linjc16/ctgov huggingface dataset:
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.

Official Title
-----------------
Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk

Conditions
-----------------
Superficial Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk Urinary cytology negative for severe dysplasia (G3). ECOG performance status 0-1 Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy Absence of other present or past neoplasias except for healed skin basalioma Exclusion Criteria: Tumours with infiltrative patterns at cystoscopy Transitional carcinoma of the upper urinary tract and prostatic urethra. Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer . |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess toxicity profile in the same group of patients. |  |  |
Experience of the Father Following the Announcement of a First Pregnancy

Study Overview
=================
Brief Summary
-----------------
Experience of the father following the announcement of a first pregnancy Its context, immediate reactions and actions. Possible impact of this moment of life a few months or years later?

Official Title
-----------------
Experience of the Father Following the Announcement of a First Pregnancy

Conditions
-----------------
Family Relations, Behavior

Intervention / Treatment
-----------------
* Behavioral: Interview by hierarchical evocation's Method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion) Exclusion Criteria: Patients with severe or neurological psychiatric disorders inducing significant cognitive impairment Patients who do not master the French language Patients who cannot give free and informed consent (guardianship, curatorship, safeguard of justice ...)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Father<br>Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion) | Behavioral: Interview by hierarchical evocation's Method<br>* Interview to describe the experience of the man during the announcement of a pregnancy that it is expected or not.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview by hierarchical evocation's method | Experience of the man during the announcement of a pregnancy that it is expected or not, without identification of an average answer, but description of the diversity of situations, contexts, felt, taken of decision and actions. Since this study is observational and descriptive, it does not have a primary judgment criterion, the aim being to describe the studied population. However, according to the method of hierarchical evocation, it can be said that the average frequency of occurrence of the words and their average polarity index will be some outcome measure. | 30-45 minutes |
Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide the first integrated examination of the interaction between muscle insulin action and exercise-stimulated muscle glucose uptake in obesity from the whole body to the cellular/molecular level.

Official Title
-----------------
Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity

Conditions
-----------------
Upper Body Obesity

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the exercise studies of leg glucose uptake - insulin sensitive group: Sedentary, normal weight, premenopausal women. Sedentary, age-matched normal weight men. Weight stable for two (2) months prior to study. Willing to provide written, informed consent. For the exercise studies of leg glucose uptake - insulin resistant group: For the exercise studies of leg glucose uptake - insulin resistant group: Upper body obese (UBO) premenopausal women. Age-matched upper body obese (UBO) men. Weight stable for two (2) months prior to study. Willing to provide written, informed consent. Exclusion Criteria: Age < 18 or > 55 years (premenopausal women and age-matched men). Use of glucose-lowering agents. For female subjects: positive pregnancy test at the time of enrollment or study History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. Active systemic illness or malignancy. Symptomatic macrovascular or microvascular disease.

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is aimed to determine whether obesity effects muscle glucose utilization during exercise.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lean<br>Control | Other: Exercise<br>* Cycling 60% VO2 max<br>|
| Experimental: Obese<br> | Other: Exercise<br>* Cycling 60% VO2 max<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle glucose uptake | Is exercise induced skeletal muscle glucose uptake different in obese compared to lean adults | 1 hour |
Effect of Metal Artifacts Reduction Orotocols and Electric Potential Difference on Metal Artifacts in Cone Beam Computed Tomography

Study Overview
=================
Brief Summary
-----------------
The effect of metal artifacts reduction protocols and tube potential difference on the metallic artifacts in cone beam computed tomography

Detailed Description
-----------------
Our study is a quantitative as well as a qualitative assessment of the metal artifacts in the CBCT images in a bio models with multiple adjacent dental implants and single isolated implants , while using different MAR protocols inherited in the CBCT soft ware , as well as change in the tube potential difference of the CBCT unit

Official Title
-----------------
Effect of Metal Artifacts Reduction Protocols and Tube Potential Difference on Metal Artifacts in Cone Beam Computed

Conditions
-----------------
Metal Artifacts

Intervention / Treatment
-----------------
* Radiation: CBCT radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bio models of a lower jaw Titanium implants Porcelain fused to metal crowns Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tube Potential difference<br>Different kVp values of the CBCT machine 70, 80 ,90 kVp | Radiation: CBCT radiation<br>* CBCT scanning<br>|
| Experimental: MAR tool<br>MAR option in the software off and on | Radiation: CBCT radiation<br>* CBCT scanning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental implant linear measurement | The implant length and width in millimeters will be assessed in the presence of the artifacts with and without the activation of the MAR tool of the CBCT soft ware, also change in the potential difference will be done with and without the activation of MAR tool | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone- implant interphase | Qualitative assessment if bone - implant interphase, will be either zero or 1 zero indicate that bone implant interphase cannot be assessed , one indicate that the bone implant interphase can be assessed | 1 month |
To Evaluate the Efficacy of Capsimax on Metabolic Rate

Study Overview
=================
Brief Summary
-----------------
Capsimax™ is a proprietary Capsicum Extract that employs Beadlet Technology. In the previous study it has been used to investigate its effect in reducing body fat/weight and increase metabolic rate. In this study, Capsimax™ will be used to assess effect on Resting Energy Expenditure (REE) using Indirect Calorimetry.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate

Conditions
-----------------
Metabolism

Intervention / Treatment
-----------------
* Other: Capsimax
* Other: Micro Crystalline Cellulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, adult, male/female participants with age ≥ 18 ≤ 55 years. A Body Mass Index (BMI) between 18.5 to 29.9 kg/m2. Fasting blood sugar ≤ 100 mg/dl Hemoglobin: Males ≥ 11 g/dl and Females ≥ 10 g/dl BP < 140/90 mmHg Exclusion Criteria: Post-menopausal females History of hypo/ hyperthyroidism. History of significant neurological or psychiatric condition such as seizures, depression, or insomnia.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double blind, randomized, placebo controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capsimax<br> | Other: Capsimax<br>* 1 capsule to be taken before breakfast.<br>Other: Micro Crystalline Cellulose<br>* 1 capsule to be taken before breakfast.<br>|
| Placebo Comparator: Placebo<br> | Other: Capsimax<br>* 1 capsule to be taken before breakfast.<br>Other: Micro Crystalline Cellulose<br>* 1 capsule to be taken before breakfast.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Investigational Product on Resting Energy Expenditure | Assessed by Indirect Calorimetry | From baseline to 4 hours. |
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).

Conditions
-----------------
Perianal Crohn's Disease

Intervention / Treatment
-----------------
* Drug: BLI-1300 low dose
* Drug: BLI-1300 high dose
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must give written informed consent. Male or female subjects, 18 years of age. Confirmed diagnosis of Crohn's Disease. Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and with clinical evidence of active PCD. Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at Visit 2. Subjects must have a qualifying perianal pain score at Visits 1 and 2. Exclusion Criteria: Women of childbearing potential who are not using adequate contraception. Women who are pregnant or breastfeeding. Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF) inhibitors, immunosuppressants, steroids). Subjects taking strong analgesics that could interfere with pain measurements. Subjects with a perianal abscess requiring incision and drainage. Subjects with anal stenosis. Subjects with fistulae outside the immediate perianal area. Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks. Subjects who have had significant anorectal surgery for Crohns disease within the past 8 weeks.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI-1300 (low dose)<br>Investigational Product (10%) Ointment | Drug: BLI-1300 low dose<br>* topical ointment<br>|
| Experimental: BLI-1300 (high dose)<br>Investigational Product (20%) Ointment | Drug: BLI-1300 high dose<br>* topical ointment<br>|
| Placebo Comparator: placebo<br>Placebo Ointment | Drug: placebo<br>* topical ointment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Perianal Pain Responders | Percent of responders during Week 12. Response is defined as ≥30% decrease in mean NRS score for perianal pain (for the 7 treatment days immediately preceding the Week 12 visit) compared to the screening period. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fistula, Crohn's disease, perianal, inflammatory bowel disease
Role of Color Doppler Ultrasound in Lymphadenopathy

Study Overview
=================
Brief Summary
-----------------
Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes Accurate lymph node characterization is important for a wide number of clinical situations, including prognosis, prediction, selecting and monitoring treatment, beyond the diagnosis itself (cancer, lymphoma, or inflammatory nodes)

Detailed Description
-----------------
Various ultrasound criteria that can help in differentiation of benign and malignant lymph nodes have been well described in literature. On Gray scale ultrasound imaging, the benign enlarged lymph nodes are hypoechoic, oval shaped with smooth border and echogenic hilum. On the other hand, the malignant lymph nodes are round with short to long axis ratio >0.5 and show loss of echogenic hilum, while the Color and Power Doppler features documented for the diagnosis of malignant lymph nodes are peripheral and mixed vascularity, with resistive index (RI) more than 0.8, and pulsatility index (PI) more than 1.5 Although Color Doppler ultrasound improves diagnostic accuracy and plays an important adjuvant role to Gray scale ultrasound in differentiating benign from malignant lymph nodes as it adds to the diagnostic confidence of predicting malignancy in enlarged lymph nodes, and also is useful if Gray scale ultrasound findings are equivocal. However, it can neither replace histopathology nor can eliminate the need for biopsy

Official Title
-----------------
Role of Color Doppler Ultrasound in Differentiation Between Benign and Malignant Lymphadenopathy

Conditions
-----------------
Lymph Node Disease

Intervention / Treatment
-----------------
* Device: Colour Doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically enlarged lymph nodes Exclusion Criteria: previous medical treatment or radiotherapy previous biopsy
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Experimental: Study group<br>patients with lymphadenopathy | Device: Colour Doppler<br>* evaluation of lymph nodes by Doppler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with benign lymphadenopathy | comparison with the biopsy result | one year |
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.

Official Title
-----------------
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-center, Randomized, Open-labeled, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic subjects Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial HbA1c at least 12% Willing and able to perform self blood glucose monitoring (SMBG) Exclusion Criteria: History of drug or alcohol dependence Receipt of any investigational drug within the last month prior to this trial Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids) Severe uncontrolled hypertension Recurrent severe hypoglycemia as judged by investigator Any disease or condition, which the Investigator feels, would interfere with the trial

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

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | At Visit 6 (14 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles) |  |  |