linjc16/ctgov huggingface dataset:
Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx

Study Overview
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Brief Summary
-----------------
This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.

Official Title
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Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx

Conditions
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Surgery, Arterial Catheterization, Peripheral

Intervention / Treatment
-----------------
* Device: Pulse oximetry


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula Exclusion Criteria: Patients in whom an arterial cannula is not indicated for the surgical procedure Patients in whom a peripheral pulse oximeter value cannot be obtained Patients in whom an invasive arterial cannula cannot be placed Patients with any type of intra-oral pathology or injury Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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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 |
| --- | --- |
| Experimental: Oropharyngeal oximetry<br>The use of a pulse oximeter in the oropharynx on either an oral airway or a tongue blade. | Device: Pulse oximetry<br>* Noninvasive method of measuring the saturation of oxygen in the blood.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Pulse Oximetry | Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations | Baseline |
Danicopan Early Access Program

Study Overview
=================
Brief Summary
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This is an EAP, designed to provide early access to danicopan for participants with PNH experiencing clinically significant EVH who have failed, not tolerated, or are unable to receive other approved treatments; in the Treating Physician's opinion, the participant is not eligible for or is not able to participate in an ongoing clinical trial of danicopan or a comparable treatment; and according to the Treating Physician, the benefit of danicopan treatment outweighs the potential risks.

Official Title
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Early Access Program (EAP) for Danicopan as Add-on Treatment to SOLIRIS® or ULTOMIRIS® in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Clinically Significant Extravascular Hemolysis (csEVH)

Conditions
-----------------
Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis

Intervention / Treatment
-----------------
* Drug: Danicopan


Participation Criteria
=================
Eligibility Criteria
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Key Inclusion Criteria Male or female, aged 18 years and older Diagnosed with PNH with clinically significant EVH as defined by anemia (Hgb ≤ 9.5 g/dL) with absolute reticulocyte count ≥ 120 × 109/L. Currently receiving treatment with SOLIRIS® or ULTOMIRIS® for at least 6 months prior to initiation of danicopan treatment. Platelet count ≥ 30,000/µL without the need for platelet transfusions. Absolute neutrophil counts ≥ 500/µL. Vaccinated against N meningitidis. Key Exclusion Criteria Participants who are nursing or pregnant (or women who are planning to become pregnant during treatment with danicopan). Laboratory abnormalities at screening, as follows: Alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN) Direct bilirubin > 2 × ULN, with the exception of: participants with increased bilirubin due to EVH in the opinion of the Treating Physician or participants with documented Gilbert's syndrome Active bacterial or viral infection, a body temperature > 38°C on 2 consecutive daily measures, evidence of other infection, or history of any febrile illness within 14 days prior to initiating danicopan treatment.

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

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

Accepts Healthy Volunteers
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No

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Danicopan|Participants will receive 150 mg danicopan three times per day (TID) orally as an add-on to a background C5i therapy (SOLIRIS® or ULTOMIRIS®). Participants may be dose-escalated to 200 mg TID based on safety and clinical effect.|

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
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paroxysmal nocturnal hemoglobinuria, PNH, component 5 inhibitors, C5i, intravascular hemolysis, IVH, anemia, EVH, extravascular hemolysis
Patterns of Urinary Bladder Cancer in Darfur, Suda

Study Overview
=================
Brief Summary
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Background: Bladder cancer (BC) exhibits extreme heterogeneity regarding clinical outcome, etiology, histology, and geographic distribution. Recent clinical observations point to alterations in the BC pattern in the Sudan, possibly as a result of lifestyle changes brought on by the enormous migration from rural to urban locations. This study aimed to identify the pattern of bladder cancer in Darfur. Patients and Methods: A cross sectional, hospital-based study, it was conducted inNyala specialized hospital, during the period from (2020 to 2022), included one hundred and five patients with bladder mass matching the inclusion criteria were studied over the diversity of demographic data , clinical finding, pathological type and possible risk factors .

Official Title
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Patterns of Urinary Bladder Cancer in Darfur, Sudan 2020 - 2022

Conditions
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Urinary Bladder Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Sudanese pts who lives in Darfur and presented with urinary bladder mass. Adult above 18 years Exclusion Criteria: Patient who does not live in Darfur. Patients refused to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- | --- |
| Patterns of Urinary Bladder Cancer in Darfur, Sudan | This research study investigates the patterns of urinary bladder cancer (BC) in Darfur, Sudan, with a focus on understanding the clinical outcomes, etiology, histology, and demographic distribution of the disease. | The research is a cross-sectional, hospital-based study conducted at Nyala Specialized Hospital in Darfur. The study spans a period from 2020 to 2022. |
Recognition of Second Twin. Second Training vs Naive Performer. PROMPT Mannequin

Study Overview
=================
Brief Summary
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Anterior foot identification in second twin delivery Two different population of resident in ObGyn Group 1 previous formal lecture on twin vaginal delivery followed by PROMPT mannequin scenario. Group 2 naive residents

Detailed Description
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The present study is addressed to evidential skills in residents with and without previous specific didactical approach to twin vaginal delivery in identification of anterior fetal foot. The two group are randomized by age, sex, seniority. Both the naive and the previous lecture groups are invited to scenario without knowing the intention to test their skills. The time to reach, the number of attempts are recorded.

Official Title
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Second Training vs Naive Performer on Second Twin Delivery on Mannequin

Conditions
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Twin Vaginal Delivery Skills

Intervention / Treatment
-----------------
* Device: twin vaginal delivery simulation


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: residents in Ob Gyn Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 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: two groups randomized One with previous lecture and training, one without
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formal lecture and training<br>exposure to single test of skills | Device: twin vaginal delivery simulation<br>* skill test after formal lecture and simulation in group 1 and after digital learning only<br>* Other names: digital learning;|
| Placebo Comparator: Digital learning only<br>exposure to single test of skill | Device: twin vaginal delivery simulation<br>* skill test after formal lecture and simulation in group 1 and after digital learning only<br>* Other names: digital learning;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of fetal foot on simulator | rate of success in identification | 6 weeks after lecture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to identify foot | time needed to identify foot | 6 weeks after lecture | 
| number of attempt to identify foot | number of attempt | 6 weeks after lecture |
Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

Study Overview
=================
Brief Summary
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This study examines tumor- en surgical characteristics of stage T3 cutaneous squamous cell carcinomas on the scalp, diagnosed between 2010 and 2018. Histological data and patient- and tumor characteristics were collected.

Detailed Description
-----------------
Cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer, following basal cell carcinoma. Following the American Joint Committee on Cancer Tumour, Node and Metastasis (TNM) Classification of Malignant Tumors staging system (TNM8), T3 cutaneous squamous cell carcinomas comprise an interesting group, especially on the scalp, because of the thin subcutaneous fat layer. According to the TNM8 criteria, T3 include all cutaneous squamous cel carcinomas with greatest tumor dimension ≥4cm, tumors with minimal bone erosion or perineural growth (defined as involvement of the nerve sheath of a nerve lying deeper than the dermis or measuring 0.1mm or larger in caliber or showing clinical or radiographic involvement of nerves without invasion of the skull base) or with deep invasion. Deep invasion is defined as invasion deeper than the subcutaneous fat or a tumor thickness >6mm. The scalp has a natural anatomical and oncological barrier for extension in depth known as the epicranial aponeurosis, also called the galea aponeurotica. This retrospective study, examines the tumor- en surgical characteristics of these stage T3 cutaneous squamous cell carcinomas on the scalp.

Official Title
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Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

Conditions
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Squamous Cell Carcinoma, Surgery, Cancer Head Neck

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: stage T3 cutaneous squamous cell carcinoma of the scalp (histologically proven) surgical treatment or radiotherapy treatment Exclusion Criteria: metastasis by diagnosis stage T1/T2/T4

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 |
| --- | --- | --- |
| Surgical characteristics | Choice of treatment, complications, reconstruction types | Between 2010-2017 | 
| Tumor characteristics | Histological data on invasion depth, tumor differentiation | Between 2010-2017 | 
| Patients characteristics | Risk factors, comorbidities | Between 2010-2017 |
PUFAs in Preterm Infants

Study Overview
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Brief Summary
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The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.

Official Title
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Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis

Conditions
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Necrotizing Enterocolitis, Intraventricular Hemorrhage, BPD - Bronchopulmonary Dysplasia, Sepsis, Periventricular Leukomalacia, Patent Ductus Arteriosus

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Infants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns. - Exclusion Criteria: Infants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization. -
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 |
| --- | --- | --- |
| Mortality and severe complications of premature infants | incidence of death，NEC，PDA，BPD，IVH，PVL and sepsis | before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | death | before discharge | 
| NEC | Bell stage II or III | before discharge | 
| PDA | confirmed by echocardiography | before discharge | 
| BPD | nasal CPAP/NIPPV or invasive ventilation requirement at 36 weeks postmenstrual age or at discharge, transfer or death if before 36 weeks | before discharge | 
| IVH | Papile grades 3-4 | before discharge | 
| PVL | periventricular cysts on cranial ultrasound or magnetic resonance imaging | before discharge | 
| sepsis | blood culture positive | before discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PUFAs
Wound Healing in Primary TKA

Study Overview
=================
Brief Summary
-----------------
Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific factors, such as vascular or immune-related medical conditions, obesity, and smoking, among others. The development of early wound complications can lead to increased length of hospital stay and more serious complications, including deep infection and major subsequent surgery. However, there are modifiable variables that could affect the risk of getting wound complications, such as the closure technique. This study aims to analyze the difference in rates of wound complications using two different closure techniques in primary TKA.

Official Title
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Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA

Conditions
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Total Knee Replacement, Wound Complication

Intervention / Treatment
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* Procedure: Skin closure using skin adhesive
* Procedure: Skin closure without skin adhesive


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old that will undergo primary TKA with a midline approach Exclusion Criteria: Previous knee arthroplasty surgeries or midline scars TKA secondary to oncologic or traumatic etiologies BMI ≥ 40 uncontrolled diabetes (measured by a Hgb A1c above 8) reported allergy to skin adhesive immunodeficiencies bleeding disorders anticoagulation other than ASA

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: suture with skin adhesive<br>After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive | Procedure: Skin closure using skin adhesive<br>* Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive<br>|
| Active Comparator: Group B: suture without skin adhesive<br>After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive. | Procedure: Skin closure without skin adhesive<br>* Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound complications | Assessed using Photographic documentation of the wound | 90 days | 
| Patient satisfaction | Assessed using the POSAS (patient and observer scar assessment scale) questionnaire | 90 days |
Yellow Fever Human Infection Model With YF-17D

Study Overview
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Brief Summary
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No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

Detailed Description
-----------------
No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

Official Title
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Yellow Fever Human Infection Model With YF-17D

Conditions
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Yellow Fever

Intervention / Treatment
-----------------
* Drug: Yellow Fever Vaccine


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: age 18-50 years Exclusion Criteria: contraindication to receive YF-17D (immune deficiency, thymus illness) previous YF vaccination pregnancy chicken egg allergy hypersensitivity to any other substance in the YF-17D vaccine interval of < 4 weeks of another live attenuated vaccine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: human infection model of yellow fever with the yellow fever 17D vaccine and viruria (virus in urine) as readout
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intervention arm<br>yellow fever vaccine arm (all participants receive the standard yellow fever vaccine (Stamaril) | Drug: Yellow Fever Vaccine<br>* vaccination according to manufacturers manual (0.5mL subcutaneously in the arm)<br>* Other names: Stamaril (yellow fever vaccine);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| yellow fever 17D in urine | yellow fever 17D in urine at sequential time points after vaccination | within 30 days of the vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak of YF 17D viruria after vaccination | days after vaccination on which most participants have a positive yellow fever virus PCR on urine as material | within 30 days of the vaccination | 
| YF-17D viremia (in plasma) after vaccination | days after vaccination on which most participants have a positive yellow fever virus PCR on plasma as material | within 14 days of the vaccination |