linjc16/ctgov huggingface dataset:
DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study will allow us to observe and follow the subjects' treatment from DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.

Detailed Description
-----------------
There have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions. Since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.

Official Title
-----------------
Longitudinal Study of Questionable Occlusal Caries Lesions

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients needed to have at least one permanent tooth with a questionable lesion. This means that subjects were at least 6 years old because that is when the permanent first molar typically erupts. Exclusion Criteria: patients under 6 years old patients 6 years old and older who do not have a questionable lesion

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Questionable occlusal lesions<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionable Caries |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assessment, Questionable Caries
Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

Detailed Description
-----------------
Participants will have a sonohysterography (SHG) performed. Fluid will be collected after instillation of 5mls of saline and again after an adequate SHG is performed. A pathologist will review this fluid to see is cancer cells are present.

Official Title
-----------------
Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Procedure: Sonohysterography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed early-stage endometrial cancer Exclusion Criteria: Recurrent or persistent endometrial cancer Evidence of distant metastases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>pre-surgical SHG | Procedure: Sonohysterography<br>* Sonohysterography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytology results |  | At completion of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial cancer, Sonohysterography
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires: Back Pain Questionnaire; Oswestry Disability Index Questionnaire; Short Form-36 (SF-36) Survey; Visual Analog Pain Scale (VAS); and The Modems Patient Satisfaction Survey. Outcome Measurements: The patient's pain is scored by a VAS normalized to 100; Patient function is based on Oswestry scores; General health is assessed by SF-36 completion; and Overall patient satisfaction will be determined by the completion of the Modems.

Official Title
-----------------
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

Conditions
-----------------
Pain, Stenosis, Spondylolisthesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary consent for an observational study One of the following diagnoses: isthmic spondylolisthesis, degenerative spondylolisthesis, pseudoarthritis, severe foraminal stenosis, and prior failed discectomies Single, two, or three level fusions Patients require treatment by TLIF or PLIF posterior fusion as determined by surgeon. Pedicle screw instrumentation will be placed in all cases. Exclusion Criteria: Infection at operative site Severe osteoporosis Inability to return for follow-up.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Triad allograft | |
| 2<br>other anterior lumbar interbody fusion (ALIF) | |
| 3<br>transforaminal lumbar interbody fusion (TLIF) | |
| 4<br>posterior lumbar interbody fusion (PLIF) | |

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
-----------------
Transforaminal lumbar interbody fusion, Posterior lumbar interbody fusion, Isthmic spondylolisthesis, degenerative spondylolisthesis, Pseudoarthritis, Severe Foraminal Stenosis
The Alpha-1 Foundation's and University of Florida's Alpha-1 Coded Testing (ACT) Study

Study Overview
=================
Brief Summary
-----------------
The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes of individuals at risk for alpha-1 antitrypsin deficiency.

Detailed Description
-----------------
Genetic testing for alpha-1 antitrypsin deficiency is sometimes delayed despite established testing indications. All genetic tests have risks and possible benefits. The ACT study evaluates the population demographics, reasons for testing, and outcomes through a confidential testing program. Co-morbidities of alpha-1 antitrypsin deficiency other than lung and liver disease are being investigated. Concerns about genetic confidentiality are lessened in this study by a coded testing procedure that returns results through the mail to study participants.

Official Title
-----------------
The Alpha-1 Foundation's and University of Florida's Alpha-1 Coded Testing (ACT) Study

Conditions
-----------------
Alpha-1 Antitrypsin Deficiency

Intervention / Treatment
-----------------
* Procedure: Alpha-1 Antitrypsin Genotype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals of any age at risk for alpha-1 antitrypsin deficiency on the basis of symptoms or family genetic risk. Exclusion Criteria: Any person who has already had genotype and AAT level testing completed and has a qualified result.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Alpha-1 Antitrypsin Genotype|Home fingerstick testing for alpha-1 antitrypsin genotype|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structured questionnaire responses on the risks and benefits of testing. | Rotating questionnaires assess the clinical course and co-morbidities associated with different genotypes of alpha-1 antitrypsin deficiency. | Before and after alpha-1 antitrypsin testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alpha-1, antitrypsin, genetic testing, alpha-1 antitrypsin deficiency, AAT, AATD
A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin

Study Overview
=================
Brief Summary
-----------------
This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.

Official Title
-----------------
A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: plazomicin
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings Key Exclusion Criteria: Estimated creatinine clearance <90 mL/min Use of tobacco- or nicotine-containing products History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin | Drug: plazomicin<br>* single intravenous dose<br>Drug: metformin<br>* single oral dose<br>|
| Experimental: Sequence 2<br>In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone | Drug: plazomicin<br>* single intravenous dose<br>Drug: metformin<br>* single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of metformin in plasma |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | 15 days | 
| Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure) |  | 8 days | 
| Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis) |  | 9 days | 
| Pharmacokinetics of metformin in urine |  | 9 days | 
| Pharmacokinetics of plazomicin in plasma |  | 9 days |
The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors

Study Overview
=================
Brief Summary
-----------------
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. These results will be compared to equivalent samples of IVF patients.

Official Title
-----------------
The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors

Conditions
-----------------
Bacterial Vaginoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oocyte donors meeting local criteria for donation. Written informed consent. Regular cycle Exclusion Criteria: Antibiotics within 1 month Vaginal products other than for menstrual hygiene within 1 month Uterine malformations(Septum, polyps, adenomyosis, fibroids) HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity. Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Oocyte donors<br>Healthy Oocyte donors fulfilling the criteria for oocyte donation are eligible. Patients may not have received any antibiotics or vaginal products (other than for menstrual hygiene - such as tampons) for the last 1 month. Informed consent is mandatory. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ascending infection/sharing of bacteria in the genital tract | vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval. | This outcome data is measured at the 1 day of oocyte retrieval. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances | qPCR to assess the microbiota. I.e. a quantitative measure Copies/mL. 16S V4 to investigate relative abundances | This outcome data is measured at the 1 day of oocyte retrieval. |
Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors

Study Overview
=================
Brief Summary
-----------------
This study assessed the relationship between pregnant women, partner support, and cigarette and alcohol use in pregnancy.

Detailed Description
-----------------
Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included. Demographic and health information was collected. A composite support score for each woman was generated from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35. Support scores were evaluated with women's current smoking and drinking status using ANOVA and Student's t-test.

Official Title
-----------------
Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors

Conditions
-----------------
Pregnancy, Smoking

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included. Exclusion Criteria: Non-English speaking.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaires|Norbeck Social Support Questionnaire (NSSQ)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite support score for each woman from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35. | Cigarette and Alcohol use in pregnancy | 2 months |
Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.

Official Title
-----------------
A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of Purastat Absorbable Haemostatic Material for the Management of Bleeding After Open Liver Resection

Conditions
-----------------
Liver Resection

Intervention / Treatment
-----------------
* Device: PuraStat®


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Male or female patient ≥ 18 years old Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up. Main Exclusion Criteria: Known allergy or hypersensitivity to any component of the investigational treatment PuraStat® Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints

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

| Intervention/Treatment |
| --- |
|Device: PuraStat®|Synthetic haemostatic material|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Time-To-Haemostasis | Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds) | Intraoperatively |
Headache Inducing Effect of Cromakalim in Migraine Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

Official Title
-----------------
The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Drug: Levcromakalim
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine patients of both sexes. 18-60 years. 50-90 kg. Women of childbearing potential must use adequate contraception. Exclusion Criteria: Headache less than 48 hours before the tests start Daily consumption of drugs of any kind other than oral contraceptives Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levcromakalim<br> | Drug: Levcromakalim<br>* To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients<br>|
| Placebo Comparator: Saline<br> | Drug: Saline<br>* To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral hemodynamic | Change on Media cerebri arterie. | Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline | 
| Headache | Occurrence of headache. | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | 
| Migraine attack | Occurrence | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levcromakalim