linjc16/ctgov huggingface dataset:
Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin

Study Overview
=================
Brief Summary
-----------------
S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.

Official Title
-----------------
Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France

Conditions
-----------------
Bone and Joint Infection, Antibiotic Resistant Staphylococcus Aureus Infection

Intervention / Treatment
-----------------
* Other: Role of rifampin in staphylococcal PJI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had acute PJI (i.e. <1 month following the implantation), DAIR with exchange of removal components) due to S. aureus and coagulase-negative staphylococci (2011-2016) Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Role of rifampin in staphylococcal PJI<br>retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (< 1 month) PJI treated with DAIR in 2011-2016 period | Other: Role of rifampin in staphylococcal PJI<br>* the aim is to determine if the dose and the duration of rifampin influenced the prognosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of the use of rifampicin : rate of use | the aim is to determine how the use of rifampin influence the prognosis in staphylococcal acute post-operative prosthetic joint infection treated with DAIR | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of failure for treatment using rifampin | Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) | 
| rate of adverse event with rifampin | Description of adverses events leading to stop the rifampicin | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) |
Vertical Augmentation With Osteon at Dental Implant Placement

Study Overview
=================
Brief Summary
-----------------
Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure.

Detailed Description
-----------------
Primary Objective • To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon. Secondary Objectives • To determine the long term success of dental implants in this augmented bone. Primary Endpoint • Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation.

Official Title
-----------------
An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement

Conditions
-----------------
Tooth Injuries, Tooth Abnormalities

Intervention / Treatment
-----------------
* Device: Osteon bone graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: missing one or two teeth bounded saddle healthy (ASA grade I & II) adult Exclusion Criteria: smoker significant medical problem (ASA III or above)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Osteon<br>Patients requiring dental implants with deficient alveolar bone height | Device: Osteon bone graft<br>* Osteon bone substitute placed to a height of 2 mm above the top of the dental implant<br>* Other names: 100% synthetic bone graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success of dental implants in alveolar bone augmented in the vertical direction with Osteon | The implants will be deemed successful at each time point if the radiographic bone level remains at 2 mm above the level of the implant, i.e. at the same height as when placed. Given that we know precisely the dimensions of the abutments placed in the implant, this provides the necessary calibration in order to undertake this assessment. If the bone level is lost, the procedure will be deemed to have failed. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bounded saddles, missing teeth, dental implants, Tooth, Nonvital
The Effectiveness of Commercial Weight Loss Programmes

Study Overview
=================
Brief Summary
-----------------
The objective is to compare the effectiveness of 4 different commercial weight-loss diets available to adults in the UK. This is achieved with a 6 month multi-centre randomised unblinded controlled trial of Dr Atkins' New Diet Revolution, The slimFast Plan, The weight Watchers Pure Points Programme, Rosemary Conley's Eat Yourself Slim Diet & Fitness Plan. No diet (control) Subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and obese adults. Main outcome measures are weight and body fat change over 6 months.

Official Title
-----------------
A Randomised Control Trial of Commercial Weight Loss Programme in a Community Based Sample of Obese Adults.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: calorie controlled diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) > 27 and < 40 kg/m2. Exclusion Criteria: History of coronary heart disease Type 1 or Type 2 diabetes Renal, liver or respiratory failure Gout Taking lipid lowering or anti-hypertensive drugs History of obesity with known cause (i.e. Cushings disease, hypothyroidism) Previous gastric or weight loss surgery Taking any weight loss drug (including Orlistat or Sibutramine) Clinical depression Eating disorders Drug or alcohol abuse Any malabsorptive state (including lactose intolerance) Being treated for a malignancy Being pregnant Breastfeeding

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: calorie controlled diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  |  | 
| Fat loss |  |  |
A Study of EGb 761® (Tanakan®) in Dementia of Alzheimer Type Onset in Patients Suffering From Memory Complaints

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.

Official Title
-----------------
Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70

Conditions
-----------------
Memory Disorders, Age-Related, Retention Disorders, Cognitive

Intervention / Treatment
-----------------
* Drug: EGb 761® (Tanakan®)
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneously reporting a memory complaint Short anxiety battery test < 6, (only if patient screened at GP site) Geriatric depression scale < 15 Mini-mental state (MMS) > 25 in GP's office (in hospital site MMS is done as complementary scale) Exclusion Criteria: Objective memory impairment Clinician rated dementia staging system > 0.5 Mini-mental state < 25 Dementia, past history of seizures, Parkinson disease

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: EGb 761® (Tanakan®)<br>* 120 mg, 1 tablet twice a day, oral route, during 5 years.<br>|
| Placebo Comparator: 2<br> | Other: Placebo<br>* 1 tablet twice a day, oral route, during 5 years.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis |  | Baseline, month 12, 24, 36, 48 and 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy on rate of cognitive abilities decline |  | Baseline, month 12, 24, 36, 48 and 60 | 
| Effect on concomitant diseases |  | Baseline, month 12, 24, 36, 48 and 60 | 
| Concomitant treatments' reports |  | Baseline, month 12, 24, 36, 48 and 60 | 
| Global evaluation of memory complaint by the patient |  | Baseline, month 12, 24, 36, 48 and 60 | 
| Clinical safety |  | Baseline, month 12, 24, 36, 48 and 60 |
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

Study Overview
=================
Brief Summary
-----------------
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.

Official Title
-----------------
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

Conditions
-----------------
Sudden Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Defibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient prescribed the ASSURE wearable cardioverter defibrillator Provided written informed consent to participate in the ASSURE Patient Registry Exclusion Criteria: Patients who do not meet the Inclusion criteria

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASSURE Registry Patients<br>Patient prescribed the ASSURE WCD who have also consented to participate in the ASSURE Patient Registry. Patients include those with reduced left ventricular ejection fraction (LVEF) and recent myocardial infarction, recent coronary revascularization, or new onset heart failure (HF) to allow for optimization of medical therapy and re-evaluation of cardiac function. Additional indications include ICD explant due to infection, postponed ICD implant, and pending heart transplant. | Device: Defibrillation<br>* External defibrillation from a wearable cardioverter defibrillator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall shock conversion rate | Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0% | Up to 3 years | 
| Inappropriate shocks per patient month | Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075 | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First shock conversion rate | Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only) | Up to 3 years | 
| Inappropriate shock rate | Percent of patients who experience at least one inappropriate shock (report only) | Up to 3 years |
A Qualitative Study Into How Patients Deal With Chemotherapy-related Side Effects at Home

Study Overview
=================
Brief Summary
-----------------
This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Data are collected through semi-structured interviews with adult patients treated with chemotherapy and analysed using a Grounded Theory approach.

Official Title
-----------------
A Qualitative Study Into How Patients With Cancer Deal With Chemotherapy-Related Side Effects at Home

Conditions
-----------------
Exploration of How Patients Deal With Side Effects From Chemotherapy

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥18 years) patients with (any type and any stage of) cancer who were undergoing chemotherapy treatment in an ambulatory setting or during short hospital stays Dutch speaking Able to provide informed consent and to participate in an interview Exclusion Criteria: Patients who were in the first 2 cycles of treatment Patients for whom an interview was considered physically, mentally and/or emotionally too burdensome. Patients who had reported not to experience any side effect from treatment at all

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 |
| --- | --- |
| Chemotherapy, Cancer<br>Adult cancer patients (with any type of cancer) being treated with chemotherapy | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's experience |  | one interview during the course of treatment, i.e. one timepoint between 2 months after the start of chemotherapy and the end of the patient's treatment |
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.

Official Title
-----------------
A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer

Conditions
-----------------
Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: ADU-S100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological confirmation of recurrent or metastatic HNSCC Measurable disease as defined by RECIST v1.1 PD-L1 positive Exclusion Criteria: Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma) Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC

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 |
| --- | --- |
| Experimental: ADU-S100 and pembrolizumab<br>All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100. | Drug: ADU-S100<br>* intratumoral<br>* Other names: MIW815;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator. | Up to 25 months |
Registro Campania Salute Network on Hypertension

Study Overview
=================
Brief Summary
-----------------
The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the management of essential hypertension by integrating the activity of general practitioners (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously allocated in the regional area, and the Hypertension Clinic of the Federico II University in Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store clinical data detected at each visit between the peripheral units and the co-ordinating centre and to support scientific analysis of the dataset.

Detailed Description
-----------------
The patients will be followed over a period of twenty years and all clinical data will be recorded in order to investigate the role of hypertension and correlated disease on this patient population

Official Title
-----------------
Registro Campania Salute Network for the Treatment of Hypertension and Correlated Diseases

Conditions
-----------------
Hypertension; Heart Disease, Hypertensive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Hypertension 18 years old Exclusion Criteria: Refused to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| MACCE | Major adverse cardiac and cerebrovascular events | every year up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, CVD
Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.

Official Title
-----------------
A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Darbepoetin Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving dialysis for 3 months or more before enrollment. The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment Adequate iron stores (serum ferritin equal to or greater than 100 ug/L Exclusion Criteria: Uncontrolled hypertension Prior history of Cardiovascular Incidents 12 weeks prior to enrollment Other hematological disorders Upper or lower GI bleed within the prior 6 months

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single<br> | Drug: Darbepoetin Alfa<br>* Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period. |  | 33 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Q2W doses over duration of study. |  | 33 weeks | 
| Hb values during the evaluation period. |  | 33 weeks | 
| adverse events during study |  | 33 weeks | 
| Hb Rate of Rise during study and excursions above 14g/dL |  | 33 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialysis, Anaemia