linjc16/ctgov huggingface dataset:
Expanded Access to Glecaprevir/ Pibrentasvir

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Glecaprevir/ Pibrentasvir

Conditions
-----------------
Hepatitis C Virus Infection

Intervention / Treatment
-----------------
* Drug: glecaprevir
* Drug: pibrentasvir


Participation Criteria
=================

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


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glecaprevir|Glecaprevir will be administered orally.|
|Drug: pibrentasvir|Pibrentasvir will be administered orally.|

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
-----------------
Special Access Scheme, Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis
Effect of Oral Tramadol Administration Prior to IUD Insertion

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to evaluate the safety and efficacy of oral tramadol administration in reducing pain during LNG- IUD insertion in adolescents and young women

Official Title
-----------------
Safety and Efficacy of Oral Tramadol Administration in Reducing Pain During Levonorgestrel Intrauterine Device Insertion in Adolescents and Young Women: a Randomized Controlled Trial

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: oral tramadol
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous adolescents and young women requesting LNG-IUD insertion Exclusion Criteria: parous women, contraindications to LNG-IUD insertion and allergy or contraindications to tramadol

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral tramadol<br>oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion | Drug: oral tramadol<br>* oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion<br>|
| Placebo Comparator: placebo<br>oral placebo tablet given 1 hour before LNG-IUD insertion | Drug: Placebo oral tablet<br>* oral placebo tablet given 1 hour before LNG-IUD insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during IUD insertion | intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where 'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the procedure | duration of IUD insertion from speculum in to speculum out in minutes | 5 minutes |
Radioimmunoimaging of AL Amyloidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Detailed Description
-----------------
To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 to 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Official Title
-----------------
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4

Conditions
-----------------
Primary Amyloidosis

Intervention / Treatment
-----------------
* Biological: 124I-labeled monoclonal antibody Mu 11-1F4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of AL amyloidosis Exclusion Criteria: New York Heart Association class IV patient on renal dialysis serum antibodies to mouse protein

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I-124 Mu 11-1F4 sterile injection<br>Single arm study | Biological: 124I-labeled monoclonal antibody Mu 11-1F4<br>* Single infusion of radiolabeled antibody: 2 mCi (1 mg)<br>* Other names: anti-amyloid radioimmunoimaging agent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioimmunoimaging of AL amyloid deposits by PET/CT |  | 10-14 days post infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radioimmunoimaging, AL Amyloidosis, PET/CT
IL-12RB and TNF-alpha Gene Polymorphism and Susceptibility and Progress of Covid-19 SARS-CoV-2: A Case Control Study

Study Overview
=================
Brief Summary
-----------------
A novel coronavirus was identified in late 2019 in Wuhan, China On 11 February, The International Committee on Taxonomy of Viruses (ICTV) announced that the official classification of the new coronavirus (2019-nCoV) is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) announced on the same day that the official name of the disease caused by the virus is Corona Virus Disease-19 (COVID-19). WHO has declared the infection a Pandemic on March 11, 2020. Based on previous studies on SARS in 2003 and SARS-MERS 2013 there was a genetic polymorphism associated with the susceptibility and severity of the disease. Interleukin-12 (IL-12) is a cytokine secreted by activated phagocytes and dendritic cells. It plays a pivotal role in promoting Th1-type immune responses and cell-mediated immunity. IL-12 triggers many biological functions: it stimulates the proliferation of activated T- and NK-cells, enhances T- and NK-cell-mediated cytolytic activity, and induces the production of IFN-γ by both T-and NK-cells. The interferon-γ production induced by IL-12 forms a major link between innate and adaptive immunity. A recent study revealed that interferon-mediated immunopathological events are associated with atypical innate and adaptive immune responses in SARS patients. Also, TNF-α is a key mediator of the inflammatory response and is critical for host defense against a wide variety of pathogenic microbes. However, the over-expression of this cytokine may lead to badness in disease recovery. The dual role of TNF, acting as an agent of both innate immunity and inflammatory pathology, poses a considerable challenge for gene regulation.

Official Title
-----------------
Association Between IL-12RB and TNF-alpha Gene Polymorphism With Susceptibility and Progress of Covid-19 SARS-CoV-2: A Case Control Study

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed COVID-19 PCR ( mild, moderate and severe cases) admitted to wards or ICU Assiut University Hospitals Exclusion Criteria: Suspected or non confirmed cases of COVID-19

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure level of polymorphisms of interleukin (IL)-12 receptor B1 (IL-12RB1) and TNF- α alpha on COVID-19 related severe acute respiratory syndrome (SARS-CoV-2). | genetic polymorphism | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, corona virus disease, SARS-CoV-2, IL-12 RB gene polymorphism, TNF gene polymorphism
Cognitive Behavioral Therapy for Complicated Grief

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for complicated grief is superior to wait list condition in patients with comorbid complicated grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be compared to changes in the wait list group.

Official Title
-----------------
Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief

Conditions
-----------------
Grief

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy for Complicated Grief


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age complicated grief diagnosis Exclusion Criteria: acute suicidality

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CG-CBT<br> | Behavioral: Cognitive Behavioral Therapy for Complicated Grief<br>* Manualized CBT with 25 sessions, once a week. Key elements are exposition and cognitive restructuring.<br>|
| No Intervention: wait list control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PG-13 (Prolonged Grief Interview - 13 Item version) |  | Change between intake (t1) and end of treatment (t2) in complicated grief severity within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Checklist 90 revised (SCL-90R; Subscale General Symptom Index, GSI) |  | Change between intake (t1) and end of treatment (t2) in general distress symptoms within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2) | 
| Comorbid Diagnoses by DIA-X-Interview |  | Change between intake (t1) and end of treatment (t2) in number of comorbid psychiatric diagnoses within 5 months; t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comorbid, Complicated
Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.

Study Overview
=================
Brief Summary
-----------------
To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.

Official Title
-----------------
Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with a diagnosis of partial epilepsy. 18 years and older. Exclusion Criteria: Having a treatable cause of seizure. Having a progressive neurological or systemic disorder

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in seizure frequency. |  |  |
Double-Lumen Tube With or Without a Carinal Hook

Study Overview
=================
Brief Summary
-----------------
Most teams use a left double-lumen tube. The double-lumen tube is available with or without a carinal hook. The hook is supposed to facilitate the positioning of the tube and avoid the mobilization of the tube during surgery. The use of double-lumen tubes with a hook is large in Europe and quite unknown in US. The literature is poor, containing only few case reports. The purpose of this research is to compare the two types of left double-lumen tube.

Official Title
-----------------
Comparison Between Left Double-lumen Tube With or Without a Carinal Hook During Lung Surgery

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

Intervention / Treatment
-----------------
* Device: Tracheal intubation
* Device: Tracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for lung surgery requiring one-lung ventilation Exclusion Criteria: pregnancy ASA class 4 prevision of difficult intubation or of pulmonary aspiration

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double lumen tube without a hook<br>Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex | Device: Tracheal intubation<br>* Tracheal intubation using a Double lumen tube without a hook<br>|
| Experimental: Double lumen tube with a hook<br>Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex | Device: Tracheal intubation<br>* Tracheal intubation with a Double lumen tube with a hook<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time required to initially position the assigned tube |  | end of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of lung collapse |  | end of anesthesia | 
| number of intraoperatively FOB examinations |  | end of anesthesia | 
| Glottic or tracheo-bronchial lesion |  | end of hospitalisation | 
| Sore throat or hoarse voice |  | end of hospitalisation |
Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenström's Macroglobulinemia (WM).

Detailed Description
-----------------
This multi-center, single-arm study of epratuzumab is in patients with Waldenström's Macroglobulinemia (WM) who failed chemotherapy. After baseline evaluations, patients receive epratuzumab infused over approximately 30-60 minutes at 360 mg/m2, administered once weekly for 4 consecutive weeks (days 1, 8, 15, 22). Post-treatment evaluations occur on the day of the last infusion, then at 6 and 12 weeks. Patients without progression of disease continue long-term follow up until disease progression or for at least 5 years, with evaluations every 3 months for 2 years, then semi-annually. Otherwise, follow-up is only required until resolution of any treatment related abnormalities.

Official Title
-----------------
A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia

Conditions
-----------------
Waldenstrom Macroglobulinemia

Intervention / Treatment
-----------------
* Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of Waldenström's Macroglobulinemia using criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002. Measurable disease, defined as serum monoclonal IgM protein ≥1000 mg/dL by electrophoresis. Lymphoplasmacytic infiltration of the bone marrow >10% involvement. Failed at least one, but no more than 3, regimen(s) of prior therapy. (Please consult with study site for full eligibility 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum measurements of IgM will be the primary determination of efficacy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epratuzumab (hLL2- anti-CD22 humanized antibody), Waldenstrom's Macroglobulinemia, Waldenstrom Macroglobulinemia, Hematologic Disease, Hematologic Diseases, Paraproteinemias, Vascular Hemostatic Disorders, Lymphoproliferative Disorders
Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars

Study Overview
=================
Brief Summary
-----------------
This study compares the application of a picosecond 1064-nm laser with a diffractive lens array with nonablative fractional laser for the treatment of acne scarring.

Detailed Description
-----------------
This trial is a 17-week, prospective, randomized split-face study that compares the results between two facial sides either receiving the picosecond 1064-nm laser or nonablative fractional laser treatment for atrophic acne scar.

Official Title
-----------------
Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars

Conditions
-----------------
Acne Scars

Intervention / Treatment
-----------------
* Procedure: Laser therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with facial atrophic acne scars Subjects who observe the schedules and protocols of the clinical trial Subjects who give informed consent to participate in the clinical trial Exclusion Criteria: Subjects who have active acne under treatment Subjects who had received any other treatments for acne scarring for 6 months prior to the first treatment Subjects who underwent other treatments including chemical, mechanical or laser resurfacing during the study period Subjects who have current acute illness Subjects who are considered inappropriate for the clinical trial under the judgement of investigators

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Interventional Model Description: Split-face comparison study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picosecond laser<br>Intervention: four consecutive sessions of 1,064-nm picosecond laser at 3-week intervals | Procedure: Laser therapy<br>* 4 consecutive sessions of laser therapy<br>|
| Active Comparator: Fractional laser<br>Intervention: four consecutive sessions of nonablative fractional laser at 3-week intervals | Procedure: Laser therapy<br>* 4 consecutive sessions of laser therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the mean of the ECCA grading scale | The ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale: minimum score 0; maximum score 270; higher values represent a worse outcome. | Week 17 |