linjc16/ctgov huggingface dataset:
Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea. Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.

Official Title
-----------------
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel

Conditions
-----------------
Inflammatory Rosacea

Intervention / Treatment
-----------------
* Drug: 0444


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of rosacea Good health with the exception of rosacea Papsules and pustules minimum and maximum requirements Exclusion Criteria: Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. Subjects who have any systemic or dermatological disorders with the exception of rosacea

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Test product that contains active pharmaceutical ingredient | Drug: 0444<br>* A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days<br>|
| Active Comparator: Reference<br>Reference product that contains active pharmaceutical ingredient | Drug: 0444<br>* A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days<br>|
| Placebo Comparator: Vehicle<br>Placebo that contains no active pharmaceutical ingredient | Drug: 0444<br>* A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the number of papules and pustules from Baseline to End of Treatment |  | 70 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the Investigator's Global Evaluation, Clear or Almost Clear |  | 70 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory Rosacea, Rosacea
Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

Study Overview
=================
Brief Summary
-----------------
Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Unfortunately, the procedure itself is not free from complications e.g. perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and considered as an invasive procedure. Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in identifying uterine cavity abnormalities due to its ability to obtain a view of three different planes of the uterus, which could be used to locate the position of intracavitary pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have 41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but its sensitivity, specificity and accuracy still a matter of debate and warrants more evaluation.

Official Title
-----------------
A Prospective Study Comparing Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

Conditions
-----------------
Female Infertility

Intervention / Treatment
-----------------
* Device: 3D-TVS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women (primary or secondary) Age between 18 and 40 years. Exclusion Criteria: age<18 years and˃ 40 years. pelvic inflammatory disease. .Active uterine bleeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Three-dimensional transvaginal ultrasonography (3D-TVS)<br>The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then, hysteroscopy will be performed. | Device: 3D-TVS<br>* The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of 3D-TVS | The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women. | At 1 week postmenstrual |
Drug Interaction Study With a Potential Alzheimer's Disease Compound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethorphan

Official Title
-----------------
Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Midazolam, Warfarin, Caffeine, Omeprazole and Dextromethorphan in Healthy Male Subjects by Administration of a Modified Cooperstown Cocktail

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)
* Drug: BMS-708163
* Drug: BMS-708163 + Cooperstown Cocktail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects 18-45 yrs old inclusive Exclusion Criteria: Women

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br> | Drug: Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)<br>* Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day<br>|
| Experimental: B<br> | Drug: BMS-708163<br>* Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days<br>|
| Experimental: C<br>+ Other | Drug: BMS-708163 + Cooperstown Cocktail<br>* Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 Days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan) |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, safety labs) |  | throughout the study |
Perfusion CT Imaging in Lung Cancer With SBRT

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.

Official Title
-----------------
Perfusion CT Imaging in Patients With Lung Malignancies Receiving Stereotactic Body Radiation Therapy (SBRT)

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Perfusion CT Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: male or female CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with Patient will sign a consent form prior to study entry Lung cancer and lung metastases are biopsy proven Exclusion Criteria: Patients who are unable to give valid informed consent Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open label<br>Perfusion CT Imaging | Device: Perfusion CT Imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging of during and after SBRT treatment for lung malignancies with a combined perfusion and routine CT to assess therapy response of lung cancer and metastases. |  | 3-6 months |
Ceftriaxone and Jaundice in Neonates

Study Overview
=================
Brief Summary
-----------------
Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have jaundice during the first postnatal week. Ceftriaxone will be given as standard of care for sepsis and investigators will observe the effect on jaundice.

Official Title
-----------------
Effect of Ceftriaxone on Neonatal Jaundice

Conditions
-----------------
Jaundice and Sepsis in Neonates

Intervention / Treatment
-----------------
* Drug: ceftriaxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infants with sepsis requiring IV antibiotics for more than 3 days and who has total serum bilirubin 6-12 mg/dL and resolving by day 4 of life. Exclusion Criteria: Infants with asphyxia (Apgar score <3 at 5 minutes), chromosomal disorder, failed hearing test at baseline, family history of hearing loss, unconjugated hyperbilirubinemia requiring phototherapy, TORCH infection, craniofacial malformations, listeria monocytogenes infection, and any clinical conditions which will preclude discharge to home.

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 7 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ceftriaxone Arm<br> | Drug: ceftriaxone<br>* Eligible infants will receive ceftriaxone as standard of care for sepsis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in bilirubin binding assays |  | baseline and through study completion, an average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Automated brain stem evoke response test |  | through study completion, an average of 1 hour |
Expanded Access Program for Avapritinib

Study Overview
=================
Brief Summary
-----------------
This record comprises the currently available Expanded Access Programs (EAP) for avapritinib (BLU-285): 1) A Post Trial Access (PTA) program to provide continued access to treatment with avapritinib to BLU-285-1107 participants with solid tumors who are unable to access commercially available avapritinib after trial BLU-285-1107 (NCT04908176) has ended.

Official Title
-----------------
Expanded Access Program (EAP) for Avapritinib

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: Avapritinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Participant has received treatment with avapritinib in BLU-285-1107 clinical trial and continues to receive clinical benefit from avapritinib treatment, as assessed by the Investigator. Exclusion Criteria: Participant requires ongoing treatment or has received treatment within 28 days before the start of avapritinib administration with drugs or foods that are strong CYP3A inhibitors or inducers. Female participants of childbearing potential who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment. Male participants who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment. Participant is pregnant, as documented by a serum β-hCG pregnancy test. Participants with β- hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor after pregnancy has been ruled out. Female participants of nonchildbearing potential (premenarchal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) do not require a serum β-hCG test. Participant is breastfeeding. Participants who require anticoagulants, with the exception of stable doses of prophylactic reversible anticoagulants. Participants who are unable to swallow tablets.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Avapritinib|Avapritinib will be administered orally at 300 mg QD.|

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
-----------------
Avapritinib, BLU-285, Solid tumors, Gastrointestinal stromal tumors (GIST), Gliomas
Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention

Study Overview
=================
Brief Summary
-----------------
Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs). Objective: To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms in adults. Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults. Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record the incidence and severity of URI symptoms

Official Title
-----------------
A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections

Conditions
-----------------
Viral Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry. Exclusion Criteria: morbid obesity (body mass index > 35 kg/m2) current tobacco use history of hypercalcemia, nephrolithiasis or sarcoidosis pregnancy recent hospitalization current liver or kidney disorders, malignancy and malabsorption use of immunosuppressants or medications that interfere with vitamin D metabolism such as phenytoin and carbamazepine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Vitamin D3 50 mcg (2000 IU) daily | Dietary Supplement: Vitamin D3<br>* Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months<br>* Other names: cholecalciferol;|
| Placebo Comparator: 2<br>Placebo tablets | Other: Placebo<br>* Placebo tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To see whether vitamin D3 supplementation during the winter prevents viral URI. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Viral URI, Influenza, Colds
ZX008 Expanded Access Protocol

Study Overview
=================
Brief Summary
-----------------
The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 clinical trials.

Detailed Description
-----------------
The treatment plan consists of an up to 24-month Treatment Period. Access is via application by your health care provider and available at one of the Expanded Access treatment centers. The dose of ZX008 for the duration of the Treatment Period will range from 0.2 mg/kg/day to a maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a total daily dose of 20 mg/day. The fenfluramine US Expanded Access Program (US EAP) is available to full-time US Residents only. Participation in the US EAP is limited to patients currently residing in the US. Residency in the US must be for the duration of participation in the US EAP. Drug may not be shipped outside the US.

Official Title
-----------------
ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan

Conditions
-----------------
Dravet Syndrome

Intervention / Treatment
-----------------
* Drug: Fenfluramine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male or female, age 2 years and older, inclusive as of Study Day 1. Patient is diagnosed with Dravet syndrome. Patient is experiencing convulsive seizures which are not controlled by current AEDs. Patient is receiving at least one AED and will remain on at least one AED for the duration of treatment. Patient has been approved for inclusion by Zogenix. Exclusion Criteria: Patient requires or starts using an unacceptable or contraindicated concomitant medication. Patient has valvulopathy. Patient is at risk for pulmonary hypertension. Patient exclusion will be at the sole discretion of the Sponsor.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fenfluramine Hydrochloride|ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Assessing Chronic Pain Conditions in General Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the percentage of women, among those attending our institute in order to do Pap test, suffering of chronic pelvic pain. To such purpose the patients will be submitted to questionnaires.

Conditions
-----------------
Chronic Pelvic Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 years of age Exclusion Criteria: unwilling or unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Pap test<br>Women attending our institute in order to do Pap test | Other: Questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pelvic pain Questionnaire |  | 5 years |