linjc16/ctgov huggingface dataset:
Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous Women

Study Overview
=================
Brief Summary
-----------------
In this study the investigators compare the difficulty at insertion of IUD between nulliparous and parous women. The investigators compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion. The investigators hypothesis is that there is no difference between nulliparous and multiparous patients.

Detailed Description
-----------------
In our study we compare the difficulty at insertion of IUD between nulliparous and parous women with an without cesarean section. We compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion. We also compare the pain the patient refers on the day of insertion and the pain the patient refers to remember a month after insertion. Our hypothesis is that there is no difference between nulliparous and multiparous patients.

Official Title
-----------------
Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous and Evaluation of Cause of Failure of Insertion

Conditions
-----------------
Complication of Device Insertion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy WOmen Exclusion Criteria: Pregnancy Use of pain medication previous to the insertion Prior use of IUDs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Nulliparous<br>Nulliparous women who were submitted to IUD device insertion | |
| Multiparous with no cesaraen section<br>Multiparous women with no cesarean sections that were submitted to IUD device insertion | |
| Mulitparous with cesarean section<br>multiparous women with a cesarean section that were submitted to IUD insertion | |

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
-----------------
Nulliparous, Multiparous, Pain, IUD device insertion
A Phase II Study of AS1411 in Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma

Official Title
-----------------
A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma

Conditions
-----------------
Metastatic Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: AS1411


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor) Exclusion Criteria: Collecting duct histology A history of bleeding disorders or currently taking oral vitamin K antagonise medication Unstable brain metastases History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AS1411 treatment | Drug: AS1411<br>* AS1411 40 mg/kg/day) will be administered on days 1-4 via a continuous iv infusion every 28-day cycle for up to 2 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Overall Response Rate to AS1411 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure progression free survival with AS1411 |  |  | 
| To measure time to disease progression with AS1411 |  |  | 
| To measure the duration of overall response and stable disease with AS1411 |  |  | 
| To determine the safety and tolerability of two cycles of AS1411 |  |  | 
| To assess the pharmacokinetic profile of AS1411 |  |  | 
| To assess pharmacodynamic markers of AS1411 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal cell carcinoma, rcc, kidney cancer
Diagnostic Tools for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The study aims to identify genetic variants associated to Parkinson's disease through the analysis of exome-sequencing data of familial cases and controls. The identified variants will be used to generate a diagnostic tool for the identification of genetic risk profiles.

Detailed Description
-----------------
Clinical evaluation of PD patients and relatives High throughput analysis of genetic variants in genome exomes Genotype-phenotype association testing Identification of genetic risk variants for PD

Official Title
-----------------
Realization of Diagnostic Tools for the Early Analysis of Parkinson's Disease Through the Identification of Genetic Risk Profiles

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to L-dopa (levodopa) Exclusion Criteria: Previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on CT or MRI, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family cases<br>Family-based Parkinson patients carrying genetic variants associated with the disease | |
| Family controls<br>Family-based Control subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genetic variants associated with Parkinson's disease | Analysis of exome sequencing data; annotation of genetic variants; selection of variants present in cases and absent in controls | Two years |
Change of Nerve Conduction Properties in IVIg Dependent Neuropathies

Study Overview
=================
Brief Summary
-----------------
IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored.

Detailed Description
-----------------
IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored

Official Title
-----------------
Change of Nerve Conduction Properties in IVIg Dependent Neuropathies

Conditions
-----------------
Guillain-Barre Syndrome, CIDP, Multifocal Motor Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: immune neuropathy age above 18 y IVIg treatment exclusion: no IVIg treatment

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 |
| --- | --- | --- |
| Clinical Improvement |  | 6 Months |
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

Study Overview
=================
Brief Summary
-----------------
To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to U-87201E. To determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in the presence of U-87201E will generate the resistant mutants that may subsequently emerge in the patients.

Official Title
-----------------
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Atevirdine mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Enrollment on protocol RV-43 (AZT resistance study). Development of a primary RV-43 study endpoint-opportunistic infection. HIV isolate with an AZT IC50 > 50 times that of the sensitive type strain. Able to swallow tablets without difficulty. Normal QTc interval on EKG. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine). Severe uncontrollable diarrhea or vomiting or known malabsorption. Symptomatic hyperlipidemia. Concurrent Medication: Excluded: Other experimental drugs. AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted). Patients with the following prior conditions are excluded: History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction. Prior Medication: Excluded: Experimental drugs within 4 weeks prior to study entry.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atevirdine mesylate|nan|

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
-----------------
Virus Replication, Acquired Immunodeficiency Syndrome, Antiviral Agents
Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez

Study Overview
=================
Brief Summary
-----------------
This research will use the Edinburgh Scale Of Post partum depression to evaluate patients during their 4th to 6th after delivery, and the investigators will compare the results with those found in other countries with population with similar characteristics as ours

Official Title
-----------------
Prevalence of Postpartum Depression in the Jose E. Gonzalez Hospital, Using the Edinburgh Postpartum Depression Scale

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Behavioral: edinburgh postpartum depression scale questionary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients on their 4th -6th week after delivery, who gave birth in our institution Exclusion Criteria: patients with previous diagnosis of psychiatric pathology
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 4-6 weeks after delivery<br>all patients on their 4th-6th weeks after delivery | Behavioral: edinburgh postpartum depression scale questionary<br>* the investigators will apply the qusetionary one time only in the period of time described previously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of postpartum depression |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sociodemographic characteristics | age | 2 months | 
| sociodemographic characteristics | level of education | 2 month | 
| obstetrical background | number of pregnancies | 2 month | 
| medical background | comorbid ities | 2 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum, depression, edinburgh postpartum depression scale, mexican population
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.

Official Title
-----------------
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine + Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified colorectal adenocarcinomas Age > 18 years Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents. Measurable disease according to RECIST 1.1 ECOG performance status 0, 1 or 2 Adequate renal, hepatic and haematological function Consent to blood samples and available paraffin embedded tumour material for translational research studies Fertile males and females (<2 years after last period for women) must use effective birth control. Signed Informed consent Exclusion Criteria: Clinically significant concurrent disease. Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ. Other experimental therapy within 30 days of treatment initiation. Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception. Clinical or radiological evidence of CNS metastasis. Planned radiation therapy against target-lesions. Known allergy to 5FU/capecitabine or gemcitabine.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine + Capecitabine|Gemcitabine: 1000 mg/m2 intravenously over 30 min. on day 1 in 2-weeks cycles. Capecitabine: Peroral tablet 2000 mg/m2 daily on days 1-7 in 2-weeks cycles.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients progression free at 3 months |  | 3 months after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | Every 12 weeks | 
| Overall survival |  | Every 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, Metastatic, Treatment resistant
The Normal Reference Values of Pulse Oximetry Plethymographic Waveform Parameters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the normal reference values of pulse oximetry plethymographic waveform parameters in Chinese population.

Official Title
-----------------
The Normal Reference Values of Pulse Oximetry Plethymographic Waveform Parameters

Conditions
-----------------
Pulse Oximetry Plethymographic Waveform, Area Under Curve, Amplitude

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healty adults; Comply with ethical requirements and signed informed consent. Exclusion Criteria: Leuconychia; Stained fingernails; Diseases that have an impact on the blood flow of the peripheral tissue (such as Raynaud's phenomenon, vasculitis and so on); Any conditions the study physicians believe not suitable for inclusion.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parameters of pulse oximetry plethymographic waveform |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulse oximetry plethymographic waveform, area under curve, amplitude
Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression and activities of mitochondrium and expression of ubiquitin.

Official Title
-----------------
Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.

Conditions
-----------------
Dilated Cardiomyopathy

Intervention / Treatment
-----------------
* Procedure: cardiobiopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopatic dilated cardiomyopathy, NYHA I, II, III, IV dilated left ventricle ejection fraction below 45% Exclusion Criteria: diabetes mellitus kidney failure (GFR < 30, creatinine below 2,5 mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>patients without heart failure, with cardiobiopsy | Procedure: cardiobiopsy<br>* 5 samples will be taken from right ventricle by Cordis bioptome<br>|
| Experimental: 2<br>patients with heart failure in NYHA class I, II | Procedure: cardiobiopsy<br>* 5 samples will be taken from right ventricle by Cordis bioptome<br>|
| Experimental: 3<br>Patients with heart failure in NYHA class III, IV | Procedure: cardiobiopsy<br>* 5 samples will be taken from right ventricle by Cordis bioptome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qualitative differences in desmin expression in cardiomyocytes of patient with heart failure |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, desmin, ubiquitin
Pulmonary Hypertension in Hypersensitivity Pneumonitis

Study Overview
=================
Brief Summary
-----------------
The investigation serves the identification of pulmonary hypertension (PH) among patients with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data from South America indicate that the prevalence of pre-capillary PH amongst patients with HP is higher than 20%. There are no reliable data from Europe so far. According to the investigators previous analysis, more than 400 HP patients have participated in pulmonary rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is to be invited to participate in the study. A diagnostic algorithm will be applied in the clinical trial, in the case of clinical suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the determination of the prevalence of PH in patients with HP the investigators aim to assess the reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.

Official Title
-----------------
Recognition of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Diagnostic Test: Right heart catheterization (in case of suspected PH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed Hypersensitivity Pneumonitis written consent Age: 18-90 years Exclusion Criteria: severe impairment of the general health condition pregnancy

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Right heart catheterization (in case of suspected PH)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pulmonary hypertension |  | 4 year |