linjc16/ctgov huggingface dataset:
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

Study Overview
=================
Brief Summary
-----------------
An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US. Access can be requested through Clinigen Healthcare Ltd via email MirumALGS@clinigengroup.com or telephone +1-877-768-4303.

Detailed Description
-----------------
The objective of this EAP is to provide access to maralixibat for eligible ALGS patients with cholestatic pruritus. Participants will be treated with 400 µg/kg/day with safety and tolerability evaluated on an ongoing basis.

Official Title
-----------------
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome

Conditions
-----------------
Alagille Syndrome

Intervention / Treatment
-----------------
* Drug: maralixibat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent and assent provided, as applicable, per Institutional Review Board (IRB) or Ethics Committee (EC) Clinical and/or genetic diagnosis of ALGS Male or female participants aged >12 months and ≥5 kg with clinically significant cholestatic pruritus associated with ALGS Willingness to adhere to an acceptable method of contraception until treatment discontinuation by females of childbearing potential who are sexually active or who become sexually active during the program No other therapeutic options or access to any ongoing ALGS clinical trials Exclusion Criteria: Diagnosis with a cholestatic liver disease other than ALGS Female who is pregnant or breastfeeding Clinically significant cardiovascular, hepatic, gastro-intestinal, pulmonary, neurologic, infectious or renal disease or other medical condition that, in the opinion of the physician or Medical Monitor, would preclude participation in the program Past medical history of compensated or decompensated cirrhosis Presence of any other disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of maralixibat or its mode of action

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: maralixibat|Maralixibat is an Apical Sodium-dependent Bile acid Transporter (ASBT) inhibitor|

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
-----------------
Liver Disease, ALGS, Maralixibat, Bile Duct Diseases, Digestive System Diseases, Biliary Tract Diseases, Cholestasis, Pruritis
Belgian Cross-sectional Allogeneic Transplant Survivor Study

Study Overview
=================
Brief Summary
-----------------
With the increasing successful use of allogeneic hematopoietic stem cell transplantation (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term effects of such a drastic treatment. This study investigates the prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation. Income, return to work, social isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality and resilience will be studied.

Detailed Description
-----------------
This is a cross sectional study, where participants are interviewed and fill in a self reported survey. The interview and survey are only taken once. It is non interventional because the patients only give us extra information, which is not usually recorded in our medical records.

Official Title
-----------------
Belgian Cross-sectional Allogeneic Transplant Survivor Study

Conditions
-----------------
Hematopoietic Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation, Allogeneic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to read and write in Dutch Age above 18 years at time of transplant Transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx) Presenting for a periodic health check in UZLEUVEN from November 15th, 2014 to November 15th 2016 Willing to provide oral and written consent Exclusion Criteria: Unable to communicate fluently in Dutch Presenting with major visual, hearing, cognitive or psychiatric conditions precluding participation Presenting with relapse or other major illness, with less than 6 months expected survival Hospitalized for a life-threatening condition

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 |
| --- | --- | --- |
| composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation | This is a cross sectional study, assessing several aspects of survivorship with multiple validated questionnaires (EQ5D, PHQ9, GAD, SFQ, etc). These questionnaires are only taken once in all survivors approached for the study. | The interview/survey will happen once per patient and will be offered to all transplant survivors (minimum 2 years post transplant) coming to the clinic between Nov 2014-Nov 2016. No follow up included. |
Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the utility of high-flow nasal oxygen during sleep endoscopy in obstructive sleep apnea patients.

Official Title
-----------------
Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: High-flow nasal oxygen
* Procedure: Low-flow nasal oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged over 19 years who are scheduled for sleep endoscopy Exclusion Criteria: 1) basal skull fracture, 2) facial anomaly, 3) consciousness disorder, 4) Risk of aspiration, 5) necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: High-flow nasal oxygen during sleep endoscopy<br>High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy. | Procedure: High-flow nasal oxygen<br>* High-flow nasal oxygen will be applied to the patients using Optiflow system through nasal openings during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.<br>|
| Active Comparator: Low-flow nasal oxygen during sleep endoscopy<br>Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy. | Procedure: Low-flow nasal oxygen<br>* Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen saturation value | Pulse oximetry will be monitored continuously during sleep endoscopy. Oxygen saturation value will be recorded during the procedure. | For 15 minutes during sleep endoscopy. At Day 0. |
Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)

Study Overview
=================
Brief Summary
-----------------
Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent.

Detailed Description
-----------------
Observation of primary outcome: Overall Survival Disease-free survival Influencing factors that will be observe: Sex Blood loss Time of surgery Number of resection and anastomosis Peritoneal Index (PI score) Cytoreductibility (CCR score)

Official Title
-----------------
Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)

Conditions
-----------------
Peritoneal Mesotheliomas

Intervention / Treatment
-----------------
* Procedure: Cytoreductive surgery and HIPEC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peritoneal mesothelioma Exclusion Criteria: Non resectable disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peritoneal Mesotheliomas<br>Cytoreductive surgery and HIPEC | Procedure: Cytoreductive surgery and HIPEC<br>* Cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Free survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal Mesotheliomas, hyperthermic intra-peritoneal chemotherapy (HIPEC), Oxaliplatin, Cytoreductive surgery, Oxaliplatin HIPEC
Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (SCT).

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells

Conditions
-----------------
Malignancy, Allogeneic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: Levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allogeneic SCT Postneutropenic period Written consent Exclusion Criteria: Fever Antibiotic therapy Neutropenia Refusal by the patient
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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the bioequivalence (comparison of the rate and extent of the active substance into the body following single administration of the drugs) between the test product V0057 and a reference product after two single oral administration separate by 7 days.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: V0057 - A mg
* Drug: Isotretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subject aged 18 to 50 years (inclusive) Exclusion Criteria: Presence of any significant medical finding or significant history that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator Presence of any clinically significant abnormal finding at examination in the Investigator's opinion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sequence 1 : Test drug - Reference<br> | Drug: V0057 - A mg<br>* Single oral administration<br>Drug: Isotretinoin<br>* Single oral administration<br>|
| Other: Sequence 2 : Reference - Test drug<br> | Drug: V0057 - A mg<br>* Single oral administration<br>Drug: Isotretinoin<br>* Single oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | 18 time points up to 72h after administration | 
| Time of Maximum Concentration (Tmax) |  | 18 time points up to 72h after administration | 
| Area under curve (AUC0-72) |  | 18 time points up to 72h after administration |
Epidemiological Study to Describe Non Small Cell Lung Cancer Clinical Management Patterns in MENA. Lung-EPICLIN/ Gulf

Study Overview
=================
Brief Summary
-----------------
The overall aim of the study is: To provide accurate and reliable information regarding NSCLC clinical management across MENA region in order to detect unmet medical needs of this disease in terms of: Patient and hospital characteristics. Diagnostic and treatment approaches: initial and subsequent. Follow-up patterns in clinical management. Outcomes: symptoms, death, functionality, quality of life. Use of resources and burden on patients and health care systems.

Detailed Description
-----------------
Epidemiological study to describe NSCLC clinical management patterns in MENA

Official Title
-----------------
Epidemiological Study to Describe NSCLC Clinical Management Patterns in MENA

Conditions
-----------------
Non Small Cells Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between November 1st, 2011 and August 30th, 2012 For PRO Sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias. Exclusion Criteria: According to the study design there will not be any exclusion criteria in order to provide a high validity and to obtain the most accurate real daily practice information.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Population<br> | |
| Sample of patients will be invited to complete Quality of Life<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of health resources by collecting data about hospital description and characteristics, Disease Diagnosis Procedures and Therapy information |  | April 2014(26 Months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes (PRO) through self-administered questionnaires and the patients will be asked to complete them at each evaluation visit(25% of the whole sample) |  | April 2014(26 Months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All patients with NSCLC attending participating hospitals
Immunopathologic Profiles and Blood Biomarkers in Patients With IPF

Study Overview
=================
Brief Summary
-----------------
Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in patients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in patients with IPF compared with other interstitial lung diseases. Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

Detailed Description
-----------------
Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in cryobiopsies from the lungs inpatients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in blood samples in patients with IPF compared with other interstitial lung diseases. Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

Official Title
-----------------
Immunopathologic Profiles of the Lung Micro- Environment Using Cryobiopsies and Identification of Blood Biomarkers in Patients With IPF

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of having an ILD who are having cryobiopsies performed Exclusion Criteria: BMI > 35 DLCO < 35% FVC < 45% Pulmonary hypertension Cardiac or other severe comorbidity that will increase the risk of complications
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IPF<br>Patients diagnosed with idiopathic pulmonary fibrosis after multidisciplinary team discussion using medical history, HRCT pattern, laboratory findings, pulmonary function tests and cryobiopsy specimens. | |
| Other ILDs<br>Patients diagnosed with other interstitial diseases other than IPF after multidisciplinary team discussion using medical history, HRCT pattern, laboratory findings, pulmonary function tests and cryobiopsy specimens. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 | Expression of PD-L1 in the epithelial cells in lungs | At diagnosis |
Liposomal Lidocaine Gel for Oral Topical Anesthesia

Study Overview
=================
Brief Summary
-----------------
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.

Detailed Description
-----------------
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.

Official Title
-----------------
Efficacy of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal lidocaine, topical anesthesia<br>Efficacy of Liposomal lidocaine in topical anesthesia. | Drug: Lidocaine<br>* 100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.<br>* Other names: Topical anesthesia in the palatal mucosa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of topical anesthetics on the oral mucosa. | The topical formulations were kept in the palatal mucosa during 2 min. The efficacy of the topical formulations was assessed after a pinprick and a local anesthetic injection on the application site. | 10 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lidocaine,, liposome encapsulation,, topical anesthesia,, palatal mucosa