linjc16/ctgov huggingface dataset:
Investigating Severe Acute Respiratory Syndrome (SARS)

Study Overview
=================
Brief Summary
-----------------
Severe Acute Respiratory Syndrome (SARS) is a newly recognized illness that can be fatal. The purpose of this study is to better understand SARS by collecting samples of blood and other body fluids of people who have been exposed to SARS or who are suspected to have the illness. Up to 300 volunteers aged 18 years or older will be enrolled in this study. Participants will donate blood samples and, if appropriate, samples of fluid from the lungs, nose, or throat. Researchers will test these samples for proteins that control or mediate inflammatory or immune responses. The patterns of these proteins will reveal how SARS affects the body and the efforts the body makes to fight off the infection.

Detailed Description
-----------------
Severe acute respiratory syndrome (SARS) is a newly recognized illness associated with substantial mobidity and mortality. Patients develop fever followed by rapidly progressive and even fatal respiratory disease. SARS is associated with infection with a novel coronavirus. The evaluation of the inflammatory responses evoked by SARS may yield information regarding its pathogenesis and help with patient management. This protocol, then, merely aims to study disease pathogenesis and natural history, by studying samples and data that are collected by outside physicians or physicians at the Clinical Center and sent for evaluation of the inflammatory response.

Official Title
-----------------
An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)

Conditions
-----------------
SARS Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA - CASES: Patients fulfilling the CDC case definition or WHO definition for suspected or probable SARS. Newly identified patients found to have recovered from SARS can also be enrolled. EXCLUSION CRITERIA - CASES: Patients diagnosed with alternative illnesses as the cause of the symptoms. INCLUSION CRITERIA - HEALTHY VOLUNTEERS: For the purpose of this study, a healthy volunteer is defined as a healthy male or female, age 18 and above. Volunteers will be excluded if they have a pre-existing or concurrent serious chronic medical or psychiatric illness. Chronic medication use will be evaluated on a case-by-case basis. They will also be excluded if they have received an investigational drug in the past 3 months.
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Coronavirus, Immunity, Interferon, Cytokine, Severe Acute Respiratory Syndrome, SARS, Healthy Volunteer, HV
Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule. Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel

Official Title
-----------------
Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Electromagnetic Navigation guided transthoracic needle aspiration
* Device: CT-guided Transthoracic Needle Aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis; Patients who are older than 18 year-old; Patients voluntarily join the study and give written informed consent for the study. Exclusion Criteria: Chest CT scan shows that the pulmonary nodule is pure ground glass opacity. Large blood vessels or important structures on the puncture path of peripheral lung tumors； Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electromagnetic Navigation group<br>Electromagnetic Navigation Guided Transthoracic Needle Aspiration | Device: Electromagnetic Navigation guided transthoracic needle aspiration<br>* Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule<br>|
| Active Comparator: CT group<br>CT-guided Transthoracic Needle Aspiration | Device: CT-guided Transthoracic Needle Aspiration<br>* Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic rate |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time |  | 18 months | 
| Adverse events |  | 18 months |
Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The primary aim of this observational study is to investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) for 12 months.

Official Title
-----------------
A 12 Month Non-interventional (Observational), International, Multi-centre, Prospective Study to Evaluate the Bleeding Pattern of Ultra-low Dose Continuous Combined Hormone Replacement Therapy Containing 0.5 mg Estradiol and 0.1 mg Norethisterone Acetate (Eviana®)

Conditions
-----------------
Menopause, Postmenopausal Bleeding

Intervention / Treatment
-----------------
* Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent, permitting the data to be processed within the scope of the study, is obtained from the patient before any study-related activities Postmenopausal amenorrhoeic women Treatment with previously combined HRT discontinued at least 3 months prior to start of 0.5 mg estradiol and 0.1 mg norethisterone acetate treatment
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)<br>* Data collection of the use of 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) in women in connection to a daily clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding profile during the 52 weeks of treatment with 0.5 mg estradiol and 0.1 mg norethisterone acetate evaluated by bleeding, and bleeding or spotting rates |  | At every lunar month (28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bleeding profile |  | During the 52 weeks of treatment | 
| Change in mean number of hot flushes per week |  | During the 52 weeks of treatment |
Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2

Study Overview
=================
Brief Summary
-----------------
Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia

Official Title
-----------------
Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: Sleep education and relaxation 1
* Behavioral: Sleep education and relaxation 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Sleep onset latency > 30 min for at least 3 nights per week Exclusion Criteria: 1) Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages). 2) Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Active Comparator: Sleep education and relaxation 1<br>Behavioral education intervention about sleep and relaxation | Behavioral: Sleep education and relaxation 1<br>* Sleep hygiene and relaxation training; Sleep education and relaxation 1<br>|
| Experimental: Sleep education and relaxation 2<br>Behavioral education intervention about sleep and relaxation | Behavioral: Sleep education and relaxation 2<br>* Modified sleep hygiene and relaxation training; Sleep education and relaxation 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep onset latency | time to fall asleep | four weeks |
A Single-patient Study of Repeat-dose Administration of Prometic Plasminogen (Human) Intravenous

Study Overview
=================
Brief Summary
-----------------
These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV infusion in one adult and one child with hypoplasminogenemia. These patients are under treatment to address wound healing and obstructions.

Official Title
-----------------
A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia

Conditions
-----------------
Hypoplasminogenemia

Intervention / Treatment
-----------------
* Biological: Plasminogen (Human)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has provided informed consent. Patient has a diagnosis of compound homozygous Type 1 plasminogen deficiency as evidence by ligneous conjunctivitis since birth as well as involvement of the conjunctiva, nasopharynx, gingiva, tracheobronchial tree, gastrointestinal tract, and urinary tract. Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 16 Months

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Plasminogen (Human)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Influence of Carob and Probiotics on Acute Diarrhea in Children

Study Overview
=================
Brief Summary
-----------------
Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: Mineral solution
* Dietary Supplement: Carob powder with probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute diarrhea Exclusion Criteria: Dehydration Chronic diseases Chronic diarrhea (more than 2 weeks) Septic shock Hypovolemia On medication Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Mineral rehydration solution | Dietary Supplement: Mineral solution<br>* Rehydration mineral solution<br>|
| Active Comparator: Carob powder<br>Carob powder and probiotics | Dietary Supplement: Carob powder with probiotics<br>* 7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in diarrhea | Measurement of number of vomiting and diarrhea bowel movements before and after intervention | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days until no diarrhea bowel movements | Measurement of number of days until diarrhea is gone | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influence, carob powder, probiotics, duration
Validation of a Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Given the severely deteriorated oral health in these schizophrenic populations, it is important to have a tool to evaluate their perception of the quality of their oral health so as to better orientate prevention programmes. The aim of this study is to validate a tool to measure the perception of oral health in patients with schizophrenia. To do this, patients will be invited to complete a series of self-questionnaires relative to the concept of oral health.

Official Title
-----------------
Validation of Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: Questionnaires completed at D0
* Other: Questionnaires completed at D15 (test-retest for 30 patients)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of schizophrenia according to DSM V Hospitalized patients or outpatients who have been taking an antipsychotic treatment for more than 2 years Patients older than 18 years Patients who have provided oral informed consent to take part in the study Exclusion Criteria: Patients who are psychiatrically unstable or delusional Subjects on chemotherapy Adults under guardianship Patients without national health insurance cover

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with schizophrenia<br> | Other: Questionnaires completed at D0<br> <br> Other: Questionnaires completed at D15 (test-retest for 30 patients)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of oral health by OHIP-14 scales |  | At inclusion | 
| Evaluation of quality of life by GOHAI scales |  | At inclusion | 
| Mc Nair Memory Questionnaire |  | At inclusion | 
| Evaluation of negative symptoms by scale |  | At inclusion | 
| Beck Depression Scale |  | At inclusion | 
| Evaluation of quality of life by S-Qol |  | At inclusion |
Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT

Study Overview
=================
Brief Summary
-----------------
The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Other: osteopathic manipulative treatment
* Other: sham therapy
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborns born in the same hospital either gender diagnosis of any pathological/clinical medical condition Exclusion Criteria: lack of guardian consent newborn transferred to/from other hospital lack of any of the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 26 Weeks
Maximum Age: 40 Weeks

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 |
| --- | --- |
| Other: osteopathic manipulative treatment<br>newborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care | Other: osteopathic manipulative treatment<br> <br> Other: usual care<br> <br> |
| Other: sham<br>newborns will receive sham treatment for the entire period of hospitalization plus usual care | Other: sham therapy<br> <br> Other: usual care<br> <br> |
| Other: usual care<br>newborns allocated in the usual care arm will receive standard care only | Other: usual care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline changes in pain score using Premature Infant Pain Profile |  | baseline and end of hospitalization, expected hospitalization 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in days |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pathology, newborn, osteopathic manipulative treatment, pain
Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome

Study Overview
=================
Brief Summary
-----------------
According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients. This study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary hypertension (PH) will be offered further investigations including right heart catheterization.

Detailed Description
-----------------
Patients with primary and secondary Sjögren Syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.

Official Title
-----------------
Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome

Conditions
-----------------
Sjögren Syndrome, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed Consent diagnosis of Sjögren Syndrome age: 18 - 90 yrs Exclusion Criteria: uncontrolled systemic hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic) relevant systolic (EF<50%) or diastolic (>Grade 1) left ventricular dysfunction uncontrolled ventricular arrhythmias uncontrolled supraventricular bradycardia or tachycardia myocardial infarction within the last 12 months pulmonary embolism within the last 6 months larger surgical interventions within the last 12 months musculoskeletal or vascular disease, that may affect ergometric investigations pregnancy (anamnesis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| prevalence of pulmonary hypertension in Sjögren syndrome | % of patients with mean pulmonary arterial pressure > 25 mmHg | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forced vital capacity | % predicted | 2 hours | 
| systolic pulmonary arterial pressure at 50 Watts | mmHg | 2 hours |