linjc16/ctgov huggingface dataset:
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy. PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.

Detailed Description
-----------------
OBJECTIVES: Determine the effectiveness of carboxypeptidase-G2 rescue in patients who develop life threatening methotrexate (MTX) neurotoxicity following accidental intrathecal MTX overdose. Study the CSF pharmacokinetics of MTX following rescue. OUTLINE: Patients undergo a lumbar puncture as soon as possible after methotrexate overdose to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5 minutes. Patients are followed for at least 1 month. PROJECTED ACCRUAL: A maximum of 10 patients will be accrued for this study.

Official Title
-----------------
A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose

Conditions
-----------------
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: glucarpidase


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Patients who received an intrathecal overdose of methotrexate of 100 mg or more PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior anaphylactic reaction to carboxypeptidase-G2 administration PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Concurrent therapy allowed
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glucarpidase|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
-----------------
unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific, neurotoxicity
Prevention and Treatment of Hypertension Study (PATHS)

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term effect of reduction of alcohol intake on blood pressure in moderate but non-dependent drinkers with mild hypertension or high normal blood pressure.

Detailed Description
-----------------
BACKGROUND: Numerous observational epidemiologic studies have established ethanol intake as one of the most important determinants of blood pressure levels. However, data from intervention studies were very limited. The study was an inter-agency agreement involving the Veterans Administration and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Protocol development occurred between October 1988 and June 1989. The protocol was approved by the VA Cooperative Studies Evaluation Committee in July 1989 and reviewed by a separate Data and Safety Monitoring Board in September 1989. DESIGN NARRATIVE: Subjects were randomized to intervention or control groups. Intervention aimed to reduce alcohol intake to no more than 14 drinks per week and 50 percent or less of each participant's baseline level. The intervention technique consisted of a cognitive-behavioral program, the intensive phase of which consisted of six counseling sessions over three months. Echocardiograms were obtained at baseline and six months after randomization. Biochemical markers were used to validate changes in alcohol consumption. The trial included an eighteen-month feasibility phase with six-month follow-up and a 36-month main trial with two years of follow-up. Recruitment for the full-scale trial ended in June 1993. Final study visits were conducted in September and October 1994. The study completion date listed in this record was obtained from the End Date entered in the Query View Report System (QVR).

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

Intervention / Treatment
-----------------
* Behavioral: behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women with a diastolic blood pressure of 80 to 89 mm Hg and alcohol intake of 21 drinks or more per week.

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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavior therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Jiaxing Birth Cohort in China

Study Overview
=================
Brief Summary
-----------------
The Jiaxing Birth Cohort (JBC) is the largest prospective cohort study to explore prenatal risk factors, early life feeding practice and growth pattern/ adiposity in Chinese children.Between 1999 and 2013, 338 413 mother-child pairs were recruited in Jiaxing area in south-east China.Children of the recruited women were followed up at 1-2, 3, 6, 9 and 12 months of age, and subsequently followed up every 6 months to 36 months of age (toddler stage), and every year to 6-7 years of age before they went to school (pre-school stage). Follow-up rate was 70.8% at the toddler stage and 68.9% at the pre-school stage up to June 2013.

Official Title
-----------------
The Jiaxing Birth Cohort in China

Conditions
-----------------
Anemia, Childhood Obesity, Pregnancy Complications, Pregnancy; Hypertension, Feeding Behavior

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women came to clinic visit at one of the local hospitals during pregnancy at Jiaxing area Pregnant women were followed up during pregnancy and their children were born alive at local hospital or clinics Exclusion Criteria: Those who did not want to participant The infant was dead at the birth Those pregnant mothers who dropped out during follow-up at pregnancy or moved out of the Jiaxing area
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 |
| --- | --- |
| Mother-child birth cohort<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overweight and obesity | BMI-z-score was calculated from height and weight. BMI-z-score>1 was defined as overweight/obesity | Up to 6-7 years old for these children |
Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses

Study Overview
=================
Brief Summary
-----------------
Investigators will characterize the body composition and metabolism of infants born from lean, overweight or obese mothers from whom they had previously obtained a placenta and/or cord blood as part of the earlier placenta and cord blood study (#111576)

Official Title
-----------------
Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses

Conditions
-----------------
Infant Body Composition and Metabolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mother's prior participation in study #111576 with successful collection of placenta infant age 12 months (+/- 9 months) Exclusion Criteria: mother did not participate in study #111576 mother did participate in study #111576, but collection of placenta was not successful infant not age 12 months (+/- 9 months)

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 21 Months

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 |
| --- | --- | --- |
GLP-1 Receptor Targeting in Diabetic and Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.

Official Title
-----------------
Clinical Proof-of-principle of the Determination of the Beta Cell Mass in Vivo by SPECT Imaging With the 111-In-labeled GLP-1 Analogue DTPA(Diethylenetriamine Pentaacetic Acid)-[K40]-Exendin 4

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: radiolabeled Exendin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 Diabetes Exclusion Criteria: breast feeding pregnant

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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 |
| --- | --- |
| Type 1 Diabetes<br>patients with long standing T1D | Other: radiolabeled Exendin<br> <br> |
| Healthy volunteer<br>healthy volunteers with normal glucose tolerance | Other: radiolabeled Exendin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic uptake of radiolabeled Exendin | uptake will be given as counts per MBq injected activity as determined by calibrated SPECT/CT scanner with attenuation correction. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain

Study Overview
=================
Brief Summary
-----------------
Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. In a controlled prospective cross-over study 19 women were randomized either to medical treatment or to resection of the nerve. Statistically significant improvements were found after surgical resection.

Official Title
-----------------
Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial

Conditions
-----------------
Chronic Pelvic Pain

Intervention / Treatment
-----------------
* Drug: Amitryptiline, gabapentin
* Procedure: Resection of the ilioinguinal nerve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment Exclusion Criteria: Drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-surgical<br>TENS, amitriptyline, gabapentin. | Drug: Amitryptiline, gabapentin<br>* For amitryptiline starting dose 20-30 mg at night, increasing until clinical effect. For gabapentin was the initial dose 300 mg tid with rapid increases up to 800 mg tid.<br>* Other names: Gabapentin - Neurontin;|
| Active Comparator: Surgical intervention<br>Resection of the ilioinguinal nerve | Procedure: Resection of the ilioinguinal nerve<br>* In general anaesthesia the nerve was identified and resected as central as possible<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales. |  | At least one year after intervention,in some cases more then five years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pelvic pain, ilioinguinal nerve entrapment, randomized study, Chronic pelvic pain in women
Study of the Immune Response in Colon Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Duration of each part of the study per patient: Screening: From 1 to 4 weeks Sampling period (blood and tissue): 1 day Follow-up by patient: 60 months Total study duration by patient: 84 months Total inclusion duration: 24 months Total Follow-up duration: 60 months Total study duration: 84 months

Official Title
-----------------
Etude de la réponse Immunitaire Dans l'adénocarcinome Colique

Conditions
-----------------
Colon Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 or more. Affiliation to a social security scheme Diagnosis of a colon adenocarcinoma. Patient have signed and dated consent of the study before undertaking procedures related to the study. Exclusion Criteria: Patients under guardianship / curatorship Following Situations Persons unable to understand, read and / or sign an informed consent Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year. No affiliation to a social security scheme, a universal medical coverage or any similar plan. Pregnant or lactating women. Patients with HIV seropositivity. Rectal tumor location.

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 |
| --- | --- | --- |
| Immune cells trafficking | Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab). | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infiltration of leucocytes in tumor tissue | Histochemical method with a panel of Ab. | Day 0 | 
| Safety (Number of adverse events, ECOG status) |  | After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60) |
Regulation of CCL18 by Corticosteroids in Severe Asthma

Study Overview
=================
Brief Summary
-----------------
The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.

Official Title
-----------------
Regulation of CCL18 by Corticosteroids in Severe Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: control subjects = non-atopic and non-smoking cutting to negative pneumoallergens, Total IgE levels less than 100 ku / L no clinical history of asthma without background treatment patients with intermittent asthma = being asymptomatic between asthma attacks, with symptoms less than once a week having a forced expiratory volume per second (FEV1) of at least 80% of the theoretical. treated by ß2 mimetics on demand and will not have inhaled corticosteroids. severe asthma insensitive to corticosteroid therapy = continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)] airway obstruction fixed with FEV1 ranging from less than 15% after 7 days of oral corticosteroid therapy to 40 mg / day of prednisolone; Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited. Severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)] reversibility of FEV1 after treatment with oral corticosteroids. Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited. controlled moderate asthma treated with inhaled corticosteroids <1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months. Exclusion Criteria: existence of a chronic inflammatory pathology other than asthma active smoking pregnant or lactating women have received oral corticosteroid treatment in the previous 3 weeks, have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non asthmatic subjects<br> | |
| intermittent asthmatics<br> | |
| severe asthmatics sensitive to corticosteroids<br> | |
| severe asthmatics resistant to corticosteroids<br> | |
| moderate asthmatics<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between CCL18 rate and asthma phenotypes by elisa test |  | Baseline: one session |
Factors Influencing the Deterioration From Cognitive Decline of Normal Aging to Dementia Among Nursing Home Residents

Study Overview
=================
Brief Summary
-----------------
Background: A dearth of differential research exists regarding the determinants of mild cognitive impairment (MCI) and moderate cognitive impairment or dementia among nursing home residents. This study aimed to identify and examine the association between medical factors (number of comorbidities, hospitalization, disability, depression, frailty and quality of life) and moderate cognitive impairment or dementia in nursing homes residents. Methods: A cross-sectional design was used in this study. Convenience sampling of 182 participants was conducted in nursing homes located in the central part of Jordan. Montreal cognitive assessment (MoCA) was used to screen both MCI and moderate cognitive impairment or dementia. Bivariate analysis, including t-test and ANOVA test, and logistic and linear regression models were used to examine and identify the medical factors associated with moderate cognitive impairment or dementia compared to mild cognitive impairment.

Official Title
-----------------
Factors Influencing the Deterioration From Cognitive Decline of Normal Aging to Dementia Among Nursing Home Residents

Conditions
-----------------
Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Jordanian participants, aged 60 years and older, and living in nursing homes Exclusion Criteria: neurological disorders, such as stroke or brain injury

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| moderate cognitive impairment |  | May, 2018-May, 2019 |