linjc16/ctgov huggingface dataset:
Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population

Study Overview
=================
Brief Summary
-----------------
Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the real life. The research will be divided into two phases: The first phase intends to define and understand the clinical practice using a questionnaire about general topics: definitions of multiexperienced patients and VL failure, therapeutic strategies and behaviour in particular cases. The second part of the research will collect the clinical data of double PIs failure patients.

Official Title
-----------------
Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Patient Population

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

Intervention / Treatment
-----------------
* Drug: TPV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients double PIs failure Exclusion Criteria: Not Applicable

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 |
| --- |
|Drug: TPV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study in the clinical practice the choice of a specific salvage regimen for multiexperienced patients. |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason of each VL failure or switching |  | 48 weeks |
Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)

Study Overview
=================
Brief Summary
-----------------
Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. With at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (MDASI-LC) and quality of life assessments (SIQOL) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. In the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years after surgery.

Official Title
-----------------
An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer

Conditions
-----------------
Patient-reported Outcomes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be pathologically or clinically diagnosed as primary lung cancer before surgery; Plan to undergo a surgical procedure. Exclusion Criteria: Aged younger than 18; Diagnosis of cognitive impairment or unable to understand the study requirements.

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 |
| --- | --- |
| Lung cancer surgical patients<br>Patient-reported symptom assessments in patients undergoing lung cancer surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC | We will use MD Anderson Symptom Inventory lung cancer module (MDASI-LC) to longitudinally assess the perioperative symptom burden for lung cancer patients. The symptom burden will be profiled as symptom severity, frequency of moderate to severe symptom and its interference with daily functioning. | less than 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
utility parameter, patient-reported outcome, perioperative symptom management, lung cancer
Observational Trial of Qigong for Patients in Pain

Study Overview
=================
Brief Summary
-----------------
This observational study documented outcomes resulting from qigong practice as a complementary self-care practice. All subjects continued with their usual medical care. Recruitment was passive, and participants consisted of those who encountered the practice as part of an earlier clinical trial, or entered the program prior to the observational period (posted information, word-of-mouth), or entered during the observational period (posted information).

Official Title
-----------------
Observational Trial of Chaoyi Fanhuan Qigong as a Complementary Practice in Patients Receiving Treatment at a Tertiary-care Pain Management Unit: Part II

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: qigong


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those undertaking qigong practice as a complementary self-care practice at the Pain Management Unit Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| qigong practice<br>Patients in this arm participated in qigong as part of their treatment at the Pain Management Unit | Behavioral: qigong<br>* Patients of the Pain Management Unit either experience usual treatment, or usual treatment plus qigong practice.<br>|
| control<br>Patients attend the pain management unit but do not undertake qigong practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory | Brief Pain Inventory, short form. Minimum is 0 (no pain), maximum is 10 (most pain) | 8 week intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Mood States | Profile of Mood States. Minimum is 30 (less depressed), maximum is 150 (more depressed) | 8 week intervals | 
| health-related quality of life | Short Form-12 item, Version 2 (SF-12V2). Minimum is 12 (lowest Quality of life), maximum is 56 (best Quality of life) | 8 week intervals | 
| Sleep | Pittsburg Sleep Quality Index. Minimum is 0 (best sleep), maximum is 21 (poor sleep). | 8 week intervals | 
| Fatigue | Chronic Fatigue Scale. Minimum is 0 (no fatigue), maximum is 42 (most fatigue). | 8 week intervals | 
| Practice log | Weekly Practice log | 8 week intervals |
A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males

Study Overview
=================
Brief Summary
-----------------
A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants

Official Title
-----------------
A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Low dose AUT00206 800mg
* Drug: High dose AUT00206 2000 mg
* Drug: Placebo
* Drug: Ketamine
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged 18 to 45 years, inclusive at Visit 1. Healthy on the basis of medical history, psychiatric history, physical examination, vital signs, 12-lead electrocardiogram (ECG), haematology, blood chemistry and urinalysis within 6 weeks of Visit 2. Right-handed. Not a regular smoker (maximum 5 cigarettes per week or equivalent). Exclusion Criteria: History of, or current condition of, migraine headaches or has undergone operations to the head. History of significant claustrophobia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose AUT00206 800 mg + Ketamine<br>Low dose AUT00206 (800 mg) + ketamine | Drug: Low dose AUT00206 800mg<br> <br> Drug: Ketamine<br> <br> |
| Experimental: High dose AUT00206 2000 mg + Ketamine<br>High dose AUT00206 (2000 mg) + ketamine | Drug: High dose AUT00206 2000 mg<br> <br> Drug: Ketamine<br> <br> |
| Placebo Comparator: Placebo + Ketamine<br>Placebo + ketamine | Drug: Placebo<br> <br> Drug: Ketamine<br> <br> |
| Placebo Comparator: Placebo + Saline<br>Placebo + saline | Drug: Placebo<br> <br> Other: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo |  | 15 Weeks |
Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Ondansetron
* Drug: Dimenhydrinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory gynecologic laparoscopy Age 18-45 years ASA class 1-2 Exclusion Criteria: The patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery History of antiemetic, anesthetic and analgesic drugs allergy Pregnancy or breast feeding Body mass index >34 kg/square metre

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal antiemetic management group<br>Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg | Drug: Dexamethasone<br>* 4 mg iv before induction for high and extremely high risk<br>* Other names: dimenhydrinate 1 mg;Drug: Ondansetron<br>* 4 mg iv before ended surgery 30 min<br>Drug: Dimenhydrinate<br>* 1 mg/kg iv before ended surgery 30 min<br>|
| Active Comparator: Control group<br>Control group: Low and moderate risk : no PONV prophylaxis High risk : Ondansetron 4 mg. iv Extremely high risk : Ondansetron 4 mg .iv | Drug: Ondansetron<br>* 4 mg iv before ended surgery 30 min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PONV in ambulatory gynecologic laparoscopy |  | four year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative Nausea and Vomiting, Ambulatory, Gynecologic laparoscopy, Incidence of postoperative nausea and vomiting.
Early Detection of Prostate Cancer by FACS

Study Overview
=================
Brief Summary
-----------------
Early detection of prostrate cancer and development of metastases. The research will attempt to match the SCM test (structuredness of the cytoplasmic matrix) in lymphocytes as an early cancer detection test using Florescent Activated Cell Sorting (FACS) as a replacement for the CellScan instrument. The test is based on measurement of cellular changes in response to the specific prostate antigen, PSA.

Conditions
-----------------
Prostate Cancer, Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experimental group : Males between the ages of 60-90 years, with medical diagnosis of prostate cancer according to both clinical and hematological examinations, before receiving any medical treatment. Control Group 1: Males between the ages of 60-90 years, with diagnosed benign prostate hyperplasia -BPH. Control Group 2: Males between the ages of 60-90 years, medically diagnosed as healthy. Control Group 3: Males between the ages of 60-90 years, medically diagnosed with another form of cancer, not prostate. Exclusion Criteria: Experimental group: Other known cancer or systemic infection. Control Group 1: Other known cancer or systemic infection. Control Group 2:Past hematological disorders nor cancer growth history. other known systemic infection, nor urinary tract infection. Patients hospitalized for orthopedic injuries of any type who are otherwise free of urinary tract infections. Control Group 3:Other known systemic infection, nor urinary tract infection. -

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>10 diagnosed men in age 60 - 90 with Prostate Cancer | |
| 2<br>10 patients with benign growth | |
| 3<br>10 health volunteers | |
| 4<br>10 patients diagnosed with other cancer | |

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
-----------------
Prostate Cancer, Hyperplasia - BPH, FACS, Prostate Cancer, Hyperplasia - BPH, Malignancy
Resource Availability Following Critical Illness

Study Overview
=================
Brief Summary
-----------------
The purpose of this qualitative study is to explore the vital issues in recovery of QOL from the perspective of survivors of critical illness and understand these patients' views on rehabilitative services in the United States (U.S.). The theoretical framework for this study is Max Weber's Rational Choice Theory (RCT). The research questions will focus on understanding post-ICU QOL and the patients' experience with rehabilitative services following critical illness. A phenomenological study design is being employed, using semi-structured individual interviews with critical illness survivors. Data from the interviews will be coded for thematic analysis. The implications for social change include defining the meaning of QOL for an ICU survivor and improving healthcare policies for the therapies necessary to return survivors to a life worth living.

Detailed Description
-----------------
The purpose of this qualitative study is to understand the patient perception of QOL after surviving critical illness and how survivors can help illuminate gaps in current health policies to provide better recovery resources for this growing population. The central research questions are: RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors? RQ2: How do survivors of critical illness describe rehabilitative services after discharge?

Official Title
-----------------
Perception of Quality of Life and Resource Availability After Surviving Critical Illness

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: qualitative study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critical illness survivors within 18 months of ICU discharge minimum 48 hours of mechanical ventilation ability to read and understand English over the age of 18 Exclusion Criteria: emotional or psychological inability to participate in a 30-min interview not meeting inclusion 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

| Intervention/Treatment |
| --- |
|Other: qualitative study|semi-structured interviews|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors? | semi-structured, open-ended qualitative interview | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
survivor, QOL, resources
Hepatotoxicity Related to Protein Kinase Inhibitors

Study Overview
=================
Brief Summary
-----------------
Although protein kinase inhibitors (PKIs) have proved effective in treating many cancers, few patients receiving PKIs may experience rare but life-threatening hepatotoxicity such as hepatic failure. Today, there is no large-scale retrospective pharmacovigilance study focusing on protein kinase inhibitors-related hepatotoxicity. The objective was to investigate reports of hepatotoxicity related to protein kinase inhibitors using FDA Adverse Event Reporting System (FAERS).

Detailed Description
-----------------
The investigators plan to include FDA approved PKIs from PKIDB, a curated, annotated and updated database of protein kinase inhibitors (https://www.icoa.fr/pkidb/). The search terms of hepatotoxicities will be extracted from Drug related hepatic disorders-comprehensive search (SMQ) in MedDRA (Medical Dictionary for Regulatory Activities).

Official Title
-----------------
Hepatotoxicity Related to Protein Kinase Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the FDA Adverse Event Reporting System (FAERS)

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Protein Kinase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case reported in the FAERS database of individual safety case reports at the time of the extraction, Patients treated with at least 1 PKIs. Exclusion Criteria: Chronology not compatible between the PKIs and hepatotoxicities
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Protein Kinase Inhibitor|This retrospective pharmacovigilance study will include protein kinase inhibitor and exclude those drugs known to cause hepatotoxicities|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatotoxicities cases reports related to PKIs (from FAERS database). | The investigators plan to identify number of cases of hepatotoxicities (especially severe toxicities such as hepatic failure) reports related to PKIs reported in the FAERS database by using reporting odds ratios (ROR) and information component (IC), two common method in disproportionality analysis. Clinical features such as gender, age and indications will be displayed, too. | From 2004 to Sep, 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the time to onset of hepatotoxicities after PKIs exposure. | The investigators plan to conduct a time to onset analysis of PKIs-related hepatotoxicities using weibull distribution | From 2004 to Sep, 2021 | 
| Description of the fatality cases. | Fatality cases of PKIs-related hepatotocities will be described. | From 2004 to Sep, 2021 |
Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.

Official Title
-----------------
A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable patients with the DSM-IV TR diagnosis of schizophrenia. These patients are to be identified via psychiatric evaluation and meet DSM-IV TR criteria for schizophrenia of paranoid (295.30), disorganized (295.10), catatonic (295.20), undifferentiated (295.90), or residual (295.60) subtype. Patient to have no significant breakthrough symptoms or exacerbations of psychiatric illness necessitating hospitalization in the 3 months prior to screening. Patient to have a CGI-S score of 3 or less at screening. On a stable regimen of treatment to include quetiapine fumarate for 3 months minimum prior to screening, and on a dose of quetiapine fumarate totaling 600 mg total per day for a minimum of 1 month prior to screening. Patients who are on qd dosing of daily quetiapine fumarate must be willing to convert to 300 mg bid dosing for the duration of the study. Exclusion Criteria: All other DSM-IV axis I diagnoses, including schizoaffective disorder, schizophreniform disorder and/or any other psychiatric diagnoses that in the opinion of the principal investigator may during the conduct of the trial become a primary treatment concern, or may interfere in the patients ability to participate in the trial. Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to quetiapine or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine Fumarate|300 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 10 days |