linjc16/ctgov huggingface dataset:
Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism

Study Overview
=================
Brief Summary
-----------------
This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis.

Detailed Description
-----------------
For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any of the exclusion criteria will be invited to participate in the study. There will be a 1 time visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.

Official Title
-----------------
Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism

Conditions
-----------------
Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female participants ≥6 to 65 yrs of age Meet AD Standard Diagnostic Criteria Exclusion Criteria: Enrollment in another clinical trial Hypersensitivity to an agent used for the skin decolonization protocol Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine, methotrexate) Phototherapy for AD within 4 weeks Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days Bleach baths within 7 days of the first Visit Use of oral or topical antibiotics within 21 days of the beginning of the study Asthmatics receiving more than 500 μg per day of inhaled corticosteroids History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,, Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease. Febrile illness at time of visits Suspected immune deficiency or family history of primary immunodeficiency

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| atopic dermatitis severity | validated assessment EASI score | baseline, only 1 time point |
Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)

Study Overview
=================
Brief Summary
-----------------
The objective of the present work is to explore and compare the diagnostic quality of sputum specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316 in patients diagnosed with interstitial lung diseases.

Conditions
-----------------
Interstitial Lung Disease

Intervention / Treatment
-----------------
* Drug: INS316 solution for inhalation
* Drug: hypertonic saline 3% sodium chloride solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18 years or older undergone diagnostic bronchoalveolar lavage within the previous 21 days diagnosed with sarcoidosis or other ILD Exclusion Criteria: having resting hypoxemia receiving corticosteroid treatment

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INS316<br>inhalation via nebulizer given for 2 doses for 60 minutes each | Drug: INS316 solution for inhalation<br>* inhalation via nebulizer given for 2 doses for 60 minutes each<br>|
| Placebo Comparator: hypertonic saline 3% sodium chloride solution<br>inhalation via nebulizer given for 2 doses for 60 minutes each | Drug: hypertonic saline 3% sodium chloride solution<br>* inhalation via nebulizer given for 2 doses for 60 minutes each<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of sarcoidosis using sputum induction (sputum weight) |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 60 minutes |
Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.

Study Overview
=================
Brief Summary
-----------------
The study involves the use of Retroperitoneal plane for TME for rectal anterior resection. Through a pilot prospective study, LR-TME will be assessed as one arm study.

Detailed Description
-----------------
This study is based on our new suggested theory for a retro-peritoneal approach. After successful 2 cases of Laparoscopic extraperitoneal-TME. A pilot study for assessment of the feasibilty of the new approach. Data will be registered prospectively and the perioperative outcomes will be assessed.

Official Title
-----------------
Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.

Conditions
-----------------
Total Mesorectal Excision, Laparoscopic

Intervention / Treatment
-----------------
* Procedure: LE-TME


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery Exclusion Criteria: contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reroperitoneal Group<br>LE-TME | Procedure: LE-TME<br>* Retroperitoneal approach for total mesorectal excision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the procedure | Feasibility of the TME by the retroperitoneal approach. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative morbidity | Intraoperative morbidity including Urteric injury, Vascular injuries, hypogastric nerve injury, intestinal loop injury. | 1 day | 
| Postoperative morbidity | Postoperative haematoma, colonic leak and/or necrosis, pelvic abscess, intestinal obstruction | Till patient discharge | 
| Pathologic report outcome | Lymph node harvest, radial and circumferential margin, complete total mesorectal excison | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LE-TME, Laparoscopic rectal resection, Retroperitoneal resection
Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.

Official Title
-----------------
The Effectiveness and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Breast Cancer.

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

Intervention / Treatment
-----------------
* Drug: Pegylated Liposomal Doxorubicin and docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed breast cancer; Age >18 years; Eastern Cooperative Group (ECOG) performance status 0-2; measurable disease (as per radiological imaging); life expectancy >12 months; adequate haematologic blood profile; normal liver and kidney function; adequate cardiac function; no metastatic disease; negative pregnancy test (premenopausal women); signed informed consent. Exclusion Criteria: Level 2 cardiac toxic effects were deﬁned as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ; Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures); Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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: Pegylated Liposomal Doxorubicin and docetaxel<br>Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles. | Drug: Pegylated Liposomal Doxorubicin and docetaxel<br> <br> * Other names: Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR rate | pathologic complete response rate | 12 months |
Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin

Study Overview
=================
Brief Summary
-----------------
In this study we compare the vitamin B12 status by measuring serum vitamin B12 and holotranscobalamin in type 2 diabetic patients with and without metformin treatment. Afterwars we investigate which biomarker could be adequate to reflect B12 status in metformin-treated patients. With the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency.

Official Title
-----------------
Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Other: Questionnaire administration
* Other: Laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of T2DM > 6 months Metformin treatment for at least 6 months Age > 18 years Ability to give written informed consent No metformin treatment in the last 6 months (control group) Exclusion Criteria: Concurrent intake of preparations containing VB12 (within the last 3 months prior to study participation) Lack of written and/or oral understanding in German, French, Italian or English languages Diagnosis of Transcobolamin transporter defect Diagnosis of Chronic or acute liver diseaseliver insufficiency with CHILD-PUGH scores B and C and acute hepatitis Diagnosis of Renal disease (Creatinine-Clearance <60 ml/min)renal insufficiency stadium III, IV and V (KDOQI) and acute renal diseases

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 |
| --- | --- |
| Diabetes mellitus type 2, Metformin<br>The case group consists of patients with diagnosed diabetes mellitus type 2 treated with Metformin. | Other: Questionnaire administration<br> <br> Other: Laboratory biomarker analysis<br> <br> |
| Diabetes mellitus type 2<br>The control group consists of patients with diagnosed diabetes mellitus type 2 which do not have metformin treatment | Other: Questionnaire administration<br> <br> Other: Laboratory biomarker analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of serum vitamin B12 and serum holotranscobalamin concentrations | VB12, HoloTc | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire results | Clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency should be determined in patients with T2DM. | day 8 |
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear

Study Overview
=================
Brief Summary
-----------------
During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. They will be then asked to rate their taste as a reference to the amount of fluid leaking to the throat through the eustachian tube.

Official Title
-----------------
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear

Conditions
-----------------
Sudden Hearing Loss

Intervention / Treatment
-----------------
* Other: Sitting after intra tympanic injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear Exclusion Criteria: Patients with abnormal sense of taste Middle or inner ear anomaly Eustachian tube dysfunction

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitting after intra tympanic injection<br>Patients with Sudden hearing loss sitting after intra tympanic injection of steroids | Other: Sitting after intra tympanic injection<br>* Sitting after intra tympanic injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bitter taste | Bitter taste described by the patients using a questionnaire with a scale of 0 to 5 | 30 minutes |
Safety of REL-1017 for Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This is a 1-year open-label study to access the safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.

Official Title
-----------------
A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: REL-1017


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 to 65 years, inclusive. Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD. Current major depressive episode. Exclusion Criteria: Any current and primary psychiatric disorder other than Major Depressive Disorder. Severe alcohol or substance use disorder. History of bipolar I and II disorder, psychosis, and/or mania. Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study. Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.

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: REL-1017 25 mg<br>Participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT). | Drug: REL-1017<br>* REL-1017 tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of REL-1017 as incidence of treatment emergent adverse events (TEAEs) |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
REL-1017
Immunization Schedule Alert Platform

Study Overview
=================
Brief Summary
-----------------
The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.

Detailed Description
-----------------
The ISAP - Immunization Schedule Alert Platform study is investigating the efficacy of ISAP SMS exposure to Caregivers with children( who have fulfilled our inclusion criteria) due for routine childhood Immunisation in influencing decision for timely and complete Immunization uptake. ISAP SMS messages contains information on the Immunization appointment schedule, time ,vaccine to be administered and the address of the Immunization centre.

Official Title
-----------------
Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria

Conditions
-----------------
Immunization

Intervention / Treatment
-----------------
* Behavioral: ISAP SMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregiver with child due for birth dose vaccination or at 6weeks-OPV1,Penta1,PCV1,Rota1. Exclusion Criteria: Caregiver with child who have already had OPV1,Penta1,PCV1and Rota1. -

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Months

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

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

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 |
| --- | --- |
| Active Comparator: ISAP SMS<br>ISAP SMS will be sent to enrolled caregivers | Behavioral: ISAP SMS<br>* ISAP SMS is a text message for caregivers use that provides immunization schedule and vaccine availability at the nearest immunization clinic.<br>|
| No Intervention: No ISAP SMS<br>No ISAP SMS will be sent to enrolled caregivers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of timely and complete vaccine uptake after ISAP SMS Intervention | Proportion of timely and complete vaccine uptake after ISAP SMS Intervention | 12 months |
Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention.

Official Title
-----------------
Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule

Conditions
-----------------
Aphasia

Intervention / Treatment
-----------------
* Other: Investigate efficacy of modified ciat schedule
* Other: examine the efficacy of standard treatment versus modified ciat schedule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of first-ever stroke aphasia in sub-acute stage german speakers Exclusion Criteria: presence of residual aphasia dysarthria and apraxia of speech

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 84 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 |
| --- | --- |
| Experimental: CIAT-Group<br>Patients received a modified constraint-induced therapy schedule | Other: Investigate efficacy of modified ciat schedule<br>* 2 hours of training over 15 days<br>|
| Active Comparator: standard treatment group<br>patients received a standard aphasia therapy | Other: examine the efficacy of standard treatment versus modified ciat schedule<br>* 2 hours of training over 15 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT) |  | pretreatment and 4 weeks | 
| change from pretreatment in Aachen Aphasia Test at 8 weeks |  | pretreatment and 8 weeks | 
| change from pretreatment in Aachen Aphasia Test at 1 year |  | pretreatment and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Communicative Activity (CAL) |  | pretreatment and 4 weeks | 
| change from pretreatment in communication activity (CAL)at 8 weeks |  | pretreatment and 8 weeks | 
| Change from pretreatment in communication activity (CAL)at 1 year |  | pretreatment and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aphasia, Rehabilitation of Speech and Language Disorders