiponectin is Raised in Newborns

Study Overview
=================
Brief Summary
-----------------
Cross sectional, hospital-based study dealing with adiponectin levels in newborns to mothers with pre-eclampsia. Venus cord blood samples were collected immediately after birth; 30 cases and 62 controls were enrolled into the study. The study was approved by the local ethics committee and all participants gave written consent.

Conditions
-----------------
Pre-Eclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-eclampsia

Ages Eligible for Study
-----------------
Maximum Age: 30 Minutes

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adiponectin, cord blood, pre-eclampsia
Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to study the associations between exercise capacity and cardiovascular (CV) risk factors in axial spondyloarthritis (axSpA) patients and to determine possible relationships with disease-related variables. Thirty eight patients and 38 controls were recruited in our cross-sectional controlled study. Comprehensive systemic and musculoskeletal examinations were carried out in both of the groups. Cardiovascular risk profile data, ASDAS-CRP, 10-year CV event risk, physical activity levels (IPAQ) were recorded. A maximal treadmill exercise test by Bruce protocol was administered to all participants.

Official Title
-----------------
Exercise Capacity in Axial Spondyloarthritis and Factors Affecting it: a Cross-sectional Controlled Study

Conditions
-----------------
Exercise Capacity, Axial Spondyloarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of axial SpA must be able to walk Exclusion Criteria: established cardiac disease including structural heart diseases, uncontrolled hypertension, cardiac rhythm disorder, unstable angina pectoris, chronical renal and/or hepatic disease, malignancy, neuromuscular disease musculoskeletal deformity the history of an inflammatory arthritis for control group

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in exercise capacity of axSpA patients and controls | maximal METs achieved by a maximal treadmill test by Bruce protocol | may- october 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in heart rate recovery of axSpA patients and controls | peak heart rate achieved by maximal exercise minus heart rate at 1st minute of recovery phase | may- october 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
axial spondyloarthritis, exercise capacity, cardiovascular risk factors, nonradiographic axial spondyloarthritis, cardiorespiratory fitness
Heat Stress and Volume Administration

Study Overview
=================
Brief Summary
-----------------
Heat stress reduces the central blood volume and causes orthostatic intolerance. The hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat stress.

Official Title
-----------------
Heat Stress and Volume Administration

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Procedure: Intravascular volume administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 < 40 Exclusion Criteria: Abnormal medical history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Procedure: Intravascular volume administration<br>* Infusion of colloid to reestablish CVP under heat stress<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac filling pressure in relation to cardiac SV |  | with varying degress of lower body negative pressures |
Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand why women choose to have their fallopian tubes removed as a method for ovarian cancer prevention. This will be done through a paper questionnaire and phone interviews. The investigators hope to gain information that will allow us to better counsel women about ovarian cancer prevention.

Detailed Description
-----------------
Women will be found eligible for this study after an eligibility questionnaire given over the phone. If one is found eligible, she will be sent a consent and paper survey to fill out and send back to the research coordinator. Once that is completed, she will be given a phone interview in order answer additional questions of interest. Lastly, the study participant will be contacted once a year over the phone to obtain follow-up information.

Official Title
-----------------
Patients Salpingectomy as a Method of Ovarian Cancer Prevention: A Descriptive Study

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female of at least 18 years of age Must speak English fluently Have had fallopian tubes removed as a method of ovarian cancer prevention Exclusion Criteria: Males Females under the age of 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Fallopian tube removal<br>Women who have had one or both fallopian tube(s) removed as method of ovarian cancer prevention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe subject experience in undergoing Salpingectomy as a means of riks reduction | Subjects will provide information on their reason for choosing salpingectomy and the process they went through in undergoing this procedure | At conclusion of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fallopian tube removal, salpingectomy, ovarian cancer prevention
Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures

Study Overview
=================
Brief Summary
-----------------
As part of the clinical routine of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children (<=1 year).

Official Title
-----------------
Retrospective Analysis of Intraoperative Electroencephalography Characteristics in Children Under One Year of Age

Conditions
-----------------
Depth of Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Children <= 1 year undergoing surgery procedure Exclusion Criteria: Incomplete patient record documentation Pre-existing neurological/psychological conditions

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 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 |
| --- | --- |
| Children below 1 year<br>Children <= 1 year for elective surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography monitoring changes | The primary objective of this study performed according to an observational post-ad-hoc design measures the perioperative EEG overall power signature. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charité will be enrolled in the study. They are followed up until their discharge from the recovery room. | 06/2017 - 06/2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic depth | Anesthetic stage is related to typical time points during an anesthetic procedure - as loss of consciousness, intubation, stable anesthesia, extubation, regain of consciousness. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room. | 06/2017 - 06/2019 | 
| Medication | Medication data are captured from the patient sheets. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room. | 06/2017 - 06/2019 | 
| Emergence Delirium | Delirium is captured form the PAED Score data in the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room. | 06/2017 - 06/2019 | 
| Pain | Pain scores are captured form the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room. | 06/2017 - 06/2019 |