linjc16/ctgov huggingface dataset:
VA111913 TS: First in Human Study

Study Overview
=================
Brief Summary
-----------------
This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy non-pregnant female volunteers of child bearing age.

Detailed Description
-----------------
VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the uterine muscle are required for normal menstruation. Women with dysmenorrhea have increased uterine myometrial tone and contractions and decreased blood flow to the uterus. These abnormalities have been shown to lead to the pain experienced in dysmenorrhea. Thus, if a drug is able to reduce the hyperreactivity of the uterus to physiological levels then the pain experienced in dysmenorrhea may be controlled. In humans, vasopressin, via the V1a receptor, is able to potently induce contractions in both uterine smooth muscle and uterine blood vessels. Thus, a V1a receptor antagonist will potentially inhibit these contractions and in turn reduce the pain experienced in dysmenorrhea.

Official Title
-----------------
A First in Human Study Consisting of a Two-Part, Double-Blind, Placebo-Controlled, Escalating Single and Multiple Dose Study of VA111913 TS in Adult Non-Pregnant Women Volunteers With a Single Dose, Open, Fed vs. Fasting Crossover Phase

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: VA111913 TS / placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females 18 to 45 years of age. Subjects must have a negative pregnancy test at screening and admission. Using acceptable form of contraceptive during and after study. Exclusion Criteria: Administration of any IMP within 12 weeks before entry to the study or any prescribed medicine within 14days of the study. Any clinically important medical disease, condition or abnormal laboratory test results. Other protocol-defined inclusion/exclusion criteria may apply

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VA111913 TS / placebo|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
-----------------
Healthy (Dysmenorrhea)
Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss

Study Overview
=================
Brief Summary
-----------------
Does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?

Detailed Description
-----------------
Over the last decade, the APS has emerged as most important treatable cause of recurrent miscarriages. The pathogenesis of fetal loss in this condition is still remains obscure. Despite the success of aspirin + heparin treatment, some pregnant women with APS repeatedly miscarry even on treatment. The trial is designed to determine if addition of steroids has an success in these women. This is in view of recent in vitro data from our unit reporting that there is an increase decidual cytokine response in APS positive women.

Official Title
-----------------
Randomised Controlled Trial of Low Dose Steroid +Aspirin +Heparin Versus Aspirin+Heparin Amongst Pregnant Women With APS

Conditions
-----------------
Antiphospholipid Syndrome

Intervention / Treatment
-----------------
* Drug: Low dose steroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of 3 or more consecutive miscarriages and positive antiphospholipid antibodies on at least two occasions more than 6 weeks apart before becoming pregnant and an unsuccessful pregnancy with aspirin + heparin with a karyotype of miscarriage either unavailable or normal (46XX/ 46XY). Exclusion Criteria: Abnormal karyotype of women or partner, previous thromboembolism, SLE, diabetes mellitus, hypertension, sensitivity to aspirin, heparin and prednisolone, multiple pregnancy.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Low dose steroids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful pregnancy outcome |  |  |
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome

Study Overview
=================
Brief Summary
-----------------
In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes. In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.

Detailed Description
-----------------
Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium. Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration. Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.

Official Title
-----------------
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome: a Prospective, Randomized Sibling-oocyte Study

Conditions
-----------------
Couple Sterility

Intervention / Treatment
-----------------
* Dietary Supplement: Myo-inositol
* Other: untreated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: couple counselled for IVF Exclusion Criteria: cryopreserved sample

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: untreated<br>Semen was prepared with routinely used media | Other: untreated<br> <br> |
| Experimental: myo-inositol<br>routinely used semen preparation media have been enriched with myo-inositol 2mg/ml. in particular the stock solution was prepared in order to add 15microliters per ml of medium | Dietary Supplement: Myo-inositol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetilization rate |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo quality |  | Day 2 to Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myoinositol, ART, EMBRYO QUALITY
Study of the Quality of Lung Resection

Study Overview
=================
Brief Summary
-----------------
In 2009, centres that carried out lung resection for cancer were required to obtain authorization following the first cancer plan. One of the criteria to obtain authorization was the volume of activity: the centre had to carry out at least 30 lung resections per year for cancer. Five years later, it would be useful to know the impact of this new organization of oncology on the quality of care. To answer this question, the PMSI database is an ideal source of an indicator of quality: in-hospital mortality. This observational cohort study will be conducted using the national PMSI database with data covering the period from 1st January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection. The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period 2008-2010 includes the implementation of authorizations for cancer surgery.

Official Title
-----------------
Measurement of the Quality: Application to Lung Resection for Cancer Using a National PMSI Database

Conditions
-----------------
Bronchial Cancer

Intervention / Treatment
-----------------
* Procedure: resection pulmonaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patients who underwent lung resection for bronchial cancer will be included in this study. The PMSI (Programme de Médicalisation des Systèmes d'Information) database will be searched for all patients with: A principal diagnosis of ICD10 (international classification of diseases) codes for bronchial cancer And CCAM (Classification Commune des Actes médicaux ) procedure codes for lung resection (segmentectomy, lobectomy, pneumonectomy). Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients undergoing lung resection<br> | Procedure: resection pulmonaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of deaths during hospitalization | number of death during hospitalization for pulmonary resection from 2005 to 2013 | 9 years |
Pancytopenia Related to PARP Inhibitors (PancytoRIB)

Study Overview
=================
Brief Summary
-----------------
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce. The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Detailed Description
-----------------
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of pancytopenia related to PARPi.

Official Title
-----------------
Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: PARP inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction, patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none) and pamiparib (none). Exclusion Criteria: chronology not compatible between the PARPi and adverse event.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PARP inhibitor|All patients treated at least with 1 PARPi|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancytopenia reports related to PARPi. | Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports. | From inception to Feb, 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the latency period since first PARPi exposure. |  | From inception to Feb, 2021 | 
| Description of the fatality rate. |  | From inception to Feb, 2021 | 
| Description of patients who experienced co-reported adverse events |  | From inception to Feb, 2021 |
Abuse Potential of Buprenorphine/Naloxone

Study Overview
=================
Brief Summary
-----------------
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

Detailed Description
-----------------
Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone. Participants will be maintained on both low and high doses of buprenorphine/naloxone. They will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. During study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

Official Title
-----------------
Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine/naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Actively abusing illegal opioids Qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry Meets DSM-IV criteria for opioid dependence Exclusion Criteria: Significant medical problems (e.g., insulin dependent diabetes mellitus) Non-substance use psychiatric disorders (e.g., schizophrenia) Seeking substance abuse treatment

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

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine/naloxone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate withdrawal |  | up to one day | 
| opiate agonist symptoms |  | up to one day | 
| physiologic measures |  | up to one day |
Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)

Study Overview
=================
Brief Summary
-----------------
The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

Detailed Description
-----------------
Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost. To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Official Title
-----------------
Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application

Conditions
-----------------
Obstetrics, Labor

Intervention / Treatment
-----------------
* Device: CLM - HA Continuous Monitoring System Heart Application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboring women refered to the maternity center in active labor (3cm dilatation and contraction) Gestational age 37-42 weeks. (GA) Single Fetus. Subjects who understand, agreed and signed the informed consent form. Exclusion Criteria: Women with abnormal placentation (Placenta previa) - Abnormal fetal presentation (Breech presentation). Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes. Need for immediate delivery (cord prolapsed or suspected placental abruption)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| 1<br> | Device: CLM - HA Continuous Monitoring System Heart Application<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring fetal heart movement |  | During labour |
Turkish Version of the Movement Imagery Questionnaire-3

Study Overview
=================
Brief Summary
-----------------
Motor imagery is the mental representation of movement without any body movement. According to recent studies motor imagery contains three strategies to mentally simulate the movements: internal visual, external visual and kinesthetic imagery. Motor imagery is associated with cortical reorganization and functional improvements and it does not only related with motor performance, it also influces cognitions. Movement Imagery Questionnaire-3 (MIQ-3) is the recent, modified version of the Movement Imagery Questionnaire-Revised, Second Edition and measures imagery ability in terms of ease of imagery. The aim of this study is to translate MIQ-3 into Turkish and evaluate its test-retest reliability for Turkish-speaking population.

Official Title
-----------------
Reliability and Validity of the Turkish Version of the Movement Imagery Questionnaire-3

Conditions
-----------------
Image, Body

Intervention / Treatment
-----------------
* Behavioral: Determining Imaginary levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18, consenting, with no limitation in mobility or movement disorder Exclusion Criteria: refuse to attend to the study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Determining Imaginary levels|Determining the motor imaginary: internal visual, external visual and kinesthetic imagery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cronbach's Alpha coefficient | Cronbach's Alpha coefficient was used to determine internal consistency of the questionnaire and its subscales | 2 years | 
| MIQ-3 total score | MIQ-3 total score was got after calculate the all values. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MIQ-3 subscale score | MIQ-3 subscore was got after calculate the all values for each subscale. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
imaginary, Turkish version, motor imagery, reliability