linjc16/ctgov huggingface dataset:
Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid- Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: N-methylnaltrexone bromide (MOA-728)
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer. Taking oral, transdermal, intravenous, or subcutaneous opioids. Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives. Exclusion Criteria: History of chronic constipation before the initiation of opioid therapy. Other GI disorders known to affect bowel transit. Women who are pregnant, breast-feeding, or plan to become 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: placebo<br>* placebo<br>|
| Experimental: 150 mg<br> | Drug: N-methylnaltrexone bromide (MOA-728)<br>* Oral<br>|
| Experimental: 300 mg<br> | Drug: N-methylnaltrexone bromide (MOA-728)<br>* Oral<br>|
| Experimental: 450 mg<br> | Drug: N-methylnaltrexone bromide (MOA-728)<br>* Oral<br>|
| Experimental: 600 mg<br> | Drug: N-methylnaltrexone bromide (MOA-728)<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment |  | 6 hours |
Ultrasound and Endometrial Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.

Detailed Description
-----------------
The objective is to identify the utility of ultrasound as a screening test for endometrial hyperplasia and cancer in an at risk cohort. Endometrial carcinoma is an understudied cancer. This study will provide benefit regardless of its outcome, because it will be the first prospectively designed screening trial in an asymptomatic population.

Official Title
-----------------
Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort

Conditions
-----------------
Endometrial Hyperplasia

Intervention / Treatment
-----------------
* Procedure: Ultrasound and Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension Exclusion Criteria: Women who have had a hysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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: Ultrasound and Biopsy<br>Transvaginal Ultrasound and Endometrial Biopsy | Procedure: Ultrasound and Biopsy<br>* Transvaginal ultrasound and Endometrial Biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Hyperplasia | A transvaginal ultrasound of the endometrium will be performed to obtain measures of the anteroposterior endometrial thickness (in the sagittal plane), the dimensions of the endometrial cavity (thickness, length and width), and the appearance of the endometrium in addition to uterine and ovarian measures. Endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with the metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity. | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Cancer | All women will then undergo an endometrial biopsy. The pipelle has been shown to be an accurate method of diagnosing endometrial cancer comparable to a full dilatation and curettage of the uterus. We believe it is important to perform a biopsy even in women with a thin endometrial stripe (<5mm), as it will be important for determining the specificity and negative predictive value of both ultrasound and any serum screening strategy we devise. | End of study |
Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

Study Overview
=================
Brief Summary
-----------------
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)

Official Title
-----------------
Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study

Conditions
-----------------
NK/T Cell Lymphoma Nos

Intervention / Treatment
-----------------
* Drug: sintilimab,pegaspargase,gemcitabine,oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved extranodal natural killer/T-cell lymphoma, nasal type; newly diagnosed stage III/IV patients; at least one evaluable lesion； ECOG PS 0-2; 18-75 years; without other malignancy; proper functioning of the major organs. Exclusion Criteria: hemophagocytic syndrome or aggressive NK cell leukemia; involvement of central nervous system; previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Sintilimab With P-GemOx<br>Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy. | Drug: sintilimab,pegaspargase,gemcitabine,oxaliplatin<br>* All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy. Patients with CR or PR will receive sintilimab maintenance therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission (CR) rate |  | 2years | 
| overall response rate (ORR) |  | 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | 2years | 
| progression survival (PFS) |  | 2years | 
| disease-free survival (DFS) |  | 2years | 
| bio-marker analysis | Correlation between programmed death-ligand 1 expression and efficacy | 2years |
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples

Study Overview
=================
Brief Summary
-----------------
This clinical research protocol is intended to allow for bone marrow aspirate/biopsy and blood specimens to be collected for research purposes, specifically allowing subjects the option of sedation during the bone marrow procedure. Samples will be banked for future research related to cancer and other diseases. Researchers hope this protocol will improve the collection of research correlative and translational biopsy specimens for clinical research.

Official Title
-----------------
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples

Conditions
-----------------
No Restrictions on Diagnosis

Intervention / Treatment
-----------------
* Other: Obtaining human tissue for basic research or biospecimen bank


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned procedure including a bone marrow aspirate and/or bone marrow biopsy The procedure is planned for the purpose of obtaining a research specimen (as part of another research study or as part of this stand-alone sample collection protocol.). Procedures with a dual purpose (i.e. to obtain both clinically-indicated specimens and research specimens) are permitted, but procedures to obtain clinical specimens only are not permitted. All subjects must provide written informed consent for the biopsy procedure, the collection of bone marrow and blood specimens for research purposes and (if planned) the administration of sedation. Exclusion Criteria: Moderate sedation may not be administrated to subjects with a clinical contraindication to its provision, or if the investigator believes that administration of moderate sedation would constitute under risk to the subject.

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 |
| --- | --- |
| Bone marrow aspirate/biopsy and blood specimens<br>Collection of blood and bone marrow specimens for research purposes and increase the successful acquisition of correlative bone marrow samples to improve translational research in bone marrow diseases | Other: Obtaining human tissue for basic research or biospecimen bank<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 2 years |
Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis is a chronic inflammatory systemic disease. It has a worldwide distribution and can affect all age group. The peak incidence is between fourth and sixth decade. It is more prevalent in women, and it's prevalence in the general population in North America is between 0.2-1.5%. The etiology of RA is unknown, although clusters of the disease in families and high concordance in mono-zydotic twins support genetic predisposition. The prevalence of fatty liver disease in patients with rheumatoid arthritis is currently unknown. We wish to study the link between the two conditions by performing a son graphic imaging of the liver in a cohort of RA patients. If indeed a high prevalence of NAFLD will be found in the RA patients, further support will be landed for the link between inflammation and fatty liver disease. These findings may also have implications regarding the management and follow up of RA patients. The validity of sonographic imaging for detection of fatty liver diseases is currently accepted: On ultrasonographic, fatty infiltration of the liver produces a diffuse increase in echogenicity as compared with that of the kidneys. Ultrasonography has a sensitivity of 89% and a specificity of 93% in detecting steatosis and sensitivity and specificity of 77% and 89% respectively in detecting increase fibrosis. In view of all the above data, we expected to find higher prevalence of fatty liver in the patients with higher inflammation markers compare with patients with lower markers.

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Procedure: Ultrasonographic imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis Exclusion Criteria: Age below 18

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

| Intervention/Treatment |
| --- |
|Procedure: Ultrasonographic imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures

Study Overview
=================
Brief Summary
-----------------
To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.

Official Title
-----------------
An Open, Randomized, Parallel Group, Single Center Study to Investigate the Effect of Lactulose Versus Plantago Ovate on the Quality of Life of Patients With Hard Stools and Hemorrhoids or Anal Fissure

Conditions
-----------------
Hemorrhoids, Anal Fissures

Intervention / Treatment
-----------------
* Drug: Lactulose
* Drug: Plantago ovata


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure. Exclusion Criteria: Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Lactulose Group | Drug: Lactulose<br>* 15 mL / 12 hours<br>|
| Active Comparator: B<br>Plantago Group | Drug: Plantago ovata<br>* 3,5 g / 12 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients with hard stools and hemorrhoids or anal fissure |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptoms Rating Scale |  | 6 weeks | 
| Bristol stool consistency scale |  | 6 weeks | 
| Number of episodes of rectal bleeding |  | 6 weeks | 
| Need of rescue medication |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lactulose, randomised clinical trial, hemorrhoids, anal fissures
The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study; Part 2

Study Overview
=================
Brief Summary
-----------------
The investigators major aims are to: determine the vitamin D status of a group of young, apparently healthy adults in Hong Kong; examine inter-relationships between vitamin D status and biomarkers of DNA damage and repair, oxidative stress, inflammation and endothelial health; and, in part 2 of the study, investigate effects of improvement in vitamin D status on these biomarkers and other measures of well-being in those young adults shown to be deficient in vitamin D.

Detailed Description
-----------------
In this part 2 of the study the investigators will investigate the effect of vitamin D supplementation on biomarkers of these 'hidden' changes in apparently healthy young adults. The investigators will also explore the effect of improvement in vitamin D status in young apparently healthy adults in regard to muscular strength and response time, glucose control, a hormone that is linked to vitamin D (parathyroid hormone (PTH) ) and mood.

Official Title
-----------------
The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: apparently healthy, non-smokers non-obese found (in part1) to have low vitamin D status Exclusion Criteria: chronic illness serious illness requiring medical treatment in previous 6 months pregnancy on regular medication or taking supplements on a regular basis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 26 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>vitamin D supplementation group (2500 IU day for 3 months) | Dietary Supplement: Vitamin D<br>* 2400 units per day for 3 months<br>* Other names: cholecalciferol;|
| Placebo Comparator: Control<br>no vitamin D supplementation | Dietary Supplement: Vitamin D<br>* 2400 units per day for 3 months<br>* Other names: cholecalciferol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarkers of oxidative stress |  | 3 months |
Bone Marrow Grafting for Leukemia and Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain tissue samples for ongoing studies regarding transplant outcomes and complications.

Detailed Description
-----------------
The purpose of this study is to acquire critical tissue and biological samples that can be evaluated to elucidate underlying mechanisms of disease control, transplant related complications and overall outcomes

Official Title
-----------------
Bone Marrow Grafting for Leukemia and Lymphoma

Conditions
-----------------
Leukemia, Lymphoma, Hematologic Diseases

Intervention / Treatment
-----------------
* Procedure: collection and storage of tissue samples for research


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- All hematopoietic cell transplant recipients and donors who agree to participate Exclusion Criteria:- Subject does not agree to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Graft recipients and donors<br> | Procedure: collection and storage of tissue samples for research<br>* Tissue samples include blood draws for the donor and recipient. A bone marrow sample may be obtained from the recipient. If the recipient undergoes a tissue biopsy for clinical reasons, a small fraction may be removed for research purposes. A small fraction of the donor graft may be removed at the time of collection for research.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify and characterize proteins and genes that may contribute to the development and progression of cancer. |  | blood sample is collected prior transplant, periodically during the first three months and then indefinately at follow up |
Evaluation of Co-morbidity Scales

Study Overview
=================
Brief Summary
-----------------
Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status (American Society of Anesthesiology) is the most commonly scale to assess this parameter and has yet been repeatedly criticized in the past for its discriminatory power. Few studies have shown both the ASA physical status and the more detailed and more time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations. The purpose of this observational study is to compare the predictive value of both scales with regards to all-cause in-hospital mortality and hospital length of stay.

Official Title
-----------------
Retrospective Data Analysis: Evaluation of Co-morbidity Scales in Peri-operative Medicine

Conditions
-----------------
Postoperative Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) All male and female Patients who underwent anesthesia within the study time period (January 2006 and December 2011) in the Charité - University Berlin, Department of Anesthesiology and Intensive Care Medicine CVK/CCM. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 100 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 |
| --- | --- |
| Anesthesia patients<br>All patients undergoing general anesthesia between January 2006 and December 2011 in Charité - University Berlin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that died after surgery during their hospital stay | Electronic patient charts are revised for the complete hospital length of stay for co-morbidities, intra-operative data and post-operative all-cause in-hospital mortality. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay associated with surgery | Electronic patient charts are revised for the complete hospital length of stay for co-morbidities, intra-operative data and post-operative all-cause in-hospital mortality | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comorbidity