linjc16/ctgov huggingface dataset:
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care? Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of time the INR is within target range will be compared between the two groups. Thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.

Official Title
-----------------
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care

Conditions
-----------------
Anticoagulation, Thromboembolism

Intervention / Treatment
-----------------
* Procedure: medical care delivery model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: completion of >3 months of warfarin indefinite warfarin therapy Exclusion Criteria: patients who currently receive >25% of INR determinations per year from local labs extended absences from VA

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: medical care delivery model|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent time in therapeutic range (TTR) using modified version of Rosendaal method |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life |  |  |
Japanese Phase 1 Study of BMS-844203 (CT322)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies

Official Title
-----------------
A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: BMS-844203 (CT-322)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate Life expectancy of at least 3 months Eastern Cooperative Oncology Group performance 0-1 Exclusion Criteria: Subject has uncontrolled diabetes or hypertension Clinical significant bleeding diathesis or coagulopathy Thrombotic or embolic cerebrovascular accident

Ages Eligible for Study
-----------------
Minimum Age: 20 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: BMS-844203 (CT-322)<br> | Drug: BMS-844203 (CT-322)<br>* Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine recommended dose for Phase 2 study of CT-322 |  | Within the first 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc. |  | Cycle 1: Day 1 to 5, 8, 15, 22 to 26 and 29 | 
| To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc. |  | Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter | 
| To assess anti-tumor activity of CT-322 |  | Every 8 weeks | 
| To assess the effects of CT-322 on plasma VEGF levels |  | Cycle 1: Day 1, 3, 8, 15, 22 | 
| To assess the effects of CT-322 on plasma VEGF levels |  | Cycle 3: Day 1 | 
| To assess the presence of anti CT-322 antibodies |  | Cycle 1: Day 1, 15, 22 and 29 | 
| To assess the presence of anti CT-322 antibodies |  | Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter |
Predictive Factors of Recurrence of Non Functioning Pituitary Adenomas : a Retrospective Study of 220 Patients in the Reims University Hospital, France

Study Overview
=================
Brief Summary
-----------------
Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient.

Official Title
-----------------
Predictive Factors of Recurrence of Non Functioning Pituitary Adenomas : a Retrospective Study of 220 Patients in the Reims University Hospital, France

Conditions
-----------------
Pituitary Adenomas

Intervention / Treatment
-----------------
* Other: Patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 year-old diagnosis of NFPAs confirmed with hormonal and histological analysis patients who underwent surgery in neurosurgery unit of the Reims university hospital between 01/01/1991 and 31/12/2004 Exclusion Criteria: -

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<br>All patients who underwent surgery for a NFPA in Reims university hospital between 01/01/1991 and 31/12/2004 | Other: Patients<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate / predictive factors of recurrence |  | up to 21 years |
Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

Study Overview
=================
Brief Summary
-----------------
99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms and legs.

Official Title
-----------------
Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

Conditions
-----------------
Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: 99mTc-rBitistatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: peripheral acute venous thrombosis diagnosed by vascular ultrasound is able to give informed consent is likely to complete the study Exclusion Criteria: is pregnant is lactating has a history of prior severe allergic reactions (anaphylactic response) prior use of GP IIb/IIIa antagonist (e.g., abciximab, eptifibatide) has a platelet count <100,000 or history of thrombocytopenia has a history of stroke has a history of recent bleeding documented by decreasing hemoglobin (>1 gm) in last 7 days

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-rBitistatin<br> | Drug: 99mTc-rBitistatin<br>* Intravenous administration of a single dose (10 mCi, 0.1 ug/kg body weight) of 99mTc-rBitistatin, followed by collection of scintigraphic (planar and SPECT) images at 1 hour and 2-4 hours.<br>* Other names: Bitis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi |  | 1-4 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously |  | 0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration |
Effect of Cueing on Gluteus Maximus Recruitment

Study Overview
=================
Brief Summary
-----------------
Do specific verbal and tactile cues and instructions help people who perform bridging exercises to improve hip muscle strength to optimize recruitment of the gluteus maximus muscle?

Official Title
-----------------
Effects of Cueing on Gluteus Maximus and Hamstring Recruitment During the Bridging Exercise

Conditions
-----------------
Muscle Contraction

Intervention / Treatment
-----------------
* Other: Cueing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female 18-40 years of age normal muscle strength in lower extremities Exclusion Criteria: evidence of patellofemoral pain syndrome evidence of femoracetabular impingement evidence of mechanical low back pain causing radicular (lower extremity) symptoms history of previous hip or knee ligament injury history of lower extremity trauma history of lower extremity surgery history of neurological conditions that impair motor function current lower extremity pain that limits functional activities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Cueing | Other: Cueing<br>* Verbal and tactile cueing to enhance gluteus maximus recruitment<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle recruitment as a percentage of the maximal voluntary isometric contraction |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electromyography, Exercise
Diagnostic Value and Biological Significant of cd71 in Lymphoid Disorders

Study Overview
=================
Brief Summary
-----------------
CD71 is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues. , reflecting the requirement for iron in hemoglobin. , CD71 expression is upregulated on immature proliferating cells and low levels on resting mature lymphocytes. In addition to this general function, CD71 appears to play a costimulatory role in T cell activation and receptor for IgA1 antibodies So it is growth receptor that may help in diagnosis of lymphoid disorder and in differentiation of malignant and benign that will be studied investigate CD71 expression in lymphoid disorders and its diagnostic value ,we from collect data patient and do rotune examination

Detailed Description
-----------------
Routine investigations for diagnosis: CBC. Bone marrow aspiration morphology. Cytochemistry. Flow cytometry immunophenotyping. Bone marrow biopsy when indicated. Special investigation is flow cytometry examination of CD71 expression. sample size calculation ; sample size cases 39 sample size controls 39 total sample size 79 sample will be collected from patient in hospital university ,Data will be analysed by SPSS program

Official Title
-----------------
Diagnostic Value and Biological Significant of cd71 in Lymphoid Dis Order

Conditions
-----------------
Lyphoid Disorders, cd71

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients wiil be diagnosed lymphoid disorders Exclusion Criteria: not present
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 |
| --- | --- | --- |
| determin diagnostic value of cd71 in lymphoid disorder | Routine investigations for diagnosis: CBC. Bone marrow aspiration morphology. Cytochemistry. Flow cytometry immunophenotyping. Bone marrow biopsy when indicated. Special investigation is flow cytometry examination of CD71 expression. total sample size 79 person .sample will be collected from patient in hospital university ,Data will be analysed by SPSS program it is growth receptor is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues | baseline |
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.

Official Title
-----------------
Phase I, Open-label, Randomized, 3-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: PN400
* Drug: Naproxen (Proxen S)
* Drug: Naproxen (Naprosyn E)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg Clinically normal physical exams and laboratory measurements Exclusion Criteria: Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PN400<br>* Oral<br>* Other names: VIMOVO™;|
| Active Comparator: 2<br> | Drug: Naproxen (Proxen S)<br>* Oral<br>* Other names: Proxen S;|
| Active Comparator: 3<br> | Drug: Naproxen (Naprosyn E)<br>* Oral<br>* Other names: Naprosyn E;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | pre-dose and multiple times post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Healthy Volunteer
Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.

Official Title
-----------------
Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults

Conditions
-----------------
Deep Vein Thrombosis, Pulmonary Embolism

Intervention / Treatment
-----------------
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE during the specified 24-month study period Exclusion Criteria: Subjects who received apixaban as part of a clinical trial Subjects who received apixaban for any indication other than local approved Contraindications included in the approved Mexican prescribing information

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 |
| --- | --- |
| Drug: Apixaban<br>Patients with VTE who are being given apixaban for the treatment and/or prevention of recurrence of DVT and PE at the sentinel site | Drug: Apixaban<br> <br> * Other names: Eliquis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians |  | Up to 24-month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE |  | Up to 24-month study period |
HaemoCerTM Application in Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
HaemoCer is a hemostatic agent to control bleedings during surgical procedures by accelerating natural hemostasis and is frequently applied during breast conserving surgery in women with breast cancer. There is however no adequate data available on the efficacy of HaemoCer regarding seroma formation or drainage output. The objective of this study is to investigate whether the intraoperative application of haemostatic powder (HaemoCer) in breast-conserving surgery in breast cancer patients reduces the postoperative drainage output and number of days until drain removal (number of hospitalization days).

Official Title
-----------------
Randomised Controlled Trial: HaemoCerTM Versus no HaemoCerTM in Breast Cancer Surgery to Reduce Postoperative Drainage Output

Conditions
-----------------
Breast Neoplasm Female, Mastectomy, Segmental

Intervention / Treatment
-----------------
* Other: HaemoCer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with breast cancer undergoing breast-conserving surgery No previous breast-conserving surgery on the same site ≥ 18 years age no current pregnancy Informed consent Exclusion Criteria: Patients with previous breast-conserving surgery on the same site -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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: HaemoCer<br> | Other: HaemoCer<br>* Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.<br>|
| No Intervention: No HaemoCer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of postoperative drained fluid (per breast) |  | 7 days | 
| Number of days until drain removal (n) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection) |  | 7 days | 
| Rate of immediate postoperative infection on the breast surgery site |  | 7 days |
Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors

Study Overview
=================
Brief Summary
-----------------
Hepatitis C Virus is constantly evolving genetically, particularly in response to the immune system. This is an observational study to examine if immunosuppressants particularly calcineurin inhibitors taken by transplant patients in order to avoid organ rejection causes predictable changes in the genetics of this virus that might be important in order to treat it effectively.

Conditions
-----------------
Hepatitis C Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV infected on immunosuppression

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |