linjc16/ctgov huggingface dataset:
Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.

Study Overview
=================
Brief Summary
-----------------
There are many surgical methods available for the treatment of patients with acromioclavicular dislocations. No single method has yet proven to be superior to the others. The purpose of this study is to evaluate the clinical outcome and complications associated with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a single transclavicle transcoracoid bone tunnel. The implantation is performed using an endobutton system that augments the repair with fibrewires. The investigators will prospecitvely follow 30 patients enrolled in the study. The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will result in good clinical outcome and few complications.

Official Title
-----------------
Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.

Conditions
-----------------
Acromioclavicular Joint Dislocation.

Intervention / Treatment
-----------------
* Procedure: Surgical treatment of acromioclavicular dislocation.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 75 years old. Shoulder trauma within last 2 weeks. Pain from the acromioclavicular joint. Exclusion Criteria: Chronic or concomitant acromioclavicular joint pathology on injured side. Previous acromioclavicular joint dislocation on contralateral side. Major shoulder pathology on affected side. Mental inability to take part in rehabilitation. Non Swedish or English speaking patients.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Surgical repair of acromioclavicular dislocation. | Procedure: Surgical treatment of acromioclavicular dislocation.<br>* Coracoclavicular ligament repair using autogenous gracilis tendon implanted using an endobutton system containing fibrewires and a single transclavicular, transcoracoid bone tunnel.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Redislocations. Other local complications, eg. infection. | 12 months after surgery. | 
| Disabilities of the Arm, Shoulder and Hand Score |  | 12 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Score |  | 12 months after surgery |
Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the effect of growth hormone on left ventricle morphology and function (systolic and diastolic).

Official Title
-----------------
Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult growth hormone deficiency At least 2 years without growth hormone treatment Exclusion Criteria: Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatropin<br> | Drug: somatropin<br>* Initial dose 0.5 IU/day and escalated up to maximum dose the first 6 months. Maximum dose 3.0 IU/day for 18 months. Injected subcutaneously (s.c., under the skin) daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular systolic function |  |  | 
| Left Ventricular diastolic function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  |  | 
| Fasting glucose |  |  | 
| HbA1c (glycosylated haemoglobin) |  |  | 
| Oral glucose tolerance test (OGTT) |  |  |
1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

Study Overview
=================
Brief Summary
-----------------
Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.

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

Intervention / Treatment
-----------------
* Drug: Travoprost/Brinzolamide
* Drug: Cosopt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IOP at screening visit <18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 &2 visits) 24 and ≤ 36 mmHg at 9:00 21 and ≤ 36 mmHg at 11:00 and 16:00 Exclusion Criteria: Severe central visual field loss Angle Shaffer grade < 2 C/D ratio > 0.8 (horizontal or vertical measurement)

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost/Brinzolamide PM, Vehicle AM<br>Travoprost/Brinzolamide PM, Vehicle AM | Drug: Travoprost/Brinzolamide<br>* Eye drop suspension, once daily<br>|
| Experimental: Travoprost/Brinzolamide AM, Vehicle PM<br>Travoprost/Brinzolamide AM, Vehicle PM | Drug: Travoprost/Brinzolamide<br>* Eye drop suspension, once daily<br>|
| Active Comparator: Cosopt<br>Cosopt BID | Drug: Cosopt<br>* Eye drop solution, one drop BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP |  | 9:00,11:00, and 1600 time points at month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12. |  | All on therapy time points not included in primary efficacy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, Patients with open-angle glaucoma or ocular hypertension
Subclinical Organ Damage in Overweight and Obese Patients: Does Presence of Metabolic Syndrome Matter?

Study Overview
=================
Brief Summary
-----------------
Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. Carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. Recent studies have shown correlations between homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but no data exists for obese or overweight patients who also have metabolic syndrome, in terms of markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular disease and since it is known that patients with metabolic syndrome are at higher risk of cardiovascular events, the investigators wanted to examine whether there is an association between homocysteine, microalbumin levels and carotid intima-media thickness in patients with or without metabolic syndrome, who are either overweight or obese.

Conditions
-----------------
Metabolic Syndrome, Subclinical Organ Damage, Overweight, Obese

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years BMI >= 25 Ex or non-smokers (must have quit smoking at least 5 years ago) Exclusion Criteria: NIDDM or IDDDM Nephropathy (GFR < 60 ml/min), previous history of coronary artery disease or peripheral arterial disease Current smokers Active infection or other acute illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| With Metabolic Syndrome<br> | |
| Without Metabolic Syndrome<br> | |

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
-----------------
metabolic syndrome, obesity, endothelial damage, homocysteine, microalbumin, carotis intima-media thickness
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.

Official Title
-----------------
An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Conditions
-----------------
Chronic Peripheral Neuropathy Pain in Diabetics

Intervention / Treatment
-----------------
* Drug: Bicifadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years or older Diagnosis of type 1 or type 2 non-insulin dependent diabetes mellitus Chronic bilateral pain due to diabetic neuropathy, pain for at least six months. Primary pain is located in the feet. Subject participated in and completed the XTL 07-001 clinical trial. Contact site for additional information. Exclusion Criteria: Symptoms of other painful conditions Presence of amputations other than toes Clinically significant psychiatric or other neuropsychological disorder Use of certain medications Clinically important other diseases Pregnancy History of alcohol or narcotic abuse within two years. Contact site for additional information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: 1<br>Bicifadine 800 mg/day for a year | Drug: Bicifadine<br>* SR dosage form of 400 mg bid or tid for one year<br>|
| Experimental: 2<br>Bicifadine 1200 mg/day for a year | Drug: Bicifadine<br>* SR dosage form of 400 mg bid or tid for one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and safety |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement; McGill Pain Questionnaire; Amount of Rescue Medication Used for Pain; Quality of Life Survey (SF-36); Patient Global Impression of Change |  | One year |
A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key post-transcriptional regulators of gene expression, differentiation. The investigators had a preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced inflammatory cascade. However, there wasn't a previous study about expression of THRIL, PACER in a human tissue. Therefore, the investigators aimed to evaluate the expression of THRIL, PACER in patients with gastrointestinal disease according to H.pylori infection.

Official Title
-----------------
A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA

Conditions
-----------------
Helicobacter Pylori Infection, Gastric Ulcer, Duodenal Ulcer, Stomach Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 years old Patients with gastric ulcer Patients with duodenal ulcer Patients with stomach cancer Patients with gastrointestinal discomfort symptoms Exclusion Criteria: Patients who has done helicobacter pylori eradication Patients who has undergone gastrectomy Patients who has undergone endoscopic submucosal dissection Patients with active upper gastrointestinal bleeding

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Gastric ulcer<br>patients who will undergo EGD for gastric ulcer | |
| Duodenal ulcer<br>patients who will undergo EGD for duodenal ulcer | |
| Stomach cancer<br>patients who will undergo EGD for stomach cance | |
| health individuals<br>patients who will undergo screening EGD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of THRIL, PACER | Expression of THRIL, PACER according to Helicobacter pylori infection by Real-time aRT-PCR | Within 2 weeks after EGD | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, long non-coding RNA, THRIL, PACER, cagA
EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients

Study Overview
=================
Brief Summary
-----------------
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.

Detailed Description
-----------------
correlation between possibly detected mutation/specific polymorphism and kind and number of neoplasm, age of patients, UV burden, duration and kind of immunosuppression.

Official Title
-----------------
EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients,Especially Patients After Organ Transplantation and Patients With HIV Infection

Conditions
-----------------
Immunosuppression, Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in an immunosuppressive condition either by immunosuppressants or by HIV infection Exclusion Criteria: written informed consent not given

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen. |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between possibly detected mutation/specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen and a composite of kind and number of neoplasm, age of patients, UV burden, duration and kind of immunosuppression. |  | 7 years |
The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China

Study Overview
=================
Brief Summary
-----------------
This is a multi-centre, cross-sectional study planned to be conducted in China. The study aims to observe about 1500 asthma patients who have already received budesonide/formoterol combination treatment by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China.

Detailed Description
-----------------
The asthma control rate achieved by budesonide/formoterol in clinical practice in China.

Official Title
-----------------
The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: without interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of asthma at least 6 months; Prescribed with budesonide/formoterol treatment at least 3 months before enrolled; Has used the same maintenance dose of budesonide/formoterol for at least 4 weeks before enrolled. Exclusion Criteria: Participation in any clinical study within 3 months; Have COPD history/suspicious COPD; ≥ 10 pack years of smoking history Used any other asthma maintenance medication accompanied with budesonide/formoterol within 3 months before enrolled With asthma exacerbation (defined as asthma symptom deterioration resulting oral/rectal/parenteral GCS medication or emergency room treatment or hospitalisation) within 4 weeks before enrolled

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 |
| --- | --- |
| Target subject population 1500<br>Asthma patients who have already received the treatment of budesonide/formoterol by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China | Other: without interventions<br>* without interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of completely controlled and well controlled asthma according to Asthma Control Test's score |  | one day | 
| The average frequency of reliever use in previous week |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, control rate, budesonide/formoterol, Non-Interventional study
Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.

Detailed Description
-----------------
Assuming the availability of some food in the household, the caregivers were instructed on how best to use the food they have and the quantity of supplementary food distributed was calculated to provide about 50% of child energy requirement.

Official Title
-----------------
Using Indigenous Foods to Reduce Malnutrition in Children

Conditions
-----------------
Wasting, Moderate Acute Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 6-59 month Weight-for-height between -3 and -2 z-scores without edema Good appetite Stable clinical conditions Exclusion Criteria: Weight-for-Height Z-score < -3 Presence of bilateral pitting edema Unstable clinical conditions Not showing appetite

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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: Ready to Use Suplementary Food (RUSF)<br>A daily ration of 40 kcal/kg of body weight during 56 days | Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days<br>* On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.<br>|
| Active Comparator: Corn Soya Blend (CSB+)<br>A daily ration of 40 kcal/kg of body weight during 56 days | Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days<br>* On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate of the children receiving CSB+ or RUSF | Children with Weight-for-Height Z-score > -2 | 56 days |