linjc16/ctgov huggingface dataset:
Smoking Cessation in Groups and With Tobacco Pastils

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.

Detailed Description
-----------------
The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.

Official Title
-----------------
Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: Oliwer Twist smokeless tobacco (tobacco)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: smoking > 13 cigarettes/day healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia) motivated for cessation motivated to use tobacco pastils motivated for group support Exclusion Criteria: severe diseases psychiatric diseases using antipsychotic drugs used NRT/bupropion in the last 3 months consuming > 6 drinks/day pregnant/lactating stopped smoking more than 2 days during last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: Oliwer Twist smokeless tobacco (tobacco)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Smoking cessation quit rate after 6 and 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects from tested tobacco product |  |  | 
| Intake of nicotine and thiocyanate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation,, nicotine,, smokeless tobacco,, cigarettes
EEG@HOME (Phase 4 of the Project)

Study Overview
=================
Brief Summary
-----------------
The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined. In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU. Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype. There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists will also be collected.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: video-EEG monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epilepsy with on EEG prominent IEDs Exclusion Criteria: /

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional video-EEG monitoring<br>conventional video-EEG monitoring with cup-electrodes and collodion | Other: video-EEG monitoring<br> <br> |
| Experimental: video-EEG monitoring with prototype<br>video-EEG monitoring of 5 hours with EEG-cap with dry electrodes | Other: video-EEG monitoring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG signal quality (visual and clinical) (scale) |  | 5 hours | 
| EEG signal quality (technical) (signal to noise ratio) |  | 5 hours | 
| User experience (questionnaire) |  | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG-technologist experience (questionnaire) |  | 5 hours |
Immunological Characteristics of COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The study will look at the immunological characteristics of COVID-19 patients and determine neutralizing antibodies against SARS-CoV-2 virus.

Detailed Description
-----------------
The immunogram (quantitative TBNK immunophenotipisation) will be performed by flow cytometry, the antibody response will be determined by IVD ELISa. Clinical biochemical and immunochemical (ECLIA) tests (including IL-6) will be performed on Cobas analyzers. Hemogram with differential blood picture will be performed with a hematology analyzer Sysmex XN 3100, examination of blood smears with CellaVision system or. microscope. Coagulation tests will be performed on BCS XP analyzers. An in-house system for the analysis of SARS-CoV-2 virus fusion inhibitors on human cells will be used to detect the ability of antibodies from patients' serum to neutralize the virus and thus potential protection against re-infection. The system is quantitative, meaning that the titer of such antibodies could be determined, and thus the potential level of protection would be evaluated.

Official Title
-----------------
Immunological Characteristics of COVID-19 Patients and Determination of Neutralizing Antibodies Against SARS-CoV-2 Virus

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written consent before being included in the essay. Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2). Exclusion Criteria: Patients who are unable to give consent or who are unable to follow up will be excluded.

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 |
| --- | --- | --- |
| Immunological changes during and after COVID-19 infection | Correlation between TBNK dynamic and increase of neutralising antibodies | July 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, SARS-CoV-2, immunology, TBNK Cells, neutralizing antibodies
Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects

Study Overview
=================
Brief Summary
-----------------
Many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. In this project, the investigators will study post-stroke gaits of human patients and compare them to those of a control population during a goal-oriented task performed in different visual conditions. The investigators want to test the hypothesis that during simple goal-oriented locomotor tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express navigational deficits.

Official Title
-----------------
Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects

Conditions
-----------------
Post-stroke Gait Assessments

Intervention / Treatment
-----------------
* Behavioral: Kinematic measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (for matching controls): Adult male and female subjects (18-->85 years old) Exclusion Criteria (for matching controls): Persons with history of an acquired or congenital neurological disorder, e.g. stroke, multiple sclerosis, Parkinson disease, increased intracranial pressure, etc.; Persons injured at the time of the experiments (fractures,…); Persons having reported repetitive spatial troubles/disorders; Persons with eye disorders and non-corrected vision problems; Pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Post-stroke patients<br>Patients who experienced stroke and who already recover gait abilities. | Behavioral: Kinematic measurements<br> <br> |
| Control population<br>Participants matching the criterion (age and gender) of the patients' group. | Behavioral: Kinematic measurements<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking stability indices of post-stroke patients |  | 1 hour and 30 minutes (including pre-tests, instructions delivery...). | 
| Spatial accuracy of walking trajectories in post-stroke patients |  | 1 hour and 30 minutes (including pre-tests, instructions delivery...). |
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients

Conditions
-----------------
Cytomegalovirus Infections

Intervention / Treatment
-----------------
* Drug: Ganciclovir
* Drug: valganciclovir [Valcyte]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=18 years of age; recipients of solid organ(s) transplant; virologic and clinical evidence of CMV disease after transplantation; patients of childbearing potential must be prepared to use effective contraception throughout, and for 90 days after the end of the study. Exclusion Criteria: life-threatening CMV disease according to the investigator's judgment; pregnant or lactating women.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: valganciclovir [Valcyte]<br>* 900mg po bid for 21 days<br>|
| Experimental: 2<br> | Drug: Ganciclovir<br>* 5mg/kg iv bid for 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment success (CMV viremia BLQ) |  | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia. |  | Throughout study | 
| AEs, laboratory parameters, appearance of ganciclovir resistance. |  | Throughout study |
Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy

Study Overview
=================
Brief Summary
-----------------
The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.

Official Title
-----------------
Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of bladder carcinoma (any histology permitted) Planned treatment with radical cystectomy. Age 65 years or older at the time of radical cystectomy Able to give consent Neoadjuvant chemotherapy is permissible Prior malignancy is permissible, without evidence of disease for at least 2 years Concomitant localized prostate cancer, skin cancer, and in situ malignancies are permissible. Willingness to complete surgical follow-up at the University of Michigan for at least 6 months after radical cystectomy. Exclusion Criteria: Evidence of metastatic bladder cancer Life expectancy less than one year Concurrent treatment on another clinical trial. Non-intervention supportive care trials or non-treatment trials, e.g. QOL, are allowed

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| ≥ 65 years / opts for radical cystectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impairment Free Survival | Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out. | 6 months |
Functional Assessment of Cancer Therapy - Bone Marrow Transplant

Study Overview
=================
Brief Summary
-----------------
Functional Assessment of Cancer Therapy - Bone Marrow Transplant

Detailed Description
-----------------
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

Official Title
-----------------
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

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

Intervention / Treatment
-----------------
* Other: Database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Exclusion Criteria: Patients with diagnosis other than HD and NHL.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Database|Database|

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
-----------------
HD, NHL
Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS. Our secondary aim is to investigate patient and surgeon satisfaction, duration of block application, postoperative complications and hospital lenght of stay.

Official Title
-----------------
Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-blind Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18 and 65 years ASA (American Society of Anesthesiologists) score I-II Exclusion Criteria: inability to communicate body mass index (BMI) > 35 kg/m2 infection in the area where the block was to be applied allergy to the drugs used mentally impaired bleeding impaired

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VAS and DVAS<br>To measure the pain score of patients after surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores in rest and coughing | Pain scores observed after surgery at 0, 1 ,2 ,6 ,12 ,24 th hours by visual analog scale. We assessed pain scores both in rest and coughing. This scale scores pain from 0 to 10. 0 means no pain and 10 means unbearable pain. | 24 hours | 
| consumption of opioids | We observed how much opioid ( how many miligrams) the patient consumed in 24 hours postoperatively with pca device. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | we compare postoperative complications like nausea, vomiting, constipation, pruritus first 24 hours after surgery. | 24 hours | 
| lenght of hospital stay | we compared how many days the patients stayed in the hospital until discharge | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thoracoscopic surgery video assisted, serratus anterior, paravertebral block
Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.

Detailed Description
-----------------
Upon determination of eligibility, patients will be receive: Thalidomide + Capecitebine

Official Title
-----------------
Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Thalidomide
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic breast cancer confirmed by biopsy Measurable or evaluable disease Females > 18 years Able to perform activities of daily living with minimal assistance Life expectancy > 3 months Adequate bone marrow, liver and kidney function All patients must give written informed consent in order to participate. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Women who are pregnant or lactating. Received more than 3 prior chemotherapy regimens in the metastatic setting. Received continuous infusion 5-fluorouracil lasting > 120 hours. Received thalidomide or capecitabine as their last prior regimen. Preexisting moderate to severe neuropathy Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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

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

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: Thalidomide|Thalidomide|
|Drug: Capecitabine|Capecitabine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 18 Months |