linjc16/ctgov huggingface dataset:
Nicotine Replacement and Counseling In Adolescents

Study Overview
=================
Brief Summary
-----------------
The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.

Official Title
-----------------
A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Nicotine nasal spray
* Behavioral: Smoking cessation counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between 15 and 18 years-old Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking. Exclusion Criteria: Adolescents who were using or had used nicotine replacement in the prior week were excluded. Those who used bupropion (Zyban®) within the past 30 days were also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum 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 |
| --- | --- |
| Experimental: 1<br>8 weeks or counseling plus 6 weeks of nicotine nasal spray | Drug: Nicotine nasal spray<br>* 8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).<br>|
| Active Comparator: 2<br>8 weeks or counseling only. | Behavioral: Smoking cessation counseling<br>* 8 weeks or counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the Nicotine Nasal Spray by Adolescents. |  | 8 weeks |
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

Study Overview
=================
Brief Summary
-----------------
To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.

Detailed Description
-----------------
Doses are escalated based on safety assessments: As soon as a dose meets the criteria for tolerated or not tolerated, doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.

Official Title
-----------------
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

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

Intervention / Treatment
-----------------
* Drug: CI-1012


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot). CD4 T cell count less than or equal to 200 mm3. HIV-1 RNA greater than or equal to 5,000 copies/mL. Exclusion Criteria Prior Medication: Excluded: Anti-HIV treatment within 8 weeks prior to entry. Systemic steroids within 4 weeks prior to entry. Prior Treatment: Excluded: Treatment with anticancer agents within 4 weeks prior to study.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CI-1012|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
-----------------
HIV-1, Dose-Response Relationship, Drug, Anti-HIV Agents
A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is a comparison between MK0787B and standard therapy.

Official Title
-----------------
A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit

Conditions
-----------------
Infection, Pneumonia

Intervention / Treatment
-----------------
* Drug: MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days
* Drug: Comparator: amikacin / Duration of Treatment: 3 Days
* Drug: Comparator: tazocin / Duration of Treatment: 3 Days
* Drug: Comparator: vancomycin / Duration of Treatment: 3 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years of age Patient is diagnosed with nosocomial pneumonia Exclusion Criteria: Immunological deficient patients Pregnant women and nursing mothers A fungus is identified before the study enrollment Received vancomycin or imipenem for more than 5 days before icu admission

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

| Intervention/Treatment |
| --- |
|Drug: MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days|nan|
|Drug: Comparator: amikacin / Duration of Treatment: 3 Days|nan|
|Drug: Comparator: tazocin / Duration of Treatment: 3 Days|nan|
|Drug: Comparator: vancomycin / Duration of Treatment: 3 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score |  |  |
Diclofenac 25mg/Paracetamol 500 mg and Diclofenac 50 mg/Paracetamol 500 mg for Patients With Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect adverse events and identify risk factors in patients that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®

Official Title
-----------------
Incidence of Adverse Events, Risk Factors, and Drug Utilization Factors Related to Treatment With Diclofenac 25 MG/Paracetamol 500 MG and Diclofenac 50 MG/Paracetamol 500 MG in Patients From Metropolitan Lima

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are prescribed Dolocordralan Extra 25 and Dolocordralan Extra Forte at any of the participating clinics Patients who sign the informed consent form Patients who agree to comply with the study procedures Exclusion Criteria: Please see the protocol for further information on exclusion criteria

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 treated with Dolocordralan<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse events (AEs) in patients receiving treatment with Dolocordralan Extra 25 and and Dolocordralan Extra Forte in patients from Metropolitan Lima records | Ongoing events will be followed up until event resolution | Approximately 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed AEs in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records |  | Approximately 13 months | 
| Risk factors in patients experiencing adverse events while receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records | Risk factors: medical history, concomitant diseases and concomitant treatment | Approximately 13 months | 
| Drug utilization factors in patients receiving treatment with Dolocordralan Extra 25 and Dolocordralan Extra Forte in patients from Metropolitan Lima records | Drug utilization factors: Dosing frequency, intake conditions, storage, and concomitant medications | Approximately 13 months |
Symptomatic Treatment of Acute Uncomplicated Diverticulitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.

Official Title
-----------------
Symptomatic Treatment of Acute Uncomplicated Diverticulitis

Conditions
-----------------
Diverticulitis

Intervention / Treatment
-----------------
* Drug: Ibuprofen
* Drug: Paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Computed tomography-diagnosed acute uncomplicated* diverticulitis No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed. Exclusion Criteria: Already commenced antimicrobial medication Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease) Suspicion of generalized peritonitis Organ dysfunction Another infection requiring antimicrobial medication Pregnancy Age < 18 years or > 90 years Missing written consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Symptomatic treatment<br> | Drug: Ibuprofen<br> <br> Drug: Paracetamol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of diverticulitis | Incidence of complications of diverticulitis (abscess, free perforation, need for surgery) | 30 days from allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (days) |  | At the end of the hospital stay, an expected average of 2 days | 
| Rate of re-admissions | Number patients re-admitted to hospital | 30 days from discharge | 
| Recurrence of diverticulitis | Number of recurrent diverticulitis within follow-up | 10 years | 
| Mortality | Number of patients deceased | 30 days from allocation | 
| Need for elective sigmoid resection | Number of patients that have undergone elective sigmoid resection | 10 years | 
| Need for emergency surgery for diverticulitis on another admission | Number of patients requiring emergency surgery for diverticulitis on another admission | 10 years | 
| Commencement of antimicrobial drug | Number of patients that have received antimicrobial drugs | For the duration of hospital stay, an expected average of 2 days | 
| Late complication of diverticulitis | Number of patients who develop late complications of diverticulitis e.g. fistula, stricture | 10 years | 
| Stoma rate | Number of patients who receive a stoma | 10 years |
HFNC for Induction During Bariatric Surgery Patients.

Study Overview
=================
Brief Summary
-----------------
This study aims to compared the effects of high flow nasal during the induction and during the weaning of anesthesia on intraoperative and postoperative oxygenation and postoperative atelectasis in obese patients undergoing bariatric surgery versus the standard of care, which consists in supplemental oxygen with face mask (Venturi mask).

Official Title
-----------------
Study Protocol for the Use of High Flow Nasal Oxygen During the Anesthesia Induction and Weaning in Patients Scheduled for Bariatric Surgery. A Randomized Pilot Study

Conditions
-----------------
Lung Collapse

Intervention / Treatment
-----------------
* Procedure: HFNC group
* Procedure: Standard group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index > 35 Kg/m2 Bariatric surgery Informed consent signed Exclusion Criteria: age <18yr or >80yr pregnancy or breast-feeding status patients with previous known respiratory disease hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC<br>HFNC with a 60 liters per minute flow will be given to the patients before anesthesia induction and before extubation at the end of the surgery | Procedure: HFNC group<br>* Positive pressure plus supplemental oxygen through a high flow nasal oxygen device<br>|
| Active Comparator: Standard<br>This patients will be managed as usual care. Pre-oxygenation before induction will be performed with supplemental oxygen but without positive pressure. After extubation patients will be oxygenated through a ventury mask. | Procedure: Standard group<br>* Supplemental oxygen through venturi mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation | The oxygenation (the ratio of partial pressure of arterial oxygen with inspiratory oxygen fraction, PaO2/FIO2) informs of the percentadge of shunt. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation | PaO2/FIO2 | First 24 postoperative hours | 
| Atelectasis | Atelectasis evaluated with X-ray | First 24 postoperative hours |
CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

Official Title
-----------------
CLDN18.2 Targeting 124I-18B10(10L) PET Imaging in Patients With Gastrointestinal Tumors

Conditions
-----------------
Gastrointestinal Cancer

Intervention / Treatment
-----------------
* Other: 124I-18B10(10L) PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Aged >18 years old; ECOG 0 or 1; 2. Patients with Gastrointestinal tumors; 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1); 4. life expectancy >=12 weeks. Exclusion Criteria: 1. Significant hepatic or renal dysfunction; 2. Is pregnant or ready to pregnant; 3. Cannot keep their states for half an hour; 4. Refusal to join the clinical study; 5. Suffering from claustrophobia or other mental diseases; 6. Any other situation that researchers think it is not suitable to participate in the experiment.

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging cohort<br>All study participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-18B10(10L) PET/CT scans | Other: 124I-18B10(10L) PET/CT<br>* Study participants will undergo 124I-18B10(10L) PET/CT scans<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value（SUV） |  | 2 years |
Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma

Study Overview
=================
Brief Summary
-----------------
Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Conditions
-----------------
Lymphoma, B-Cell

Intervention / Treatment
-----------------
* Biological: CART20


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory CD20+ B-cell lymphoma. Measurable disease. Performance status ECOG 0-2. Age:18-65. Fertile females/males must consent to use contraceptives during participation of the trial. Signed informed consent Exclusion Criteria: Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. Patients with primary CNS lymphoma. Known human immunodeficiency virus (HIV) infection. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. Patients that do not consent to that tissue and blood samples are stored in a biobank. Pregnancy. -

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: CART20<br> | Biological: CART20<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year |
Effects of Pesticide Exposure on Neurodevelopment/Growth/Respiratory Health

Study Overview
=================
Brief Summary
-----------------
Exposure and health study of pesticide and allergen exposures to pregnant women and children. Intervention study is planned after assessment is completed.

Detailed Description
-----------------
Exposure assessment and pathway analysis of organophosphate pesticides to low income pregnant women and children living in the Salinas valley of California. Health study investigating neurodevelopment, growth, and asthma in children.

Conditions
-----------------
Environmental Exposure

Intervention / Treatment
-----------------
* Procedure: Pesticide application procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Female, at least 18 years of age. Live in Salinas valley in California. Pregnant. Medical eligible.

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

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pesticide application procedures|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
-----------------
Epidemiology, pesticide, asthma, children, exposure