linjc16/ctgov huggingface dataset:
Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.

Official Title
-----------------
An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics. Clinically localized (no evidence on clinical or imaging studies of advanced disease). No hormonal therapy including LHRH (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable. Sufficient amount of tissue remains from biopsy to perform genomic testing. Exclusion Criteria: Patients with a known history of hypogonadism

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

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

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 |
| --- | --- | --- |
| Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®). |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation) |  | 1 month | 
| Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient. |  | 2 months |
Early Support and Physiotherapy for Children and Their Motor Skills

Study Overview
=================
Brief Summary
-----------------
The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and precisely describe the needs and difficulties present during the child's rehabilitative care during the first months of life.

Official Title
-----------------
Identification of the Needs and Difficulties Associated With the Perceptual-motor Management of Infants at High Risk of Cerebral Palsy During the First 24 Months Following Neonatal Hospitalization. Qualitative Study Among Parents and Health Professionals

Conditions
-----------------
Infant, Cerebral Palsy, Neonatal

Intervention / Treatment
-----------------
* Other: Focus group
* Other: Semi-directive interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the parents: Parents of children under 24 months of age at high risk of cerebral palsy who have given their oral consent. Children at high risk of cerebral palsy are defined as : Premature children ≤ 31 WG + 6 days or birth weight less than 1000g. Children who have had a stroke or stage 2 or 3 hypoxia-ischemia according to the Sarnat classification. The selection of parents may be retrospective with less than 24 months since hospital discharge. For the health professionals: Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy. Exclusion Criteria: A person who is physically or cognitively unable to participate in a one-on-one interview or who does not have a sufficient command of the French language. Parents aged <18 years Parents in protective custody Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy. Parents of a child with a genetic disease.

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 |
| --- | --- |
| Parents<br>man or woman | Other: Semi-directive interview<br>* Conducting a semi-directive interview by a sociologist after discharge from hospital<br>|
| Professionals<br>health professionals in charge of monitoring children | Other: Focus group<br>* Holding of a focus group by a sociologist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Typology and categorization of the needs and difficulties encountered by the parents. | collected through semi-directive individual interviews with parents | Through study completion an average of 21 months |
CONDOR Study of Osteonecrosis of the Jaws (TMJ)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ), including the possible association with bisphosphonates (BPs). This study used the research infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN, PEARL, PRECEDENT). De-identified data from the DPBRN were merged with comparable de-identified data from PEARL and PRECEDENT to form a single trans-PBRN data set used for analysis.

Detailed Description
-----------------
The aims of this study were to (1) test the hypothesis that (BP) treatment is a risk factor for (ONJ); (2) to test the hypothesis that dental diseases (particularly periodontal disease), and invasive dental procedures such as dental extractions are true risk factors for (ONJ).

Official Title
-----------------
Trans-PBRN Case-control Study of Osteonecrosis of the Jaws

Conditions
-----------------
Osteonecrosis of the Jaw

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants directly involved in this study were patients of dentists from the dental practice based research networks (DPBRN, PEARL, PRECEDENT). Exclusion Criteria: participants with a history of sickle cell anemia participants with a history of external severe trauma to the jaws

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONJ
Sun Protection Factor Assay (343/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521
* Drug: SPF Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-104)<br>Drug: SPF Control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy

Official Title
-----------------
Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Anlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved nasopharyngeal carcinoma; stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs. Exclusion Criteria: allergic to anlotinib; female within gestation period or lactation; patients received drug of other clinical trial within 4 weeks.

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: Anlotinib<br> | Drug: Anlotinib<br>* All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate | disease control rate | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | overall response rate | 30 months | 
| progression-free survival | progression-free survival | 30 months | 
| overall survival | overall survival | 30 months | 
| duration of response | duration of response | 30 months |
The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester

Study Overview
=================
Brief Summary
-----------------
Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by physical examination, additional tests are needed. These tests have false positive and false negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of having PPROM.

Official Title
-----------------
Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester

Conditions
-----------------
Fetal Membranes, Premature Rupture, Ultrasonography

Intervention / Treatment
-----------------
* Device: insemination cervical cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age 14-23 Single fetus Suspected rupture of membranes Oligohydramnios Exclusion Criteria: Vaginal bleeding Suspected chorioamnionitis

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Insemination cervical cap<br> | Device: insemination cervical cap<br>* Primary abdominal ultrasound (US) for amniotic fluid index (AFI), Single vertical pocket, and dimensions of pocket below the presenting part. Speculum vaginal examination. In a sterile manner a cervical cap is adjusted on the cervix. the patient is kept recumbent for 6 hours. A repeat US exam is performed. The cervical cap is removed. After one hour another US is performed.<br>* Other names: France;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/ |  | the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chorioamnionitis and abortion |  | one week from the start of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy
A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk among African-American men who have sex with men (MSM).

Official Title
-----------------
A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with men


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: identify as African-American, Black, Caribbean Black or multiethnic Black, report sex with men Exclusion Criteria: Participated in pilot Identify as transgender Plan to move before end of study Refuse HIV testing at baseline or identified as a newly diagnosed HIV through testing at the baseline Under 18 years of age

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Receives HIV testing and counseling and 5 week intervention | Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with men<br>* 5 week intervention to increase skill level of participants with talking to their social networks and sexual partners about reducing high risk sexual behaviors while preparing a healthy meal<br>|
| No Intervention: 2<br>Receives only HIV Testing and Counseling | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary goal of the intervention is to reduce HIV transmission or acquisition by reducing the frequency of unprotected anal intercourse among African-American MSM. |  | 3 months after completing intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners. |  | 3 months after completing the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Prevention, African-American, gay, bisexual, intervention trial, HIV Seronegativity
Efficacy and Safety of Endoscopic Resection

Study Overview
=================
Brief Summary
-----------------
An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.

Official Title
-----------------
Efficacy and Safety of Endoscopic Resection

Conditions
-----------------
Gastrointestinal Neoplasms, Endoscopic Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients who are at least 18 years old. Clinical indication for endoscopic exam and endoscopic resection Patients must freely accept their involvement in this study. They shall give a written informed consent Exclusion Criteria: Patients who do not desire to be included in this study

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of complete resections without recurrence |  | 6 month post-endoscopic resection |
Photodynamic Therapy for Permanent Hair Removal

Study Overview
=================
Brief Summary
-----------------
24 test persons are treated with a dye suspension followed by a laser intervention. A decrease of hair density is expected.

Conditions
-----------------
Hypertrichosis, Hirsutism

Intervention / Treatment
-----------------
* Procedure: application of a dye suspension followed by a laser intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 Exclusion Criteria: anormal behavior pregnancy pathologic skin conditions medication that my interfere with the study allergy against the photosensitizer lack of compliance other reasons considered important by the investigator

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: application of a dye suspension followed by a laser intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging.Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the thoracic skin to epidural space depth in children and define the ratio between the straight and inclined thoracic skin to epidural depth.

Detailed Description
-----------------
Thoracic epidural in children confers clinical benefits but are technically challenging. The prediction of thoracic skin epidural depth (SED) might increase the success rate and decrease complications. Magnetic resonance imaging (MRI) is the most comprehensive imaging modality of the spine, and the measurements derived can be more accurate. The present study is based on Magnetic Resonance Imaging (MRI)-based measurements to evaluate the thoracic SED and define the ratio between the straight and inclined SED at the two thoracic levels (T6-7 and T9-10) in children.

Official Title
-----------------
Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging

Conditions
-----------------
Anesthesia, Epidural, Magnetic Resonance Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation Exclusion Criteria: Patients with scoliosis, myelomeningocele, tumors of the spinal cord or vertebral bodies, spina bifida, tethered cord, spinal metastasis

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 8 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of thoracic epidural space in children | Derive a formula for predicting the thoracic skin epidural depth in children | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic epidural, Magnetic Resonance Imaging, Children