linjc16/ctgov huggingface dataset:
Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire

Study Overview
=================
Brief Summary
-----------------
To analyze the proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations; the ctDNA characteristics in patients with ovarian cancer; the correlation between the clonal status of mutations and therapy response; whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence; and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.

Detailed Description
-----------------
100 OC cases with available matched tumor DNA and plasma will be collected. All patients will be treated according to clinical guidelines, and receive circulating tumor DNA (ctDNA) liquid biopsy at the time of diagnosis, at mid treatment, at the end of treatment and during follow-up. The study will be ended when the patients have progressive disease (PD) or reach the longest follow-up time (2 years).

Official Title
-----------------
Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have not received treatment including radiotherapy, chemotherapy, and surgery. Expected to achieve satisfactory tumor cytoreductive surgery. Estimated lifetime is more than 3 months. Understand the research plan and voluntarily participate in the study, sign the informed consent form. Ability to collect specimens from each time point and provide corresponding clinical information. Exclusion Criteria: Patients who will receive new adjuvant therapy. Patients who have other primary cancer. Pregnant or breast-feeding woman. Patients with severe mental illness. Patients achieve unsatisfactory tumor cytoreductive surgery. Patients who voluntarily withdraw for any reason. Patients who cannot complete the research plan.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| The ctDNA characteristics in patients with ovarian cancer , the correlation between the clonal status of mutations and therapy response and whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer. |  | 1 years |
Effect of Large Volume Paracentesis on Fatigue in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen).

Official Title
-----------------
The Effect of Large Volume Paracentesis on Fatigue in Cirrhosis

Conditions
-----------------
Ascites, Fatigue, Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory patient with cirrhosis baseline Cr <2 ability to complete psychometric testing refractory ascites Exclusion Criteria: Cr >2 history of Gastrointestinal bleed history of infection history of renal failure

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 |
| --- | --- |
| Group 1<br>Patients with cirrhosis, who have refractory ascites requiring large volume paracentesis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Fatigue symptomatology, as defined by fatigue questionnairre |  | instantly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sleep |  | post paracentesis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life
Acupuncture and Auditory Evoked Potentials

Study Overview
=================
Brief Summary
-----------------
To investigate whether body acupuncture of acupuncture points specific for hearing influences the auditory avoked potentials in comparison to puncture of non-specific acupuncture points

Official Title
-----------------
Effects of Acupuncture on the Auditory Evoked Potentials: a Randomized Volunteer Crossover Study

Conditions
-----------------
Evoked Potentials, Healthy Volunteers

Intervention / Treatment
-----------------
* Behavioral: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers aged 20-40 years Physical status I according to American Society of Anesthesiologists (ASA) classification No history of nervous or psychiatric disease Normal audiogram before the study No chronic consume of analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol No local infection at the site of acupuncture Volunteers who have given informed consent Exclusion Criteria: Pregnant or nursing females. History of peripheral neuropathy Abnormal skin conditions (infection, scars, psoriasis, eczema) Inflamed site of acupuncture within 1 week

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum acupuncture<br>Acupuncture of specific acupuncture points | Behavioral: Acupuncture<br>* Body acupuncture of 1 specific point per trial session<br>|
| Sham Comparator: Sham acupuncture<br>Acupuncture of non-specific acupuncture points | Behavioral: Acupuncture<br>* Body acupuncture of 1 specific point per trial session<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latencies of Auditory Evoked Potentials |  | before acupuncture stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain | 30 min |
Genetic Basis of Melanocytic Nevi

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to further elucidate the genetic mutations that drive melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole genome, whole exome, or targeted sequencing of de-identified specimens. Herein, the investigators plan to isolate DNA from de-identified skin biopsy specimens and blood samples: From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the tissue will be submitted for routine diagnostic dermatopathology and investigational histomorphologic and immunohistochemical analysis. From corresponding normal tissue (blood). DNA isolated from blood will be used as a normal control when analyzing sequencing data to identify somatic mutations in lesional tissue.

Official Title
-----------------
Genetic Basis of Melanocytic Nevi

Conditions
-----------------
Melanocytic Nevi

Intervention / Treatment
-----------------
* Other: Collecting Nevi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female subjects that are 18 years or older Subjects with melanocytic nevi\ Exclusion criteria: Patients less than 18 years of age Patients without melanocytic nevi Patients with a bleeding disorder or are taking anticoagulation medication

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 |
| --- |
|Other: Collecting Nevi|Will be collecting Nevi and completing a DNA analysis, no intervention will be made.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genome Wide Mutation Analysis | Will be performing genome wide mutation analysis to quantify the number of mutations. | Feb 2017 - December 2018 |
Response to Periodontal Therapy in a Chronic Kidney Disease Population

Study Overview
=================
Brief Summary
-----------------
This study will evaluate periodontal and systemic parameters of a cohort of chronic kidney disease (stage 5) patients, before and three months after non-surgical periodontal treatment. It does not consider a control group.

Detailed Description
-----------------
Dental biofilm is a source of inflammation and infection of periodontal tissues. In the last 20 years the interaction between periodontal infections and systemic conditions has been largely studied, suggesting that the inflammation caused in the periodontal tissues could cause a response in other parts of the body. Recent studies suggest that there could be an association between periodontal disease and chronic kidney disease.

Official Title
-----------------
Response to Non Surgical Periodontal Therapy in a Chronic Kidney Disease Population Candidates to Kidney Transplant

Conditions
-----------------
Chronic Kidney Disease Stage 5, Periodontal Disease

Intervention / Treatment
-----------------
* Procedure: Non Surgical Periodontal Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease patients in Stage 5 (candidates to renal transplant) Exclusion Criteria: Younger than 18 year old.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Experimental<br>Non surgical periodontal therapy | Procedure: Non Surgical Periodontal Therapy<br>* Non Surgical Periodontal Therapy in 2 to 3 sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Attachment Level (CAL) | Change from baseline CAL (in mm) at three months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bleeding on probing (BOP) | Change from baseline BOP (%) at three months | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glomerular filtration rate, Periodontitis, Chronic kidney disease
Gemcitabine (GFF) in Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).

Detailed Description
-----------------
This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.

Official Title
-----------------
A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.

Conditions
-----------------
Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: gemcitabine, folinic acid, 5-FU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological proved pancreatic cancer inoperable disease informed consent adequate bone marrow reserve Exclusion Criteria: under 18 years brain metastasis lactating woman life expectancy under 3 months

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: Gemcitabine/folinic acid/5-FU<br>Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m² | Drug: gemcitabine, folinic acid, 5-FU<br>* gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours<br>* Other names: 5-fu;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of treatment |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, gemcitabine, combination
Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

Study Overview
=================
Brief Summary
-----------------
To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery. This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit a different pharmacokinetic profile and therefore may respond differently to rFIX infusions when compared with older children and adults. This evaluation will provide data from which recommendations can be made regarding rFIX dosing and treatment of these patients. Surveillance for certain observations that have been made in patients treated with rFIX in the clinical and postmarketing setting will be performed, including inhibitor development, thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC agglutination. Comparisons will be derived from published reports and communications describing experience with other FIX products and protein therapeutics in general.

Official Title
-----------------
An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Children Less Than 6 Years of Age With Severe Hemophilia B

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Drug: BeneFIX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe hemophilia B Less than 5 years of age In the investigator's judgment, the patient and/or caregiver will be compliant to study procedures Exclusion Criteria: A currently detectable FIX inhibitor. A family history of inhibitors will not exclude the patient. Impaired liver function Impaired renal function

Ages Eligible for Study
-----------------
Maximum Age: 5 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the incremental recovery of rFIX in children following a 75-IU/kg bolus infusion. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia B
Image-Guided Tumorboost of Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.

Official Title
-----------------
Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study

Conditions
-----------------
Bladder Neoplasms

Intervention / Treatment
-----------------
* Radiation: Radiation boost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Muscle invasive bladder cancer (transitional carcinoma) Unifocal TNM stage T2a-4a, N0-1, M0 unfit for radical cystectomy Exclusion Criteria: Hyperthyroidism Multinodular goiter Pregnancy Breast feeding WHO preformance status more than 2 Iodine allergy MRI or CT contrast media allergy Bi-lateral hip-prosthesis

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumor-boost<br>Image-guided tumorboost of the bladder cancer. | Radiation: Radiation boost<br>* Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor control |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and late adverse effects of the radiotherapy treatment |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Image-guided Radiotherapy, Fiducial marker, Adverse effects
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure

Official Title
-----------------
A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard Medical Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Ferric Carboxymaltose
* Drug: Standard Medical Care (SMC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 18 to 85 years of age NDD-CKD Patients TSAT </= 25% Hgb </= 11.5 Ferritin </= 300 HD-CKD Patients TSAT </= 30% Hgb </= 12 Ferritin </= 500 Exclusion Criteria: Previous participation in a FCM trial Known Hypersensitivity to FCM History of anemia other that anemia due to chronic renal failure Current history of GI bleeding Received IV Iron within the last 30 Days Anticipated need for surgery Malignancy history AST or ALT greater than normal Received an investigational drug within 30 days of screening Pregnant or sexually active females who are not willing to use an effective form of birth control

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Ferric Carboxymaltose (FCM)<br>Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. | Drug: Ferric Carboxymaltose<br> <br> |
| Active Comparator: Standard Medical Care (SMC)<br>SMC for IDA (as determined by the Investigator) for treating CKD related anemia. | Drug: Standard Medical Care (SMC)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-emergent Serious Adverse Events (SAE's) |  | from Day 0 through 30 days after the last dose of study drug |