linjc16/ctgov huggingface dataset:
Re-fixating Dislocated Scleral Fixing Intra-ocular Lens

Study Overview
=================
Brief Summary
-----------------
To minimize multiple manipulations and to decrease the economical burden; here, we describe how to utilize the patient's own dislocated intraocular lens to re-fixate with the sclera.

Detailed Description
-----------------
When a scleral fixated intraocular lens (IOL) is displaced; routinely it is extracted and exchanged with another IOL and re-fixated to the sclera or another modality can be used. Both can carry many complications due to multiple manipulations. Nevertheless, suture and/or haptic end exposure is another expected future complication, which can range from foreign body sensation to endophthalmitis. Here, the investigators utilized the same participant's IOL with minimum manipulations and the haptic ends buried inside scleral pockets to prevent future exposure and complications. The pocket entry is sutured with 8/0 vicryl, which is absorbable, to overcome complications.

Official Title
-----------------
A Novel Technique of Re-fixating Dislocated Scleral Fixing Intra-ocular Lens

Conditions
-----------------
Intraocular Lens Complication

Intervention / Treatment
-----------------
* Other: The surgical intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dislocated primary scleral fixed IOL Exclusion Criteria: Iris claw IOL Anterior chamber IOL
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The scleral pocket for the primary implanted IOL<br>single arm | Other: The surgical intervention<br>* The participant's primary IOL is re-fixed without utilizing any new material.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The slit-lamp examination. | To assess the intra-ocular pressure mmHg, the re-fixated intraocular lens position ( central, tilted or displaced),and leakage from the incisions, and the hemorrhage ( whether in the anterior segment or in the posterior segment). | The fourth week post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visual acuity. | To assess both the uncorrected and the best corrected visual acuity ( with glasses). | The fourth week post-operatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraocular lens dislocation, Scleral re-fixation, scleral fixation
Functional and Neurochemical Brain Changes Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.

Official Title
-----------------
Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression

Conditions
-----------------
Depression, Bipolar

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Depressed bipolar patients (N=100; 15-20 patients/year): Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138 Patient has experienced a maximum of three documented affective episodes. Patient has been off medications for one week prior to study enrollment. Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20 Patient is between the ages of 12 and 35 years. Exclusion criteria: All subjects will be excluded from participation for the following reasons: Any chemical use disorder within 3 months. Any history of significant suicidality that would place the patient at risk to participate in this protocol. Current score ≥3 on item 3 of the HDRS-17 (Suicide Item) Any medical or neurological disorder that could influence fMRI results. A history of mental retardation or an estimated IQ total score <85. An MRI scan is contraindicated in the subject for any reason. The patient lives >100 miles from the University of Cincinnati or cannot attend follow-up visits. Meets DSM-IV criteria for a bipolar mixed episode

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 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 |
| --- | --- |
| 1<br>Study subjects on lithium | |
| 2<br>study subjects on quetiapine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Leuprolide in Treating Adults With Hypogonadotropism

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Hypogonadotropism is an abnormal condition caused by decreased production of gonadotropins, a group of hormones that stimulate the parts of the reproductive system that produce and release eggs from the ovaries or sperm from the testicles. Leuprolide may stimulate the production of gonadotropins and be effective in increasing testosterone in men and inducing ovulation in women. PURPOSE: Clinical trial to study the effectiveness of leuprolide in treating adults who have hypogonadotropism.

Detailed Description
-----------------
PROTOCOL OUTLINE: Male patients receive leuprolide subcutaneously every 5 days for up to one year and are followed at weeks 4, 6, 8, and 12, then every 2 months. Female patients receive leuprolide subcutaneously on days 1, 6, and possibly 11. Patients are followed 2 months after the last injection. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Study of Leuprolide in Adults With Hypogonadotropism

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: leuprolide


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of hypogonadotropism Men: Small testes, abnormal semen analysis, and subnormal plasma testosterone levels without an elevation in gonadotropin levels Women: Amenorrhea and subnormal plasma estradiol levels, or lack of cornification of the vaginal mucosa without an elevation in gonadotropin levels OR Hypothalamic amenorrhea in normally estrogenized women with amenorrhea or oligomenorrhea and normal plasma free testosterone and gonadotropin levels Patients with hyperprolactinemia eligible only if hypogonadotropism persists after correction of hyperprolactinemia by dopamine agonist therapy --Prior/Concurrent Therapy-- At least 2 months since sex hormone treatment --Patient Characteristics-- Other: Not pregnant No chronic systemic, metabolic, or endocrine disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leuprolide|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
-----------------
endocrine disorders, hypogonadism, rare disease
Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube

Study Overview
=================
Brief Summary
-----------------
Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan

Official Title
-----------------
Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial

Conditions
-----------------
Intubation, Expected Duration of Ventilation > 48h

Intervention / Treatment
-----------------
* Device: Airway medix closed suction system
* Device: standard closed suctioning systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to an ICU 18 years old or more expected to be intubated for more than 48 hours less than 24 hours from intubation fraction of inspired oxygen set at the ventilator <80% Exclusion Criteria: Current or past participation in another intervention trial conflicting with the present study expected survival less than 24 hours Acute severe asthma Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO Double lumen endotracheal tube in place Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation) other contraindications posed by staff physicians

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>Airway Medix Closed Suction System | Device: Airway medix closed suction system<br> <br> |
| Active Comparator: control<br>standard closed suctioning systems | Device: standard closed suctioning systems<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of secretions | Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan | within 12 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | report of major and minor adverse events related to the use of the device | until extubation, death or tracheostomy (approximately 2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal tube, ct scan, cleaning device, biofilm, mechanical ventilation
Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).

Official Title
-----------------
Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain

Conditions
-----------------
Physical Disability, Cardiovascular Risk Factors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-institutionalized Spanish resident 60 years and over Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Change from baseline in Frailty | Method of assessment: Fried criteria | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Cardiovascular health | Method of assessment: 7 cardiovascular health metrics as defined by American Heart Association | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular health, Diet, Functional limitations, Frailty, Older adults
The Effect of Laryngeal Manual Therapy as a Management of Globus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat).

Detailed Description
-----------------
This is a prospective study that include patients who met the inclusion criteria. Data collection includes patients age,gender,clinical manifistations,laboratory parameters and treatment. An endoscopic examination will be done by an expert Otolaryngologist. for each patients we will perform one session of laryngeal manual massage therapy by an expert in the field .

Official Title
-----------------
The Effect of Laryngeal Manual Therapy as a Management of Globus(Sensation of a Lump in the Throat )- COMPARATIVE PROSPECTIVE STUDY

Conditions
-----------------
Globus

Intervention / Treatment
-----------------
* Other: laryngeal manual therapies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients more than 18 years old male and females patients complaning from Globus without an organic cause patients who underwent throat endoscopy and was normal. Patients who received conventional drug therapy without benefit. Globus complaints more than two months . Exclusion Criteria: below 18 Patients diagnosed with reflux(as a cause to globus) Patients who considered at high risk of reflux according to REFLUX SYMPTOM INDEX (RSI) more than 13 patients who diagnosed with reflux and improved after anti-reflux manegment . patients with laryngeal disease/finding that can explain the globus. patients with organic cause that can explain the globus .

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: laryngeal manual therapies<br>The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus . | Other: laryngeal manual therapies<br>* The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From symptomatic to asymptomatic patient | after one therapy session we will evaluate the effect of the therapy on the patients . | baseline and week 1 |
Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo

Study Overview
=================
Brief Summary
-----------------
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed

Official Title
-----------------
Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.

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

Intervention / Treatment
-----------------
* Drug: Cilostazol, Ginkgo biloba and placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male adult volunteer between 19 and 45 years of age and within 15% of ideal body weight by broca's formula. the subjects who doesn't have any congenital or chronic diseases and symptoms or signs of diseases after physical examinations.] Exclusion Criteria: the subject who has abnornal lab. ( In particular, AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit/170,000 < Platelet < 360,000 / PT or aPTT or BT> >upper limit the subject who receive any metabolic enzyme inducing or inhibiting drugs like barbiturates or drink excess alcohol within 1 month prior to the study.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo | Drug: Cilostazol, Ginkgo biloba and placebo<br>* dosing time<br>|
| Active Comparator: 2<br>Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba | Drug: Cilostazol, Ginkgo biloba and placebo<br>* dosing time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concetration of Cilostazol at steady state |  | within 12hrs after cilostazol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD parameter: change from baseline after administration (change value of aggregation %) |  | within 12hrs after cilostazol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
Westeinde Brachialgia Study

Study Overview
=================
Brief Summary
-----------------
The Westeinde Brachialgia Study (WEB) is a randomized controlled trial to establish the effect of cervical collar or physiotherapy compared to a wait-and-see policy in patients with acute cervical radiculopathy.

Detailed Description
-----------------
Cervical radiculopathy caused by spondylosis or disc protrusion is a common disorder with a usually benign natural course. Often, physiotherapy (exercise programs) and/or cervical collar are prescribed. However, there are no reliable data on the effects of these conservative therapies. In this study, patients with acute cervical radiculopathy, defined by clinical criteria, are randomized for cervical collar, physiotherapy or a wait-and-see policy.

Official Title
-----------------
A Randomized Controlled Trial of Conservative Therapy in Cervical Radiculopathy

Conditions
-----------------
Radiculopathy, Cervical

Intervention / Treatment
-----------------
* Other: cervical collar
* Other: physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following: provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm; or muscle weakness in one or more adjacent myotomes. Exclusion Criteria: Arm pain existing longer than one month Clinical signs of spinal cord compression Previously treated with physiotherapy or a cervical collar

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: wait and see<br> | |
| Experimental: collar<br> | Other: cervical collar<br> <br> |
| Experimental: physiotherapy<br> | Other: physiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain and disability at 3 and 6 weeks and at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time back to work |  |  | 
| persistent signs and symptoms |  |  | 
| surgery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical radiculopathy conservative treatment
Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog treatment on psoriatic skin lesions in patients with type 2 diabetes.

Detailed Description
-----------------
The objective of this study is to analyse short and medium-term efficacy on clinical, immunological and histopathological parameters of a GLP-1 receptor agonist on moderate to severe psoriasis plaques in a group of patients with type 2 diabetes.

Official Title
-----------------
Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients

Conditions
-----------------
Type 2 Diabetes, Psoriasis

Intervention / Treatment
-----------------
* Drug: GLP-1 analog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients treated with oral anti-hyperglycaemic agents and/or insulin and presenting stable psoriasis plaques for at least one year, which failed to respond to previous systemic and/or topical treatments. Exclusion Criteria: Type 1 diabetes Secondary diabetes Liver, renal or pancreatic disease Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1 analog<br>Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day. | Drug: GLP-1 analog<br>* GLP-1 analog treatment<br>* Other names: Liraglutide, Victoza or Exenatide, Byetta.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of PASI score |  | 4 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of BMI (body mass index) | number of patients with weight loss | 4 to 6 months | 
| Evolution of immunological data | cytokines and T cells | 4 to 6 months | 
| Evolution of histopathological data | thickness, dermis infiltrate in skin plaques and in control areas | 4 to 6 months | 
| Evolution of glycaemic control | HbA1c | 4 to 6 months | 
| Evolution of routine laboratory measures | number of participants with biological adverse effects (pancreatitis enzymes) | 4 to 6 months | 
| Evolution of BMI | weight | 4 to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, psoriasis, exenatide, liraglutide