linjc16/ctgov huggingface dataset:
Assessment of The Clinical Course of Dyspnea in Acute Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF) signs and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations every year, resulting in an enormous public health burden. Approximately 1/3rd of patients will either be re-hospitalized or die within three months, and the resultant financial costs are large. As such, improving outcomes for AHF patients is critically important. Shortness of breath is the most common reason why patients with AHF present to the ER. As such, understanding how severe this symptom is, how much it improves with current treatments is very important to both patients and physicians. The purpose of this study is to determine the degree to which your shortness of breath improves during the first few days of hospitalization and its association with how fast you are breathing.

Official Title
-----------------
Assessment of The Clinical Course of Dyspnea and Its Association With Respiratory Rate in Patients With Acute Heart Failure Syndromes

Conditions
-----------------
Acute Heart Failure, Dyspnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 18 years of age AHFS is the primary working diagnosis for ER management and treatment with planned admission Have received IV diuretic therapy Enrolled within 3 hours of initial diuretic dose Exclusion Criteria: BNP level is ≤ 300 pg/mL (may be initially enrolled and then will be excluded for second assessment) Transplant recipients of any kind Fever > 101.5 Severe lung disease (required home O2 or daily oral steroids) Any ACS event within last 30 days Life expectancy less than 12 months for any reason Current treatment for any malignancy of any kind Cardiogenic shock and/or requiring IV inotropic therapy Pregnant or recently pregnant within last 90 days Inability to give appropriate written consent

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 |
| --- | --- | --- |
| To determine the association between respiratory rate and self-reported dyspnea in AHF patients. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyspnea, shortness of breath, respiratory rate, orthopnea
Dental Anxiety Among Children Pre and Post COVID 19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention

Official Title
-----------------
Dental Anxiety Among Egyptian Children Pre and Post COVID 19

Conditions
-----------------
Dental Anxiety

Intervention / Treatment
-----------------
* Other: routine dental restorative procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parental consent no previous dental experience medically free children Exclusion Criteria: children with negative behavior according to Frankl Rating Scale children require general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre pandemic<br> | Other: routine dental restorative procedures<br>* pulp and restorative therapy<br>|
| Post pandemic<br> | Other: routine dental restorative procedures<br>* pulp and restorative therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental anxiety level | Assessment will performed by using Facial image scale (FIS)It consists of 5 faces ranging from very happy to very unhappy. At the beginning, the 5 faces have been explained to all children and they were asked to point to the face which best describes how he/she felt at the moment | through study completion, an average of 3 months |
Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Fatigue is a common symptom and a leading concern in patients with inflammatory bowel disease (IBD) and often persists despite clinical and endoscopic remission. This study evaluates the metabolomic profile of fatigued patients with IBD.

Detailed Description
-----------------
To date, there is only one non-published study using metabolomics in quiescent IBD patients with and without fatigue. The investogators designed this study to examine if there are metabolomics factors associated to fatigue in IBD patients. This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent. (1) IBD outpatients attending the Hospital de Sabadell Gastroenterology Day-care unit were consecutively included for analytical monitoring of immunosuppressant treatment or infliximab infusion. The investigators recorded demographic data, IBD classification according to the Montreal classification, and history of drug administration. In addition, clinical activity of the disease was measured using the Harvey-Bradshaw score for Crohn's disease (CD) and the modified Mayo score for ulcerative colitis (UC). The Functional Assessment of chronic Illness Therapy-Fatigue (FACIT-F) was used to assess fatigue.

Official Title
-----------------
Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

Conditions
-----------------
Fatigue, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) . Exclusion Criteria: Age below 18 years. Refusal to give written informed consent prior to participation Active infection at the time of inclusion. Concomitant diseases not related to IBD (e.g., cancer, heart disease, pulmonary disease) that might contribute to the presence or the severity of fatigue. Active flare of IBD in the last 3 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients with Inflammatory Bowel Disease<br>This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent. (1) IBD outpatients attending the Hospital de Sabadell Gastroenterology Day-care unit were consecutively included for analytical monitoring of immunosuppressant treatment or infliximab infusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in metabolomic profile | The metabolic profile consisted in 75 metabolites that were measured | 1 year |
Rett Syndrome Registry

Study Overview
=================
Brief Summary
-----------------
The Rett Syndrome Registry is a longitudinal observational study of individuals with MECP2 mutations and a diagnosis of Rett syndrome. Designed together with the IRSF Rett Syndrome Center of Excellence Network medical directors, this study collects data on the signs and symptoms of Rett syndrome as reported by the Rett syndrome experts and by the caregivers of individuals with Rett syndrome. This study will be used to develop consensus based guidelines for the care of your loved ones with Rett syndrome and to facilitate the development of better clinical trials and other aspects of the drug development path for Rett syndrome.

Official Title
-----------------
Rett Syndrome Real World Data Observational Registry

Conditions
-----------------
Rett Syndrome, Rett Syndrome, Atypical, Genetic Disease, Genetic Diseases, X-Linked, Intellectual Disability, Neurobehavioral Manifestations, Neurologic Manifestations, Neurologic Disorder, Neurodevelopmental Disorders, Nervous System Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female with a pathologic loss of function alteration of MECP2 Exclusion Criteria: Male or female with a gain of function alteration of MECP2, including those with MEPC2 duplication or triplication

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Natural History | To longitudinally evaluate the natural history of patients with mutations on the MECP2 gene, estimating and defining their clinical spectrum (e.g. disease course and complications of disease). | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rett syndrome, MECP2, Neurodevelopmental disorder, Registry, Natural History Study
Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students

Study Overview
=================
Brief Summary
-----------------
At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.

Conditions
-----------------
Hepatitis B, Immune Response, Seroprevalence

Intervention / Treatment
-----------------
* Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region Exclusion Criteria for vaccination study: acute illness immunocompromised conditions renal insufficiency pregnancy allergic history to HB vaccine or yeast positive for any of HBsAg, anti-HBs or anti-HBc

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBV vaccine<br>HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) | Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc |  | Anti-HBs was assayed at Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students |  | seroprevalence at baseline | 
| Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc |  | Anti-HBs immune response at Month 1 | 
| Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc |  | Anti-HBs immune response at Month 6 | 
| Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc |  | Anti-HBs immune response at Month 20 |
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).

Official Title
-----------------
Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

Conditions
-----------------
Relapsed NLPHL

Intervention / Treatment
-----------------
* Drug: Ofatumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsed nodular lymphocyte predominant hodgkin lymphoma age 18 - 75 review of diagnosis by experienced pathologist no major organ dysfunction Exclusion Criteria: classical hodgkin lymphoma CD20 antibody treatment within the last 6 months prior enrollment chronic or current infectious disease requirering systemic antibiotics other past or current malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Drug: Ofatumumab|300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 12 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of response |  | 12 months after end of treatment | 
| Progression free survival |  | 12 months after end of treatment | 
| adverse events |  | 12 months after end of treatment |
Cognitive Hyper-performance - Effects of Stimulating Substances in Chess-players

Study Overview
=================
Brief Summary
-----------------
Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of chess players in chess games and neuropsychiatric standardized tests. We hypothesize that substances will change cognitive performance in chess players leading to changed results in chess games and neuropsychiatric tests.

Official Title
-----------------
Phase I Study About Effects of Caffeine, Methylphenidate, Modafinil and Placebo on Cognitive Performance of Chess Players.

Conditions
-----------------
Cognitively Healthy Subjects Influenced by Psychoactive Drugs

Intervention / Treatment
-----------------
* Drug: Drugs use: methylphenidate
* Drug: Drug use: modafinil
* Drug: caffeine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 18-60 years old existence of ELO-number Exclusion Criteria: physical diseases (e.g. diabetes mellitus, etc.) with necessity of using prescription drugs psychiatric diseases (e.g. psychosis, bipolar disorders, etc.) with necessity of using prescription drugs addiction of psychoactive substances smoker or quitter (< 5 years) use of more than 5 cups of coffee per day irregular day-night-rhythm (e.g. shift workers)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br>Methylphenidate | Drug: Drugs use: methylphenidate<br>* 40 mg tablets<br>|
| Experimental: modafinil<br>modafinil | Drug: Drug use: modafinil<br>* 40 mg tablets<br>|
| Experimental: caffeine<br>caffeine | Drug: caffeine<br>* 400 mg<br>|
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chess games (win/ lose/ tie) |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time period for decision of chess games |  | results of ches games | 
| Cognitive performance measured with standardized neuropsychiatric tests (Tower of Hanoi, Trail-Making test, Stroop-Test, Psycho-Motor-Vigilance test, Wisconsin-Card-Sorting-Test, Balloon Analog Risk Task) |  | outcome of tests | 
| measuring of risk taking behaviour, motivation, mood using standardized questionnaires |  | outcome of tests | 
| adverse events |  | type of adverse events | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chess, cognition
Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections

Study Overview
=================
Brief Summary
-----------------
Cephamycin related to 2nd generation cephalosporins, the use of cefoxitin has long been limited to antibiotic prophylaxis. Because of its spectrum (sensitive staphylococci, enterobacteria including ESBL, streptococci, anaerobes), its stability and its low cost, it could be useful in curative bone and joint infections, especially in case of infection polymicrobial disease in patients for whom antibiotic alternative per os is limited.

Official Title
-----------------
Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections

Conditions
-----------------
Antibiotic Reaction, Bone and Joint Infection

Intervention / Treatment
-----------------
* Other: bone and joint infection treated with cefoxitin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration Exclusion Criteria: -

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 |
| --- | --- |
| bone and joint infection treated with cefoxitin<br>patients having had a bone or joint infection treated by cefoxitin in combination. Cefoxitin has been administered by continuous way, at home. A serum dosage of cefoxitin has been systematically achieved at equilibrium. | Other: bone and joint infection treated with cefoxitin<br>* the patients had cefoxitin in combination in continuous parenteral administration to treat their bone / joint infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Treatment Failure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of use of this strategy | Descriptions of patients managed with this strategy | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cefoxitin, Bone and Joint Infection
Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)

Study Overview
=================
Brief Summary
-----------------
Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example). A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique. The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.

Official Title
-----------------
Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)

Conditions
-----------------
Central Nervous System Lymphoma

Intervention / Treatment
-----------------
* Other: Retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults With a lymphoma of the central nervous system Patients having signed the consent for the conservation of their samples within the cohort Exclusion Criteria: <18 old years Other diagnosis than lymphoma of the central nervous system No consent form signed

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Retrospective study|Retrospective study to search mutations associated with Central nervous system lymphoma and study of the prognostic impact (overall survival and progression-free survival) of these mutations.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Analysis of progression-free survival correlated with genomic data and mutation data | Up to 48 months |