linjc16/ctgov huggingface dataset:
How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.

Official Title
-----------------
Immunotherapy Multi-omics Specimen Protocol A

Conditions
-----------------
Skin Cancer, Autoimmunity, Melanoma, Merkel Cell Carcinoma, Squamous Cell Carcinoma of the Skin, Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: Immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age. Diagnosis of skin cancer. Planning to initiate or already on ANY type of immunotherapy. Able to provide urine and stool specimens. Exclusion Criteria: Bowel resection. Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.

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 |
| --- |
|Biological: Immunotherapy|Medications that increase the activity of the immune system.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune-related Adverse Events (irAEs) | Electronic medical records will be queried for specific drug-related adverse events known as immune-related Adverse Events (irAEs) including but not limited to colitis, hypophysitis, hepatitis, pneumonitis, pancreatitis, arthritis, rash, and vitiligo. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall Survival | 2 years |
The Nordic Consensus Study

Study Overview
=================
Brief Summary
-----------------
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.

Detailed Description
-----------------
The primary objective is to evaluate the usability of the Body Assessment Tool for the nurse. The secondary objectives are to explore if the use of Body Assessment Tool has an impact on the leakage associated Quality of Life and leakage incidences. Forty to fifty ostomates will be enrolled from each Nordic country (i.e. Denmark, Sweden, Norway and Finland). The users will be recruited from 5-10 clinics in each country. The evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user (end-of study phone visit). The usability of the Body Assessment Tool will be evaluated by the nurses. The user's leakage and QoL will be evaluated by the end-users.

Official Title
-----------------
The Nordic Consensus Study

Conditions
-----------------
Stoma Site Leakage, Quality of Life, Nurse's Role, Stoma Ileostomy, Colostomy Stoma

Intervention / Treatment
-----------------
* Other: Body Assessment Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ostomates Male or female ≥18years Leakage issues Exclusion Criteria: Requires a caretaker or is unable to participate in the study Is pregnant or lactating

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 |
| --- | --- |
| Ostomates<br>Ostomates with leakage issues and stoma created at least 3 months ago | Other: Body Assessment Tool<br>* Assessment tool to evaluate stoma to find proper ostomy products<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Assessment | Evaluate Body Assessment Tool based on the Nurse Evaluation Form | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | Rating of the user's leakage associated QoL | 1 months |
Utility of Renal Biomarkers in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. The investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and pre-renal causes. Finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.

Official Title
-----------------
Utility of Renal Biomarkers in Cirrhotic Patients

Conditions
-----------------
Cirrhosis, Ascitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Known or suspected cirrhosis Suspected ascitis Informed consent signed Exclusion Criteria: Proven multifocal hepatocellular carcinoma Acute gastric hemorrhage (active or < 2 weeks) Known end-stage renal disease or on dialysis before admission Recipients of kidney or liver transplants Transferred from another institution

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 |
| --- | --- | --- |
| Early detection of acute kidney injury in hospitalized cirrhotic patients with ascitis using new renal biomarkers | Acute kidney injury will be defined using RIFLE and AKIN criteria. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality). |  | 30 days | 
| Discrimination between different type of AKI. |  | 30 days | 
| Prediction of AKI developement using renal artery resistive indexes. |  | 30 days |
An Integrated Radio-immunological Approach

Study Overview
=================
Brief Summary
-----------------
The most aggressive primary brain tumors in adults, glioblastomas, are characterized by a profound local and systemic immune suppression. During tumor progression, the infiltration of inflammatory leukocytes, especially of myeloid origin, endowed with immunosuppressive function is observed. Aim of this study is to evaluate myeloid cell infiltrate and iron metabolism in tumor-associated macrophages by combining a multimodal MRI imaging technique with immunophenotyping of the tumor microenvironment.

Official Title
-----------------
Identification of the Immuno Suppressive Characteristics of Glioma Patients by an Integrated Radio-immunological Approach

Conditions
-----------------
Glioma, Malignant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with histologic confirmation of malignant glioma Patients must be age >= 18 years Patients must be able to obtain an MRI scan with gadolinium contrast Patients must sign informed consent indicating that they are aware of the investigational nature of this study:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Evaluate leukocyte/myeloid cell-infiltrate in gliomas by using a multimodal PET/MRI imaging technique | apply iron-sensitive MRI sequences in glioma patients to identify macrophage iron deposits as biomarker of in vivo immune suppression, and correlate these findings with 5-Ala intraoperative data and analysis of MG and BMDM infiltration. | 24 months |
Effects of Alcohol History on Effects of Nitrous Oxide - 9

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.

Official Title
-----------------
Effects of Alcohol History on Effects of Nitrous Oxide

Conditions
-----------------
Alcohol-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 0% N2O and 10% N2O
* Drug: 0% N2O and 20% N2O
* Drug: 0% N2O and 30% N2O
* Drug: 0% N2O and 40% N2O


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 37 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Light drinkers<br> | Drug: 0% N2O and 10% N2O<br> <br> Drug: 0% N2O and 20% N2O<br> <br> Drug: 0% N2O and 30% N2O<br> <br> Drug: 0% N2O and 40% N2O<br> <br> |
| Active Comparator: Moderate drinkers<br> | Drug: 0% N2O and 10% N2O<br> <br> Drug: 0% N2O and 20% N2O<br> <br> Drug: 0% N2O and 30% N2O<br> <br> Drug: 0% N2O and 40% N2O<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of nitrous oxide vs placebo | Two subject groups (light drinkers vs moderate drinkers) were asked to inhale a given conc of N2O and inhale a placebo, then choose for a third inhalation. The subject & the technician administering the inhalant were blinded. Testing was done at each dose. | After 30 min inhalation each of N2O and placebo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitrous oxide, subjective effects, ethanol, healthy volunteer
Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Study Overview
=================
Brief Summary
-----------------
Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.

Detailed Description
-----------------
The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.

Official Title
-----------------
Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Conditions
-----------------
Abortion, Missed

Intervention / Treatment
-----------------
* Drug: Mifepristone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: midtrimester late abortion midtrimester induced abortion Exclusion Criteria: placenta previa infected abortion rupture of membranes s/p cesarean section *2 or more

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitocin<br>Treatment with Pitocin after mifegine | Drug: Mifepristone<br> <br> |
| Active Comparator: Cytotec<br>Treatment with cytotec after mifegine | Drug: Mifepristone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of abortion induction |  |  | 
| abortion induction duration |  |  |
Nonalcoholic Steatohepatitis in Chinese Children

Study Overview
=================
Brief Summary
-----------------
Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality. A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.

Official Title
-----------------
Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 1-18 with biopsy-proven NAFLD Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively Exclusion Criteria: with viral hepatitis, e.g. HBV, HCV with a1-anti-trypsin disease with autoimmune hepatitis with Wilson disease with liver impaired by drugs

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|There will be no specific intervention to these paediatric NASH patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver related death | Whether the patients die from liver-related causes | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of cirrhosis | Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up | Through study completion, an average of 1 year | 
| Liver biopsy |  | Through study completion, an average of 2 year | 
| Liver transplant | Whether the patients have liver transplant during the follow-up | Through study completion, an average of 1 year |
Drug-Drug Interaction Study in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of K 877 in healthy adult subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: K-877
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening. Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening. Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening. Exclusion Criteria: Subject has clinically relevant abnormalities in the screening or check in assessments. Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females). Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-877<br>K-877 | Drug: K-877<br> <br> |
| Experimental: K-877 with Fluconazole<br>K-877 with Fluconazole | Drug: K-877<br> <br> Drug: Fluconazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration curve (AUC) |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult Volunteers
Clinics and Epidemiology of Pituitary Diseases in Modena Area Population

Study Overview
=================
Brief Summary
-----------------
This is an observational, longitudinal, single-center study. The study is divided in two phases: FIRST PHASE (retrospective): registration of all patients affected by pituitary disorders followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena SECOND PHASE (prospective): enrollment of all patients affected by pituitary disorders who attend the Unit of Endocrinology of the Azienda Ospedaliero-Universitaria of Modena. An anonymized database will be created to collect the data of the patients. In particular, the data collected for each patient will include: personal data, data relating to pituitary pathology, symptoms at diagnosis, physical examination, radiological imaging, visual field data, data on surgical intervention, data on histological examination, biohumoral examinations, hormone tests, densitometric data, data on replacement therapies, medical therapies or other pharmacological therapies, data on comorbidities.

Official Title
-----------------
Pituitary Diseases in Modena Population: Clinical and Epidemiological Data Register of Pituitary Patients Attending the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena (DataPit)

Conditions
-----------------
Pituitary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena Exclusion Criteria: subjects under 18 years old

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 |
| --- | --- | --- |
| Characterization of pituitary patients | The primary aim of the study is to characterize subjects with pituitary disease by collecting anamnestic, clinical, biohumoral, radiological data, and data related to the treatment approach, in terms of surgery, medical therapies and/or hormone replacement therapies. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of pituitary patients | The second aim is to integrate these data with current knowledge, in order to improve the clinical-diagnostic-therapeutic management of patients suffering from pituitary diseases, as well as to identify risk factors for the development of the disease. | 10 years |
Exploration of Patient Self-medication Practices During and After Cancer in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the patient self-medication practices during and after cancer in France, using an online questionnaire

Detailed Description
-----------------
Patients will be contacted by email from patient's associations. Patients will be informed of the objectives of the study and will be free to answer or not to the online questionnaire.

Official Title
-----------------
Exploration of Patient Self-medication Practices During and After Cancer in France: Cross-sectional Observational Study With Online Response

Conditions
-----------------
Cancer, Self-medication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Past or active cancer Exclusion Criteria: Speaking French Not living in France

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 |
| --- | --- | --- |
| Self-medication | declaration of a practice of self-medication | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Class of products used in self-medication | non-prescription medicine, herbal medicine, aromatherapy, homeopathy, and food supplements | day 1 | 
| Indication for self-medication | For treatment of side-effects, improvements in anti-cancer effects | day 1 | 
| Origin of self-medication products | pharmacy, market, internet, other | day 1 | 
| Perception of adverse effects and drug-drug interaction related to self medication | yes / no | day 1 | 
| QLQ-C30 questionnaire | Global health status Functional scales Physical functioning Role functioning Emotional functioning Cognitive functioning Social functioning Fatigue Nausea and vomiting Pain Dyspnoea Insomnia Appetite loss Constipation Diarrhoea Financial difficulties | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, self-medication, quality of life