linjc16/ctgov huggingface dataset:
The Role of Kinesiophobia in the Functional Recovery After Hip Replacement

Study Overview
=================
Brief Summary
-----------------
Several authors explain as the kinesiophobia plays an important role for the recovery after orthopaedic surgery. The aim of the investigators study is to investigate if the kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure the fear level of movement. All the other variable that could influence the ILOA Score are identified and collected: age, sex, body max index, ability of patient pre-surgery, type of anesthesia, length of stay, pain, haemoglobin, possible complications.

Official Title
-----------------
Is Kinesiophobia a Predictive Factor of the Early Functional Recovery After Total Hip Replacement? - An Observational Study

Conditions
-----------------
Hip Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip joint replacement Clinical symptoms from more than 3 months Exclusion Criteria: other orthopaedic surgery on the lower limb In the last year Not italian speaking Hip arthroplasty following fractures, revision surgery, and partial replacement Patients with concomitant neurologic (Parkinson, ictus), rheumatologic (rheumatoid arthritis) diseases, cognitive impaired.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iowa Level of Assistance (ILOA) Score | The outcome considered was the level of autonomy achieved by the patients at the 5th days after surgery, measured by the Iowa Level of Assistance (ILOA) scale that took into account the patient's autonomy in carrying out functional 5 activities: supine-to-sitting, sitting-to-standing, walking, climbing 3 steps, and gait speed. The total score ranged from 0 to 50, where 0 was the patient's complete autonomy and 50 the maximum dependence. The score was based on the level of help that was supplied to the patient by the operator for the safe execution of activities, with a range between 0 and 30, and the type of assistive device used with a range between 0 and 20. The physiotherapist will collect the ILOA Score. | 5 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip replacement,, rehabilitation,, early ambulation,
D3-GHR Polymorphism and Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
The protein polymorphism of the growth hormone receptor characterized by the genomic deletion of exon 3 has been linked to the magnitude of the first-year-growth response to growth hormone (GH) in girls with Turner syndrome. Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to this GHR polymorphism in a mainly retrospective design (chart-review).

Official Title
-----------------
D3-Growth Hormone Receptor Polymorphism and Total Effect of Recombinant Human Growth Hormone on Growth in Girls With Turner Syndrome

Conditions
-----------------
Turner Syndrome, Short Stature

Intervention / Treatment
-----------------
* Drug: recombinant human growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Turner syndrome defined by a structural aberration or lack of the X chromosome. Growth velocity less than 2 cm/year at the time of final analysis (= final height). Exclusion Criteria: Age <3.5 or >14 years at start of GH therapy, GH peak serum levels < 8 ng/ml in two independent tests, Thelarche at start or during the first year of treatment, Oxandrolone therapy for any time and a duration of GH therapy less than 2 years.

Ages Eligible for Study
-----------------
Minimum Age: 38 Months
Maximum Age: 14 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: recombinant human growth hormone|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
-----------------
growth hormone receptor polymorphism, pharmacogenomics, growth promoting therapy
Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

Study Overview
=================
Brief Summary
-----------------
For many years, researchers and doctors have studied different kinds of treatments to improve the survival of men with testicular cancer. However, recent research has shown that many years later, men who had testicular cancer appear to be at higher risk for developing heart disease (heart attack or heart failure), especially if they received chemotherapy. Since these studies were done many years after men received treatment, there was no way to know if other factors contributed to the health problems they experienced. This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.

Detailed Description
-----------------
The aim of this pilot study is to examine global and regional LV systolic and diastolic function, cardiac output, cardiac reserve, VO2peak and CVD risk profile in males recently diagnosed with testicular cancer treated with surgery alone or surgery and chemotherapy.

Official Title
-----------------
Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

Conditions
-----------------
Testicular Cancer, Seminoma, Non-seminomatous

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery and surveillance surgery and multi-cycle chemotherapy both good and intermediate prognosis seminoma and non-seminomatous germ cell testicular tumors Karnofsky performance index > 70% no contraindications to cardiopulmonary testing Exclusion Criteria: documented cardiovascular disease or evidence of myocardial ischemia on the incremental exercise (VO2peak) test.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Testicular cancer patients who have received surgery and are scheduled for surveillance | |
| 2<br>Testicular cancer patients who have received surgery and are scheduled for chemotherapy | |

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
-----------------
cardiovascular risk factors, cardiac function, VO2peak, Chemotherapy
Clinical Parameters Predicting Unsatisfactory Cervicovaginal Cytology in Conventional Smears

Study Overview
=================
Brief Summary
-----------------
According the terminology of Bethesda 2001, the unsatisfactory cervical cytology can be categorized into specimen rejected, or specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality. Most of the unsatisfactory cervical cytology was due to scanty epithelial cells, which was defined by less than an estimated 8,000 to 12,000 well-visualized squamous cells for conventional smears. Follow-up of unsatisfactory smear found an increased rate of cervical preinvasive and invasive lesions. Thus, an unsatisfactory smear deserves careful follow-up and studies. Although the Bethesda system allows criteria modification in cases of hysterectomy, pelvic irradiation therapy, or chemotherapy, no studies investigated the clinical factors related to the incidence of unsatisfactory smear. Thus, the investigators designed this trial to study the clinical factors relating to unsatisfactory cervicovaginal smear.The list of patients who received Papanicolaou smear between March 2006 and August 2006 in our hospital will be obtained from the Pathological Department first. Then the investigators will review the medical records from HIS system and pathologic files of these patients. On estimation, 7,437 cases will be enrolled for analysis. Clinical parameters for analysis include: age, gravidity, parity, abortion, menopause, location of Pap smear, history of pelvic malignancy, pelvic irradiation, cervical conization, hysterectomy; at pregnancy; three months postpartum; vaginal bleeding, vaginal abnormal discharge, intrauterine device, and cervical polyp found during pelvic examinations. Patients who missed any of above data will be excluded for analysis. The investigators will use univariate and multivariate analysis for data processing and statistic analysis to find out the relationship between clinical parameters and unsatisfactory cervicovaginal Pap smears.

Conditions
-----------------
Unsatisfactory Pap Smear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital Exclusion Criteria: nil
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 |
| --- | --- | --- |
| unsatisfactory Pap smear rates in various clinical conditions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unsatisfactory, Pap smear
CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.

Official Title
-----------------
An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: CDC-501


Participation Criteria
=================
Eligibility Criteria
-----------------
Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment. Subject must understand and voluntarily sign an informed consent document. Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline ECOG (Zubrod) performance status of 0 to 2. Subject must be able to adhere to the study visit schedule and other protocol requirements. Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CDC-501|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed M-Protein Response During Single Agent CDC-501 Therapy | M-Protein response evaluated every 4 weeks through urine and serum electrophoresis. | Response assessed every 4 weeks; up to 62 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Revimid, CC5013
Canadian Registry of ICD Implant Testing Procedures

Study Overview
=================
Brief Summary
-----------------
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

Detailed Description
-----------------
To document types of defibrillation testing (DFT) procedures are in current use in Canada, rates of use an dno use of DFT testing, medical indications for non use of DFT testing, rate of successful testing of first lead configuration, rates and types of complications from DFT testing, costs of implant procedures and the costs associated with DFT testing, short term outcomes of patients with different types of implant procedures.

Official Title
-----------------
Canadian Registry of ICD Implant Testing Procedures

Conditions
-----------------
Ventricular Fibrillation

Intervention / Treatment
-----------------
* Device: GUIDANT ICD SYSTEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving a Guidant ICD system, including replacements Exclusion Criteria: New epicardial lead(s) implanted, included in another cardiovascular trial (may be in the ELECTION 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br> | Device: GUIDANT ICD SYSTEM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals |  | 3 years |
Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.

Official Title
-----------------
Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency

Conditions
-----------------
Zinc Deficiency

Intervention / Treatment
-----------------
* Drug: NPC-02


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The serum zinc concentrations are under the nomal level before registration Able to taking a tablet Exclusion Criteria: Heavy hepatitis Malignant tumor Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc. The serum albumin under 2.8 g/dL Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement) Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration Pregnant, suspected pregnant, lactating, patients who wish to have a child Patient who participated in other clinical trials within 12 weeks before registration Unsuitable as a target of this clinical trial judged by doctor
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: NPC-02<br> | Drug: NPC-02<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of the patients who could maintain target serum zinc concentration |  | approx. 12-24 weeks |
Steady State Vestibular Evoked Myogenic Potentials

Study Overview
=================
Brief Summary
-----------------
Objective: At present, vestibular evoked myogenic potentials are analyzed only in the time domain. A technique to evaluate this potential in the frequency domain could provide more information, but has only been applied within the last year. Design and Study Sample: In this study we recorded vestibular evoked myogenic potential in the time domain, in 156 ears of 78 normal-hearing young adults, at frequencies of 250, 500, 1000 and 2000 Hz, with intensity of 90 dB nHL. Next, the steady state vestibular evoked myogenic potential was recorded at the same carrying frequencies, modulated at 20, 37, 40, 43, 70, 77 and 80 Hz. Results: The responses found by modulated frequency, regardless of carrier, recorded a higher presence of peaks and mean amplitudes between 20 and 70 Hz, especially at 40 Hz. Conclusions: The results show that the observation technique in the frequency domain is feasible and shows a strong association with the time domain for recording vestibular evoked myogenic potentials, at carrying frequencies of 250, 500, 1000 or 2000 Hz.

Official Title
-----------------
Steady State Vestibular Evoked Myogenic Potentials

Conditions
-----------------
Normal Vestibular Evoked Potentials in Frequency Domain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age between 18 and 35 years and auditory threshold less than or equal to 20 dBHL, between 0.5 and 8 kHz, with inter-ear frequency difference less than or equal to 10 dB. Exclusion criteria were: exposure to occupational or leisure noise; otological surgery; more than three ear infections within the last year; use of ototoxic medication; buzzing in the ear, vertigo, dizziness or other cochlear-vestibular symptoms ; presence of systemic alterations that could contribute to cochlear-vestibular pathologies, such as diabetes, hypertension, dyslipidemias and/or hormonal alterations.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br>The sample was composed of 78 individuals (156 ears), 40 females (80 ears) and 38 males (76 ears). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A technique to evaluate vestibular evoked myogenic potential in the frequency domain |  |  |
Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome

Study Overview
=================
Brief Summary
-----------------
Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome.

Detailed Description
-----------------
Antibiotics combined with lavage have demonstrated a reduction in the bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, as immunologic defense is focused on controlling the septic focus, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome. The aim of this study is to evaluate prospectively the effect of peritoneal lavage with clindamycin and gentamicin on the oncologic outcome of colorectal tumours.

Official Title
-----------------
Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution During Elective Colorectal Cancer Surgery on the Oncologic Outcome

Conditions
-----------------
Colorectal Tumors

Intervention / Treatment
-----------------
* Procedure: Antibiotic lavage
* Procedure: Normal saline lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of colon neoplasms plans to undergo an elective surgery with curative aims Exclusion Criteria: preoperative diagnosis of chronic renal failure (because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption) allergy to gentamicin or clindamycin.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic lavage<br>Peritoneal irrigation with Gentamycin - clndamycin solution | Procedure: Antibiotic lavage<br>* Peritoneal irrigation with gentamycin-clindamycin solution<br>|
| Active Comparator: Normal saline lavage<br>Peritoneal irrigation with normal saline | Procedure: Normal saline lavage<br>* Peritoneal irrigation with normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global survival |  | 36 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 36 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrence