linjc16/ctgov huggingface dataset:
Treatment of Low Back Pain in Pregnant Women : Uses of Drugs and Other Therapies

Study Overview
=================
Brief Summary
-----------------
Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies. The primary objective of this study is to determinate how many pregnant women use these alternative therapeutics. In a second time, we want evaluate efficiency of these therapeutics, especially in pain modification and on quality of life. Our study is a declarative study on pregnant women in Lorraine.

Official Title
-----------------
Treatment of Low Back Pain in Pregnant Women ; Uses of Drugs and Other Therapies (Acupuncture, Manipulative Medicine, Physical Therapies, Homeopathy) : an Observational Study

Conditions
-----------------
Low Back Pain, Pregnancy Related

Intervention / Treatment
-----------------
* Other: no intervention / observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women Exclusion Criteria: medical history of : bifida spina, discal hernia, osteoporosis, vertebral compaction, spondylolisthesis, scoliosis ( over 30°)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women with low back pain<br> | Other: no intervention / observational study<br>* no intervention / observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of use of other therapies in pregnant women with low back pain ( acunpucture, manipulative medicine, physical therapies, homeopathy) |  | one day : when each pregnant women submit the questionnaire | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of visual analog scale for pain after and before treatment |  | one day : when each pregnant women submit the questionnaire | 
| Difference of quality life scale after and before treatment | Including : affect, walking, sleep, work, social relations. Scale between 0 and 10 for each item | one day : when each pregnant women submit the questionnaire |
Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History

Study Overview
=================
Brief Summary
-----------------
It remains unclear why some individuals are able to clear HBV from their bodies while in others HBV is a persistent infection. We plan to investigate this process by collecting blood and analysing how the patient's white blood cells respond to different pieces of the HBV virus. We will use new tools that can precisely tell us which component of the immune response may be different in individuals who are chronically infected with HBV and also in individuals who are also infected with HIV. The primary aims are therefore: To characterize HBV-specific T cell responses in HBV chronic carriers, and identify novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals. To determine the effect of HIV infection on HBV-specific T-cell responses

Official Title
-----------------
Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History

Conditions
-----------------
Hepatitis B, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: There are two groups of patients in this study. Group A mono-infected with Hepatitis B, and those with co-infection HBV/HIV. Group A inclusion criteria: (also split into 6 recruiting groups) Acute hepatitis B Chronic hepatitis B, HBV DNA+ve , normal ALT , HBeAg +ve Chronic hepatitis B, HBV DNA +ve , normal ALT, HBeAg -ve Chronic hepatitis , HBV DNA +ve, increased ALT, no HBV treatment B, HBeAg +ve Chronic hepatitis B, HBV DNA +ve , increased ALT, no HBV treatment B, HBeAg -ve Chronic hepatitis B, undergoing 'flare' of hepatitis Group B inclusion criteria: To be HIV/HBV co-infected All patients: To be over 18 years Exclusion Criteria: Those who do not fit the inclusion criteria.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

Study Overview
=================
Brief Summary
-----------------
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin

Official Title
-----------------
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy Receiving Carboplatin

Conditions
-----------------
Neoplasms, Gynecologic

Intervention / Treatment
-----------------
* Drug: Thrombopoietin
* Procedure: Platelet-pheresis
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients with gynecologic malignancy for whom treatment with carboplatin is indicated. Age >/= 15 years. Adequate hematologic, renal, and hepatic functions. Life expectancy >/- 3 months. Karnofsky Performance Status >/= 80. Signed informed consent form. EXCLUSION CRITERIA: Patients with rapidly progressive disease. Pregnant or lactating women. Patients with comorbid condition which renders patients at high risk of treatment complication. History of CNS metastasis. Patients with significant cardiac disease (NYHA Class III or IV), dysrhythmia, or recent history of MI or ischemia, transient ischemic attack or CVA within the 6 months of study entry. Prior chemotherapy, immunotherapy, any experimental drug within 4 weeks, use of myeloid (G-CSF or GM-CSF) growth factors within 2 weeks or erythropoietin within 4 weeks. Use of any nitrosourea (BCNU, CCNU) or mitomycin - C within 6 weeks. Prior surgery or RT within 2 wks of study entry. Patients with history of prior high dose chemotherapy with stem cell transplant or with history of prolonged thrombocytopenia (> 2 weeks). History of leukemia. History of any platelet disorders including ITP, TTP or bleeding disorders. History of > 3 prior chemotherapy regimens (all platinum regimens will be counted as 1 regimen). Demonstrated lack of response to platinum-based therapy.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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 |
| --- | --- |
| Experimental: rhTPO-Derived Autologous Platelets Transfusion<br> | Drug: Thrombopoietin<br> <br> Procedure: Platelet-pheresis<br> <br> Drug: Carboplatin<br> <br> * Other names: Paraplatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | Continuous | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dose-intensified carboplatin, autologous cryopreserved platelets, thrombopoietin, Gynecologic malignancy
Anderson-Fabry Disease in Chronic Kidney Disease Patients Not on Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
Anderson-Fabry disease is a rare X-linked lysosomal storage disorder due to the deficiency of alfa-galactosidase A (AGAL). The subsequent accumulation of glycosphingolipids may lead to to cardiac, renal, and central nervous system impairment as well as premature death. Recently published studies suggest that the true incidence of the disease may be underestimated in certain risk groups, e.g. in patients with chronic kidney disease (CKD). Therefore, the investigators initiated a multicenter case-finding study in Austria by screening patients with chronic kidney disease not yet on renal replacement therapy. Molecular isoforms of globotriaosylceramide (Gb3), characterized by different chain lengths of their N-acyl residues, will be determined in a urine sample. Characteristic parameters, including the ratio of C24/C18 isoforms will be used for identifying patients liable to have the disease. A positive result will be confirmed by biochemical and genetic testing. A sample size of 5.000 chronic kidney disease patients is envisaged allowing for detection of 1 to 25 patients with Anderson-Fabry disease.

Official Title
-----------------
A Case Finding Study for Anderson-Fabry Disease Among Patients With Chronic Kidney Disease Not on Renal Replacement Therapy

Conditions
-----------------
Focus of Study: Prevalence of Fabry Disease in CKD Population

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease KDOQI stage 1-5 Informed consent Exclusion Criteria: Patients already on renal replacement therapy Not willing to participate

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anderson Fabry disease, chronic kidney disease, prevalence
A Drug-Drug Interaction Study of Digoxin and PA21

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Digoxin is affected by PA21.

Official Title
-----------------
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Digoxin in Healthy Male and Female Adults

Conditions
-----------------
Drug Interaction Potentiation

Intervention / Treatment
-----------------
* Drug: PA21
* Drug: Digoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Written informed consent Exclusion Criteria: No significant medical conditions Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21 and Digoxin with food<br>The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day | Drug: PA21<br>* The maximum dose of PA21 will be 15.0 g/day.<br>Drug: Digoxin<br>* The maximum dosage of Digoxin will be 0.5 mg/day<br>|
| Experimental: No PA21; Digoxin with food<br>The maximum dosage of Digoxin will be 0.5 mg/day | Drug: Digoxin<br>* The maximum dosage of Digoxin will be 0.5 mg/day<br>|
| Experimental: PA21 with food and Digoxin 2hrs later<br>The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day | Drug: PA21<br>* The maximum dose of PA21 will be 15.0 g/day.<br>Drug: Digoxin<br>* The maximum dosage of Digoxin will be 0.5 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve from time zero to 24 hours (AUC0-24) | Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post digoxin dose on Days 0, 11, 22 | 
| Area Under the Curve from time zero to infinite (AUC0-infinity) | Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on Days 0, 11, 22 | 
| Maximum observed plasma concentration (Cmax) |  | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on days 0, 11, 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-drug interaction, Pharmacokinetics, PA21
Salivary Markers in Patients With Xerostomia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient

Detailed Description
-----------------
Primary Outcome Measures: salivary Proinflammatory and anti-inflammatory cytokines questionnaire is provided to the patient for xerostomia characterization Secondary Outcome Measures: Probing pocket depth Probing pocket depth and clinical attachment level Gingival index Plaque index Bleeding on probing

Official Title
-----------------
Oral Health and Salivary Markers in Patients With Xerostomia

Conditions
-----------------
Xerostomia Due to Hyposecretion of Salivary Gland

Intervention / Treatment
-----------------
* Diagnostic Test: Analysis of the saliva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • The patient must have clinical symptoms of xerostomia (dry mouth) Exclusion Criteria: Head and neck radiotherapy Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months Patients who are unable or unwilling to cooperate Patient suffering from cancer
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: Analysis of the saliva|IFN-, IL-10, IL-1b, IL-4 and IL-6|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| saliva flow rate | Unstimulated salivary flow rate. Pathological < or 1.5 ml/ 15 minutes. | 2 months | 
| Xerostomia | Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ). | 2 months | 
| Interleukins | Analytes in saliva IFN-(pg/ml), IL-10(pg/ml), IL-1b(pg/ml), IL-4 (pg/ml)and IL-6 (pg/ml) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Exam | Caries number, natural teeth number | 4 months | 
| Periodontal evaluation | periodontal( gingival index, bleeding index, clinical attachment level, probing depth,number dental implant .A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects according to American Academy of Periodontology classification of periodontal diagnosis | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saliva , dental , oral health
Assessment Of Different Scores In Predicting Outcome In AECOPD Patients In Emergency Department

Study Overview
=================
Brief Summary
-----------------
evaluate the value of different scores in predicting hospital mortality and Need for MV In patients presented to ED with AECOPD.

Detailed Description
-----------------
Chronic obstructive pulmonary disease (COPD) is one of the top three causes of death worldwide, and 90% of deaths occur in low- and middle-income countries. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is defined as an acute change in patient's dyspnea, cough, or sputum beyond normal variability that is sufficient to warrant a change in therapy. AECOPD has a negative effect on the quality of life, admission and readmission rates, and disease progression. For these reasons, appropriate management of acute exacerbations is recommended by national and international organizations. Identifying high-risk dying patients on hospital admission helps in triaging them to the required level of care. The use of early warning scores in follow-up is recommended for the early detection of critically ill patients and the prediction of clinical deterioration. CURB65, BAP65, qSOFA , DECAF and NEWS, which mainly involve mental status, respiratory rate, oxygen saturations, pulse, blood pressure, age, BUN level, etc., can be used to predict AECOPD-associated mortality in ED given the simple structure and data availability.

Official Title
-----------------
Assessment Of Different Scores In Predicting Outcome In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Patients In Emergency Department

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient presented to ED with acute exacerbation of COPD. Exclusion Criteria: Patient presented with acute insult affecting other system. Patient transferred to other centers. Inadequate data.

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 |
| --- | --- | --- |
| Evaluate the value of different scores in predicting hospital mortality | Assessment Of Different Scores In Predicting Outcome In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Patients In Emergency Department as DECAF(dyspnea grade V according to eMRCD,esinopenia<0.05x10*9/L,consolidation,acidemia<7.30,atrial fibrillation) 1=mild,2_3=moderate,4_5=severe can be used to predict AECOPD-associated mortality in ED given the simple structure and data availability. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of these scores in predicting need for MV. | Value of these scores in predicting need for MV in AECOPD patient in ER | one year |
Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the clinical results for patients suffering from plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.

Detailed Description
-----------------
All patients will be instructed in stretching exercises. Half of the patients will be randomized to proximal medial gastrocnemius recession. All patients will be followed for 1 year. Additional long term follow-up will be 6 years after inclusion

Official Title
-----------------
Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis. A Randomized Controlled Trial.

Conditions
-----------------
Plantar Fasciitis

Intervention / Treatment
-----------------
* Procedure: surgical proximal medial gastrocnemius recession


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of plantar fasciitis lasting more than 12 months. Isolated gastrocnemius contracture Exclusion Criteria: No previous surgery to foot or ankle No active arthritis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gastrocnemius recession<br>gastrocnemius recession | Procedure: surgical proximal medial gastrocnemius recession<br>* proximal medial gastrocnemius recession<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score | The change in AOFAS from baseline to follow-up, as well as the difference between the groups treated non-operatively and operatively will be reported on a 0-100 scale. | 1 year and 6 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0-10 points Visual analog pain score | Difference in pain between groups will be reported on 0-10 points visual analog scale | 1 year and 6 years postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plantar fasciitis, gastrocnemius recession