linjc16/ctgov huggingface dataset:
Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.

Official Title
-----------------
A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: CGC-11047


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic hormone refractory prostate cancer. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1. testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy. Progressive disease after androgen deprivation. Exclusion Criteria: Patients whose clinical condition would make chemotherapy clearly indicated. Patients who have received systemic chemotherapy for the treatment of metastatic disease. Peripheral neuropathy > Grade 1 Prior anti-angiogenic therapy, including thalidomide. Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry. Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. Patients with known brain metastases or history of brain metastases. History of stroke within 6 months of treatment or other significant neurological limitations. Patients who have received more than 2 prior investigational treatments. Uncontrolled intercurrent illness Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias

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

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

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: 1<br>CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle) | Drug: CGC-11047<br>* CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Throughout and for 28 days post drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Hormone Refractory, Metastatic
Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study

Study Overview
=================
Brief Summary
-----------------
Aim of the study: Assess the correlation between salivary alkaline phosphatase levels and dental caries. Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme. Assess the effect of growth of children on caries experience and severity.

Official Title
-----------------
Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 6 to 8 years old. Children with and without previous dental visits. Exclusion Criteria: Children with any systemic or mental illness. Children whose parents refuse to sign the informed consent. Children who will not cooperate on participation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|There is no intervention as this is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Alkaline Phosphatase levels in children with and without dental caries | Measured by spectrophotometry (unit: U/L) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries index | Measured by DMFT and deft (unit: scores) | 2 months | 
| Caries severity | Measured by ICDAS (unit: scores) | 2 months |
Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.

Conditions
-----------------
Leber's Hereditary Optic Neuropathy

Intervention / Treatment
-----------------
* Drug: Idebenone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or equal 10 years and < 65 years Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR No explanation for visual loss besides LHON Exclusion Criteria: Any previous use of idebenone Participation in another clinical trial of any investigational drug within 3 months prior to Baseline Previous participation in Study SNT-II-003 (RHODOS) for idebenone.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Idebenone<br> | Drug: Idebenone<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
In a longitudinal, prospective and observational study, patients with PCOS and controls wore the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile were performed.

Official Title
-----------------
Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: SenseWear Armband (SWA) monitoring
* Diagnostic Test: total body dual-energy X-ray absorptiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . PCOS diagnosed according with the Rotterdam Consensus Conference criteria Exclusion Criteria: presence of a late-onset adrenal enzyme defect Significant liver or renal impairment pregnancy and nursing neoplasm cardiovascular disease other hormonal dysfunctions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS<br> | Diagnostic Test: SenseWear Armband (SWA) monitoring<br>* Participants wore the SWA on their right arm<br>Diagnostic Test: total body dual-energy X-ray absorptiometry<br>* DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue<br>|
| controls<br> | Diagnostic Test: SenseWear Armband (SWA) monitoring<br>* Participants wore the SWA on their right arm<br>Diagnostic Test: total body dual-energy X-ray absorptiometry<br>* DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in resting metabolic rate |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in body fat distribution |  | 1 day |
PET-CT for Squamous Cell Carcinoma (SCC) of the Neck Nodes Unknown Primary Malignancy

Study Overview
=================
Brief Summary
-----------------
Patients with squamous cell cancer of neck nodes but unknown primary will have a PET-CT scan prior to biopsies. The utility of PET-CT will be determined in this subset of patients.

Official Title
-----------------
The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of the Neck Nodes With Unknown Primary Malignancy

Conditions
-----------------
Squamous Cell Cancer

Intervention / Treatment
-----------------
* Other: PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: squamous cell cancer of neck nodes with unknown primary site Exclusion Criteria: unable to tolerate PET-CT unable to undergo examination under anaesthesia

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 |
| --- | --- |
| A<br>Patients with Squamous cell cancer of neck nodes, unknown primary | Other: PET-CT<br> <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
-----------------
Squamous, Unknown Primary, Patients with Squamous cell cancer neck nodes
Calcium and Bone Mass in Young Females

Study Overview
=================
Brief Summary
-----------------
We originally suggested that calcium in the diet is important in determining the amount of bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of the girls was 11 years, and they had not yet reached puberty. The study will also provide information about the effect of calcium on body composition (body fat) and blood pressure in young women. We have been giving calcium to one group of participants in this study and giving a placebo (an inactive pill, or sugar pill) to the other group. The results of this research will be important in preventing osteoporosis, because building more bone as a young person should reduce a woman's chances of developing osteoporosis later in life.

Detailed Description
-----------------
This study evaluates the effect of calcium on bone mass accretion over 7 years in a cohort of 354 young females who were in pubertal Stage II at the start of the study. The average age of study participants at entry was 11 years; at the end of the study participants were 18 years old. The study looks at skeletal development under the influence of heredity, nutrition (calcium), and physical exercise. We gave calcium to participants in one arm of this clinical trial calcium. Participants in the other arm of the trial were given a placebo. The main outcome variable is the bone mass measured at different skeletal regions. The study will also provide data about the efficacy of calcium supplementation with regard to hypertension prevention and obesity. The results of this research will be important in preventing osteoporosis.

Official Title
-----------------
Long Term Effects of Calcium on Bone Mass in Young Females

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pubertal stage II Calcium intake below a threshold level Caucasian Normal health Exclusion Criteria: Medications affecting calcium and bone metabolism Chronic diseases Metabolic bone disease Abnormality in calcium metabolism

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calcium|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
-----------------
Dietary calcium, Osteoporosis, Puberty, Bone density, Bone mass, Primary prevention of osteoporosis
Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization

Study Overview
=================
Brief Summary
-----------------
This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.

Official Title
-----------------
A Randomized, Double-Blind, Placebo/Positive Controlled, Evaluation of the Effects of MNTX on ECG Parameters and Cardiac Repolarization in Normal Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Methylnaltrexone (MNTX)
* Drug: Methylnaltrexone (MNTX)
* Drug: Methylnaltrexone (MNTX)
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and free of acute active illnesses Males and females between the ages of 18 and 45 years, inclusive Body mass index between 18-30, inclusive, and weight between 50-110 kgs ECG within normal limits (including PR <220, QRS <110, and QTc <450 ms.) Exclusion Criteria: Previous MNTX exposure Currently pregnant or nursing History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders Consumption of alcoholic beverages within 7 days prior to study confinement Any evidence of congenital or familial long-QT syndrome History of drug abuse of positive findings on urine drug screen Known allergy or hypersensitivity to MNTX or its excipients, moxifloxacin, opioids, or related drugs or a history or relevant adverse drug reactions of any origin.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Arm 1<br> | Drug: Methylnaltrexone (MNTX)<br>* Dose 1<br>|
| Experimental: Arm 2<br> | Drug: Methylnaltrexone (MNTX)<br>* Dose 2<br>|
| Experimental: Arm 3<br> | Drug: Methylnaltrexone (MNTX)<br>* Dose 3<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br> <br> |
| Active Comparator: Arm 5<br> | Drug: Moxifloxacin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of MNTX on QTcI duration | The primary objective of the study is to compare the effects of clinical and supratherapeutic doses of MNTX with the effects of placebo on QTcI duration in healthy volunteers. | 3 days |
Eziclen Drug Utilisation in Real Life Setting

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess Eziclen/Izinova drug utilisation in the real life setting in a representative sample of the European target population.

Official Title
-----------------
A Multicentre, European, Observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a Bowel Cleansing Preparation

Conditions
-----------------
Bowel Cleansing

Intervention / Treatment
-----------------
* Drug: Eziclen®/Izinova®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation. Patient having provided written informed consent. Exclusion Criteria: Patient not eligible for a prescription of BLI800 (Eziclen®/Izinova®) as a cleansing bowel preparation in accordance with the marketing authorisation. Specifically, patients in whom there is a contraindication for use of this product, including patients with congestive heart failure, severe renal insufficiency of active inflammatory bowel disease, are not eligible for inclusion in this study. Patient being prescribed a cleansing bowel preparation other than BLI800 (Eziclen®/Izinova®).

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 |
| --- | --- |
| Colorectal diseases patients<br> | Drug: Eziclen®/Izinova®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of liquid intake | Assessment of non-compliance in terms of insufficient liquid intake. The volume of water and clear liquids taken will be derived from the remaining volumes as recorded on the patient's leaflet and reported by the Investigator. Compliance to the hydration guidelines expressed in terms of a ratio (actual volume taken versus theoretical volume). | on the day of the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Up to 2 years |
Effect of Steep Trendelenburg in Laparoscopic Surgery on IOP & RNFL Thickness

Study Overview
=================
Brief Summary
-----------------
The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery

Detailed Description
-----------------
To measure IOP and RNFL thickness in subjects undergoing laparoscopic operations in steep trendelenburg before, during, and after the operation

Official Title
-----------------
The Effect of Steep Trendelenburg Position Used During Laparoscopic Surgery on Intraocular Pressure During Surgery and on the Retinal Nerve Fiber Thickness After Surgery

Conditions
-----------------
Intraocular Pressure, Retinal Nerve Fiber Bundle Deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: OCT (Optical coherence tomography)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SUBJECTS INTENDING TO UNDERGO LAPROSCOPIC SERGURY WHICH HAVE NO EYE DISEASES Exclusion Criteria: SUBJECT WITH EYES DISEASE PREGNANCY DURING THE STUDY PERIOD

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 120 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IOP and OCT RNFL measurements<br>all subjects will undergo ophthalmological exams including IOP and RNFL OCT measurements | Diagnostic Test: OCT (Optical coherence tomography)<br>* RNFL AND IOP MEASUREMNTS<br>* Other names: CARE (ICARE FINLAND Oy);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular Pressure (IOP) | IOP measurement will be taken before, during and after surgery using ICARE tonometer | Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery | 
| Retinal Nerve Fiber Layer Thickness (RNFL) using OCT | RNFL measurement will be taken before and after surgery using spectralis OCT | Change in OCT RNFL thickness from baseline to OCT RNFL thickness during surgery and to one week and to three months following surgery |