linjc16/ctgov huggingface dataset:
Experience of Arab American Women With Breast Cancer: In-depth Interviews

Study Overview
=================
Brief Summary
-----------------
The investigators are conducting a study entitled 'Experience of Arab American Women with Breast Cancer: In-depth Interviews' through which they hope to learn more about Arab women's experience with breast cancer.

Official Title
-----------------
Experience of Arab American Women With Breast Cancer: In-depth Interviews A Qualitative Study to Explore the Influence of the Arab Culture on Coping With Breast Cancer

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

Intervention / Treatment
-----------------
* Behavioral: one-time qualitative assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AMBER participant diagnosed with breast cancer who attended at least 1 support group meeting Aged 18 to 85 Arabic-speaking Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arab American Women with Breast Cancer<br>We conducted a study using an evaluation assessment survey to assess the impact of the AMBER support groups on quality of life parameters, compliance with treatment appointments, and patient/family support. After reviewing preliminary results, we identified several recurrent themes, such as the need for health information, discrepancies around the extent of family support and disease disclosure, and an overall satisfaction with the support groups. To further examine these themes, we are initiating a qualitative research study using an in-depth interview guide. A trained interviewer bilingual in Arabic and English will conduct 10-15 in-depth interviews, to saturation, with AMBER's support group participants over a 6 month period. | Behavioral: one-time qualitative assessment<br>* The study involves a one-time qualitative assessment to explore key cultural influences on AMBER breast cancer survivors' health behavior. We will focus on self-efficacy in healthcare, coping with breast cancer, social networks of support, and culturally-sensitive support groups. The study investigator will administer questions from the structured interview guide, estimated to take 90 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding the influence of Arab culture on health behavior | particularly with regard to breast cancer by in-depth interviews | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
support group, 15-246, The Arab American Breast Cancer Education and Referral Program (AMBER)
Study to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO

Study Overview
=================
Brief Summary
-----------------
This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement of gastrointestinal motility between each dose group by comparing the effectiveness and safety in patients undergoing colon resection.

Official Title
-----------------
A Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel, Phase II Clinical Trial to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO in Patients Undergoing Colon Resection

Conditions
-----------------
Colon Resection, _large Interstinal Surgery

Intervention / Treatment
-----------------
* Drug: LD02GIFRO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 20 years Subject is scheduled for a partial colon resection with primary anastomosis via laparotomy Subject is scheduled to receive primary postoperative pain management with intravenous patient-controlled analgesia (PCA) opioids Exclusion Criteria: Subject is scheduled for a total colectomy, colostomy, ileostomy Subject has complete bowel obstruction Subject is scheduled for laparoscopic surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Group 1<br>300mg/day | Drug: LD02GIFRO<br>* comparison of different dosages of drug<br>|
| Experimental: Group 2<br>600mg/day | Drug: LD02GIFRO<br>* comparison of different dosages of drug<br>|
| Experimental: Group 3<br>900mg/day | Drug: LD02GIFRO<br>* comparison of different dosages of drug<br>|
| Placebo Comparator: Placebo<br>Control Group | Drug: LD02GIFRO<br>* comparison of different dosages of drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of gastrointestinal motility | Evaluation gastrointestinal function to the time of improvement gastrointestinal motility | in hospitalization (Maximized 14 days) |
The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion

Study Overview
=================
Brief Summary
-----------------
Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used in the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of GLP-1 are increased in response to acipimox. The hypothesis is that G protein coupled receptors on enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion. In a controlled, open, randomized experiment, eight healthy, overweight men will be studied on an intervention day, where they receive acipimox, and on a control day. The study day includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and a biopsy from adipose tissue.

Official Title
-----------------
The Effect of Acipimox on GLP-1 Secretion in Healthy Subjects: a Pilot Study

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

Intervention / Treatment
-----------------
* Drug: Acipimox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult men Healthy BMI 25-35 Exclusion Criteria: Known DM2 Receiving hypolipidemic drugs

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acipimox<br>Administration of acipimox 250 mg p.o. | Drug: Acipimox<br>* P.o. administration of 250 mg acipimox<br>* Other names: Olbetam;|
| No Intervention: Control<br>No intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of GLP-1 in plasma |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipolytic activity in adipose tissue by measuring FFA (free fatty acid) levels |  | 9 months | 
| Insulin sensitivity by measuring blood glucose after an OGTT |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acipimox, GLP-1, Insulin secretion
Acute Pain and Inflammation After Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe acute pain after surgery and measure the natural course of inflammatory mediators study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac

Detailed Description
-----------------
Randomizized controlled trial

Official Title
-----------------
Acute Pain and Role of Ketolorac in Inflammatory Mediators After Knee Arthroscopy Evaluated by Microdialysis

Conditions
-----------------
Knee Injuries

Intervention / Treatment
-----------------
* Drug: 1 Ketorolac intraarticular
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Day case surgical patients above 18 years old Non pregnant Exclusion Criteria: -

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ketorolac | Drug: 1 Ketorolac intraarticular<br>* Ketorolac intraarticular 5 mg<br>* Other names: Saline;|
| Placebo Comparator: 2<br>saline | Drug: Placebo<br>* Saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief local anti-flammatory effects |  | 2 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue analgesic consumption |  | 2 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute pain, Inflammatory pain, Inflammatory mediators, Pain relief, Microdialysis
Sex-Informed Data in the COVID-19 Pandemic.

Study Overview
=================
Brief Summary
-----------------
Sex and gender matter to health equity, especially in a pandemic. Sex (a biological attribute) and gender (a social construct) may influence an individual's susceptibility, vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARS and MERS), male sex was associated with worse outcomes. Both immune and the hemostatic response display ample sexual dimorphism. The primary aim of the study is to determine whether sex differences in biomarkers of platelet and immune function, gut microbiome, clinical characteristics, therapy, clinical cost sensitive outcomes (i.e. in-hospital transition of care, case severity, and mortality due to COVID-19) exist in patients affected by COVID-19.

Official Title
-----------------
Sex-Informed Data in the COVID-19 Pandemic.

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with laboratory confirmed SARS-Cov-2 infection of any severity. Exclusion Criteria: Pregnancy. Younger than 18 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| female COVID19 patients<br>Females with COVID19 disease | |
| male COVID19 patients<br>Males with COVID19 disease | |
| female matched COVID19-free patients<br>Free from disease COVID19 Females matched. | |
| male matched COVID19-free patients<br>Free from disease COVID19 males matched. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex differences in platelet and immune function and COVID19 severity | Sex differences in biomarkers of platelet and immune function correlate with severity of disease | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome and COVID19 severity | Differences in the gut microbiome correlate with severity of disease | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sex, gender, thrombosis, immunity, gut microbiota
Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

Detailed Description
-----------------
The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Official Title
-----------------
Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative. Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation. Patient is willing to comply with follow up Exclusion Criteria: Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms. Patient had active infection Implants were implanted without bone cement Patients did not have sufficient bone stock to allow for insertion and fixation of components Patient did not have sufficient soft tissue integrity to allow for stability Patient had a neurological or muscular deformity that did not allow for control of the knee.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Medial Bicompartmental Knee Arthroplasty<br>Patient who have received a robotic-arm assisted medial and patellofemoral knee arthroplasty. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with Revisions | To determine the revision rate in this patient population | 10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with Revisions | To determine the revision rate in this patient population | 2 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, medial, bicompartmental, patellofemoral
Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia

Detailed Description
-----------------
The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)

Official Title
-----------------
Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

Conditions
-----------------
Safety Issues, Efficiency

Intervention / Treatment
-----------------
* Biological: microtransplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: de novo acute myeloid leukemia age 60-80 Exclusion Criteria: have no suitable donor or donor refused patient refused to accept donor cells

Ages Eligible for Study
-----------------
Minimum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cord blood group<br>standard induction and consolidation chemotherapy with cord blood microtransplantation | Biological: microtransplantation<br>* HLA mismatched donor cord blood infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | Bone marrow <5% blasts； Absolute neutrophil count >1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease. | 1 month | 
| time of hematopoietic recovery | Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression | Measured from complete remission to the relapse | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cord blood microtransplatation
Clearpath Miniprep Colonoscopy Study

Study Overview
=================
Brief Summary
-----------------
Use of Clearpath to facilitate successful completion of colonoscopy procedures with sub-optimal preparation.

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Device: Clearpath Lower GI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient 18-70 years Scheduled for colonoscopy Providing informed consent Exclusion Criteria: Known large polyps (> 2 cm) for polypectomy Inflammatory Bowel Disease (IBD) Previous colonic surgery Known or suspected stricture Significant co morbidity Significant diverticular disease Contraindicated to receive oral Sodium Picosulfate solution

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: SOC preparation and colonoscopy<br> | |
| Experimental: Miniprep and Clearpath<br> | Device: Clearpath Lower GI<br>* Clearpath device for cleaning of colon by irrigation and evacuation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.

Official Title
-----------------
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Drug: Talactoferrin alfa
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Onset of severe sepsis within the previous 24 hours Must be receiving antibiotic therapy Informed consent form signed by patient, legal next-of-kin or legal guardian Able to take medication by mouth or feeding tube Exclusion Criteria: Receipt of investigational medication within 4 weeks prior to participation in the study Pregnant or breast-feeding Severe congestive heart failure Known severe HIV infection Presence of severe burns Patients on high dose immunosuppressants Patients whose death is considered imminent Patients whose life expectancy for concurrent illness is less than 6 months Severe hypoxic encephalopathy or persistent vegetative state Severe liver disease Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Talactoferrin alfa | Drug: Talactoferrin alfa<br>* 15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 28-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 3 months | 
| All-cause mortality |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lactoferrin, sepsis, talactoferrin, recombinant human lactoferrin