linjc16/ctgov huggingface dataset:
Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: Recombinant Human Interleukin-2 and Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis and disease status: Subjects with CD20+, B-cell, Non-Hodgkin's lymphoma of low-grade or follicular histology with measurable relapsed or unresponsive disease after prior therapy; mantle cell and chronic lymphocytic leukemia subtypes are excluded. Subjects who previously received a single-agent course of rituximab and showed no tumor response, or had a response lasting < 6 months. The previously administered rituximab must have included at least 75% of the standard 4-week regimen (4 x 375 mg/m2). A record of the previous rituximab treatment and response must be available as a source document at the site. Exclusion: Subjects who showed no tumor response or a response lasting <6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates). HIV positive. Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism. Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms If cardiac ejection fraction has been measured, it must be greater than 50%.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Recombinant Human Interleukin-2 and Rituximab|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
-----------------
Low-Grade or Follicular Non-Hodgkin's Lymphoma
Pain Prevalence After Cesarean Section in Siriraj Hospital

Study Overview
=================
Brief Summary
-----------------
Spinal morphine has been widely provided for acute postoperative analgesia. However, the analgesic effect of spinal morphine usually last 12-24 hours. Therefore the investigators are interested in the pain characteristics during the 2nd postoperative day. The investigators will also explore the regimens for pain therapy in our hospital.

Official Title
-----------------
Pain Prevalence After Cesarean Section in Siriraj Hospital

Conditions
-----------------
Pain, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing Cesarean section Exclusion Criteria: History of drug addict

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

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

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 |
| --- | --- | --- |
| Number of patients who have moderate to severe pain after Cesarean section | Number of patients who have moderate to severe pain after Cesarean section | 24-48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain
Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)

Study Overview
=================
Brief Summary
-----------------
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.

Official Title
-----------------
Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients

Conditions
-----------------
Non-alcoholic Fatty Liver Disease (NAFLD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is able to travel to MRI centers All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit Patient is male or female and at least 18 years of age At least 5 patients have type 2 diabetes mellitus or pre-diabetes Exclusion Criteria: Female patient is pregnant or has a positive pregnancy test at screening; Patient has known liver disease other than fatty liver Patient has a history of neoplastic disease Patient is HIV positive Patient has known claustrophobia or other contraindication to MRI

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 |
| --- | --- |
| Traveling cohort<br>Overweight patients with or without type 2 diabetes or pre-diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method |  | 28 +/- 7 days from Imaging Visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICC for repeated HFF measurements from the 3-point Dixon method |  | 28 +/- 7 days from Imaging Visit 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Hepatic Steatosis Study
Treatment of Moderate to Severe Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: botulinum toxin
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older. Moderate to severe GL at maximum frown as assessed by the Investigator. Moderate to severe GL at maximum frown as assessed by the subject. Exclusion Criteria: Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment. Female who is pregnant, breast feeding, or intends to conceive a child during the study. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.

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

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection | Biological: botulinum toxin<br>* neuromodulator to be injected in the GL region<br>* Other names: QM1114-DP;|
| Placebo Comparator: Placebo<br>A buffered solution; Mode of administration: intramuscular injection | Biological: Placebo<br>* Placebo to be injected in the GL area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month. | The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe) | One Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown |  | One Month |
Timing of HCG Administration in IUI Cycles

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

Detailed Description
-----------------
Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.

Official Title
-----------------
Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild male factor infertility or unexplained infertility. Exclusion Criteria: Advanced male factor infertility. Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria. Endometriosis. Tubal disease. Uterine abnormalities or myoma. Previous uterine surgery. Metabolic or hormonal abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>IUI at time of HCG | Drug: HCG<br>* Women will be given HCG before IUI<br>* Other names: Pregnyl;|
| Active Comparator: Group B<br>IUI 12 hours after HCG | Drug: HCG<br>* Women will be given HCG before IUI<br>* Other names: Pregnyl;|
| Active Comparator: Group C<br>IUI 34-36 hours after HCG | Drug: HCG<br>* Women will be given HCG before IUI<br>* Other names: Pregnyl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after IUI) divided by the number of IUI cycles | 4-6 weeks after IUI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrauterine insemination, IUI, HCG
Using Hydration Monitor to Detect Changes in the Hydration Status Athletes

Study Overview
=================
Brief Summary
-----------------
The study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. The study will also test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles.

Official Title
-----------------
The Validity of Ultrasound Velocity to Detect Changes in the Hydration Status of Male and Female Athletes During Acute Dehydration and Rehydration

Conditions
-----------------
Dehydration

Intervention / Treatment
-----------------
* Device: Hydration Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female athletes ages 18-25 years old Exclusion Criteria: open wounds or rashes on calf testing area active skin infection pregnant female subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| young healthy adult athletes<br>Hydration Monitor measurement of the ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing 3% acute dehydration and a 2-hr rehydration period | Device: Hydration Monitor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe statistically significant changes in ultrasound velocity associated with acute dehydration |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dehydration
Translation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)

Official Title
-----------------
Validation of the French Confusion Assessment Method for the Intensive Care Unit Among Adult ICU Patient

Conditions
-----------------
Patients With Mental Confusion

Intervention / Treatment
-----------------
* Behavioral: CAM-ICU.fr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, > or equal to 18-yr Richmond Agitation Sedation Scale (RASS) > or equal -3 Francophone Exclusion Criteria: Diagnostic of cognitive disorders Admission for brain injury Psychotic disorders Diagnostic of cognitive disorders Visual or auditory impairments

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 |
| --- | --- |
| Other: CAM-ICU.fr<br>CAM-ICU and ICDSC evaluation proceed by two investigators and a Neuropsychologist (Speech & language therapist specialized in neuropsychology) | Behavioral: CAM-ICU.fr<br>* Neuropsychological testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist). | Investigators team: evaluation by the CAM- ICU in French and Intensive Care Delirium Screening Check list (ICDSC) during 2 minutes for the concomitant CAM- ICU and ICDSC , carried out at 30 minutes intervals by two Clinical Research Nurse of the investigative team . The neuropsychologist will do the evaluation according to criteria common DSM5. Neuropsychologists now used DSM 5 criteria to diagnose delirium at our institution since new DSM 5 criteria have been published in French. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices | Statistics ICDSC criteria will be assessed against the Gold Standard . The reproducibility of the CAM- ICU and ICDSC will be evaluated according to different inter-observer. | Day 0 |
The Patient's Journey - the Time to Final Diagnosis in Patients With SiNET

Study Overview
=================
Brief Summary
-----------------
The patient's journey is an interview based study assessing the patients' experience from the first symptoms to a final diagnosis focusing on patients with small intestinal neuroendocrine tumors.

Detailed Description
-----------------
The project focus on patients with small intestinal neuroendocrine tumors (SiNET's) with an incidence of 1-2/100 000 yearly. The primary tumor(s) are often small and symptoms usually arise when the disease has become metastatic with hormonal symptoms and/or symptoms due to local growth. As the tumors grow slowly and the symptoms in many cases are rather diffuse and develops gradually over a long time period there is often a long delay from onset to a final diagnosis both depending on patient's delay and doctor's delay The aim of the current project is to map and analyze the patient's journey from the first appearance of symptoms to the time point of a final diagnosis and to try to identify factors contributing to a delayed process. The method is interview based and the interviews will be analyzed through the Design Thinking Methodology

Official Title
-----------------
The Patient's Journey - Assessing the Time to Final Diagnosis in Patients With Neuroendocrine Tumors (NET) in Western Sweden

Conditions
-----------------
Neuroendocrine Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients living in Western Sweden > 18 years of age Performance status 0-3 Expected remaining survival of > 6 months Diagnosed with a small intestinal neuroendocrine tumor during 2016-2018 Exclusion Criteria: Not able to read and/or understand Swedish language Dementia/memory loss Performance status >3

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 |
| --- | --- | --- |
| Initial symptoms | Mapping of patients initial symptoms and their time points through indepths interviews by design thinking methodology | October 2019 | 
| Health care actions | Mapping of corresponding health care actions and their time points regarding the investigations of symptoms | October 2019 | 
| Reasons for a delayed diagnosis | Mapping of herdles and delays in reaching a final diagnosis through design thinking methodology analysing the patients symptoms and the corresponding Health care actions | October 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' efforts | Mapping of actions taken by the patient, trying to be diagnosed correctly, through indepths interviews by design thinking methodology | October 2019 |
Creativity Group for Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a creativity skills group for Borderline Personality Disorder can reduce symptoms of BPD, depression, and anxiety.

Official Title
-----------------
Creativity Group for Borderline Personality Disorder

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Other: creativity group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older participant self-reports clinical diagnosis of Borderline Personality Disorder currently seeing an individual therapist on a regular basis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creativity group for persons diagnosed with BPD<br> | Other: creativity group<br>* This is a creativity group intervention. There will be 4 groups. Each group has one session per week. Each session is a duration of two hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline Evaluation of Severity Over Time (BEST) |  | baseline, 5th week, post-intervention (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) |  | baseline, week 5, week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Borderline Personality Disorder, Borderline Personality, Borderline