linjc16/ctgov huggingface dataset:
Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.

Detailed Description
-----------------
We have fulfilled our enrollment requirements for this study. This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study. Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

Conditions
-----------------
Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
-----------------
* Drug: Rezular 15mg
* Drug: Placebo
* Drug: Rezular
* Drug: Rezular


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fulfilling Rome III criteria for IBS-D Exclusion Criteria: major cardiovascular disease psychiatric illness except mild or moderate depression pregnancy presence of other GI disease that could explain IBS-like symptoms history of major gastric, hepatic, pancreatic or intestinal surgery or perforation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* placebo<br>|
| Experimental: 2<br> | Drug: Rezular 15mg<br>* Oral Tablets<br>|
| Experimental: Rezular 37.5mg<br> | Drug: Rezular<br>* Rezular 37.5mg 3xday up to 12 weeks<br>|
| Experimental: Rezular - 75mg<br> | Drug: Rezular<br>* Rezular 75mg 3xday up to 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate Relief |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS, IBS-D, R-verapamil, Arverpamil, Rezular
CYSTEA-BONE Clinical Study

Study Overview
=================
Brief Summary
-----------------
Nephropathic Cystinosis (NC) is an orphan inherited autosomal recessive disease characterised as a generalized lysosomal storage disease due to a deficiency of the cystine lysosomal transport protein, cystinosin. Patients with NC usually receive cysteamine. Bone impairment was recently recognized as a late complication of NC, occurring at adolescence or early adulthood. Even though the exact underlying pathophysiology is unclear, at least six hypotheses are discussed, and mainly cysteamine toxicity and/or direct bone effect of the Cystinosin (CTNS) mutation. Because of the potential dramatic impact on quality of life of this novel complication, research should aim to better understand bone disease in NC. The primary objective of this study is to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. The Secondary objective is to describe the clinical bone status of NC patients depending on their underlying genotype.

Official Title
-----------------
A European, Multicenter, Prospective Clinical Study to Evaluate Cysteamine Toxicity on Human Osteoclasts. The CYSTEA-BONE Clinical Study.

Conditions
-----------------
Nephropathic Cystinosis

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with confirmed diagnosis of nephropathic cystinosis (defined by clinical signs, White Blood Cells (WBC) cystine level and/or mutation), currently receiving oral cysteamine. Age > 2 years. Subjects and/or their parents/ legal guardian must provide non opposition prior to participation in the study. Exclusion Criteria: Subjects who, in the opinion of the Investigator, are not able or willing to comply with the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| nephropathic cystinosis patients receiving cysteamine<br>nephropathic cystinosis patients receiving cysteamine. The blood samples of the group will be used to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. | Other: Blood sampling<br>* 25 mL blood sample will be collected on citrate tubes for osteoclastic analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive Tartrate-resistant acid phosphatase (TRAP) cells | Number of positive TRAP cells will be assessed at the end of osteoclast differentiation from circulating monocytes | 1 day |
Chicory Fiber Effect on Satiety and GI Tolerance

Study Overview
=================
Brief Summary
-----------------
The investigators are comparing 2 fiber treatments to a fiber free treatment for acute satiety and GI response.

Detailed Description
-----------------
The investigators are measuring satiety and GI response after subjects consume 3 acute breakfast meals: 1. fiber-free control; 2. chicory root flour containing inulin; 3. inulin fiber supplement. After breakfast, subjects will complete subjective satiety instruments and describe any GI symptoms.

Official Title
-----------------
The Effects of 2 Inulin Sources on Satiety and Gastrointestinal Tolerance

Conditions
-----------------
Diet, Healthy

Intervention / Treatment
-----------------
* Other: food containing dietary fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no food allergies; healthy; willing to consume breakfast in laboratory setting; usual low fiber diet; Exclusion Criteria: smokers, taking dietary supplements containing fiber -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: no fiber<br>Breakfast with hot chocolate with no fiber | Other: food containing dietary fiber<br>* commercially available chicory root flour and chicory root fiber<br>|
| Experimental: chicory root flour<br>Breakfast with hot chocolate with chicory root flour | Other: food containing dietary fiber<br>* commercially available chicory root flour and chicory root fiber<br>|
| Experimental: chicory root fiber supplement<br>Breakfast with hot chocolate with chicory root fiber supplement | Other: food containing dietary fiber<br>* commercially available chicory root flour and chicory root fiber<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satiety | subjective instrument to assess how full you feel | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal response | subjective description of any GI symptoms | 24 hours |
Use of Activated Recombinant FVII in Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.

Official Title
-----------------
Evaluation of Safety of Activated Recombinant FVII as an Add-On Therapy in Spinal Surgery

Conditions
-----------------
Acquired Bleeding Disorder, Spinal Fusion

Intervention / Treatment
-----------------
* Drug: eptacog alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective spinal fusion surgery. Exclusion Criteria: History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis) Any trauma within the last 3 months leading to hospitalization > 24 hours Angina or known coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: eptacog alfa (activated)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables |  | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy variables |  |  |
Parental Attitudes in Invitro Fertilization

Study Overview
=================
Brief Summary
-----------------
The relationship between revelation of mode of conception and child behavior is not known

Detailed Description
-----------------
start of assisted reproductive techniques over the past 25 years made many otherwise infertile couples to become parents to genetically related children.

Official Title
-----------------
Parental Reports Toward in Vitro Fertilization

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Other: questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents who were enrolled in ICSI and pregnancy occurred Exclusion Criteria: ICSI with no pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionaire|A questionaire will be offered to every parents|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who got pregnant that will tell others by that | The number of women who got pregnant that will tell others by that method | within one year |
Immune Fitness Prediction

Study Overview
=================
Brief Summary
-----------------
The overall objective of the study is to determine whether self-rated, perceived immune fitness (using questionnaire) is associated with biological assessment of immune fitness (immune signatures in the blood).

Official Title
-----------------
Observational Study to Determine the Association Between Self-rated, Perceived Immune Fitness (Using Questionnaire) With Biological Assessment of Immune Fitness (Immune Signatures in the Blood).

Conditions
-----------------
Healthy Adults

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand and sign the informed consent Healthy adult men and/or women, 35-65 years old BMI >18 and <30 kg/m2 Exclusion Criteria: Volunteer who cannot be expected to comply with the protocol Individuals with self-reported chronic disease; or who have any clinical condition which the investigator deems relevant for exclusion from the study, Individuals with an impaired immune system that may confound immune response testing; i.e. any condition that impairs participant immune response through either the condition itself or through the treatment of the condition, Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of different immune cell types in whole blood | Immune cell type profiling in whole blood by mass cytometry | 6 - 12 months after the start of the trial | 
| Relative quantification of immune protein in plasma | Proteomic analysis in plasma by proximity extension assay | 6 - 12 months after the start of the trial | 
| Amount of cytokines expressed by peripheral blood mononuclear cells | Cytokine quantification by proximity extension assay | 6 - 12 months after the start of the trial | 
| Amount of analytes in serum | Blood chemistry | 6 - 12 months after the start of the trial |
Comparison of Two Chest Radiograph Prescription Strategies in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status at the morning physical examination. Here the investigators compared Routine and On-demand strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by at least 20% with the On-demand strategy, with no reduction in quality of care.

Detailed Description
-----------------
Based on a cluster-randomized two-period two-strategies cross-over design, respectively 11 and 10 participating ICUs applied the Routine and On-demand strategies during the first period, each enrolling 20 consecutive patients requiring mechanical ventilation for at least two days. Each ICUs applied then applied the alternative strategy during the second period, again enrolling 20 consecutive patients.

Official Title
-----------------
A Cluster-Randomized Two-Period Cross-Over Study Comparing Routine and on-Demand Prescription of Chest Radiographs in Mechanically Ventilated Adults : the RARE Study

Conditions
-----------------
Patient Care, Quality of Health Care, Intensive Care Units, Ventilation, Mechanical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit-any day during their ICU stay Exclusion Criteria: Patients with mechanical ventilation lasting less than 2 days

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 |
| --- | --- |
| 1<br>Routine strategy of chest radiograph prescription | |
| 2<br>On-demand strategy of chest radiograph prescription | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of chest radiographs per patient-day during mechanical ventilation |  | Every patient-day during mechanical ventilation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate in ICU |  | During the inpatient stay in ICU | 
| Average length of stay |  | During the inpatient stay in ICU | 
| Average duration of mechanical ventilation |  | During the inpatient stay in ICU | 
| Number of radiographs with new findings leading to therapeutic or diagnostic interventions |  | During the inpatient stay in ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiography, Thoracic, Intensive Care Units, Ventilation, mechanical, Matched-Pair Analysis
Determining Molecular Drivers of Radiation Dermatitis

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin or a rash on swollen, reddened skin).

Official Title
-----------------
Determining Molecular Drivers of Radiation Dermatitis

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving standard-of-care postoperative radiation therapy (2-2.7 Gy per fraction) to the breast and/or chest wall for breast cancer treatment. Tissue diagnosis of breast cancer. Age > 18 years Signed informed consent. Complete blood count within normal limits within the preceding 2 weeks. Exclusion criteria: Induction chemotherapy or biologic therapy Concurrent chemotherapy or biologic therapy Autoimmune disease with skin manifestations - psoriasis, dermatomyositis, scleroderma, eczema, polymyositis Allergy to lidocaine anesthesia Known bleeding diathesis (anticoagulation with warfarin, coagulation/bleeding disorders, vitamin C or K deficiency, thrombocytopenia) History of keloids or easy scarring

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

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 |
| --- | --- | --- |
| Change in skin | A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation. | Baseline, final week of radiation |
Evaluation of Fanconi Syndrome and Cystinosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Classify renal tubular defects using clinical and biochemical findings in patients with Fanconi syndrome and cystinosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive a clinical and biochemical evaluation, including a psychometric assessment and molecular, renal, and thyroid studies.

Conditions
-----------------
Cystinosis, Fanconi Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inherited renal tubular defects, i.e., Fanconi syndrome Fanconi syndrome due to cystinosis eligible

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fanconi syndrome, cystinosis, rare disease, renal and genitourinary disorders
Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how different types of breast implants contour to the chest wall.

Official Title
-----------------
Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine

Conditions
-----------------
Breast Augmentation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: had previous primary breast augmentation had previous replacement of breast implants has Baker Class I breast implant capsule Exclusion Criteria: has scar capsule contracture around the breast implants of Baker Class II-IV is pregnant or may be pregnant has possibility or previous history of metallic foreign body

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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