linjc16/ctgov huggingface dataset:
Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

Study Overview
=================
Brief Summary
-----------------
This project will expand current knowledge of reproductive biology in women with bipolar disorder as well as assessing the impact of lamotrigine use for the treatment of bipolar disorder on reproductive function. Specifically, this study examines mood over the menstrual cycle and ovulation for three consecutive menstrual cycles in women treated for bipolar I, II, or NOS (not otherwise specified) with lamotrigine. In addition, testosterone and lipid concentrations will be measured before the participant starts receiving lamotrigine, as well as six months after receiving lamotrigine.

Official Title
-----------------
Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:: Female Ages 18 through 45 Diagnosis of bipolar disorder (I, II, or NOS) Willing to sign the Human Subject Protection Consent Form prior to enrollment into the study Willing to use lamotrigine Never used lamotrigine prior to study entry Exclusion Criteria:- Unwilling or unable to comply with study requirements, e.g. complete forms, or attend scheduled evaluations Significant alcohol and/or substance abuse or dependence within the prior 6 months Used lamotrigine prior to study entry, or currently using lamotrigine at study entry

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

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

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 |
| --- | --- | --- |
| Changes in weight, glucose, lipid levels , insulin and testosterone concentrations over 6 months onmedication | This is a research study to determine how effective lamotrigine is in the treatment of bipolar disorder in women of reproductive age. Participants are between the ages of 18 and 45, have been diagnosed with bipolar disorder, and have indicated that they are about to begin or are considering treatment with lamotrigine. The purposes of this study are to explore the safety of lamotrigine in treating bipolar I disorder, bipolar II disorder, and rapid cycling bipolar disorder in women compared to other mood stabilizers and anti-depressants. In addition, this study aims to explore lamotrigine's effects on the association between the mood and the menstrual cycle and to compare the effects of various medications that participants receive for treatment of their illness in regards to reproductive hormone levels. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual cycle length and presence or absence of ovulation |  | 6 months |
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

Study Overview
=================
Brief Summary
-----------------
A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer

Official Title
-----------------
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

Conditions
-----------------
Advanced Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Administration of high dose simplified folfiri


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven adenocarcinoma of the colon or rectum Documented progressive metastatic disease Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST) WHO performance status of 0 or 1 Adequate laboratory values of haematology, liverfunction and renal function No previous chemotherapy for metastatic colorectal cancer Exclusion Criteria: Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years. Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis. Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion. Active uncontrolled infection Other concomitant anticancer agent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of high dose simplified folfiri|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resectability |  |  | 
| Safety |  |  | 
| TTP |  |  |
Explorative Assessment of Biomarkers in Overweight and Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The rationale for this trial is to apply a simple and minimally strenuous pre-screening approach prior to performing more extensive trial-specific screening and baseline-characterization activities in the resulting pre-selected population of subjects.

Detailed Description
-----------------
The pre-screening assessments are designed to characterize the metabolic risk profile / prediabetic status in an unselected population of overweight and obese volunteers, aiming to pre-select high risk and prediabetic subjects as a target population who may specifically profit from primary diabetes intervention (prevention) strategies.

Official Title
-----------------
Explorative Assessment of Biomarkers Indicative of Insulin Resistance and Prediabetes in Overweight and Obese Subjects

Conditions
-----------------
Prediabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese and overweight subjects Considered generally healthy Exclusion Criteria: Clinically significant acute illness within 2 weeks before study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Generally healthy<br>Generally healthy | |
| Type 2 diabetes mellitus<br>Type 2 diabetes mellitus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric measures and metabolic biomarkers indicative of prediabetes | One blood sample taken on day 1 of the study | Day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-subject and inter-subject variability of analyzed biomarkers | Several circulating markers including the traditionally used fasting serum insulin and fasting plasma glucose as well as an oral glucose tolerance test may serve as indicators of prediabetes. Importantly, these parameters show considerable intra-individual short-term variability. The assessments will therefore be repeated three times within a one month period to determine intra-subject variability of the analyzed parameters under the conditions that apply to the trial site and experimental conditions. | within one month |
Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

Study Overview
=================
Brief Summary
-----------------
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
* Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma or ocular hypertension in both eyes Currently being treated with latanoprost 0.005% QD IOP greater than or equal to 18mm Hg on latanoprost 0.005% Best-corrected VA of 20/200 or better in each eye Visual field within 6 months of study entry Exclusion Criteria: Secondary glaucoma Active intraocular inflammation or macular edema Intraocular surgery or laser surgery within the past 3 months

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: 1<br> | Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops<br>* latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months<br>* Other names: Alphagan® P;|
| Active Comparator: 2<br> | Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops<br>* latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months<br>* Other names: Azopt®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | Month 3 |
Effect of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception

Study Overview
=================
Brief Summary
-----------------
Investigating The Effects of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception

Detailed Description
-----------------
Investigating The Effects of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception by joint position sense assessment

Official Title
-----------------
Effect of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception

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

Intervention / Treatment
-----------------
* Procedure: mulligan mobilisation
* Procedure: sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-85 years Exclusion Criteria: having any elbow condition having any neurological condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>mobilisation group | Procedure: mulligan mobilisation<br>* an active mobilisation with movement on elbow according to mulligan's protocol<br>|
| Sham Comparator: control<br>sham control group | Procedure: sham<br>* a lateral glide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| elbow proprioception assessment by evaluating joint position sense | joint position sense error measurement with universal goniometer at 70 and 110 degrees of flexion | 35 minutes |
Surgical Treatment of Mild Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea (OSA) is one of the most common sleep disorder. There are numerous conditions that are related to OSA, such as diabetes, cardiovascular diseases, and metabolic syndrome. If the patient with OSA have large tonsils, soft and largened uvula or flacid soft palate, one might benefit from operative treatment of OSA. The aim of our study is to find out whether an operative treatment is effective in mild OSA patients with carefully assessed anatomical predispositions. Our ultimate goal is to evaluate the effects of operative treatment in mild OSA itself and in the diseases related to OSA. We measure the cardiovasculary functions, symptoms, postoperative recovery, antropometry, laboratory tests, the quality of life, the quality of sleep and the inflammatory system in sleep apnea before and after the surgery.

Official Title
-----------------
The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: Modified tonsillectomy
* Other: Lifestyle counselling by physician


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 BMI <35 AHI 5-30 events/h Largened tonsils Grade ≥1 Exclusion Criteria: Age <18 or > 65 BMI >35 AHI <5 or >30 Tonsil size < 1 Severe nasal polyposis Pregnancy Chronic kidney, liver or thyroid disease Active treatment of OSA of any kind

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br> | Procedure: Modified tonsillectomy<br>* Tonsillectomy Uvulectomy Soft palatal resection Lifestyle counselling by physician: General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance<br>|
| Other: II<br> | Other: Lifestyle counselling by physician<br>* General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index |  | One year(before and after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | One Year |
PET/CT Imaging of Aneurysm Wall Inflammation

Study Overview
=================
Brief Summary
-----------------
Rationale: Aneurysm development, progression and rupture are characterised by extensive inflammation, dominated by the infiltration of T-cells, B-cells and macrophages. Recent studies into the pathophysiology of aneurysm wall degradation suggest a close relation between increased mechanical stress and the local activation of infiltrated lymphocytes and macrophages. The non-invasive detection of aneurysm wall inflammation, using 18-fluorodeoxyglucose positron emission tomography (FDG-PET) might therefore provide valuable information on the extend of the disease and could clarify the role of mechanical stress on the propagation of aneurysm wall inflammation. Objective: Correlation of FDG uptake and in vitro aneurysm wall tensile strength. (primary objective). The effect of aneurysm sac depressurisation, after endovascular aneurysm repair, on aneurysm wall inflammation (secondary objective). Study design: Observational case series (pilot). Study population: Patients scheduled for conventional (open) and endovascular aneurysm repair. Main study parameters: Standard uptake value (SUV) measurements to asses FDG uptake in the aneurysm wall and in vitro aneurysm wall strength (N/mm). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients scheduled for conventional (open) or endovascular aneurysm repair are admitted to the hospital the day before surgery. At that point all patients will be evaluated using FDG-PET. Although intake of sugar-free liquids is permitted, glucose intake is restricted 6 hours prior to FDG-PET imaging. One hour after intravenous injection of 200-220 MBq FDG, whole body emission and transmission images will be acquired. To determine inflammation markers ( e.g. CRP), blood and urine samples will be collected prior to the operation and again 6 weeks after surgery. For in vitro aneurysm wall tensile strength testing wall specimens will be harvested during conventional aneurysm repair.

Official Title
-----------------
Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography.

Conditions
-----------------
Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for conventional (10 patients) or endovascular (25 patients) aneurysm repair. Informed consent Exclusion Criteria: Diabetes Mellitus type 1 en 2
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients scheduled for conventional aneurysm repair | |
| 2<br>Patients scheduled for endovascular aneurysm repair | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A New Non-invasive Marker to Detect Silent Hypoxia in Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.

Official Title
-----------------
The Somatic-to-cerebral Oxygen Saturation Gradient as a Non-invasive Index of Anaerobic Threshold in High-risk Cardiac Surgical Patient

Conditions
-----------------
Cardiac Surgical Procedures, High-risk Surgical Patient, Anaerobic Threshold

Intervention / Treatment
-----------------
* Device: Near infrared spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 yo Cardiac surgical procedure under cardiopulmonary bypass High-risk surgical patient fulfilling one of the following items: Euroscore >= 6 Ejection fraction < 40% Creatinine clearance < 40mL/min Pulmonary arterial pressure > 45mmHg Signed informed consent Social security affiliation Exclusion Criteria: Emergency situation Patient on ECMO Pregnancy or lactation

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 |
| --- | --- |
| High-risk cardiac surgery patient<br> | Device: Near infrared spectroscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke

Study Overview
=================
Brief Summary
-----------------
In collaboration with the Neurointerventional programs at state university of new york Buffalo, state university of new york Stonybrook, Swedish Medical Center, Erlanger Health System, Vanderbilt University, and West Virginia University School of Medicine, the investigators aim to prospectively collect experiences where direct aspiration as a first pass technique is used for thrombectomy procedures. The investigators also want to compare specific characteristics from these cases to other stroke cases where traditional thrombectomy devices were used.

Detailed Description
-----------------
Traditionally, at a physician's discretion, first pass attempts at thrombectomy procedures are performed with any number of FDA cleared catheters, guide wires, and devices designed for efficient removal of clot within an intracranial vessel. Among institutions involved in this case study, the latest devices are readily available and fully support standard treatment paradigms. However, several cases, recently completed, using only large bore catheter and aspiration have anecdotally demonstrated a superior ability to remove clot from vessels, restoring blood flow to the affected vessel and brain tissue. In these limited number of cases, full restoration of blood flow has been achieved. While this combination of approved devices is minimalistic, the efficiency of the procedure, rapid technical success, and relative simplicity of the approach is unique and should be thoroughly reviewed and possibly prepared for publication.

Official Title
-----------------
ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke

Conditions
-----------------
Stroke Technique

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were treated with direct aspiration as a first pass choice or treated with a stent retriever will be included. Exclusion Criteria: Patients not treated with either direct aspiration as a first pass, or stent retriever will not be included.
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 |
| --- | --- | --- |
| Discharge national institutes of health stroke scale (NIHSS) | a national institutes of health stroke scale (NIHSS) will be obtained at the time of the each patient's discharge or approximately 7 days | approximately 7 days after index stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 day modified Rankin Score (mRS) | 90 days after procedure each patient's modified Rankin Score will be obtained. | 90 days after procedure |