linjc16/ctgov huggingface dataset:
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV), 2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.

Official Title
-----------------
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients

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

Intervention / Treatment
-----------------
* Drug: Cinacalcet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic (> 3 months) hemodialysis population of > 18 years old PTH > 300 ng/L corrected Ca > 2.10 mmol/L stable hypertensive drugs (> 1 month) stable doses of phosphate binders and dialysis calcium concentration palpable femoral pulse systolic BP of 90-180 mmHg expected survival of > 6 months Exclusion Criteria: hemodialysis > 3 years acute infection history of myocardial infarction or stroke within the past 3 months inability to consent intolerance to cinacalcet inadequate birth control

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cinacalcet<br> | Drug: Cinacalcet<br>* One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness |  | Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular function |  | Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet |
Amplification and Selection of Antimicrobial Resistance in the Intestine

Study Overview
=================
Brief Summary
-----------------
The worldwide increase in the incidence of multidrug-resistant (MDR) pathogens is alarming. Antimicrobial treatment is a risk factor for the isolation of MDR pathogens and can therefore contribute to the observed trend. Differences in the degree of selection pressure caused by various antimicrobials have not been systematically investigated until today. The aim of the proposed project is the determination of the impact of antibiotic treatment on the copy number of resistance genes in the human intestinal microbiome using metagenome shotgun sequencing. The resistance gene count in the gastrointestinal tract will be determined in a clinical cohorts of patients treated with either ciprofloxacin or cotrimoxazol as monotherapy. The subsequent quantification and comparison of the selection pressure facilitates the application of antibiotics with a lower potential to select for resistance. To achieve this goal, a self-controlled, prospective observational epidemiological study will be performed at two centres of the German Centre for Infection Research (Tübingen, Cologne).

Official Title
-----------------
Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine

Conditions
-----------------
Acute Leukaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patients ≥ 18 years patients with acute leukaemia admission to one of the 2 study centres obtained written consent Exclusion Criteria: treatment with antibiotics in the previous 30 days pregnancy patients currently treated for HIV and/or hepatitis b/c patients who can not estimate scope and consequences of their participation in the study patients who will most likely not be able to follow the study protocol

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 |
| --- | --- | --- |
| Changes from Baseline of Antimicrobial Resistance Gene Content in the human Intestine at three Time Points with respect to different Antibiotic Treatment Regimes. | Stool samples will be collected from patients at four time points: t0 (baseline) The time point serves as a control. The stool sample will be obtained before treatment start. t1 (early phase) The time point reflects the early phase at day 1 of treatment with either ciprofloxacin or cotrimoxazol. t2 (early-late phase) The time point reflects the early-late phase at day 3 of treatment. t3 (late phase) The time point reflects the end of treatment (max. day 7). | day 0, day 1, day 3, end of antimicrobial treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metagenomics, antimicrobial resistance, multidrug resistance
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD in healthy subjects.

Official Title
-----------------
A Randomized, Open-labeled, Comparative 3-way Crossover Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: pelubiprofen (30mg) tablet IR
* Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Healthy males aged 20 45 years weight over 45 kg, ideal body weight ±20%[Ideal weight] = [Height(cm)-100] X 0.9 Subjects who voluntarily agreed with written consent Exclusion Criteria: Patients with acute disorder within 28 days before clinical trial drugs administration History of disorders(inflammatory GI tract disease, stomach ulcer, gastrectomy, liver disease) which can affect ADME of drugs Patients with active GI tract, cardiovascular, respiratory, renal, endocrinal, haematological, central nerval, psychiatric disease or malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pelubiprofen (30mg) tablet IR TID, fasting<br> | Drug: pelubiprofen (30mg) tablet IR<br> <br> |
| Active Comparator: pelubiprofen (30mg) tablet IR TID, fed<br> | Drug: pelubiprofen (30mg) tablet IR<br> <br> |
| Experimental: pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD<br> | Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of pelubiprofen(30mg) tablet IR TID |  | 0, 1, 2, 8, 9, 15, 16, 22 day | 
| AUC of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD |  | 0, 1, 2, 8, 9, 15, 16, 22 day | 
| Cmax of pelubiprofen(30mg) tablet IR TID |  | 0, 1, 2, 8, 9, 15, 16, 22 day | 
| Cmax of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD |  | 0, 1, 2, 8, 9, 15, 16, 22 day |
Protocol For Collecting Long-Term Follow-Up Data On Recipients of Bone Marrow and Blood Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
This protocol allows for ongoing data collection to assess the long-term clinical and psychosocial outcomes of pediatric patients who have received a hematopoietic stem cell transplant at St. Jude Children's Research Hospital.

Detailed Description
-----------------
The purpose of this protocol is to provide ongoing data collection and review of long-term outcome and late effects in a large cohort of St. Jude Children's Research Hospital autologous and allogeneic hematopoietic stem cell recipients. Central coordination of clinical and psychosocial late effects monitoring and reporting can facilitate timely communication about life-threatening or unanticipated clinical outcomes as well as significant psychological, social and behavioral sequelae effects on the recipient and their family members. The resultant data may enable researchers in their development of current clinical and psychosocial studies, as well as monitoring predisposed survivors who may benefit from preventive or corrective interventions. Physicians and researchers may be able to learn how to identify these problems earlier, to take better care of these problems, or to implement preventive measures for future transplant recipients

Official Title
-----------------
Protocol For Collecting Long-Term Follow-Up Data On Recipients of Hematopoietic Stem Cell Transplant

Conditions
-----------------
Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Other: Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: St. Jude patients actively monitored in the BMT-AFU clinic after receiving HSC transplant for a malignant or non-malignant condition. St. Jude alumnus who has received a hematopoietic stem cell transplant for a malignant or non-malignant condition and is monitored by the Tumor Registry
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Data Collection | Other: Data Collection<br>* Data Collection, Outcomes Research, Statistical Data Analysis, Longitudinal Study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide ongoing review of long-term clinical and psychosocial outcomes and late effects of hematopoietic stem cell recipients at St. Jude Children's Research Hospital |  | Long Term Follow Up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematopoietic stem cell transplant, Follow-up studies, Outcomes research, Data collection
Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
This study is an experimental single-center pilot study investigating Volatile Organic Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed Back Surgery Syndrome.

Official Title
-----------------
Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study

Conditions
-----------------
Failed Back Surgery Syndrome

Intervention / Treatment
-----------------
* Device: SCS is switched off
* Device: SCS is switched on


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation. Exclusion Criteria: Patients with a diagnosis of cancer. Patients with major psychiatric problems. Patients with an underlying respiratory disease.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCS off<br> | Device: SCS is switched off<br>* Spinal cord stimulator is switched off for 12 hours<br>|
| Experimental: SCS on<br> | Device: SCS is switched on<br>* Spinal cord stimulator is functioning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breath changes | The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose. | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity scores using the Visual Analogue Scale | Pain intensity score on that time on a Visual Analogue Scale (VAS) ranging from zero (no pain) towards 10 (worst possible pain) for the pain intensity. | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. |
Driving Ability of Drug Dependant Patients in Maintenance Therapy

Study Overview
=================
Brief Summary
-----------------
Mobility is a contributing factor in today's society. Drug dependence displays not only a medical but also an economic problem: Especially for an intended reintegration of a drug dependant patient in maintenance therapy the possession of a driving licence could be decisive for a job allocation and therefore the intended reintegration to society. Subject of this study was to verify if patients under substitution therapy with R, S- Methadone, S- Methadone, Buprenorphine and Buprenorphine plus Naloxone are just as fit to drive a car as a non drug dependent person. For this investigation we compared 121 drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC) with non- drug dependant subjects of the same gender, age and level of education. This is the largest study on this topic worldwide. The neuro- cognitive working order was tested by means of the Vienna Test System an objective, reliable and valid test quantifying reaction time, attention efficiency, concentration, maximum resilience and orientation. Current use of any other psychotropic substance or alcohol just as any serious illness (including psychiatric diseases, except for an effectively treated depression) lead to exclusion from this study.

Official Title
-----------------
Driving Ability of Drug Dependant Patients in Maintenance Therapy

Conditions
-----------------
Driving Ability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC) Written agreement on attending this study after full clarification majority Exclusion Criteria: Patients, who do not approve or are not able to approve, to this study Patients, who are not legally competent Patients in emergency situations Patients under age Consumption of any other psychotropic substances than the maintenance drug Severe illnesses p.e. malignant diseases, serious psychiatric illness

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Maintenance Medication D, S- Methadon<br> | |
| Maintenance Medication S- Methadon<br> | |
| Buprenorphine<br> | |
| Buprenorphine+ Naloxone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.

Official Title
-----------------
An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Biological: FB-401


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor Exclusion Criteria: Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01 Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological Pregnant (or planning to become pregnant during the period of the study) or lactating females

Ages Eligible for Study
-----------------
Minimum Age: 2 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: FB-401<br>FB-401 applied topically | Biological: FB-401<br>* Topical<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Safety evaluations | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
commensal Gram-negative bacteria, transdermal water loss, dermatitis, eczema, skin diseases, skin diseases, eczematous, immune system diseases, Atopic dermatitis, microbiome, probiotic, allergic diseases
Bacterial Ecology of Pilonidal Cysts

Study Overview
=================
Brief Summary
-----------------
Bacterial ecology of pilonidal cysts Single centre retrospective exploratory study of medical data contained in the medical records of patients operated on in the centre between 01/08/2020 and 30/11/2020.

Detailed Description
-----------------
From the medical records of a series of patients treated for pilonidal cysts: Describe the bacteriological analyses performed on a series of non-abscessed pilonidal cysts before laser treatment Compare the bacterial flora of cysts operated on in the first instance and those reoperated on This is a retrospective monocentric study of medical data contained in the medical records of patients operated on for pilonidal cysts and who received the same protocol: Antibiotic prophylaxis (injection of 2g of Augmentin) Treatment of the cyst by laser, under general anaesthesia, after dilatation of the pilonidal sinus, evisceration and bacteriological swabbing. Post-operative monitoring and local care

Official Title
-----------------
Bacterial Ecology of Pilonidal Cysts

Conditions
-----------------
Pilonidal Cysts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or older, Patient who has been informed about the research; Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure. Exclusion Criteria: Patient under legal protection, guardianship or curatorship; Patient who has indicated his opposition to the use of his data; Patient undergoing emergency surgery for an abscess.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main germs incidence rate | Calculation of the the incidence rates of the main germs | Day 1 |