linjc16/ctgov huggingface dataset:
A Comparative Study of KW-2246

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.

Official Title
-----------------
Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)

Conditions
-----------------
Cancer Related Pain (Breakthrough Pain)

Intervention / Treatment
-----------------
* Drug: KW-2246
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled ECOG PS =< 3 Exclusion Criteria: Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics Severe respiratory dysfunction Asthma Severe bradyarrhythmia Severe hepatic function disorder Severe renal function disorder Severe psychoneurotic disorder Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KW-2246<br> | Drug: KW-2246<br>* Rescue medication at an optimal dose, which is determined by dose titration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity difference | Pain scores on the visual analog scale | 30 minutes after each dose |
Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis

Study Overview
=================
Brief Summary
-----------------
Herpes Simplex Virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. Despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate. One of the contributing factors of bad prognosis is the development of encephalitis mediated by autoantibodies, most often directed against NMDA receptors, in the weeks following viral encephalitis. The description of this pathology is recent, the pathophysiology of this process remains poorly understood, and the management of these patients is not yet codified.

Official Title
-----------------
Study of 12 Cases of Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis and Review of the Literature

Conditions
-----------------
Herpetic Encephalitis, Autoimmune Encephalitis, Anti NMDA Receptor Encephalitis

Intervention / Treatment
-----------------
* Other: Description and analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical autoimmune encephalitis with anti-NMDA antibodies and documented by CBA in the CSF After a herpetic encephalitis documented by a positive viral PCR for HSV in the CSF Without age limit Exclusion Criteria- No respect of inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort NMDARE-HSE<br>Patients developing clinical autoimmune encephalitis with anti-NMDA antibodies after a herpetic encephalitis, managed by the National Reference Center for Paraneoplastic Syndromes and Autoimmune Encephalitis at the Neurological Hospital of Bron. | Other: Description and analysis<br>* Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Details of clinical, biological, imaging, therapeutic characteristics and patient's evolution. | Retrospective collection of clinical, diagnostic and therapeutic data, evolution at 6 and 12 months. | at 6 and 12 months |
Mapping Novel Disease Genes for Dilated Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
To identify new dilated cardiomyopathy genes by genetic linkage and mutational analyses.

Detailed Description
-----------------
BACKGROUND: Dilated cardiomyopathy (DCM) is a heritable, genetically heterogeneous disorder causing congestive heart failure. Current medical therapy has minimal impact on prognosis and cardiac transplantation is the only definitive treatment for end-stage disease. The molecular and cellular mechanisms underlying DCM are poorly defined, but the importance of single gene defects in disease pathogenesis is becoming increasingly apparent. DESIGN NARRATIVE: The genetic epidemiology study will identify novel dilated cardiomyopathy genes using genetic linkage and mutational analyses. The first aim is to determine the chromosomal location of novel familial dilated cardiomyopathy genes. This will be accomplished by genome-wide genotyping and genetic linkage analyses in three large families with autosomal dominant dilated cardiomyopathy. Previously identified dilated cardiomyopathy genes have been excluded in these families. The second aim is to identify mutations in novel genes that cause familial dilated cardiomyopathy by linkage and sequence analyses of candidate genes mapping to dilated cardiomyopathy loci. Once novel genes for familial dilated cardiomyopathy are identified, the third aim will be to determine the role of these genes in a large cohort of unrelated patients with familial and sporadic dilated cardiomyopathy. High throughput DNA sequence analyses will be performed to identify additional inherited and de novo mutations.

Conditions
-----------------
Cardiomyopathy, Congestive, Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
A2R and Ectonucleotidases Expression in Lung Cancer Circulating Tumor Cells

Study Overview
=================
Brief Summary
-----------------
Early non-small cell lung cancer (NSCLC), treated by surgery or radiotherapy in the case of inoperability, relapses in almost 50% of cases. Circulating tumour cells (CTCs), which can be detected before surgery, represent a promising prognostic tool, but the markers characterising their aggressiveness remain to be determined. The NSCLC microenvironment, in which purinergic signalling is a key pathway, controls tumour development. Adenosine derived from the action of CD39 and CD73 ectonucleotidases hydrolysing extracellular ATP, induces immunosuppression of NSCLC by activating A2R receptors. The expression and prognostic relevance of A2R, CD39 and CD73 on CTCs is unknown. The objectives are to (i) compare the expression of A2R and CD39 and CD73 on primary tumour cells and CTCs of patients operated on for early NSCLC, (ii) correlate these data with molecular characteristics and clinical response, (iii) determine on lung cancer lines whether irradiation impacts on the expression of A2R, CD39 and CD73. This work could contribute to the identification of new theranostic biomarkers.

Official Title
-----------------
Assessing the Expression of A2R Receptors and CD39 and CD73 Ectonucleotidases on Circulating Tumour Cells of Non-small Cell Lung Carcinoma

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Biological: Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
i) Inclusion criteria: Patient of legal age (>18 years), any gender, operated on for stage (IA to IIB) non-small cell lung cancer (NSCLC) ii) Exclusion criteria: Patient with any other active cancer. Lack of evaluable material.

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 |
| --- | --- |
| NSCLC patients<br>Patients with proven stage IA-IIB non-small cell lung cancer (NSCLC). | Biological: Sample<br>* Sample of whole blood and tissue for ex vivo expression of A2R, CD39, CD73 and P2RX7<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ex vivo expression of A2R (adenosine receptor), CD39, CD73 and P2RX7 on NSCLC and CTC | Presence versus Absence of expression (immunohistochemistry) | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vitro impact of radiation therapy on the A2R, CD39, CD73 expression by cells lineage | Upregulation / Downregulation of expression (mRNA by real time PCR) | At inclusion |
Prognostic Evaluation Of Severe Sepsis And Septic Shock. Procalcitonin Versus Delta Sofa

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the tendency of plasma concentration and clearance of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and septic shock with another marker of early prognosis represented by 48 hours delta sofa.

Detailed Description
-----------------
This is a cohort prospective observational study that will include adult patients admitted to a multidisciplinary ICU of a tertiary hospital.

Official Title
-----------------
PROGNOSTIC EVALUATION OF SEVERE SEPSIS AND SEPTIC SHOCK. PROCALCITONIN VERSUS DELTA SOFA

Conditions
-----------------
Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients admitted to the ICU severe sepsis and septic shock Exclusion Criteria: Children Pregnant.

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 |
| --- | --- |
| PROCALCITONIN<br> | |
| DELTA SOFA<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MORTALITY |  | 28 DAYS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis, Sepsis, Septic shock, Procalcitonin, SOFA
Use of 3D Ultrasound to Predict Anal Sphincter Defects

Study Overview
=================
Brief Summary
-----------------
Injury to the muscles of the back passage (anal canal) is a relatively common problem. This injury can result in problems with bowel control later in life and usually occurs during vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently women who have sustained injury to the muscles of the back passage undergo an ultrasound scan by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of the back passage has healed i.e is intact or has a defect. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the defects and hence avoid inserting the probe into the back passage. In addition to getting the above information using 3D ultrasound scan, the investigators would also like to identify injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury to this muscle are known to develop prolapse later on in life.

Official Title
-----------------
Use of 3D Ultrasound to Predict Anal Sphincter Defects

Conditions
-----------------
Obstetric Anal Sphincter Injury

Intervention / Treatment
-----------------
* Other: Pelvic Floor Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who sustained an obstetric anal sphincter injury referred to the perineal clinic Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pelvic Floor Ultrasound|Transperineal Ultrasound (3D TPUS) and Endovaginal Ultrasound (3D EVUS)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS) | To calculate the diagnostic test characteristics (e.g sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio) to enable comparison of three methods of ultrasound assessment of the anal sphincter following sphincter injury after vaginal delivery | 3 months Postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury | To calculate the prevalence of LAM avulsion in women with OASIS | 3 months Postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstetric anal sphincter injury,, Ultrasound diagnosis
A Non-Interventional Study To Assess Sweating

Study Overview
=================
Brief Summary
-----------------
To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.

Detailed Description
-----------------
This is a Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals . The objective of this study is to determine the threshold gravimetric measurement for subjects with palmar hyperhidrosis.

Official Title
-----------------
A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Other: gravimetric


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females should not be pregnant or lactating. For subjects with palmar hyperhidrosis: Primary palmar hyperhidrosis of at least 6 months's duration and Hyperhidrosis disease severity score of 3 or 4 at baseline For healthy participants: no history or current report of hyperhidrosis and Hyperhidrosis disease severity score of 1 at baseline Exclusion Criteria: Recent therapeutic interventions or treatments for palmar hyperhidrosis Any major illness within 30 days before the screening Females who are pregnant, lactating, or planning a pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| with hyperhidrosis<br>Patients with primary palmar hyperhidrosis | Other: gravimetric<br> <br> |
| healthy<br>Healthy adult patients | Other: gravimetric<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gravimetric Measurement by Weight | Sweat production quantified by measuring weight of absorbing gauze | 14 Days |
Measurement of the Distribution of Optical Properties in Adult Human Muscle

Study Overview
=================
Brief Summary
-----------------
The researcher can use Diffuse Optical spectroscopy technique that uses harmless levels of near-infrared light to probe the concentrations and states of important physiological molecules such as hemoglobin water and lipids in human muscle,.

Detailed Description
-----------------
The researcher can monitor muscle physiology, for example during exercise or in response to external factors such as shock by Diffuse Optical spectroscopy technique. The Diffuse Optical spectroscopy technique can determine significant changes in muscle, muscle structure, muscle tissues metabolism and hemodynamics.

Official Title
-----------------
Measurement of the Distribution of Optical Properties in Adult Human Muscle

Conditions
-----------------
Muscle Disorder

Intervention / Treatment
-----------------
* Device: Diffuse Optical Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female age 18 years and older Diagnosed of Cachexic condition Diagnosed of Cellulite adult female 18 years and older Exclusion Criteria: Pregnant women Taking light sensitive drugs for use in photodynamic therapy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Diffuse Optical Spectroscopy|Muscle properties|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Muscle |  | upto 4 weeks |
Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.

Official Title
-----------------
A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: isophane human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive Non-smoker, defined as no nicotine consumption for at least one year Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L) Exclusion Criteria: Previous participation in this trial or other clinical trials within the last 3 months Body weight above 87.5 kg Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant) History of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br> | Drug: isophane human insulin<br>* Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits<br>|
| Active Comparator: Formulation B<br> | Drug: isophane human insulin<br>* Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve (AUC 0-24 hours) |  |  | 
| Maximum serum insulin concentration (Cmax) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve (AUC 0-inifinity hours) |  |  | 
| Time to maximum serum insulin concentration (tmax) |  |  | 
| Terminal serum insulin half life (t½) |  |  | 
| Adverse events |  |  |