linjc16/ctgov huggingface dataset:
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin

Study Overview
=================
Brief Summary
-----------------
The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.

Official Title
-----------------
A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin

Conditions
-----------------
Platelet Inhibition

Intervention / Treatment
-----------------
* Drug: PN400
* Drug: ASA
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable without clinically significant disease Exclusion Criteria: Use of NSAID within 2 weeks Type 1 or 2 DM GI disorder

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PN400 + ASA | Drug: PN400<br>* naproxen 500 mg/esomeprazole 20 mg oral tablet<br>Drug: ASA<br>* Asprin 81 mg enteric coated tablet<br>* Other names: Asprin;|
| Placebo Comparator: 2<br>Placebo + ASA | Drug: ASA<br>* Asprin 81 mg enteric coated tablet<br>* Other names: Asprin;Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic: Mean percent inhibition of serum thromboxane B2 |  | measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2 | 
| Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events |  | during approx 6 week study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thromboxane B2
Identification of Genomic Changes in Families Having Multiple Members With Tumors

Study Overview
=================
Brief Summary
-----------------
This study will compare genomic alterations between the parents and the patients with high-grade glioma.

Detailed Description
-----------------
Genomic changes leading to the formation of brain tumors are slowly being discovered. Despite advances in genomic technology, much analysis is hindered by the lack of control samples that could better delineate genomic alterations leading to disease. The ideal genomic control would be the genetic material of the parents of afflicted individuals. The researchers propose to then compare the genomic material from parents of siblings, both of whom have a diagnosis of a high-grade glioma. Additionally, the researchers will then compare the genomic alterations between the parents and the patients. This analysis will provide an unprecedented insight into genomic level changes that take place between parents and patients that resulted in the formation of a high-grade glioma.

Official Title
-----------------
Identification of Genomic Changes in Families Having Multiple Members With Tumors

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Other: saliva or blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older. Family history of brain tumor in first degree relative Exclusion Criteria: less than 18 years

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

| Intervention/Treatment |
| --- |
|Other: saliva or blood sample collection|Single saliva or blood sample measuring 10mL for genomic analysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total genomic sequencing | Researchers will perform total genomic sequencing using next generation sequencing technology to identify common variants associated with familial brain tumors. Upon sequencing of the genomic material, the data analysis will be done using standard statistical methods. We will use bioinformatics tools (high throughput sequencing of genome) to identify genomic changes between parents and patients. | within 30 days of blood or saliva collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain tumor
Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs

Study Overview
=================
Brief Summary
-----------------
Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.

Detailed Description
-----------------
Therefore there are two treatment arms, acupuncture verum and acupuncture placebo. Investigators will evaluate for 4 weeks primary current pain, secondary the unassisted jaw opening.

Official Title
-----------------
Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie

Conditions
-----------------
Temporomandibular Disorders

Intervention / Treatment
-----------------
* Other: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non chronified TMD pain written informed consent Exclusion Criteria: dysfunctional TMD pain systematic diseases affecting the joints or pain perception pregnancy needle phobia

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verum<br>Acupuncture therapy. For this study arm following acupuncture points suitable for facial pain, according to traditional chinese medicine, were chosen: F2, F3, F34, IT3, IT19, S7, T21 and temporomandibular joint ear acupuncture points. Only intervention is the acupuncture therapy. | Other: acupuncture<br>* classical acupuncture therapy<br>|
| Placebo Comparator: Placebo<br>Placebo acupuncture therapy. For this study arm points outside of the meridians according to traditional chinese medicine, were chosen. Only intervention is the acupuncture therapy. | Other: acupuncture<br>* classical acupuncture therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| current pain measured on Numerical Rating Scale |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum unassisted jaw opening in mm |  | 4 weeks |
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain

Conditions
-----------------
Acute Ankle Sprain

Intervention / Treatment
-----------------
* Drug: Diclofenac Sodium
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours. Exclusion Criteria: Pain medication was taken within the 6 hours that precede randomization.During the past 3 months: Grade I-III sprain of the same ankle.During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Topical gel-4 times daily<br>|
| Experimental: Diclofenac sodium topical gel 1%<br>Diclofenac sodium topical gel 1% | Drug: Diclofenac Sodium<br>* Topical gel 1%-4 times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Movement | Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Pain Relief | Onset of perceptible pain relief. | On day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle Sprain, soft tissue injury
Study With Healthy Japanese and Non-Asian Participants With BMS-986231

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants

Conditions
-----------------
Heart Decompensation, Acute

Intervention / Treatment
-----------------
* Drug: BMS-986231
* Drug: BMS-986231 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ancestry First generation Japanese Non-Asian with grandparents and parents of non-Asian descent Body weight greater than or equal to 45kg and less than or equal to 110kg Women of childbearing potential have specific birthcontrol methods Males sexually active with women of childbearing potential have specific birthcontrol methods Exclusion Criteria: History of chronic illness Chronic headaches Recurrent dizziness Personal or family history of heart disease Personal history of bleeding diathesis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panel 1 Arm<br>BMS-986231 and BMS-986231 Placebo intravenously | Drug: BMS-986231<br> <br> Drug: BMS-986231 Placebo<br> <br> |
| Experimental: Panel 2 Arm<br>BMS-986231 and BMS-986231 Placebo intravenously | Drug: BMS-986231<br> <br> Drug: BMS-986231 Placebo<br> <br> |
| Experimental: Panel 3 Arm<br>BMS-986231 and BMS-986231 Placebo intravenously | Drug: BMS-986231<br> <br> Drug: BMS-986231 Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations |  | 11 days |
Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)

Study Overview
=================
Brief Summary
-----------------
Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement

Conditions
-----------------
Continuous Renal Replacement Therapy

Intervention / Treatment
-----------------
* Device: use of continuous renal replacement machine for renal replacement
* Device: use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with kidney injury requiring continuous renal replacement therapy and volume removal Exclusion Criteria: unable to provide or obtain patient consent not expected to survive 48 hours

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard volume management<br>patients on this arm will receive usual care volume management during continuous renal replacement therapy | Device: use of continuous renal replacement machine for renal replacement<br>* usual care with volume removal during continuous renal replacement therapy<br>|
| Active Comparator: continuous volume management<br>use of Critline, Hemametrics USA, in conjunction with continuous renal replacment therapy to determine volume removal | Device: use of continuous renal replacement machine for renal replacement<br>* usual care with volume removal during continuous renal replacement therapy<br>Device: use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal<br>* blood volume monitoring device, Critline, Hemametric, USA, will be used in conjunction with continuous renal replacement to determine rate of volume removal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare number of hypotensive events in treatment versus control arms | compare the number of hypotensive events during use of crit-line monitor over 24 hour period versus during control 24 hour period | 24 hour for each arm | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volume, acute kidney injury, continuous renal replacement
A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
This non-interventional, prospective, multi-centric, cross-sectional study is aimed to obtain the distribution of measurements of CIMT in Indian subjects and will involve approx. 30 investigative sites from all over the country. Each investigative site will be expected to enrol 50 subjects and Carotid intima-media thickness (CIMT) values will be taken for each individual as described in the protocol. All the procedures could be completed in a single day, however due to any reason any study variable is not taken subject may be asked to come back for a second visit within 7 days of the first visit.

Detailed Description
-----------------
A Study to derive normative distribution of CIMT and to determine its cOrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population. (SCORE India)

Official Title
-----------------
A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors in Asymptomatic Nationwide Indian Population (SCORE India)

Conditions
-----------------
Carotid Intima- Media Thickness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of subject informed consent Female or male aged 30 years and over Exclusion Criteria: Subjects with established cardiovascular event Intake of lipid lowering drug in the past 3 month Subjects with known hypersensitivity to carotid bulb Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| subjects who are meeting the inclusion criteria<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease. |  | at visit 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular disease, correlation with cardiovascular Risk factors, CIMT
Study of the Treatment of Algerian Patients With Early Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.

Official Title
-----------------
Case Study of the Treatment of Early Rheumatoid Arthritis in Algerian Patients in Both the Private and Public Healthcare Sectors.

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis progressing for < 2 years. Exclusion Criteria: Rheumatoid arthritis progressing for < 3 months. Rheumatoid arthritis onset at < 18 years of age. Participation in another clinical study. Rheumatoid arthritis related connective tissue disorder. Any neuropsychological disorders.

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 |
| --- | --- |
| Patients with Rheumatoid Arthritis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression. |  | Single observational visit [Day 1] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure disease activity using DAS 28 assessment. |  | Single observational visit [Day 1] | 
| Assess joint damage using the modified SHARP method. |  | Single observational visit [Day 1] | 
| Assess functional status of patients using the Health Assessment Questionnaire (HAQ). |  | Single observational visit [Day 1] |
Anlotinib in Advanced Solid Tumors With FGFR Alteration

Study Overview
=================
Brief Summary
-----------------
This clinical trial aims to evaluate the efficacy, safety of Anlotinib in advanced solid tumors with FGFR alteration.

Official Title
-----------------
Anlotinib in Advanced Solid Tumors With FGFR Alteration

Conditions
-----------------
Advanced Solid Tumor

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be histologically diagnosed with advanced solid tumors; Patients with FGFR mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks; Exclusion Criteria: Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: advanced solid tumors with FGFR alteration<br> | Drug: Anlotinib<br>* Anlotinib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate(ORR) | Evaluation of tumor burden based on RECIST criteria. | up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anlotinib, FGFR, solid tumors