linjc16/ctgov huggingface dataset:
A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
Objective: The purpose of this study is to demonstrate: -the non-inferiority of an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis patients.

Official Title
-----------------
A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: Experimental Peritoneal Dialysis Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have given written informed consent after the nature of the study has been explained. Patients who are at least 18 years of age. Patients who have been treated with CAPD using specific solutions for at least 60 days before the baseline visit. Exclusion Criteria: Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit. - Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit. Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection. Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit. Patients who have severe malnutrition (serum albumin < 25 g/l by bromocresol green method). Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted. Patients who have received an investigational product within 30 days preceding the screening visit. Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study). Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Experimental Peritoneal Dialysis Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.

Official Title
-----------------
A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: docetaxel
* Drug: PF-3512676


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with confirmed advanced breast cancer. Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen. Patients with adequate general well-being, kidney and liver function. Exclusion Criteria: Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study. Patients who have had prior chemotherapy for advanced breast cancer. Patients of child-bearing potential who are unwilling to use contraception.

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

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: PF-3512676|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Tumor assessment every 6 weeks until disease progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression |  |  | 
| Overall Survival - Patients will be followed for survival |  |  | 
| Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up |  |  | 
| Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy |  |  |
Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration

Study Overview
=================
Brief Summary
-----------------
The rational of the study is to assess the implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and ovulation.

Official Title
-----------------
Cryopreserved-Thawed Embryo Transfer in Natural Cycle or in Natural Cycles Controlled by External Administration of hCG: a Prospective Randomized Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: HCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age <40 BMI:18-29Kg/m2 day 3 embryo transfers previously IVF or ICSI Exclusion Criteria: irregular cycles oocyte donation cycles

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 40 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HCG GROUP | Drug: HCG<br>* 5000IU<br>* Other names: pregnyl;|
| No Intervention: 2<br>LH pick | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natural cycle, FET, spontaneous LH pic, HCG
AADI Glaucoma Shunt - a Quality Control Study

Study Overview
=================
Brief Summary
-----------------
To prospectively investigate the effect and safety of implantation of the AADI glaucoma tube in eyes with medically intractable glaucoma in the period 2019 to 2020, at the Department of Ophthalmology, Odense University Hospital. The device will be implanted in eyes instead of the Bearveldt drainage device. Patients and data are prospectively registered to evaluate the effect and safety of the AADI device.

Official Title
-----------------
AADI Glaucoma Shunt - a Quality Control Study

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: AADI glaucoma shunt


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients referred to glaucoma shunt implant (Baerveldt) will recieve the AADI glaucoma shunt
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: AADI glaucoma shunt|Implantation of the nonvalved AADI glaucoma shunt instead of the Bearveldt tube shunt, in eyes with intractable glaucoma. It is not a RCT study, but a prospective evaluation of the AADI device, and the study has been approved as a quality control study at the Department of Ophthalmology, at Odense University Hospital|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IOP | Intraocular pressure before and after surgery | Baseline and after 12 months | 
| The change in number of IOP lowering drugs | Number of IOP lowering drugs before and after the surgery | Baseline and after 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AADI; glaucoma tube shunt
The Neural Representation of Self in Depression Patients

Study Overview
=================
Brief Summary
-----------------
To be aware of oneself as a unique entity in the world occurs early in human development and is the prerequisite of normal social functioning. The disturbance of self representation characterizes a variety of mental disorders such as autism and schizophrenia. Negative self-bias was found to serve as the core cognitive mechanism of depression disorder. However, there was no evidence to show the reason lead to negative bias. In the current study, investigators hypothesized that the blurring self representation was the neural correlates in depression disorder.

Detailed Description
-----------------
To test investigators' hypothesis, investigators adopted the self-referential task and fMRI to investigate the neural representation of self in depression patients, and compared with healthy control.

Official Title
-----------------
The Different Neural Representation of Self in Depression Patients and Healthy Individuals.

Conditions
-----------------
Healthy, Depression Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be clinical diagnosis of major depression disorder. Healthy control participants should be age-matched with depression group, and should have no history of neurological or psychiatric diagnoses Exclusion Criteria: Patients who also have bipolar disorder, schizophrenia, anxiety disorder Healthy controls who have history of mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Neural representation of self | We adopted the self referential task. In the task, participants were asked to judge whether a given word was appropriate to describe oneself (self-judgement condition), a celebrity (other-judgement condition) by pressing one of the two buttons with the index or middle finger. For judgments of each target person (i.e, self and celebrity), there were 3 categories of words describing the mental (personality traits, such as hard-working, friendly), physical (physical attributes, such as black hair, big eyes) and social (social roles, such as student, American) dimension of person knowledge. The fMRI task contained 6 runs, with 4.6 minutes per run. This paradigm and task allowed us to investigated the neural representation of self by comparing the BOLD activity under self-judgement condition with BOLD activity under other-judgement condition. | through study completion, an average of 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, self-referential, neural representation
A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension

Official Title
-----------------
A Phase 1/2 Multicenter, Randomized, Controlled Dose-Finding Study to Evaluate the Safety and Ocular Hypotensive Efficacy of 3 Dose Levels of the VS101 Subconjunctival Latanoprost Insert for 3 Months in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: VS101 Insert Dose A
* Drug: VS101 Insert Dose B
* Drug: VS101 Insert Dose C
* Drug: Latanoprost 0.005% eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Open angle glaucoma or Ocular Hypertension Exclusion Criteria: uncontrolled medical conditions wearing of contact lenses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VS101 Insert Dose A<br>VS101 Insert Dose A placed under the conjunctiva | Drug: VS101 Insert Dose A<br>* Sustained release of latanoprost into the eye<br>|
| Experimental: VS101 Insert Dose B<br>VS101 Insert Dose B placed under the conjunctiva | Drug: VS101 Insert Dose B<br>* Sustained release of latanoprost into the eye<br>|
| Experimental: VS101 Insert Dose C<br>VS101 Insert Dose C placed under the conjunctiva | Drug: VS101 Insert Dose C<br>* Sustained release of latanoprost into the eye<br>|
| Active Comparator: Latanoprost 0.005% eye drops<br>Latanoprost 0.005% eye drops administered once daily on the eye | Drug: Latanoprost 0.005% eye drops<br>* Latanoprost 0.005% eye drops administered once daily on the eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-ocular pressure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-ocular pressure |  | Week 8 | 
| Intra-ocular pressure |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Intra-ocular pressure, Slow Release, Controlled release
Melatonin and Adiponectin in Hypertensive Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome. We have also demonstrated that exogenic melatonin supplementation can improve blood pressure profile in nondipper patients. The aim of this study is to find whether there is a difference between melatonin secretion in hypertensive kidney recipients versus normal hypertensive patients. Secondly, to ask if there is any correlation between melatonin secretion and adiponectin levels.

Conditions
-----------------
Hypertension, Kidney Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertension kidney transplantation ( group 1) good renal function Exclusion Criteria: diabetes mellitus cancer renal failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| 1<br>kidney transplant with hypertension | |
| 2<br>hypertensive patients with native kidneys | |
| 3<br>healthy controls | |

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
-----------------
hypertension, kidney transplant, melatonin, adiponectin
Weight Set-Point and HDL Concentration in Runners

Study Overview
=================
Brief Summary
-----------------
To investigate the differences in diet, fat cell morphology and lipoprotein metabolism in previously- overweight and naturally lean men and women who ran and who lived sedentary lifestyles in order to better understand the relationship between lipoprotein metabolism and weight set-point.

Detailed Description
-----------------
BACKGROUND: The elevated high-density lipoprotein (HDL) cholesterol concentrations of long distance runners has been ascribed almost exclusively to increased muscle lipoprotein lipase. Based on data collected in cross-sectional and longitudinal studies, the investigators proposed an alternative theory: long-distance runners had the HDL-cholesterol metabolism of men who were below their sedentary weight rather than the HDL-cholesterol metabolism of lean sedentary men who were at their usual sedentary weight. In other analyses, they found that the most significant determinant of male runners' plasma HDL-cholesterol concentrations was the difference between the runners' greatest weight and their current weight. HDL- cholesterol levels were highest in runners who had lost the most weight, i.e., highest in those who were presumed to be the furthest below their weight set-point The study was a result of a Program Announcement (PA) released in October, 1994 on Physical Activity and Cardiopulmonary Health. The PA was jointly sponsored by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research. DESIGN NARRATIVE: In this cross-sectional study, runners and sedentary men and women were measured for lipoprotein cholesterol, triglycerides, polyacrylamide gel electrophoresis of HDL and low-density lipoprotein subclasses, apolipoproteins A-I and B, intravenous fat clearance rate, post-heparin lipoprotein lipase and hepatic lipase, adipose tissue lipoprotein lipase, cholesteryl ester transfer activity, diet, percent body fat, and regional adiposity. It was hoped that the survey would confirm or reject the weight set-point hypothesis, provide a possible explanation of the lipoprotein differences between male and female runners, and elucidate the mechanism for the lipoprotein changes that occur during exercise-induced weight loss. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Obesity, Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure

Study Overview
=================
Brief Summary
-----------------
Pressure generated by cough is an expression of expiratory muscle strength. Cough pressure (Pcough) is usually measured with gastric and/or esophageal catheters, but these are often either inconvenient or uncomfortable for the patient. The aim of this study was to evaluate whether central venous, vesical or rectal catheters could be useful to measure cough pressures as alternative sites to standard esophageal and gastric balloons.

Official Title
-----------------
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure

Conditions
-----------------
Respiratory Physiology

Intervention / Treatment
-----------------
* Procedure: Cough pressure measurement
* Device: Pcough


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 to 75 years and scheduled for colon cancer surgery were recruited. Informed consent signed. Exclusion Criteria: Rectal surgery, advanced cancer, abdominal wall disorders, respiratory or neuromuscular illness, body mass index > 30, chronic pain, pregnancy and inability to cough adequately.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cough<br> | Procedure: Cough pressure measurement<br> <br> Device: Pcough<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough pressure |  | From baseline until 1 hour |