linjc16/ctgov huggingface dataset:
Treatment for Patients Suffering From Anemia Due to Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Official Title
-----------------
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Conditions
-----------------
Anemia, Breast Cancer

Intervention / Treatment
-----------------
* Drug: Darbepoetin Alfa
* Drug: Recombinant Human Erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV) infection

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin Alfa|nan|
|Drug: Recombinant Human Erythropoietin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia correction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living, patient preference |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, darbepoetin alfa, Amgen
Individual Patient Compassionate Use of Fedratinib

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib. Expanded access is only available in markets where fedratinib is not yet approved.

Detailed Description
-----------------
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Official Title
-----------------
Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib

Conditions
-----------------
Myelofibrosis

Intervention / Treatment
-----------------
* Drug: Oral Fedratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018. Exclusion Criteria: Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral Fedratinib|Oral fedratinib administered as directed by treating physician.|

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
-----------------
Expanded Access, Compassionate Use
Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels

Study Overview
=================
Brief Summary
-----------------
Recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 To the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly preferred, on antimicrobial peptides secreted from the oral epithelium. Therefore, our aim in this study is to evaluate the effect of chlorhexidine and essential oil mouthwash on hBD2 and LL-37 in saliva.

Detailed Description
-----------------
Periodontal health continues with a balanced interaction of the oral microflora with the host defense line.

Official Title
-----------------
The Effect of Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels

Conditions
-----------------
Mouth and Tooth Diseases, Periodontal Diseases, Gingivitis

Intervention / Treatment
-----------------
* Drug: undefined


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systemically healthy, presence of ≥20 natural teeth, agreement to participate in the study . Exclusion Criteria: known systemic illness, smoking habit, pregnancy/ lactation, long-term use of anti-inflammatory drugs.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| H group<br>healthy periodontium, BOP at \20 % of the sites and no sites with probing depth (PD) [3 mm and clinical attachment level (CAL) [2 mm or alveolar bone loss (N = 20, 12 males, 8 females, mean age: 33.38 | Drug: undefined<br>* Rinsing with mouthwashes<br>* Other names: Mouthwash Product;|
| G group<br>gingivitis, BOP at ≥20 % of the sites and no sites with PD and CAL [3 mm or bone loss (N = 20, 6 males, 14 females, mean age: 32.35); | Drug: undefined<br>* Rinsing with mouthwashes<br>* Other names: Mouthwash Product;|
| CP group<br>chronic periodontitis, ≥4 teeth in each jaw with PD of ≥5 mm, CAL of C4 mm, BOP at [≥80 % of the proximal sites and radiographic evidence of interproximal bone loss | Drug: undefined<br>* Rinsing with mouthwashes<br>* Other names: Mouthwash Product;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of periodontal parametres changes | Incidence of Gingivitis | 6 Months | 
| Rate of periodontal parametres changes | Incidence of Periodontitis | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontitis, Gingivitis, Mouthwashes
Interaction of Potassium and Genetic Risk Variants on Diabetes Risk

Study Overview
=================
Brief Summary
-----------------
The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in Communities (ARIC) and Jackson Heart Study (JHS) cohorts. The investigators also propose to test for an interaction between serum K and these genetic variants. By testing for such an interaction, it will be determined if, among participants with these genetic variants, a low-normal serum K was a stronger predictor of diabetes risk compared to those participants without these genetic variants.

Official Title
-----------------
Interaction of Potassium Measures With Potassium Channel Genetic Variants on Diabetes Risk: The Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS)

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of the Atherosclerosis Risk in Communities (ARIC) Study or Jackson Heart Study (JHS) cohorts Exclusion Criteria: Had not fasted 8 or more hours for the baseline visit Prevalent diabetes at baseline exam Missing information on serum potassium Missing single nucleotide polymorphism (SNP) data Evidence of kidney dysfunction Race other than black/African American or white/Caucasian Missing other covariates

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| ARIC and JHS participants<br>A combined cohort of Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS) participants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations of serum potassium and KCNJ11 variants with incident diabetes as represented by odds ratio | Calculation of odds ratio will be used to represent the risk of incident diabetes associated with serum K, rs5215, and rs5219 within the cohort | through study completion, mean of 8 years of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Potassium, Genetic Variants
Vitamin D Treatment to Patients Suffering From Chronic Pain and Vitamin D Hypovitaminosis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to check whether vitamin D will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain.

Detailed Description
-----------------
Vitamin D is a complex nutrient that functions as a hormone to benefit numerous body tissues. Vitamin D is naturally produced by skin exposed to ultraviolet B. Despite the fact that Israel is a sunny country, a majority of all patients, and particularly those with pain, have inadequate intake of vitamin D. Vitamin D therapy is easy for patients to self administer, well tolerated, and very economical. In this study, we'll check whether vitamin D will lead to a decrease in pain intensity in patients suffering from chronic low back pain.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled Study to Check Whether Vitamin D Will Lead to a Decrease in Pain Intensity in Patients Suffering From Chronic Pain and Hypovitaminosis D

Conditions
-----------------
Back Pain, Hypovitaminosis D

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women over 18, who suffer from chronic pain and hypovitaminosis D Exclusion Criteria: patients that are treated with vitamin D

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Vitamin D<br>34,500 IU vitamin D per week | Drug: Vitamin D<br>* 34,5000 IU vitamin D per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to check whether vitamin D will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
back pain, hypovitaminosis D
The Superficial Lesions in the Peri-auricular Region

Study Overview
=================
Brief Summary
-----------------
Superficial lesions on and around the ear are uncommon with many differential diagnoses and different characteristic histopathologic features. The purpose of this study was to describe a series of peri-auricular superficial lesions and characterize the distinctive types of these lesions.

Detailed Description
-----------------
Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated. Data were retrieved, reviewed, and analyzed. The primary analysis outcome measures were patient history (age, gender, complaint, medical advice clinic, and associated medical diseases), lesions examination (site, laterality, clinical presentation, and the number of lesions). Also, the needed investigations for diagnosis, type of intervention, postoperative patient satisfaction were evaluated. Evaluation of the patients' follow up was done.

Official Title
-----------------
The Superficial Lesions in the Peri-auricular Region; Retrospective Study

Conditions
-----------------
Superficial Cyst or Mass and Sinus on and Around the Ear

Intervention / Treatment
-----------------
* Procedure: Complete excision to superficial lesions around the ear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) operated during the period extending between 2017 and 2019 Available full demographic, clinical and histopathological data Exclusion Criteria: deep lesions involving parotid or parapharyngeal space Missed demographic, clinical and histopathological data
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
Interventional Model Description: Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Complete excision to superficial lesions around the ear|Complete excision of these lesions and histopathology|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and Histopathlogical types of superficial lesion around the ear |  | Cases operated between in the previous 3 years from 2017 and 2019 |
The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

Study Overview
=================
Brief Summary
-----------------
Cataract surgery is the most prevalent surgical procedure. Since most candidates are elderly patients, hypertension is common among these patients. Preoperative anxiety and tension may cause elevation of patient's heart rate and blood pressure and thus expose them to serious potential complications such as stroke and myocardial infarction. Medical clowns are known to reduce preoperative anxiety of both children and their parents. It is possible therefore that medical clown may have such a beneficial effect also on patients scheduled for cataract surgery under local anesthesia.

Official Title
-----------------
The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

Conditions
-----------------
Blood Pressure, Heart Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing an elective, ambulatory cataract surgery (phacoemulsification technique) Surgery planned to be performed under local anesthesia Age > 40 years Patients signed an informed consent Exclusion Criteria: Hypertensive patients who did not take their prescribed medications on the day of surgery Uncontrolled hypertension during the month preceding the surgery Patients with systolic and diastolic BP values of >190 and 100 mmHg respectively, measured 1hr prior to surgery Patients not suitable for surgery under local anesthesia Patients in whom the planned phacoemulsification technique was converted to either the ECCE or ICCE technique Patients in whom an anterior vitrectomy had to be performed during surgery Patients treated regularly by anti-anxiety or analgetic treatment

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Medical clowns treatment<br>Patients scheduled for an elective cataract surgery will receive pre-operative conventional treatment and in addition will be exposed to medical clowns effect | |
| Conventional treatment only<br>Patients scheduled for elective cataract surgery will receive only conventional pre-operative treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical clowns, Cataract surgery, Blood pressure, Heart rate
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.

Official Title
-----------------
Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)

Conditions
-----------------
Failure to Thrive

Intervention / Treatment
-----------------
* Drug: Somatropin (rDNA origin) for injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Turner Syndrome or SHOX disorder SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL Exclusion Criteria: GH deficiency or known insensitivity Evidence of tumor activity Diabetes mellitus or history of impaired glucose tolerance Any severe illness known to interfere growth

Ages Eligible for Study
-----------------
Minimum Age: 3 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

| Intervention/Treatment |
| --- |
|Drug: Somatropin (rDNA origin) for injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency. |  |  | 
| Non inferiority to somatropin treated patients with Turner syndrome |  |  | 
| Adult height of treated patients |  |  |
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB was complicated and unclear in many aspects. In particular, the research about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to analyze the differences of cardiac conduction and heart rate variability before and after tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB and OAB female patients, and before and after tolterodine treatment.

Official Title
-----------------
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome

Conditions
-----------------
Antimuscarinic Drug

Intervention / Treatment
-----------------
* Drug: tolterodine, solifenacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases are female patients with lower urinary tract symptoms

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

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

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: antimuscarinic drug<br> | Drug: tolterodine, solifenacin<br>* The enrolled women before March 2009 were treated with tolterodine 4 mg slow-release, and after March 2009 were treated with solifenacin 5 mg once a day for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of heart rate variability after antimuscarinics | Changes of heart rate variability after 3-months' antimuscarinics treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of arterial stiffness after antimuscarinics treatment | Changes of arterial stiffness after 3-months antimuscarinics' treatment | 3 months | 
| Changes of psychologic distress after antimuscarinics treatment | Changes of psychologic distress after 3-months' antimuscarinics treatment | 3 months |