linjc16/ctgov huggingface dataset:
Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements

Study Overview
=================
Brief Summary
-----------------
Although the results of studies looking at tetrabenazine have shown its effectiveness in the management of hyperkinetic(too much) movement disorders, it has not been made available in the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of the protocol is to provide an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

Detailed Description
-----------------
The purpose of the protocol is to provide compassionate use of an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

Official Title
-----------------
Compassionate Use of Tetrabenazine in the Treatment of Hyperkinesias

Conditions
-----------------
Hyperkinetic Movement Disorders

Intervention / Treatment
-----------------
* Drug: tetrabenazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects evaluated here at Baylor in the PDCMDC demonstrating need for tetrabenazine treatment. Willing to sign informed consent. Willing to comply with procedures required as part of this study. Exclusion Criteria: Those subjects unwilling to comply with study requirements. Subjects unable to give informed consent.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tetrabenazine|25 mg titrated to optimal dose per patient|

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
-----------------
dyskinesia, hyperkinetic, chorea
Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.

Official Title
-----------------
Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts

Conditions
-----------------
Breast Neoplasms, Breast Abnormalities

Intervention / Treatment
-----------------
* Procedure: Breast Tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females 30 years of age or older. Dense Breasts. Has undergone clinical two view mammogram and diagnostic breast imaging evaluation. Suspicious or palpable mass and scheduled for biopsy. Exclusion Criteria: Pregnant or lactating women. Prior personal history of breast cancer. Prior breast augmentation with implants or silicon injection. male patients. No two view mammogram as part of breast imaging evaluation. Breast density of almost entirely fatty/scattered fibroglandular densities.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes. | Procedure: Breast Tomosynthesis<br>* 3D breast imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of digital tomosynthesis and digital mammography test performance. | Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets. | 3 weeks |
Retaining Donors and Increasing Donation Frequency

Study Overview
=================
Brief Summary
-----------------
To retain individuals as blood donors once they have entered the voluntary blood donation system and to increase the frequency of their donations.

Detailed Description
-----------------
BACKGROUND: The study continued research previously funded as part of a National Research and Demonstration Center (NRDC) in Transfusion Medicine. DESIGN NARRATIVE: There were six components to the study. The first identified significant factors influencing regular blood donations by individuals with different donation histories - first-time, second-time, committed (frequent), and lapsed donors. The second component developed and assessed the validity of behavioral models to increase donor retention and to predict whether first and second time donors would contribute again. The third developed donor-retention interventions, especially for the first and second time donors. The fourth component identified homogeneous subgroups among first, second and committed donors who might be receptive to different types of intervention strategies to increase the frequency of their donations. The fifth component evaluated the success of cost-effectiveness of the new interventions compared to existing blood center maintenance strategies. The sixth identified whether or not donors had a limit or ceiling on how often they donated per year. The investigators drew on two related social psychological theories to combine cognitive and behavioral approaches to blood donor retention and to use the findings to construct a multiattribute model of donor decision-making. A behavioral decision model was used to predict donor behavior prospectively and to target and direct the design of interventions to increase donor retention and the frequency of donations. Approximately 33 percent of the total project supported the subproject on retaining donors.

Conditions
-----------------
Blood Donors

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
AZD6088 Single Ascending Dose Study

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.

Official Title
-----------------
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: AZD6088
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture. Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator. Normal and suitable EEG, as judged by a neurologist Exclusion Criteria: History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder. Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator. Any clinically important abnormalities in the ECG.

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD6088 oral solution | Drug: AZD6088<br>* Oral solution. Each subject will receive a single-dose of AZD6088.<br>|
| Experimental: B<br>Placebo oral solution | Drug: Placebo<br>* Oral solution. Each subject will receive a single-dose of placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp) |  | Sampling occasions during all visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Intense PK-sampling during 3 pre-defined study days for PK profiling. | 
| Pharmacodynamics |  | Sampling occasions during 3 pre-defined study days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Healthy
A Brief Behavioral Sleep Intervention for Depression Among Military Veterans

Study Overview
=================
Brief Summary
-----------------
This study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans.

Official Title
-----------------
A Brief Behavioral Sleep Intervention for Depression Among Military Veterans

Conditions
-----------------
Insomnia, Depression, Suicidal Ideation

Intervention / Treatment
-----------------
* Behavioral: Sleep Intervention I
* Behavioral: Sleep Intervention II


Participation Criteria
=================
Eligibility Criteria
-----------------
Age 18 or older Veteran Insomnia Symptoms Depression

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention I<br>This non-medication group treatment (Sleep Intervention I) consists of four 90-minute sessions. | Behavioral: Sleep Intervention I<br>* Insomnia-focused behavioral treatment (4 sessions).<br>|
| Active Comparator: Behavioral Intervention II<br>This non-medication group treatment (Sleep Intervention II) consists of four 90-minute sessions. | Behavioral: Sleep Intervention II<br>* Insomnia-focused behavioral treatment (4 sessions).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation |  | Change from Baseline in Suicidal Ideation at 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Symptoms |  | Change from Baseline in Insomnia Symptoms at 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Insomnia, Suicidal Symptoms, Suicidal Ideation, Military Veteran, Service Member, Depression
Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach.

Detailed Description
-----------------
Hyperchloremic acidosis is frequent in critically ill patients. Renal tubular acidosis (RTA) may contribute to acidemia in the state of hyperchloremic acidosis, but the prevalence of RTA has never been studied in critically ill patients. Therefore, we aimed to investigate the prevalence, type, and possible risk factors of RTA in critically ill patients using a physical-chemical approach. This prospective, observational trial was conducted in a medical ICU of a university hospital. 100 consecutive critically ill patients at the age ≥18, expected to stay in the ICU for ≥24h, with the clinical necessity for a urinary catheter and the absence of anuria were included. Base excess subset calculation based on a physical-chemical approach on the first seven days after ICU admission was used to compare the effects of free water, chloride, albumin, and unmeasured anions on the standard base excess. Calculation of the urine osmolal gap (UOG) - as an approximate measure of the unmeasured urine cation ammonium - served as determinate between renal and extra-renal bicarbonate loss in the state of hyperchloremic acidosis.

Official Title
-----------------
Renal Tubular Acidosis is Highly Prevalent in Critically Ill Patients

Conditions
-----------------
Acidosis, Renal Tubular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted to the medical ICU of the Div. of Gastroenterology & Hepatology of the Medical University of vienna age ≥18 expectancy to stay in the ICU ≥24hours clinical necessity for a urinary catheter Exclusion Criteria: anuria

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 |
| --- | --- |
| critically ill patients<br>critically ill patients at the age ≥18, expected to stay in the ICU for ≥24h, with the clinical necessity for a urinary catheter and the absence of anuria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal-tubular acidosis | Diagnosis of renal-tubular acidosis in critically ill patients within 7 days after ICU admission. | up to 7 days after ICU admission |
Esophageal High Resolution Manometry and Dysphagia

Study Overview
=================
Brief Summary
-----------------
Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.

Official Title
-----------------
Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Device: Conventional manometry
* Device: High resolution manometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female older than 18 years Patient with unexplained dysphagia Patient without cause of dysphagia on eso-gastro-duodenal endoscopy Patient referred for esophageal manometry Patient with health insurance Informed consent signed Exclusion Criteria: Patient younger than 18 years Allergy to one component of manometry catheter Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry Patient unable to give his consent or legally incompetent Patient non qualified according to the investigator Patient refusal or absence of informed consent signed Concomitant participation to another study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional manometry<br> | Device: Conventional manometry<br>* Conventional esophageal manometry<br>|
| Experimental: High resolution manometry<br> | Device: High resolution manometry<br>* High resolution esophageal manometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients correctly diagnosed for esophageal motility disorder |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure) |  | 24 hours | 
| Duration of examination and study analysis |  | day 0 | 
| Cost of patient care within the 6 months following the manometry |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysphagia, Conventional manometry, High resolution manometry
A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product

Study Overview
=================
Brief Summary
-----------------
This protocol intends to detail investigations necessary to evaluate the ocular safety of subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot 8716-098).

Official Title
-----------------
A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).

Conditions
-----------------
Siderosis

Intervention / Treatment
-----------------
* Other: Observational Trial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A subset of subjects enrolled in study A4321001 and who have received formulated drug product (Lot 8716-098) will be included in the safety follow up study. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 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 who have received drug.<br>Patients who have received drug. | Other: Observational Trial<br>* No intervention is being used in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow up for ocular safety and clinical features of ocular siderosis |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERG changes |  | 12 months | 
| Anterior segment and fundal photography |  | 12 months |
Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction. The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to participate. Each participant will complete one study visit. They will be asked for details of their background including their age, sex, ethnicity, country of origin and parental country of origin. They will be asked to give two samples to test for the presence of the genetic marker HLA-B*5701. The two samples are: A cheek swab A blood sample In selected centres patients may be asked to provide up to two additional blood samples. These samples will be used to help develop and validate new methods of determining HLA-B*5701 testing.

Official Title
-----------------
Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients

Conditions
-----------------
Infection, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Procedure: Cheek swab & blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: HIV-1 infected patients over 18 years of age Patient willing & able to understand and provide written informed consent Exclusion criteria: None

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

| Intervention/Treatment |
| --- |
|Procedure: Cheek swab & blood test|Cheek swab & blood test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HLA-B*5701 in the UK population via central labs | The widespread of HLA-B*5701 applied in the selected area in each participant of the UK population was tested via central labs. The result is summarized here. | 2 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HLA-B*5701 in major UK ethnotypes in the study population. |  | 2 Hours | 
| Description of HLA-B*5701 in the UK population via local labs. |  | 2 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infection, HIV, HLA-B*5701, Abacavir hypersensitivity reaction