linjc16/ctgov huggingface dataset:
Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of the administration of a copper chelating agent, tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous treatment. The primary endpoint for this study is safety with secondary endpoints including change in pulmonary function, exercise capacity, and quality of life.

Official Title
-----------------
Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Tetrathiomolybdate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic pulmonary fibrosis Disease progression despite six months of treatment (steroids with/without azathioprine or cyclophosphamide) defined by at least one of the following: Increased symptoms Decline in forced vital capacity of at least 10% Decline in diffusion capacity for carbon monoxide of at least 20% Increased infiltrate on CXR or high resolution CT scan Taking < 15 mg prednisone for at least 30 days prior to screening Age 35-80, inclusive Able to understand a written informed consent and comply with the study protocol Exclusion Criteria: Significant environmental exposure Diagnosis of collagen vascular disease Evidence of active infection Clinically significant cardiac disease: Myocardial infarction, coronary artery bypass or angioplasty within 6mo Unstable angina pectoris Congestive heart failure requiring hospitalization within 6 months Uncontrolled arrhythmia Poorly controlled or severe diabetes mellitus Pregnancy or lactation Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant) Current enrollment in another experimental protocol Physiologic Criteria: FEV1/FVC < 0.60 Laboratory Criteria: Total bilirubin > 1.5 X upper limit normal AST or ALT > 3X upper limit normal Alkaline phosphatase > 3X upper limit normal White blood cell count < 2,500/mm3 Hematocrit < 30% Platelets < 100,000/mm3 Prothrombin time INR > 1.5

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Tetrathiomolybdate<br> | Drug: Tetrathiomolybdate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 1 year |
Evaluating the Efficacy and Feasibility of a Novel Wireless ECG Recording System in Monitoring Patients After Atrial Fibrillation Ablation Procedure

Study Overview
=================
Brief Summary
-----------------
The investigators goal in this study is to examine the feasibility and efficacy of AliveCor iphone case monitoring device in monitoring patients after AF ablation by comparing transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor (TTM). A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM system from the patient's perspective

Conditions
-----------------
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between > 18 and < 75 years of age Paroxysmal or persistent atrial fibrillation Scheduled to undergo an AF ablation procedure Already has iPhone 4 or iPhone 4S with data plan Willing to use the iPhone Alive Cor case Written informed consent Exclusion Criteria: Unable or unwilling to use the Alive Cor case for their iPhone or iPhone 4S Residing outside the United States
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 |
| --- | --- | --- |
| The proportion of AF/flutter events detected by the AliveCor device will be compared to events detected by the TTM for each episode. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of transmissions from smartphone in comparison with traditional TTM method |  | 3 months |
Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function

Study Overview
=================
Brief Summary
-----------------
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function.

Official Title
-----------------
An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older.

Conditions
-----------------
Malaria, Falciparum

Intervention / Treatment
-----------------
* Drug: Artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 12 years of age or older P. falciparum parasitemia between 50 and 100,000 parasites/μl History of fever or presence of fever (temperature ≥ 37.5°C) Exclusion Criteria Signs/symptoms of severe/complicated malaria Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months History of any drug-related hearing impairment. Abnormal hearing function at study entry Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems (Other protocol-defined inclusion/exclusion criteria may apply.)

Ages Eligible for Study
-----------------
Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Artemether-lumefantrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test) |  |  | 
| Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test) |  |  | 
| Relationship between changes in auditory function and drug exposure. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malaria, hearing, co-artemether, auditory, Plasmodium falciparum, marsh fever, Plasmodium infections, remittent fever, paludism, artemether, artemisinins, benflumetol, lumefantrine
Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The aforementioned study was designed to evaluate short term ovarian reserve as assessed by anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation, as part of cesarean sections performed in women requesting future sterilization. The investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the investigators' institution, 2 of which request sterilization (allocated to tubal ligation or bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following. This is preformed in light of validated data offering better sterilization and possible diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be just as safe as tubal ligation. This will be performed as a randomized controlled trial.

Conditions
-----------------
Ovarian Reserve

Intervention / Treatment
-----------------
* Procedure: Bilateral salpingectomy
* Procedure: Tubal ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn Exclusion Criteria: Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral salpingectomy<br>Cesarean section with bilateral salpingectomy | Procedure: Bilateral salpingectomy<br>* Surgical bilateral removal of fallopian tubes (not involving ovaries)<br>|
| Active Comparator: Tubal ligation<br>Cesarean section with tubal ligation | Procedure: Tubal ligation<br>* Bilateral ligation of fallopian tubes (not involving ovaries)<br>|
| No Intervention: No intervention<br>Cesarean section with no additional intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks | AMH levels | Baseline and 8 weeks following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Study, focus, ovarian, reserve
The Registration on the Use of Feilike Heji in Minors

Study Overview
=================
Brief Summary
-----------------
Feilike HeJi is produced by Guizhou Jianxing Pharmaceutical Co. LTD. For the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary Chinese medicine (approval number: Z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. In order to fully understand the safety of Feilike HeJi in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of Feilike HeJi in a wide range of people, so as to guide the clinical rational drug use.

Official Title
-----------------
A Study on the Registration of the Use of Feilike Heji in Minors

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All minor patients (age <18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) . Voluntarily participate in this study and meet ethical requirements. Exclusion Criteria: Not Applicable.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| AE | All adverse events occurred during the study were determined according to CTCAE V5.0 for severity. | The range of adverse events was from the beginning of the use of Feilike HeJi to 3 days after the cessation of the use of Feilike HeJi. |
Will Lactobacillus Increase Cure Rate After Treatment of Bacterial Vaginosis and Chronic Vulvovaginal Candida

Study Overview
=================
Brief Summary
-----------------
From the earlier studies the investigators have treated women with bacterial vaginosis and cronic vulvovaginal candida. The investigators have then treated them with laktobacilli 10 days for 2 month. The investigators will continue to follow them and investigate if treatment with lactobacilli every week for 6 month will increase cure rate.

Detailed Description
-----------------
Clinical diagnosis of bacterial vaginosis using air dried smears combined with Hay/Ison classification. Test of cure every month or every menstrual cycle using self taken smears. The cure will be if the woman are in group 1 according to Hay/Ison classification. This will also allow us to use molecular diagnosis of BV to test cure and compare this with hay/Ison. Test of cure for candida patiens are no visibel candida on wet smear and free of symtoms of candida.

Official Title
-----------------
Vaginal Colonization After Treatment With Lactobacillus in Women With BV or Candida Will That Increase the Cure Rate After Treatment With Clindamycin for BV and Flucnazole for Candida

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Other: lactobacillus (EcoVag)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bacterial vaginosis according to Hay/Ison or with candida diagnosed with wet smear. Exclusion Criteria: Women with chlamydia infection, Pregnancy, Herpes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: lactobacillus (EcoVag)|Probiotic human lactobacillus (L. gasseri and L rahmnosus)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonization of lactobacilli |  | 6 month |
Epidemiology of SAIDs.

Study Overview
=================
Brief Summary
-----------------
Systemic autoinflammatory diseases (SAIDs) are inflammatory conditions caused by a defect of the innate immune system. Most are hereditary, but little is known on recent entities. The investigators aim to (1) establish correlations between the main mutations and symptoms presented by patients (genotype-phenotype correlation), and (2) describe the most recently described clinical, genetic, and demographic characteristics of SAIDs.

Detailed Description
-----------------
Background SAIDs are a heterogeneous group of diseases linked to a deregulation of the innate immune system. They are characterized by systemic or organ inflammatory attacks. In the absence of accurate diagnosis and adequate treatment, evolution can be lethal. Most SAIDs are hereditary, and the diagnosis is based on genetic analysis because the clinical features overlap. The investigators have been among the first in France to routinely develop Next Generation Sequencing (NGS), which allows a simultaneous and exhaustive analysis of a constantly evolving panel of now more than 60 genes involved in SAIDs. While there are epidemiological studies on the first described MAIs, nothing has been done regarding the newest clinical entities. Objectives The investigators want to study and value the data the investigators have collected on the most recent SAIDs (500 patients) Main objective: Establish correlations between the main mutations and symptoms presented by patients (genotype-phenotype correlation). Secondary objectives: Descriptive epidemiology study: Describe the most recently described clinical, genetic, and demographic characteristics of SAIDs. Methodology The investigators have over the last 20 years set up a database that continues to evolve. These data are collected prospectively from patients (N> 7000) with SAID refered to our laboratory for genetic analysis. This database contains invaluable demographic, clinical and genetic data, carefully collected for each patient, on a standard file of analysis request made with clinicians from the reference center for auto-inflammatory diseases and amyloidosis (CeRéMAIA). The collection of consent is systematic (declared collection).

Official Title
-----------------
Epidemiology and Clinico-genetic Correlations of Auto-inflammatory Diseases

Conditions
-----------------
Autoinflammatory Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - NGS autoinflammatory panel performed Exclusion Criteria: - None
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 |
| --- | --- | --- |
| Number of genetically ascertained patients | Number of genetically ascertained patients | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic autoinflammatory diseases (SAIDs)
Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?

Study Overview
=================
Brief Summary
-----------------
The present study aims to assess the prevalence and impact of comorbid psychiatric disorders among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on exercise tolerance and physical activity post-PR and HRQoL, as well as to determine the processes by which these psychiatric disorders may impact on these patient behaviours.

Official Title
-----------------
Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 40 will be eligible if they are diagnosed with moderate-severe COPD, currently participate to a PR program, and agree to participate. Exclusion Criteria: They will be excluded if: they have any comorbidity that is more important (i.e., more likely to cause morbidity or mortality) than COPD (e.g., active cancer), they have contraindications to exercise (though they will not likely be referred to PR), they have participated in a PR program in the past year, and if they are unable to provide informed consent due to language difficulties or cognitive impairment.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| The change in exercise tolerance at 1-year post-PR | Exercise tolerance will be measured with the 6-minute walking test (6MWT). | Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in health-related quality of life (HRQoL) at 1-year post-PR | HRQoL will be measured with the 12-Item Short Form Survey and the COPD Assessment Test | Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Rehabilitation, Chronic Obstructive Pulmonary Disease, Psychiatric Disorders
Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to adapt and validate to the Spanish the European Quality Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically ill and dying patients in the ICU.

Detailed Description
-----------------
The aim of this study is to adapt and validate a Spanish-language version of the European Quality Questionnaire (EuroQ2). Using a forward-backward translation methodology, we will translate the EuroQ2 into Spanish and will evaluate its psychometric characteristics in a clinical sample of 200 family members responsible for making medical decisions for patients who are discharged from the ICU or who died in the ICU. Cronbach's alpha values, confirmatory factor analysis (CFA) will be evaluated in order to know the reliability, construct validity, and convergent validity.

Official Title
-----------------
Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family members of patients admitted to the ICU for 48 hours or more. Family members responsible for patient decision making in the ICU who consent participate. Exclusion Criteria: Family members younger than 18 years, Family members not able to read or write Spanish

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 |
| --- | --- | --- |
| European Quality Questionnaire (euroq2) | Opinions about Quality of care of ICU after the stay | 48 h after discharge of patients alive from ICU or 1 month after the death into ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family, Quality, Validate, ICU