linjc16/ctgov huggingface dataset:
Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.

Official Title
-----------------
Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: Antihemophilic factor, recombinant, manufactured protein-free


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed Baxter protocol 069901 Subject is HIV-1 seronegative or, if HIV-1 seropositive, has a CD4+ lymphocyte count >= 400/mm3 documented within three months of the screening visit Subject (and his legally acceptable representative, in the case of study participants >= 10 and < 18 years of age) has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter Exclusion Criteria: The subject received factor VIII products other than rAHF-PFM upon completion of Baxter protocol 069901 The subject developed an inhibitor to factor VIII, measured in the central laboratory, during Baxter protocol 069901. An inhibitor is defined as a Bethesda titer > 1.0 or, if Bethesda titer < 1.0, confirmation using the Nijmegen modification of the Bethesda assay with a titer > 0.6 The subject is scheduled to receive an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids) during the course of the study The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Antihemophilic factor, recombinant, manufactured protein-free|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal phase half-life for Recombinant Antihemophilic Factor (rAHF-PFM) |  | Within 30 minutes prior to the pharmacokinetic infusion and at 1 hour ± 5 minutes, 9 ± 1 hour, 24 ± 2 hours, and 48 ± 2 hours after the infusion. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Factor VIII Deficiency
InBody Validation Study

Study Overview
=================
Brief Summary
-----------------
With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.

Detailed Description
-----------------
This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.

Official Title
-----------------
Validation of the InBody 770® for the Assessment of Body Composition

Conditions
-----------------
Validation Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 65 years of age Have a Body Mass Index ≥ 18.5 kg/m2 Exclusion Criteria: Are not English speaking Are younger than 18 years of age Weigh more than 450 lbs Taller than 6'6 due to size constraints of the iDXA Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator People having radioactive iodine thyroid treatment. People who have had a nuclear medicine study or a barium X-ray within the last 5 days. People with large amounts of metal in their bodies. People with arthritis of the spine recorded in the medical record. Are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Group 1<br>BMI 18.5 to 24.9 | |
| Group 2<br>BMI 25 to 29.9 | |
| Group 3<br>BMI 30 to 34.9 | |
| Group 4<br>BMI ≥ 35 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition Measures | compare body composition measures between InBody and iDXA | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Mass Index, BMI, InBody, iDXA, validation
Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section

Study Overview
=================
Brief Summary
-----------------
Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is associated with hypotension and bradycardia, which may be deleterious to both parturient and baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following subarachnoid block in parturients undergoing elective caesarean section.

Official Title
-----------------
Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Drug: Ondansetron
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing an elective lower segment caesarean section. Exclusion Criteria: Patients with contraindications to subarachnoid block (patient refusal, unstable haemodynamics, coagulation abnormality), History of hypersensitivity to ondansetron or local anaesthetic agents, Hypertensive disorders of pregnancy, Cardiovascular insufficiency, Receiving selective serotonin reuptake inhibitors or migraine medications.

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ondansetron<br>Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia | Drug: Ondansetron<br> <br> |
| Placebo Comparator: control<br>Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia | Drug: Normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Systolic BP <90 mmHg or Diastolic BP <60 mmHg | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bradycardia | HR <50 beats/min | intraoperative |
Imaging Biomarkers in ALS

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if we are able to find one or more biomarkers of Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy controls.

Official Title
-----------------
A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)

Conditions
-----------------
Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21 to 75 years of age inclusive. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB). ALS patients: A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria. Exclusion Criteria: Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc). Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days. Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes. The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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 |
| --- | --- |
| Amyotrophic Lateral Sclerosis<br>Patients with ALS | |
| Healthy Controls<br>Healthy control volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging biomarkers | Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects. | 12 months |
Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based chemotherapy and whose disease continues to progress. The treatment involves a 1-hour treatment given intravenously (IV), and repeated once every 21 days. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over a 24 hour period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.

Official Title
-----------------
A Phase II, Open-Label Study of Ispinesib in Subjects With Platinum/Taxane-Refractory or Resistant Relapsed Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Ispinesib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Must have a screening CA-125 of greater than or equal to 40 U/ml. Must have received only one prior platinum/taxane-based chemotherapy regimen. Blood tests will be done to check if blood counts are adequate for taking part in the study. Exclusion criteria: Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function. Females who are pregnant or nursing. Any unstable, pre-existing major medical condition or history of other cancers. Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ispinesib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days |  | once every 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety/tolerability, progression-free survival, time-to-response, response duration, and characteristics of Ispinesib administered as an infusion once every 21 days |  | once every 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, platinum/taxane-refractory chemotherapy, Persistent, Recurrent
DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the prevalence of ONJ in the patient population of 2 large HMOs and study the risk factors associated with the development of this condition.

Detailed Description
-----------------
The electronic database from Kaiser Permanente and HealthParnters of Minnesota were used to identify all ONJ cases that occured between 1994 and 2006 and then demographic, social and medical risk factors possibly associated with the disease were abstracted and analyzed.

Official Title
-----------------
Retrospective Cohort Study of ONJ

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ONJ sufferers and control biphosphonate users older than 40, of any gender, race and ethnic origin

Ages Eligible for Study
-----------------
Minimum Age: 41 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 |
| --- | --- |
| ONJ sufferers<br>history of jaw osteonecrosis | |
| Bisphosphonate exposure<br>patients with exposure to bisphosphonates | |

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
Formulations of Liposomal Local Anesthetics

Study Overview
=================
Brief Summary
-----------------
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

Detailed Description
-----------------
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

Official Title
-----------------
Formulations of Liposomal Local Anesthetics for Dental Anesthesia

Conditions
-----------------
Underdosing of Local Anesthetics, Initial Encounter

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anesthetic efficacy<br>Local anesthetics were injected at the apex of the maxillary right canine. | Drug: Ropivacaine<br>* 1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.<br>* Other names: 2% lidocaine with epinephrine 1:100.000;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After anesthetic injection the pulpal response was assessed by an electrical pulp tester. |  | 100 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness. |  | 240 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liposomes, ropivacaine, dental anesthesia, dentistry
A Modified Orbital Implantation Technique in Enucleation

Study Overview
=================
Brief Summary
-----------------
To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique in hydroxyapatite orbital implants

Detailed Description
-----------------
To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique between 2005 and 2009. All the patients underwent primary enucleation and implantation of non-wrapped HA implants using a technique that involves drawing the ends of the rectus muscles anteriorly and suturing them into a cross-shape in front of the implant. Main outcome measures included occurrence of pain or discharge, soft tissue problems, implant motility, upper lid position, and patients' satisfaction.

Official Title
-----------------
Evaluation of the Functional and Cosmetic Outcome of Enucleation With Rectus End-to-end Suturing Surgical Technique in Coralline Hydroxyapatite Orbital Implants

Conditions
-----------------
Orbital Implants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: bilateral enucleation severely traumatized orbits, and little or no function of the extraocular muscles adjunctive radiotherapy and/or chemotherapy diabetes vessel inflammation follow-up of less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 73 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 |
| --- | --- | --- |
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Study Overview
=================
Brief Summary
-----------------
To determine the ability of a monophasic oral contraceptives (OC) regimen of Levonorgestrel (LNG) 90 mg and Ethinyl Estradiol (EE) 20 mg to inhibit ovulation during 84 days of continuous therapy.

Official Title
-----------------
A Single Center, Open-Label Study to Evaluate the Effects on Ovulation of Levonorgestrel 90mg and Ethinyl Estradiol 20mg in a Daily, Continuous, Oral Regimen.

Conditions
-----------------
Ovulation

Intervention / Treatment
-----------------
* Drug: Levonorgestrel
* Drug: Ethinyl Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women of legal age of consent who are willing to use a combination OC. Subjects must be under the age of 36 at the time of enrollment (visit 3). Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses. Other inclusions apply. Exclusion Criteria: A history or the presence of any of the following will prevent enrollment: Thrombophlebitis, thrombosis, or thromboembolic disorders. Deep vein thrombosis. Pulmonary embolism. Other exclusions apply.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 36 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levonorgestrel|nan|
|Drug: Ethinyl Estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovulation, Oral Contraceptive