linjc16/ctgov huggingface dataset:
Patogenic Mutation in 5 Genes

Study Overview
=================
Brief Summary
-----------------
This is a pathogenic mutation profile of colorectal patients specifically in 5 genes, i.e. APC, TP53, PIK3CA, KRAS, and MLH1. Single nucleotide variants identified were synchronized with patients' characteristics.

Official Title
-----------------
Genomic Landscape of APC, KRAS, TP53, PIK3CA, and MLH1 in Colorectal

Conditions
-----------------
Colorectal Cancer, APC Gene Mutation, TP53 Gene Mutation, PIK3CA Gene Mutation, KRAS Mutation-Related Tumors, MLH1 Gene Mutation

Intervention / Treatment
-----------------
* Other: co-occuring mutation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FFPE samples fullfilling purity criterion and pass quality control Exclusion Criteria: none

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 |
| --- | --- |
| Age<br> | Other: co-occuring mutation<br>* APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA<br>|
| Grade<br> | Other: co-occuring mutation<br>* APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA<br>|
| Tumor location<br> | Other: co-occuring mutation<br>* APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA<br>|
| Stage<br> | Other: co-occuring mutation<br>* APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA<br>|
| Lymphovascular invasion<br> | Other: co-occuring mutation<br>* APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of clinical characteristics | Age, gender | January 2017 - June 2021 | 
| Description of tumor nature | grade, stage, lymphovascular invasion, tumor location | January 2017 - June 2021 | 
| Description of survival | Median of life expectancy | January 2017 - June 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
next-generation sequencing, colorectal cancer, indonesia population, co-occurring mutation
Alpha Lipoic Acid for Burning Mouth

Study Overview
=================
Brief Summary
-----------------
Discussion and evaluation of patients with sore and burning mouth to determine whether alpha lipoic acid is helpful in managing their symptoms.

Official Title
-----------------
Review of Mayo Clinic Experience With Burning Mouth Syndrome - Use of Alpha Lipoic Acid

Conditions
-----------------
Burning Sore Mouth

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients seen in the Department of Dermatology with diagnosis of burning mouth syndrome between 2000 and 2005

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.

Detailed Description
-----------------
Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20.

Official Title
-----------------
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Ranitidine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Asymptomatic HIV-1 infection. CD4 count of 400-700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant illness. Acute illness at randomization. Hemodialysis. Prior Medication: Excluded: Antiretroviral use within 60 days prior to study entry.

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
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ranitidine hydrochloride|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
-----------------
Ranitidine
Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

Official Title
-----------------
Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program.

Conditions
-----------------
Hepatitis C, Chronic, Hepacivirus

Intervention / Treatment
-----------------
* Biological: Peginterferon alfa-2b (SCH 54031)
* Drug: Ribavirin (SCH 18908)
* Behavioral: Patient assistance program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with hepatitis C Exclusion Criteria: According to the products' labeling (refer to Warnings, contraindications, and safety sections).

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 |
| --- | --- |
| Patients with hepatitis C<br>Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria. | Biological: Peginterferon alfa-2b (SCH 54031)<br>* Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.<br>* Other names: PegIntron, PegIntron pen;Drug: Ribavirin (SCH 18908)<br>* Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.<br>* Other names: Rebetol;Behavioral: Patient assistance program<br>* Assistance programs will be classified as follows: Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program |  | 24 or 48 weeks (depending on genotype) and 24 weeks of follow up | 
| Average Length of Treatment With PegIntron/Rebetol |  | After start of treatment |
Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

Study Overview
=================
Brief Summary
-----------------
Despite advances in cardiac arrest resuscitation survival from cardiac arrest is less than 20-30% and new therapies are urgently needed. Sodium nitrite infused during resuscitation from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac arrest and our group is eager to test this hypothesis in a clinical trial. Our overall hypothesis is that an infusion of 2 μmole/kg sodium nitrite during resuscitation will increase the proportion of patients who will survive cardiac arrest. In preparation for a clinical trial, preliminary safety and efficacy data (phase 1) is needed which is the primary goal of this study.

Detailed Description
-----------------
Sixteen patients will be randomized to receive normal saline (n=5) or doses of IV nitrite (n=11). During the nitrite infusion and for 120 min after the infusion is completed, blood pressure and heart rate will be monitored. The first 3 patients randomized to receive IV nitrite will receive the lowest dose (1 mg) of IV nitrite and compared to one placebo treated patient. If there is no significant decrease in blood pressure or elevation in heart rate, we will then dose escalate to the 6 mg dose in 4 patients and placebo in two patients. Dose escalation to the highest (14 mg) dose will again be contingent on the absence of significant hypotension or tachycardia in the drug treated patients compared to the pooled (n=3) placebo treated patients. The final block of patients will be randomized to the high nitrite dose (n=4) or placebo (n=2). Final comparisons of all groups will be made to the pooled (n=5) placebo group

Official Title
-----------------
Phase 1 Hospital Based Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: nitrite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successfully resuscitated from cardiac arrest by paramedics in the field Age 18 or older Comatose IV access Exclusion Criteria: traumatic cause of cardiac arrest known DNAR Patient requiring vasopressors at time of randomization SBP <105 PaO2 of less than 90% on FiO2 of 1.0

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nitrite|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 2 hour | 
| nitrite concentration levels in blood |  | 2 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, ventricular fibrillation, nitrite
Children's Susceptibility to Enterovirus 71 in Different Areas of Taiwan

Study Overview
=================
Brief Summary
-----------------
EV71 has caused large epidemics with lots of fatal cases and cases with sequelae. However, the clinical syndromes and severity of the same EV71 strain are very diverse, ranging from asymptomatic (71%) to fatal (0.05%) disease, and the pathogenesis remains unknown. In addition, the severe or fatal case incidence varies significantly differently in different areas of Taiwan. Although some viral virulence studies were performed, no clear viral virulence factor has been found. Therefore, host factors may be important to the clinical outcomes of EV71 infections. In addition, there were significantly different incidences of severe or fatal cases in different areas of Taiwan, for example, significantly more fatal or severe cases occurred in the central or southern Taiwan in comparison with in northern Taiwan. Whether this is related to host factors, social, behavioral or environmental factors remains unanswered. To find the most important factors associated with EV71 susceptibility, a thorough study involving genetics, social, behavioral or environmental factors among different areas of Taiwan is warranted and the findings will provide future prevention of EV71 and give help on early precaution and treatment of EV71.

Detailed Description
-----------------
The specific aims are to find factors associated with different severe/fatal incidences in different areas of Taiwan. We will do Comparison of gene variants in EV71 cases with different severity and normal children in different areas of Taiwan to find susceptible genes and genetic polymorphism related to the clinical outcomes Social, behavioral and environmental factors related to EV71 infections in different areas of Taiwan

Official Title
-----------------
The Specific Aims Are to Find Factors Associated With Different Severe/Fatal Incidences in Different Areas of Taiwan. We Will do 1. Comparison of Gene Variants in EV71 Cases With Different Severity and Normal Children in Different Areas of Taiwan to Find Susceptible Genes and Genetic Polymorphism Related to the Clinical Outcomes 2. Social, Behavioral and Environmental Factors Related to EV71 Infections in Different Areas of Taiwan

Conditions
-----------------
Enterovirus 71, Host Genetics, Social, Behavior, Environmental Factors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Enterovirus type 71 Exclusion Criteria: - not Enterovirus type 71

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enterovirus 71, host genetics, social, behavior, environmental factors
PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: PRC-063 oral capsules
* Drug: Placebo oral capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 18 to 60 years of age Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional Subject is willing and able to comply with all the protocol requirements. Exclusion Criteria: Primary and/or comorbid psychiatric diagnosis other than ADHD Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug; Has used any investigational drug within 30 days of the screening visit;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br>PRC-063 25, 35, 45, 55, 70, 85, or 100 mg | Drug: PRC-063 oral capsules<br>* Daily dose<br>|
| Placebo Comparator: Placebo Treatment<br>Matched placebo | Drug: Placebo oral capsules<br>* Daily dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit | PERMP-T measures the number of completed and number of attempted math problems completed during a 10 minute test. The scale ranges from 0 to 800, with a higher score indicating a better outcome. | Full-day ALC - 13 hours |
Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women

Study Overview
=================
Brief Summary
-----------------
To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in non-infertile women.

Official Title
-----------------
Ovarian Reserve Does Not Predict Pregnancy in Non-Infertile Women: An Assessment Using the Donor Sperm Insemination Model

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

Intervention / Treatment
-----------------
* Diagnostic Test: Anti Mullerian Hormone Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: absence of male partner complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm absence of previous history of infertility. d ta on AMH and AFC assessment before the first dIUI cycle. Exclusion Criteria: previous history of infertility. Presence of any gynaecological condition that could impair the inseminations results: endometriosis, hydrosalpinx,…

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women who undergo donor sperm insemination<br>Non infertile women who undergo donor sperm insemination cycle | Diagnostic Test: Anti Mullerian Hormone Measurement<br>* Anti Mullerian Hormone was measured in all patients within two months before the first insemination cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy | Clinical Pregnancy evaluated by ultrasound with fetal heart beat | 6 weeks after insemination procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage rate | Number of clinical miscarriage after clinical pregnancy | Evaluated until 15 weeks after insemination procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Donor sperm insemination, Anti Mullerian Hormone, Ovarian reserve, Antral follicle count
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

Study Overview
=================
Brief Summary
-----------------
Patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to conventional therapy, or with no known effective therapy, will be treated. Experiments in the laboratory have shown the experimental drug RAD001C (RAD001, Everolimus) can prevent cells from multiplying. RAD001 is now being tested in diseases such as cancer, in which excessive cell multiplication needs to be stopped. The drug has been tested in adult cancer patients and has been well tolerated by subjects in these studies. It is experimental and, therefore, available in clinical trials.

Detailed Description
-----------------
Although a Phase II portion of this study was planned, it was never initiated.

Official Title
-----------------
Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors

Conditions
-----------------
Tumors, Brain Tumors, Rhabdomyosarcoma, Sarcoma, Soft Tissue

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adequate performance status Adequate bone marrow, kidney, heart, and liver function Exclusion Criteria: Must not be receiving concomitant anti-cancer treatment Must not be pregnant

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 21 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: Phase 1<br> | Drug: Everolimus<br>* The drug is given orally in 28 day courses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To find the highest dose of RAD001 that can be given to children with refractory or relapsing solid tumors, leukemias, or brain tumors without causing severe side effects |  | Within 30 days per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To find out if there are changes in the body's blood cells and tumor cells after treatment with RAD001 |  | Within 30 days per subject | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain tumors, Soft Tissue Sarcomas, Refractory solid tumors, Recurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas