linjc16/ctgov huggingface dataset:
Tumor-specific T Cells in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.

Official Title
-----------------
Tumor-specific Effector T Cells in Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Bone marrow aspiration from the iliac crest
* Device: Illinois bone marrow aspiration neddle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group) Healthy donors (control group) written informed consent Exclusion Criteria: Autoimmune disease Patients receiving immunomodulatory drugs, e.g. tacrolimus Prior malignancy Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung cancer group<br>Bone marrow puncture in patients with non-small cell lung cancer | Procedure: Bone marrow aspiration from the iliac crest<br> <br> Device: Illinois bone marrow aspiration neddle<br> <br> |
| Experimental: Control group (healthy donors)<br>Bone marrow puncture in healthy donors | Procedure: Bone marrow aspiration from the iliac crest<br> <br> Device: Illinois bone marrow aspiration neddle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequencies of tumor-specific T cells | % of all T cells | 2 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor-specific T cells location determined by Enzyme Linked Immuno Spot Assay (ELISPOT) analysis of peripheral blood and bone marrow samples from the same patient | location: peripheral versus bone marrow | 2 weeks postoperative | 
| Long-term survival | OS | 5 years postoperative |
Epidemiological Survey of Hepatitis D Virus Infection in China

Study Overview
=================
Brief Summary
-----------------
This cross-sectional study will screen out hepatitis D virus-infected patients in HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among HBsAg positive people. The provinces of China are divided into 5 geographical areas (North, South, East, West and Central) to recruit patients according to the population density of each area. After statistical calculation, the total number of population needed is 3808.

Detailed Description
-----------------
Entry criteria：1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV infection (HBsAg positive) 4.Ability to sign informed consent. Exclusion criteria：Patients who disagree to participate in the trial. After the informed consent was signed, the quantitative data of the previous surface antigen or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on the same day or the remaining serum from the surface antigen or hepatitis B quantitative test was collected for the detection of hepatitis D antibody and/or the quantitative detection of hepatitis D RNA. After statistical analysis, calculate the hepatitis D infection status in China.

Official Title
-----------------
Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China

Conditions
-----------------
Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis B surface antigen or HBV DNA positive Exclusion Criteria: Can't sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| HBV patients<br>HBV patients with HBsAg positive and/or HBV DNA positive | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of hepatitis D virus | Proportion of hepatitis D infection in people with hepatitis B infection | 2019-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBsAg positive, HBV DNA
Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to improve wound healing and the resulting scar consequences following suturing of a wound.

Official Title
-----------------
A Post Market Clinical Study Evaluating the Safety, Device Performance and Possible Emergent Risks of Celotres in the Improvement of Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound

Conditions
-----------------
Scar

Intervention / Treatment
-----------------
* Other: Celotres
* Other: Surgical Closure by Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients electing to undergo a surgical procedure; Patients able and willing to give written informed consent Exclusion Criteria: Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celotres<br>Scar halves randomized to treatment with device, opposite side treated per standard of care. | Other: Celotres<br>* Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.<br>|
| Active Comparator: Standard surgical wound closure<br>Scar halves randomized to treatment with device, opposite side treated per standard of care. | Other: Surgical Closure by Standard of Care<br>* Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety as defined by the incidence of device related adverse events. | Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Patient and Observer Scar Assessment Scale (POSAS) | Assessed at Months 1, 3, 6, 9 and 12 | 
| Device Performance Evaluation | Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator | Assessed at Day 1 |
Efficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical benefits that can be expected by the Embryo transfert procedure with hypnosis to the usual embryo transfer procedure

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

Intervention / Treatment
-----------------
* Procedure: hypnosis during embryo transfer or usual transfer procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent to participate in study Age ≥ 18 years and < 41 years IVF or IVF/ICSI attempt GnRH antagonist or agonist stimulation protocol Scheduled transfer of 1 or 2 embryos Exclusion Criteria: Refusal to provide consent refusal hypnosis FSH > 13 mUImL CFA < 8 follicles AMH < 0.5 ngml Patient not covered by the social security system (NHS)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 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 |
| --- | --- |
| Active Comparator: hypnosis<br>embryo transfer procedure with hypnosis | Procedure: hypnosis during embryo transfer or usual transfer procedure<br> <br> |
| Active Comparator: usual<br>embryo transfer usual procedure | Procedure: hypnosis during embryo transfer or usual transfer procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | sonography | between weeks 5 and 7 after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypnosis embryo transfer IVF ICSI
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.

Official Title
-----------------
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: lasofoxifene
* Other: placebo
* Drug: lasofoxifene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck. Exclusion Criteria: Metabolic bone disease other than osteoporosis; Taking approved medications for osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lasofoxifene 0.5 mg/day<br> | Drug: lasofoxifene<br>* 0.5 mg once per day, orally<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* placebo<br>|
| Experimental: lasofoxifene 0.25 mg/day<br> | Drug: lasofoxifene<br>* 0.25 mg once per day, orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New morphometric vertebral fractures |  | 3 years | 
| New cases of breast cancer |  | 5 years | 
| New non-vertebral fractures |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events |  | 3 years | 
| All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events |  | 5 years |
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators sought to determine whether an acoustic cardiographic assessment of heart function is equivalent to Doppler-echocardiography in patients who are treated with cardio-toxic cytostatic agents.

Detailed Description
-----------------
Patients receiving cardio-toxic cytostatic agents are examined by Doppler-echocardiography and acoustic cardiography before, during, and after the cytostatic treatment. Doppler-echocardiography measures ejection fraction, TDI, speckle tracking, and further parameters. Acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. Heart function as assessed by Doppler-echocardiography is then compared to the heart function as assessed by Audicor ECG.

Official Title
-----------------
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography in Patients With Cytostatic Therapies

Conditions
-----------------
Heart Failure, Congestive, Antineoplastic Agents

Intervention / Treatment
-----------------
* Device: Doppler-echocardiography and acoustic cardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with malignant disease with scheduled anthracycline and trastuzumab therapy

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

| Intervention/Treatment |
| --- |
|Device: Doppler-echocardiography and acoustic cardiography|Patients receive a Doppler-echocardiography and an acoustic cardiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of echocardiographic parameters and changes of electromechanical activation time (EMAT)and development of third heart sound as indicators of congestive heart failure |  | Repeated measurements over a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of clinically overt congestive heart failure |  | One year |
UMOX - New Device for Oropharyngeal Preoxygenation

Study Overview
=================
Brief Summary
-----------------
The UMOX is a device that has been designed as an alternative to the conventional face mask for preoxygenation to be used when an optimal preoxygenation with a facemask is difficult to achieve(i.e: when a leak is present. A previous study in our hospital (unpublished data) has shown that the UMOX was only as effective as the conventional mask when a nose clip was used to prevent the patients from breathing in some air through the nose, thus preventing the dilution/contamination of the 100% oxygen delivered.In that study, the verbal indication giving to the subjects to breathe through the mouth was better than no indication at all but still yielded unsatisfactory results. For this reason, the present study was designed to verify the hypothesis that while using the UMOX for preoxygenation, the verbal indication of breathing 8 vital capacity breaths added to the indication of breathing through the mouth would bring equivalent results -measured by the expired fraction of oxygen- as a preoxygenation of normal tidal breathing through a facemask during 3 to 5 minutes. Preoxygenation was performed with the 60 volunteers placed in the supine position with 100% oxygen. All volunteers went though preoxygenation with two techniques: 1) breathing normal tidal volumes at a normal respiratory rate for a period of 5 minutes through a tight fitting conventional face mask, and 2) eight deep breaths (i.e. vital capacity breaths) through the UMOX device with verbal indication to use only the mouth to breathe.

Conditions
-----------------
Preoxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II, smoker or non smoker Exclusion Criteria: patients under 18 years old or over 65 years old; edentulous patients or those with craniofacial malformations, beards or mustaches; patients that have >30 kg over their ideal weight; and patients with moderate to severe pulmonary pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
-----------------
preoxygenation, UMOX
A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

Study Overview
=================
Brief Summary
-----------------
This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.

Official Title
-----------------
A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence

Conditions
-----------------
Methamphetamine Dependence, Treatment Seeking

Intervention / Treatment
-----------------
* Drug: Acamprosate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Methamphetamine dependence Treatment seeking Urine sample (+) for methamphetamine Exclusion Criteria: Pregnancy Dependence on other drugs (except nicotine) DSM-IV axis I disorder unrelated to drug abuse Serious medical condition in clinicians opinion. AIDs Untreated syphilis Allergy to acamprosate Methadone, or other ORP, maintenance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acamprosate<br> | Drug: Acamprosate<br>* 2 gr/day (333 mg, TID)<br>* Other names: Campral;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methamphetamine Abstinence |  | 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  | 7 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methamphetamine, crystal, treatment
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Official Title
-----------------
An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy

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

Intervention / Treatment
-----------------
* Drug: Pegasys
* Drug: Ribavirin
* Drug: epoetin beta [NeoRecormon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; chronic hepatitis C; quantifiable serum HCV RNA; Pegylated interferon + ribavirin treatment started <6 months before study; Hb <10g/dL. Exclusion Criteria: treatment with ESA during preceding 12 weeks; poorly controlled hypertension; history of cancer, except for basal cell cancer and cervical cancer in situ.

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: 1<br> | Drug: Pegasys<br>* As prescribed<br>Drug: Ribavirin<br>* As prescribed<br>Drug: epoetin beta [NeoRecormon]<br>* 30,000 IU sc/week (starting dose)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, pulse rate. |  | 6 and 12 months | 
| AEs, and laboratory parameters. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving correction of anemia |  | 3 months | 
| Percentage of patients not requiring blood transfusion |  | 12 months | 
| Course of Hb concentration |  | 12 months | 
| Percentage of patients maintaining initial ribavirin dose |  | 12 months |