linjc16/ctgov huggingface dataset:
Safety and Tolerability Study With Single Ascending Doses of ORM-12741

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ORM-12741 in healthy volunteers.

Official Title
-----------------
Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Single Ascending Doses of ORM-12741

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ORM-12741


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health ascertained by detailed medical history and physical examinations Males between 18 and 45 years Body mass index (BMI) between 18-30 kg/m2 Weight 55-90 kg Exclusion Criteria: Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study Susceptibility to severe allergic reactions Regular consumption of more than 14 units of alcohol per week Current use of nicotine-containing products more than 5 cigarettes or equivalent/day Inability to refrain from using nicotine-containing products during the stay in the study centre Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre Blood donation or loss of significant amount of blood within 3 months prior to the screening visit Abnormal finding in ECG, vital signs, laboratory tests or physical examination Participation in a drug study within 3 months prior to the start of this study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORM-12741<br> | Drug: ORM-12741<br>* Alternating panel single dose escalation.<br>|
| Placebo Comparator: Placebo<br> | Drug: ORM-12741<br>* Alternating panel single dose escalation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values |  | About 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 5 days after each dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer study
In Vitro Diagnostic Device for the Detection of Strep A

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.

Official Title
-----------------
Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A

Conditions
-----------------
Streptococcal Sore Throat

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are 3 years of age or older Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including: presence of sore throat, and at least one other symptom from the list below: redness of the posterior pharyngeal wall pharyngeal or tonsillar exudate tonsillar swelling tender cervical lymphadenopathy fever, >38C at presentation or within the past 24 hours Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian Exclusion Criteria: Subjects treated with antibiotics currently or within the previous 7 days.

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- | --- |
| Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture |  | Results based on samples collected at initial visit |
Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
Summary: As this is an open label study, all patients will receive SDX-105 by 30-60 minute intravenous infusion on day 1 and day 2. Treatment will repeat every 21 days. Treatment can continue for up to one year in the absence of disease progression or unacceptable toxicity. Patients will be followed until disease progression. Rationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in patients who are refractory to Rituxan.

Official Title
-----------------
A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: SDX-105


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented indolent or transformed B-Cell NHL indolent NHL: follicular B-Cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma Documented refractory disease to rituximab therapy, given as a single agent or in combination (defined as no response, or progression within 6 months of completing rituximab treatment.) Age of at least 18 years at Screening Visit (Site specific requirement may differ) Exclusion Criteria: Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously. Use of investigational agents within 28 days of study History of prior high dose chemotherapy with allogeneic stem cell support

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SDX-105|nan|

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
-----------------
NHL, indolent NHL, non-Hodgkin's lymphoma, lymphoma
Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.

Study Overview
=================
Brief Summary
-----------------
Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.

Official Title
-----------------
Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.

Conditions
-----------------
Assess Marginal Bone Height Changes Around Dental Implants

Intervention / Treatment
-----------------
* Procedure: Dental Implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Free from any systemic diseases affecting the bone metabolism. Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration. Residual alveolar ridge with adequate height and width. Angel's class I classification maxillo - mandibular relationship. Sufficient inter arch space Exclusion Criteria: Smoker. Patients with parafunction habits (clenching or bruxism).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Interventional Model Description: Ten completely edentulous patients aged from 50-60 years
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Dental Implants|Resorbable blast media surface treated dental implant and Acid etched surface treated dental implant.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone height changes | The marginal bone changes around each type of dental implant were assessed by cone beam computed tomography. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implant surface treatment, Marginal bone height, Cone beam computed tomography
Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

Study Overview
=================
Brief Summary
-----------------
Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy. Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.

Detailed Description
-----------------
Patient serum levels of copeptin would be measured after phlebotomy of 3 ml of blood in EDTA tube twice a) within 1-4 hours of extubation and b) within 4-24 hours of extubation (the morning following surgery).

Official Title
-----------------
Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

Conditions
-----------------
Sellar and Suprasellar Masses, Pituitary Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester. Exclusion Criteria: * Patients with preexisting CDI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Predict central diabetes insipidus development | Using the measured lab value, we will access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy. | 2 years | 
| Predict lack of central diabetes insipidus development | Using the measured lab value, we will access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy | 2 years | 
| Assess relative change | Using the measured lab value, we will access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development. | 2 years |
The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.

Study Overview
=================
Brief Summary
-----------------
The overall purpose is to explore the link between the gut and the bones by investigating meal stimulated changes in the blood level of a number of hormones and markers related to intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric bypass). The hormones will be measured in blood samples taken before and after surgery. The results are compared with changes in body weight and body composition as measured by DEXA scanning.

Official Title
-----------------
The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.

Conditions
-----------------
Obesity, Bone Loss

Intervention / Treatment
-----------------
* Other: Meal test and dexa scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasians fulfilling the criteria for laparoscopic gastric bypass. BMI>40kg/m2. Exclusion Criteria: Pregnancy Chronic obstructive pulmonary disease Diabetes mellitus Chronic inflammatory bowel disease Major psychiatric disorder Drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Obese subjects<br>Meal test and dexa scan | Other: Meal test and dexa scan<br>* Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal stimulated changes in gut hormones and bone markers. |  | Before surgery and 4 weeks and 6 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone mass and body composition. |  | Before surgery and 6 months after surgery. |
Accuracy of Pulse Oximeters With Profound Hypoxia

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 & 2018-02.

Official Title
-----------------
Accuracy of Pulse Oximeters With Profound Hypoxia

Conditions
-----------------
Hypoxemia

Intervention / Treatment
-----------------
* Diagnostic Test: Data acquisition using DT-400 pulse oximetry system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Pregnancy -

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acquisition<br>Subjects will undergo profound hypoxia with stable plateaus. | Diagnostic Test: Data acquisition using DT-400 pulse oximetry system<br>* Acquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saturation level measurement | Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable | Within 12 months of subject recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoxia, Pulse oximetry
Symphion® System In-Office Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.

Detailed Description
-----------------
The purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.

Official Title
-----------------
A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment

Conditions
-----------------
Uterine Leiomyomas, Endometrial Polyps

Intervention / Treatment
-----------------
* Device: Symphion® Bipolar Hysteroscopic Tissue Resection System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion Subject has signed written Informed Consent Exclusion Criteria: Subjects who are pregnant Subjects who have an active genital tract infection (as assessed by the physician) Subjects who have cervical malignancies Subjects who have previously been diagnosed with endometrial cancer Subjects who have Type 2 intracavitary myomas Type 0 or 1 intracavitary myoma greater than 3.0 cm

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symphion®<br>Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. | Device: Symphion® Bipolar Hysteroscopic Tissue Resection System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas. | Absence of device related adverse events, or death. | 2 weeks |
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids

Study Overview
=================
Brief Summary
-----------------
The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.

Detailed Description
-----------------
This is an observational study only for all consented subjects who undergo an Exablate treatment. The Exablate procedure is a commercial treatment. The objective of this registry is to collect data about the effect of Exablate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.

Official Title
-----------------
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids

Conditions
-----------------
Uterine Fibroid

Intervention / Treatment
-----------------
* Device: Body System - Functional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - - Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exablate<br>Observational study of Exablate treatment. | Device: Body System - Functional<br>* MR-Guided Focused Ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | All adverse events and/or serious adverse events will be documented and reported according to protocol. | Through study completion, an average of 2 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uterine Fibroids, Exablate
Effect of Prophylactic Ketorolac on CME After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.

Official Title
-----------------
Effect of Prophylactic NSAID Drops on Cystoid Macular Edema After Cataract Surgery Using Optical Coherence Tomography

Conditions
-----------------
Macular Edema, Cystoid

Intervention / Treatment
-----------------
* Drug: ketorolac tromethamine 0.5% (Acular®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First cataract surgery (i.e., first eye). Exclusion Criteria: hypersensitivity to the NSAID drug class, pregnancy.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ketorolac tromethamine 0.5% (Acular®)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of cystoid macular edema by means of OCT (total macular volume) measurements |  |  |