linjc16/ctgov huggingface dataset:
Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty

Study Overview
=================
Brief Summary
-----------------
The All-inside method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called classical method, the fixation is achieved with interference screws. The hypothesis of this study was that the All-inside technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.

Official Title
-----------------
Pain Evaluation After ACL Ligamentoplasty: All-inside Versus Classical Technique. A Prospective Randomised Comparative Study

Conditions
-----------------
Arthroscopic Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
-----------------
* Procedure: All-inside
* Procedure: Classical technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total or partial tear of the Anterior Cruciate Ligament Exclusion Criteria: Patient refusal

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All-inside technique<br> | Procedure: All-inside<br>* The All-inside technique is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation.<br>|
| Active Comparator: Classical technique<br> | Procedure: Classical technique<br>* The Classical technique is a usual procedure for anterior cruciate ligament reconstruction (ACL). The fixation is achieved with interference screws.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment on a Visual Analogical Scale |  | One month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment on a Visual Analogical Scale |  | First ten days | 
| Analgesics consumption |  | First ten days | 
| Functional evaluation with IKDC score |  | Change from base-line in IKDC objective score at 6 months | 
| Discharge of crutches and orthesis |  | Time frame from surgery | 
| Radiographic analysis of tunnels positioning according to Aglietti's criteria |  | One month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior cruciate ligament, Arthroscopy, Incomplete bone tunnels, Anterior cruciate ligament reconstruction
Defunctioning Stoma and Postoperative Morbidity

Study Overview
=================
Brief Summary
-----------------
In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is common to create a diverting stoma at the same procedure. Several studies have shown that ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and postoperative complications after major colorectal surgery. The aim of this study is to evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects postoperative morbidity in patients treated within an ERAS program.

Detailed Description
-----------------
See above.

Official Title
-----------------
Diverting Stoma and Postoperative Morbidity After Low Anterior Resection for Rectal Cancer Within an Enhanced Recovery After Surgery,ERAS, Program

Conditions
-----------------
Loopileostomy, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients operated with low anterior resection for rectal cancer at Ersta Hospital between 2002 and 2011 registrated in ERAS database Exclusion Criteria: none

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rectal cancer<br>Low Anterior Resection for Rectal Cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical anastomotic leakage | Evaluate if a diverting stoma after low anterior resection affects postoperative Morbidity in patients treaated within an ERAS program | 0 to 9 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Permanent stoma |  | 0 to 9 years after surgery |
5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes

Study Overview
=================
Brief Summary
-----------------
Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.

Official Title
-----------------
CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.

Conditions
-----------------
Uveal Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of Uveal Melanoma Patients whose physician deems them appropriate for DecisionDx-UM testing Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data Exclusion Criteria: Patients with any other form of cancer

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay | Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern | Approximately 3-6 weeks after biopsy of uveal tumor | 
| Time to metastasis |  | Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in health care costs | review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing | Patients followed for up to 10 years at 6 month intervals | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
occular melanoma, melanoma of eye, DecisionDx-UM
Relation Between Vasovagal Tendency and Smoking Among University Students

Study Overview
=================
Brief Summary
-----------------
Almost everyone is aware these days is aware about the risk of smoking. Still many people start this habit specially in early life and during college year. We aim to investigate in this study if there is a drive to smoke in people with vasovagal tendency to improve their symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness, smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation between smoking and a positive tilt table test which is indicative of vasovagal tendency. By collecting the information regarding smoking habit and vasovagal symptoms analysis can be done to see if there is correlation between these two factors

Detailed Description
-----------------
Methods A questionnaire will be conducted among university students to investigate the tendency toward vasovagal symptoms and also smoking habits. Statistical correlation will be subsequently conducted to see if there is correlation between those two problems (vasovagal symptoms and smoking) Study criteria inclusion Benefit to the patient: There is no direct benefit for participation in the study. The information obtained may help in the future to find factors that increase smoking and being aware of these factors may help in controlling the habit of smoking.

Official Title
-----------------
Relation Between Vasovagal Tendency and Smoking Among University Students

Conditions
-----------------
Vasovagal Syncope, Smoke Inhalation

Intervention / Treatment
-----------------
* Behavioral: Comparison between two groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: College students who agree to participate in the questionnaire Exclusion Criteria: Unable or does not consent to fill the form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Smoker<br>Vasovagal tendency will be compared among smokers and non smokers | Behavioral: Comparison between two groups<br>* Comparison will be made between smokers and non smokers regarding vasovagal tendency<br>|
| Non-smokers<br>Vasovagal tendency will be compared among smokers and non smokers | Behavioral: Comparison between two groups<br>* Comparison will be made between smokers and non smokers regarding vasovagal tendency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of vasovagal tenancy in smokers and non smokers |  | 6 months |
Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety

Study Overview
=================
Brief Summary
-----------------
CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.

Official Title
-----------------
A Phase 1, Open Label, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Grapefruit Juice On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: CP-945,598
* Drug: CP-945,598


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 27 to 40 kg/m2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Exclusion Criteria: Non-prescribed use of drugs of abuse/ recreational drugs; Recent treatment with experimental drugs or herbal experiments; EKG and blood pressure parameters falling outside of protocol-specified limits; History of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-945,598 with Grapefruit Juice<br>CP-945,598 with Grapefruit Juice | Drug: CP-945,598<br>* Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21<br>|
| Experimental: CP-945,598 alone<br>CP-945,598 alone | Drug: CP-945,598<br>* Subjects take CP-945,598 alone for 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20. |  | 21 days | 
| Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22 |  | 21 days | 
| Adverse event monitoring throughout duration of the study |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21. |  | 2 days |
Outcome Following Orthopaedic Surgery

Study Overview
=================
Brief Summary
-----------------
By investigating the long-term functional status of patients who have undergone various types of orthopaedic surgery we will have a basis for devising guidelines for future patients and surgeons.

Detailed Description
-----------------
The purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of orthopaedic surgery. These data will yield a valuable database that can be used to address future research questions. For example, there are three common surgical treatments for medial osteoarthritis of the knee: tibial osteotomy, Oxford partial knee replacement, or total knee replacement. No clear guidelines exist regarding which treatment options are optimal for which patients. By gathering functional data from patients who have undergone these treatments, we will have a basis for devising such guidelines.

Official Title
-----------------
A Prospective Database for Orthopaedic Surgery

Conditions
-----------------
Osteoarthritis of Knee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are scheduled to undergo orthopaedic surgery are eligible to be included in the database. Exclusion Criteria: Those patients who do not meet the above inclusion criteria will be excluded from the study.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Koos | baseline,1y-2y-5y-7y10y | 10y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ShortForm-12 | baseline,1y-2y-5y-7y10y | 10Years | 
| Tegner-ulca | baseline,1y-2y-5y-7y10y | 10Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional outcome, Orthopaedic surgery
Muscle-in-vein Conduits for Digital Nerve Reconstruction

Study Overview
=================
Brief Summary
-----------------
The actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture.

Official Title
-----------------
Evaluation of Sensory Recovery After Reconstruction of Digital Nerves of the Hand Using Muscle-in-vein Conduits in Comparison to Nerve Suture or Nerve Transplantation

Conditions
-----------------
Sensory Recovery

Intervention / Treatment
-----------------
* Procedure: Nerve reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complete digital nerve injuries, nerve reconstruction in the first 6 months post trauma Exclusion Criteria: total or subtotal amputations

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 75 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 |
| --- | --- |
| N<br>nerve suture | Procedure: Nerve reconstruction<br> <br> |
| NT<br>nerve transplantation | Procedure: Nerve reconstruction<br> <br> |
| VM<br>vein-in-muscle conduit | Procedure: Nerve reconstruction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semmes-Weinstein-Monofilament test |  | The earliest 6 months post-OP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-point-discrimination |  | The earliest 6 months post-OP |
Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)
* Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)
* Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis the subjects were antiretroviral drug-naïve a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml Exclusion Criteria: pregnancy or breastfeeding anticipated nonadherence AIDS-defining illness within 2 weeks of entry white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range

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: B<br> | Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)<br>* Stavudine (d4T) 30mg bid (W>60Kg)20mg bid (W<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid<br>|
| Experimental: A<br> | Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)<br>* Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W>60Kg)125mg bid (W<60Kg) Nevirapine (NVP) 200mg bid<br>|
| Experimental: C<br> | Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)<br>* Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid<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
-----------------
Acquired Immunodeficiency Syndrome, adverse effects, Treatment Outcome, Drug Resistance, Viral, treatment naïve
AL-15469A for the Treatment of Bacterial Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.

Official Title
-----------------
AL-15469A for the Treatment of Bacterial Conjunctivitis

Conditions
-----------------
Bacterial Conjunctivitis

Intervention / Treatment
-----------------
* Drug: quinolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signs & Symptoms of conjunctivitis Exclusion Criteria: Under 1 mo. age

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quinolone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure and microbiological success |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual signs and symptoms of bacterial conjunctivitis at each visit |  |  |