linjc16/ctgov huggingface dataset:
Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula

Study Overview
=================
Brief Summary
-----------------
This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula. Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula. Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.

Detailed Description
-----------------
This study is a cross-sectional study of 110 Malawian women who present for medical evaluation at the Fistula Care Centre in Lilongwe, Malawi. If a woman enrolls in the study, her demographic, medical history, physical exam, and lab data will be abstracted from her medical records at the Fistula Centre. She will also a pelvic ultrasound on each participant so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length, endometrial thickness and ovarian volume) can be evaluated. If the participant has an obstetric fistula, she will also complete an additional blood draw for lab testing. The laboratory tests will evaluate three hormones that are associated with amenorrhea and infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.

Official Title
-----------------
Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula

Conditions
-----------------
Obstetric Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presentation to the Fistula Care Centre in Lilongwe for medical evaluation Ability to consent for study participation in Chichewa Female aged 18-45 years Willingness to undergo pelvic ultrasound for assessment of pelvic organs Exclusion Criteria: No history of pregnancy History of hysterectomy Current pregnancy or pregnancy within the past six weeks Seriously or terminally ill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Malawian women<br>Malawian women who present for care at the Fistula Care Centre | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical length |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal levels | FSH, Estradiol, AMH | baseline |
Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Study Overview
=================
Brief Summary
-----------------
Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip. Extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. Distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent. Investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the V leads, record as V(-) and V(+). Monitoring positions of the electrodes by V(-) and V(+) could provide more information about the tip position. Comparing the QRS amplitudes between V(-) and V(+), when catheter tip enters right ventricle chamber: the case of V(-) > V(+) infers tip toward apex ventricle wall ; conversely, the case of V(-)<V(+) indicates tip directs to outflow tract. The investigators hypothesis this monitoring will help precisely placement.

Official Title
-----------------
Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Conditions
-----------------
Bradycardia; Syncope, Bradyarrhythmia, Brady-tachy Syndrome, Tachycardia Bradycardia, AVB - Atrioventricular Block, Tachyarrhythmia

Intervention / Treatment
-----------------
* Procedure: Temporary transvenous cardiac pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indication of temporary transvenous pacing Exclusion Criteria: Not applicate to IC-ECG monitoring.

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Non-floating catheter<br>When using non-floating catheter. | Procedure: Temporary transvenous cardiac pacing<br>* Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.<br>|
| Floating catheter<br>When using floating catheter. | Procedure: Temporary transvenous cardiac pacing<br>* Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacer leads location | Satisfy location is in the apex of the right ventricle. | One day. | 
| Catheter-related complications | Pacing catheter related complications: tip dislocation caused pacemaker malfunction, myocardial injury, perforation, death. | One month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other complications | Complications not relate to pacing catheter. | One month. |
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.

Official Title
-----------------
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: Imatinib Mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: underwent macroscopically curative resection; immunohistochemically confirmed KIT (CD117)-positive tumors; judged as being high-risk according to the criteria for risk classification Exclusion Criteria: synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years; received therapy with Imatinib Mesylate prior to study entry; cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria) Other protocol-defined inclusion / exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: Imatinib Mesylate<br>400 mg once per day | Drug: Imatinib Mesylate<br> <br> * Other names: STI571;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate overall survival, relapse free |  | 3 years | 
| Safety |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIST, Imatinib, Postoperative Adjuvant
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin

Study Overview
=================
Brief Summary
-----------------
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to botulinum toxin.

Detailed Description
-----------------
A full description of the patient registry can be found in the paper titled: Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Clin Infect Dis. 2019 Apr 15;70(9):1950-1957.

Official Title
-----------------
Botulinum Antitoxin Patient Registry for the Evaluation of Safety and Clinical Outcomes of Pediatric and Adult Patients Following BAT Treatment for Confirmed or Suspected Exposure to Botulinum Toxin.

Conditions
-----------------
Botulism

Intervention / Treatment
-----------------
* Drug: BAT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient of any age [age category: pediatric-newborn infants (0 to 27 days), infants and toddlers (28 days to 23 months), children (2 to 11-years), and adolescents (12 to <17-years); adult (17-64-years); and geriatric (≥65-years)] with a confirmed or suspected exposure to botulinum toxin who were treated with BAT® provided by the CDC. 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 |
| --- | --- |
| Participants treated with BAT®<br>Any patient of any age with a confirmed or suspected exposure to botulinum toxin who were treated with BAT®. | Drug: BAT<br>* Noninterventional, retrospective, observational phase 4 patient Registry<br>* Other names: Botulism Antitoxin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with serious and non-serious adverse events | The data obtained will more clearly define the absolute risk (incidence rates) of hypersensitivity/allergic reactions, including serum sickness, febrile reactions, hemodynamic instability, bradycardia, and other serious adverse events in pediatric and adult patients that are treated with BAT® due to a confirmed or suspected case of botulism. | From BAT® administration up to discharge from hospital (200 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry, Botulinum antitoxin, Botulism Antitoxin Heptavalent- (Equine), BAT®
An Observational LTFU Study for Patients Previously Treated With Autologous ex Vivo Gene Therapy for ADA-SCID

Study Overview
=================
Brief Summary
-----------------
This observational long-term follow-up study is designed to collect safety and efficacy data from ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS-ADA LV encoding for human adenosine deaminase (ADA) gene (EFS-ADA LV), as part of the OTL-101 clinical development program. No investigational medicinal product will be administered to these patients as part of the OTL-101-6 study.

Official Title
-----------------
An Observational Long-term Follow-up Study for Patients Previously Treated With Autologous ex Vivo Gene Therapy for Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency (ADA-SCID)

Conditions
-----------------
Adenosine Deaminase Deficiency, Severe Combined Immunodeficiency (SCID)

Intervention / Treatment
-----------------
* Biological: autologous ex vivo gene therapy products based on the EFS LV encoding for the human adenosine deaminase (ADA) gene (EFS-ADA LV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient is eligible for enrollment in the study if all of the following criteria are met: the patient has been treated with an autologous ex vivo gene therapy product based on the EFS-ADA LV, as part of the OTL-101 clinical development program; the patient displays persistent detectable gene marking, as determined by the Investigator; the patient or, if applicable, the patient's parent(s)/legal guardian(s), are able and willing to provide informed consent. Exclusion Criteria: There are no exclusion criteria for participation in this observational LTFU study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: autologous ex vivo gene therapy products based on the EFS LV encoding for the human adenosine deaminase (ADA) gene (EFS-ADA LV)|ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS LV encoding for the human adenosine deaminase (ADA) gene (EFS-ADA LV)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Establishing efficacy through overall survival | 15 years post-treatment | 
| Event-Free Survival | Establishing efficacy through event-free survival | 15 years post-treatment | 
| Incidence of Adverse Events | Long-Term Safety incidence of AEs and SAEs | 15 years post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OTL-101
Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries

Study Overview
=================
Brief Summary
-----------------
Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.

Official Title
-----------------
Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients Undergoing Upper Abdominal Surgeries.

Conditions
-----------------
Post Operative Pain, Acute

Intervention / Treatment
-----------------
* Procedure: Quadratus lumborum block
* Procedure: Caudal epidural injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision Exclusion Criteria: parents refusal to participate in the study, previous history of allergy to local anesthetics hemodynamic instability Coagulopathy,

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadratus Lumborum<br>Patients will receive Ultrasound-guided quadratus lumborum block | Procedure: Quadratus lumborum block<br>* Ultrasound-guided quadratus lumborum block<br>|
| Active Comparator: Caudal epidural<br>Patients will receive single Caudal epidural injection | Procedure: Caudal epidural injection<br>* Single Caudal epidural injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Face, leg, activity, cry and consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia | 24 hours postoperative |
Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)

Study Overview
=================
Brief Summary
-----------------
This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty

Official Title
-----------------
A Prospective, Randomized Controlled Trial to Evaluate the Efficacy of Cell Saver to Redue Blood Loss in One-stage Bilateral Total Hip Arthroplasty (THA)

Conditions
-----------------
One-stage Bilateral Total Hip Replacement

Intervention / Treatment
-----------------
* Other: Cell Saver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is over 21 years of age Subject with bilateral degenerative disease of hips who are candidate for one-stage bilateral THA Subject willing and able to provide written informed consent Exclusion Criteria: Subject with significant comorbidities identified by Charleston index of ≥ 3 Subject with malignancy Subject with history of heart disease, myocardial infarction, pulmonary insufficiency, pulmonary embolus, documented fat emboli syndrome, adult respiratory distress syndrome, documented patent ductus arteriosus or septal defect, chronic renal failure and/or acute hepatic failure or chirhosis Subjects with hematologic disorders such as anemia (Hb < 10 g/dL) and sickle cell disease, acquired or congenital coagulopathies, acquired or congenital bleeding disorders, Subject who received anticoagulant such as aspirin or Warfarin (Coumadin) or antiplatelet agents such as clopidogrel (Plavix) within 7 days of surgery Subject who received hemostatic agents such as tranexamic acid and aprotinin Subjects utilizing acute normovolumic haemodilution Subject is not permitted to remain without his/her anti-coagulant regimen (eg Plavix) for 48 hours postoperatively Subject is known to be pregnant. Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery. Presence of contaminants such as urine, fat, bowel contents, and most importantly infection in the operative field Presence of vasoactive drugs such as papaverine in the operative field

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Active Comparator: Cell Saver<br> | Other: Cell Saver<br> <br> |
| No Intervention: Non Cell Saver<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
NGS Panel of Incomplete Forms of Ocular Albinism

Study Overview
=================
Brief Summary
-----------------
Implementation of a next-generation sequencing panel of genes to identify deleterious variants in patients with incomplete forms of albinism.

Detailed Description
-----------------
Scientific context : Albinism is clinically characterised by cutaneous hypopigmentation and ophthalmologic features. These features common to all forms of albinism are foveal hypoplasia, misrouting of the optic nerves at the chiasm, retinal hypopigmentation, translucent irides and nystagmus. The molecular genetic lab at Bordeaux University Hospital is the national reference for the study of this disease. More than 1400 patients have been analyzed with a strategy including next-generation sequencing of the 19 known genes of albinism and array-CGH. Despite this thorough analysis, 25% of patients remain without molecular diagnosis. Our experience tells us that these patients often show an incomplete form of albinism with the presence of only few ophthalmologic signs. The molecular diagnosis is very challenging as the phenotype often overlaps with other ophthalmologic disorders.

Official Title
-----------------
Implementation of a Next-generation Sequencing Analysis of a Panel of Genes Implicated in Incomplete Forms of Albinism

Conditions
-----------------
Albinism, Ocular

Intervention / Treatment
-----------------
* Biological: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minor and adult patient. Patient presenting a clinical diagnosis of incomplete form of albinism with presence of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic nerves at the chiasm. Registered for the social security system. Informed consent signed by patient or parent of a minor patient. Exclusion Criteria: Refusal to participate in research protocol.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Patient with a diagnosis of incomplete form of albinism<br> | Biological: Blood samples<br>* Performed a 10 ml blood sample (2 unnamed samples of 5ml) in each of the 100 patients included.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients for whom a molecular diagnosis is obtained based on the panel of targeted genes | the prevalence of finding at least two pathogenic variants is 10%. | Enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Next generation sequencing, Albinism