linjc16/ctgov huggingface dataset:
To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.

Official Title
-----------------
A Comparative Bioavailability Study of Fluoxetine Hydrochloride Capsules, 40 mg

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
* Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc) | Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)<br> <br> |
| Active Comparator: 2<br>Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly) | Drug: Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
Use of Acetyl Salicylic Acid and Terbutalin in Assisted Reproductive Techniques (ART)

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and Terbutalin on ART treatment.

Detailed Description
-----------------
This study aims to determine the possible effects of ASA and Terbutalin on ART treatment.

Official Title
-----------------
Use of Acetylsalicylic Acid and Terbutalin in ART

Conditions
-----------------
Reproductive Techniques, Assisted

Intervention / Treatment
-----------------
* Drug: Acetyl Salicylic Acid and Terbutalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women below 39 years of age Exclusion Criteria: Women who may react allergically to the drugs administered Women with hyperthyroid or IDDM Women who do not want to participate in the study Women who are unable to give informed, written consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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: 1<br>FER | Drug: Acetyl Salicylic Acid and Terbutalin<br>* ASA 75 mg, Terbutalin 5mg<br>|
| No Intervention: 2<br>FER | |
| Experimental: 3<br>SET | Drug: Acetyl Salicylic Acid and Terbutalin<br>* ASA 75 mg, Terbutalin 5mg<br>|
| No Intervention: 4<br>SET | |
| Experimental: 5<br>DET | Drug: Acetyl Salicylic Acid and Terbutalin<br>* ASA 75 mg, Terbutalin 5mg<br>|
| No Intervention: 6<br>DET | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy |  | 7 weeks |
The Effect of Voltaren-ophtha 0.1% Eye Drops on INR Levels (International Normalized Ratio) in Patients Taking Warfarin

Study Overview
=================
Brief Summary
-----------------
A prospective study intended to examine the effect of topical Voltaren-Ophtha 0.1% eye drops after cataract surgery on INR levels (international normalized ratio) in patients taking warfarin.

Detailed Description
-----------------
Objective: To examine the effect of topical Voltaren-Ophtha 0.1% eye drops after cataract surgery on INR levels ( international normalized ratio) in patients taking warfarin. Methods: A prospective study. The study population will include approximately 100 patients, taking warfarin and that are candidates for cataract surgery. These patients will continue their warfarin therapy as usual and at the same dose, before and after the operation. INR levels (international normalized ratio) will be checked once a week while taking Voltaren eye drops as is customary after cataract surgery.

Official Title
-----------------
The Effect of Voltaren-ophtha 0.1% (Diclofenac Sodium 0.1%) Eye Drops After Cataract Surgery on INR Levels (International Normalized Ratio) in Patients Taking Warfarin

Conditions
-----------------
Blood Coagulation Disorders

Intervention / Treatment
-----------------
* Drug: Voltaren ophtha 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people taking warfarin candidates for cataract surgery Exclusion Criteria: age <18 years pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Voltaren ophtha 0.1%|All study patients will be treated with Voltaren ophtha 0.1% after cataract surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INR levels (international normalized ratio) - change is being assessed | change is being assessed | 1 week, 2 weeks, 3 weeks and 4 weeks after taking Voltaren Optha 0.1% | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
warfarin, Voltaren eye drops, INR
Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective for treating symptoms of sleepiness and fatigue associated with Major Depressive Disorder when added to a SSRI.

Detailed Description
-----------------
Approximately 100 male and female outpatients, who are between the ages of 18 and 65, will be enrolled at four sites in the United States. This study consists of two parts. The first part consists of 6 weeks of open label treatment with a selected SSRI & double blind treatment with Provigil or placebo (inactive medication). After the six week double blind treatment phase all patients will enter a four week open label treatment phase with Provigil. The dose of Provigil is not to exceed 400 mg and cannot be less than 100 mg per day. They will continue taking the prescribed SSRI.

Official Title
-----------------
A DOUBLE-BLIND PILOT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PROVIGIL® (MODAFINIL) AT FIXED/FLEXIBLE DOSES, IN CONJUNCTION WITH IDENTIFIED SSRIs FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH MILD TO MODERATE DEPRESSION WITH ATTENDANT SYMPTOMS OF SLEEPINESS AND FATIGUE

Conditions
-----------------
Major Depression, Mental Health

Intervention / Treatment
-----------------
* Drug: Provigil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depressive Disorder MADRS score ≥ 15 at both screen & baseline. Significant fatigue as evidenced by FSS ≥4 at both screen & baseline. Excessive sleepiness as evidenced by ESS ≥ 10 at both screen & baseline. Exclusion Criteria: Treatment refractory depression Serious or unstable medical condition. Pregnancy Primary diagnosis of another Axis I or II disorder Alcohol or substance abuse or dependence within the past 12 months.

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: Provigil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale (ESS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D 31 item) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression
PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.

Official Title
-----------------
PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: Mandibular Advancement Device ( MAD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years body mass index (BMI) ≤ 35 kg/m² OSAS, as defined by the American Academy of Sleep Medicine Task Force apnea-hypopnea index (AHI) < 50 Exclusion Criteria: Other sleep disorders (i.e. parasomnias) Invasive upper airway surgery for sleep-disordered breathing Known genetic disorders with craniofacial and/or upper airway malformations Use of benzodiazepine and/or antidepressants Known history of psychiatric disease Known history of fibromyalgia and/or chronic fatigue syndrome Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mandibular Advancement Device (MAD)<br>Mandibular Advancement Device (MAD) | Device: Mandibular Advancement Device ( MAD)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of DISE and CFD | Positive and negative predictive values for AHI based treatment outcome | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSAS, American Academy of Sleep Medicine Task Force
A Shared Decision-making Training for Inpatients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Shared decision-making is being promoted as a promising approach for engaging patients with schizophrenia in medical decisions and improving satisfaction and adherence. To implement shared decision-making, both physicians and patients should commit to it and engage in a mutual decision process. Most research, however, has addressed interventions that either focus on the doctors' side (e.g. communication skills) or on informing patients about treatment options (e.g. decision aids). These approaches have been shown to be feasible in clinical practice but had no strong effects on treatment patterns or adherence, possibly because they were insufficient to motivate and enable patients to engage actively in decision-making. Moreover, these interventions still rely on the doctor's willingness to share decisions, which has been shown to vary considerably. To overcome these limitations and since many patients do not feel competent to participate in decision-making we developed an intervention that focuses on patients' communicative competencies. this intervention, a five session group-training, will be implemented for inpatients suffering from schizophrenia.

Official Title
-----------------
A Shared Decision-making Training for Inpatients With Schizophrenia

Conditions
-----------------
Schizophrenia, Schizo-affective Disorder

Intervention / Treatment
-----------------
* Behavioral: shared decision making training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 icd diagnosis F2 sufficient German language skills Exclusion Criteria: debility

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>5 hour cognitive training | Behavioral: shared decision making training<br> <br> |
| Experimental: intervention<br>5 hour shared decision making training | Behavioral: shared decision making training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to antipsychotic medication |  | 12 months |
Low Birth Weight Follow-up

Study Overview
=================
Brief Summary
-----------------
The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. The study assistants will ask about the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar status of both child and parents will be checked.

Official Title
-----------------
Follow-up of Low Birth Weight Cohort of 2008-2013

Conditions
-----------------
Non Specific Effects of Vaccine, Bacillus-Calmette-Guerin, Low Birth Weight, Maternal Immunisation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation during the low birth weight BCG trial between 2008 and 2013. Exclusion Criteria: Not living in the Bandim Health Project's study area.
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 |
| --- | --- |
| early BCG<br>Children received BCG soon after their birth between 2008 and 2013. | |
| delayed BCG<br>Children received BCG when they are 2,5kg between 2008 and 2013. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality differences between group who received early BCG and late BCG |  | up to 8 years of age | 
| mortality by parental scar status |  | up to 8 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization rate between early BCG and late BCG group |  | last two weeks | 
| consultation rate between early BCG and late BCG group |  | last two weeks | 
| medication use between early BCG and late BCG group |  | last two weeks |
Patient Satisfaction After Ingrown Toenail Surgery

Study Overview
=================
Brief Summary
-----------------
In this study, demographic characteristics (age, gender, which toe is involved, family history) of the patients who were operated because of ingrown nails were examined, and the post-operative satisfaction score of the patients was noted, and the recurrence rate and complications were recorded.

Detailed Description
-----------------
The study was designed as single-center, single-surgeon observational study. Approximately 4000 patients who were operated on by the same surgeon between 2015-2020 due to ingrown nails were reached by phone, and patients' satisfaction was assessed by using the Surgical Satisfaction Questionnaire (SSQ-8). Outcomes such as retrospective treatment processes and complications were asked using a questionnaire, and patients' demographic characteristics were also recorded.

Official Title
-----------------
Patient Satisfaction After Ingrown Toenail Surgery. A Review of 1200 Cases

Conditions
-----------------
Ingrowing Nail With Infection

Intervention / Treatment
-----------------
* Procedure: Toenail surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent ingrown toenail surgery Patients who could be reachable by phone over contact details on medical records Exclusion Criteria: Patients who were not reachable Patients who underwent another surgery on the targeted foot rather than ingrown toenail surgery Patients who had fractures on the targeted foot Clinical diagnosis of Alzheimer disease or patients who have lost their cognitive functions.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Toenail surgery|modified Winograd procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Surgical Satisfaction Questionnaire (SSQ-8) | SSQ-8 is a validated tool for the assessment of patients who had been operated on. | At least one year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Recurrence rate is noted | At least one year after surgery | 
| The shape of nail clipping | straight or round cut | through study completion, an average of 2 years | 
| Family history | Positive or negatif family history | through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ingrown toenail, onychocryptosis, patient satisfaction, operative treatment
Real-time Assessment of Frameless Intrafraction Motion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the ability of a modified thermoplastic mask system in keeping an individual head stationary for a predefined amount of time. The investigators hope to know if the modified mask is study enough, and also if the modification on the mask will allow the investigator see and track the individual's movement underneath the mask by means of a camera that can detect light reflected from the individual. Participants will lay down on their backs and their heads will be held in place with the mask system for approximately 1 hour.

Official Title
-----------------
Use of Real-time Infrared Reflective Marker Tracking and Surface Texture Mapping to Assess the Integrity of a Novel Thermoplastic Mask System for Frameless Immobilization

Conditions
-----------------
Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individual Age > 18 years. Males and females of all races and ethnic groups Exclusion Criteria: Severe claustrophobia

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