linjc16/ctgov huggingface dataset:
Nasospore Stent For Use in Enodscopic Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.

Detailed Description
-----------------
This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.

Official Title
-----------------
Nasospore Stent For The Use in Endoscopic Sinus Surgery

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Drug: Merogel Nasal Stent and Nasopore Stent
* Drug: Nasopore Stent and either Gentamycin or Bacitracin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evaluation by Otolaryngologist & determined to need endoscopic sinus surgery Only subjects with Bilateral disease Exclusion Criteria: Pediatric subjects(under the age of 18)

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Merogel stent vs. Nasopore Stent<br>This study has two arms consiting of 50 subjects each (100 total) Arm 1 will recieve the standard stent (merogel)in their right sinus and a nasopore stent in their left sinus. | Drug: Merogel Nasal Stent and Nasopore Stent<br>* Merogel Nasal Stent and Nasopore Stent<br>* Other names: Gentamicin soaked stent;|
| Experimental: bacitracin vs. gentamicin treated stent<br>The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus. | Drug: Merogel Nasal Stent and Nasopore Stent<br>* Merogel Nasal Stent and Nasopore Stent<br>* Other names: Gentamicin soaked stent;Drug: Nasopore Stent and either Gentamycin or Bacitracin<br>* Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)<br>* Other names: Gentamicin soaked stent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution |  | prospective |
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Official Title
-----------------
A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: No Treatment Added
* Drug: Milnacipran Added


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria tolerate at least 300 mg/day of pregabalin have an incomplete response to pregabalin treatment Exclusion Criteria: suicidal risk substance abuse pulmonary dysfunction renal impairment active cardiac disease liver disease narrow angle glaucoma autoimmune disease cancer inflammatory bowel disease unstable endocrine disease prostatic enlargement

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milnacipran Added<br> | Drug: Milnacipran Added<br>* Milnacipran 100 mg/d added<br>|
| Experimental: No Treatment Added<br> | Drug: No Treatment Added<br>* No added treatment<br>* Other names: Lyrica (r);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change (PGIC) Responder Rate at End of Study | The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as very much improved or much improved (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1. | End of Randomized treatment period (11 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study | The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain). | Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibromyalgia, milnacipran, pregabalin, treatment, Forest Research Institute
Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 in healthy male subjects.

Detailed Description
-----------------
This is an exploratory study to assess the absolute bioavailability of a single oral dose of AZD9668 with respect to an intra-venous microdose of [14C]AZD9668 in healthy male subjects.

Official Title
-----------------
An Exploratory Study to Assess the Absolute Bioavailability of a Single Oral Dose of AZD9668 With Respect to an Intra-venous Microdose of [14C]AZD9668 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD9668


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg and no more than 100 kg. Exclusion Criteria: Any clinically significant disease or disorder Any clinically significant abnormalities at screening examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD9668<br>Tablets and intravenous (IV) dose | Drug: AZD9668<br>* Tablets of AZD9668 and IV dose of [C14]AZD9668<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute bioavailability and evaluation of pharmacokinetic parameters (AUC, AUC (0-t), Cmax, t½, tmax, and MRT of of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 |  | Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD9668: Adverse events, clinical chemistry, haematology, urinalysis, vital signs, electrocardiogram, physical examination |  | measured within 21 days of drug administration and up to 7 days following drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, tolerability, healthy, microdose
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Study Overview
=================
Brief Summary
-----------------
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.

Official Title
-----------------
Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: alprazolam commercial sublingual formulation
* Drug: alprazolam test sublingual tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male or female subjects BMI 18 to 26.9 must give informed consent Exclusion Criteria: clinically significant disease narrow angle glaucoma positive drug screen

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alprazolam commercial sublingual tablet<br> | Drug: alprazolam commercial sublingual formulation<br>* 0.5 mg tablet, single dose<br>|
| Experimental: Alprazolam test sublingual tablet<br> | Drug: alprazolam test sublingual tablet<br>* 0.5 mg tablet, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC) |  | 11 days | 
| Alprazolam bioavailability as assessed by peak concentration (Cmax) |  | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam time of maximum concentration (Tmax) |  | 11 days | 
| Half life of alprazolam |  | 11 days | 
| Clinically significant safety laboratory tests |  | 11 days | 
| Clinically significant adverse events |  | 11 days | 
| Clinically significant vital signs |  | 11 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alprazolam, sublingual, bioequivalence
Influence of Resentment and Forgivingness on Quality of Life in People Living With HIV

Study Overview
=================
Brief Summary
-----------------
Life stress is strongly associated with poor mental and physical health and its effects explain significant morbidity and mortality. Forgiveness is one of the factors that can influence the effects of stress on health. By definition, forgiveness is the release of negative feelings, emotions, and behaviors - and possibly the release of positive feelings - toward an offender. Numerous studies have shown that forgiveness is associated with several mental and physical health benefits. The literature argues that high levels of propensity to forgive (trait) predispose that person to experience forgiveness (state) more often. In other words, a stronger forgiving disposition is believed to increase the experience of forgiveness, which, in turn, mitigates the negative effects of stress. Forgiveness is therefore a coping style that can play a beneficial role in the stress-health relationship. Patients living with HIV (PLHIV) are patients particularly exposed to stress, not only because of their chronic pathology but also because of the stigma attached to this disease. Very few studies have studied the impact of forgiveness (state or trait) on the physical health of PLHIV and even fewer the impact of an intervention promoting the disposition to forgive. The objective of this prospective observational monocentric study is to show in a very secular country that forgiveness has an effect on well-being as well as on other health parameters.

Official Title
-----------------
Influence of Resentment and Forgivingness on Quality of Life in People Living With HIV

Conditions
-----------------
Hiv, Forgiveness, Stress, Stigma, Health

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Belonging to the PLHIV followed at the Amiens University Hospital, not likely to move within the year Possibility of follow-up in teleconsultation (usual support of the service) Benefiting from a social security scheme Consent to participate in the research Exclusion Criteria: Erratic follow-up (non-compliance, predictable move) or moribund patient Illiterate or not speaking french

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| establishment of correlation between the inclination to forgiveness and the quality of life |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Forgiveness, forgivingness, Hiv, Stress, stigma, health
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

Study Overview
=================
Brief Summary
-----------------
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.

Detailed Description
-----------------
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.

Official Title
-----------------
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

Conditions
-----------------
Full Thickness Rotator Cuff Tear

Intervention / Treatment
-----------------
* Procedure: Operative management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair Exclusion Criteria: less than 18 years old, non-operative rotator cuff tears, calcific tendonitis, fracture, adhesive capsulitis, severe osteoarthritis of the shoulder, no prior shoulder surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Non-operative<br>Patients whom elected non-operative treatment | |
| Operative<br>Patients whom elected operative treatment | Procedure: Operative management<br>* Rotator cuff surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans Rand VR-12 Quality of Life Score |  | baseline | 
| Veterans Rand VR-12 Quality of Life Score |  | 4 weeks | 
| Veterans Rand VR-12 Quality of Life Score |  | 8 weeks | 
| Veterans Rand VR-12 Quality of Life Score |  | 16 weeks | 
| Veterans Rand VR-12 Quality of Life Score |  | 32 weeks | 
| Veterans Rand VR-12 Quality of Life Score |  | 48 weeks | 
| Veterans Rand VR-12 Quality of Life Score |  | 64 weeks |
Prevalence of MIH Among Group of Egyptians Children Aged From 8 to 12 in Damietta

Study Overview
=================
Brief Summary
-----------------
Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old in Damietta governate. This study will determine the severity of molar incisor hypomineralization which will help in its managment ,also will increase the awareness pf pediatric dentists about the prevalence of molar incisor hypomineralization in Egyptian children.Also it will allow the early detection of molar incisor hypomineralization which will make the parents seek early treatment for it. Participants fromprimary schools in Damietta governate will be included in the study. Clinica examination will be carried out in the school lab or in embty class, in day light.

Official Title
-----------------
Prevalence of Molar Incisor Hypomineralization Among a Group Of Egyptian Children Aged From 8 to 12 Years Old in Damietta

Conditions
-----------------
Molar Incisor Hypomineralization

Intervention / Treatment
-----------------
* Diagnostic Test: Mirror and prope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive subject acceptence for participation in the study. children aged from 8 to 12 years old. Eruption of at least two first permanent molars. Both genders. Exclusion Criteria: Uncooperative child. Children with prthodontic appliances. Children with systemic diseases. Children suffering from any other type of enamel defect as enamel hypoplasia.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Mirror and prope|Mirror and probe will be used for each patient. Mirrors for proper visualization especially for maxillary teeth, explorers will be used to aid in tactile sensation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of molar incisor hypomineralization. | Prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old. Participants will be examined in the school lab using disposable diagnostic set. Clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH based on EAPD. To diagnose MIH, at least one affected first permanent molar is required. | On the same day of examination |
Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

Official Title
-----------------
Phase II Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

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

Intervention / Treatment
-----------------
* Drug: Ixabepilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 20 years or older Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination Exclusion Criteria: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Ixabepilone<br> | Drug: Ixabepilone<br>* Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles<br>* Other names: BMS-247550;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the tumor response using RECIST Criteria to determine the best overall response and response rate |  | For a maximum of 9 3-week cycles or until unacceptable toxicity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria |  | Every cycle | 
| To evaluate the duration of achieved responses |  | For a maximum of 9 3-week cycles or until unacceptable toxicity | 
| To evaluate time to progression (TTP) |  | For a maximum of 9 3-week cycles or until unacceptable toxicity |