cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Molecular Typing and Neoadjuvant Chemotherapy in Breast Cancer Patients Based on Mammaprint/Blueprint Test

This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the technical analysis of Mammaprint in patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in tumor tissues and evaluated the accuracy and sensitivity of Mammaprint test in the efficacy of neoadjuvant chemotherapy.A new model for predicting NCT effect of breast cancer with combined risk genes and clinical parameters was established based on the clinical characteristic parameters of patients to study the accuracy and sensitivity of Mammaprint monitoring for prognosis determination of breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed new breast cancer (invasive cancer)
* Clinical stage II-III
* women
* Aged 25-80
* At least 6 months of follow-up data, clinical diagnosis and treatment information and personal information available for follow-up are complete
* Complete biological samples required for the study: fresh/frozen tissues/white tablets/wax blocks meeting the requirements of the experiment (before neoadjuvant chemotherapy)
* Tumor markers and imaging data were complete
* Neoadjuvant chemotherapy is commonly recommended by the standard NCCN guidelines

Exclusion Criteria:

* Subjects refuse to participate
* First diagnosis of stage I or IV breast cancer
* Pathological diagnosis of concurrent (or previous) other malignant tumors
* Prehistory breast cancer
* Younger than 25 or older than 80
* Clinical diagnosis and treatment information or biological samples required by the research institute do not meet the needs of the experiment
Neurocognitive Functions of Recovered COVID-19 Patients

This study is carried on in Wuchang Hospital in Wuhan, China. The investigators plan to recruit 80 patients with COVID-19 and 80 matched healthy control. Using the design of case-control study, the study aims to assess the neurocognitive functions such as executive function and attentional bias in recovered patients with COVID-19 under normal and stress conditions, and to analyze the influencing factors of neurocognitive functions, such as mental health conditions, inflammation indicators and cardiopulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Recovered COVID-19 patients or uninfected residents in Wuhan, with an education level above elementary school and are able to complete cognitive tasks;
* Willing to participate in this study and sign informed consent.

Exclusion Criteria:

* Subjects with body temperature\> 38°C;
* Subjects who are in menstruation and pregnancy;
* Subjects suffering from cardiopulmonary diseases before the new coronary pneumonia epidemic (such as heart disease, pulmonary hypertension, congestive heart failure, etc.);
* Subjects with severe disturbances in consciousness, cognitive dysfunction, mental disorders, visual and hearing disorders, bone and joint diseases, etc.;
* Subjects with abnormal immune system and severe organ dysfunction (heart, liver, kidney, etc.);
* Subjects who are unwilling to participate in this study and cannot complete all surveys and cognitive function tests.
Symptom-Based Markers for COVID-19 Transmission

In this study, COVID-19 positive patients will be added to a bidirectional texting program to receive daily surveys about their symptoms with the infection. This data will further the understanding of COVID-19 symptom development throughout the infection period, as well as how those symptoms vary at different points of the day. This study will be a single cohort, observational study of COVID-19 patients.

One important approach for decreasing COVID-19 transmission in healthcare settings is to prevent healthcare professionals from working while ill. Currently, facilities are asking screening questions and measuring temperatures to help identify symptomatic healthcare professionals and exclude them from providing patient care. Simulations can be used to inform the effectiveness of different screening approaches, but the results of these simulations depend upon the effectiveness of the intervention, e.g., the ability to identify healthcare professionals on their way to work, or to study the impact of healthcare professionals returning to work too early. Thus, simulations must necessarily depend upon realistic disease parameters: for example, it is suspected that a non-trivial proportion of patients with COVID-19 may be asymptomatic or have minimal symptoms, but the relative size of the asymptomatic subpopulation is unknown.

The plan for this study is to develop a method for granular measurement of twice-daily symptoms from healthcare professionals and other research subjects of similar ages. After being diagnosed, the goal is to determine what symptoms participants have and how long they have had them. This will be done using a previously-developed bidirectional texting platform to query participants about symptoms at least twice a day for ten days post diagnosis. Participants will be asked about subjective symptoms, including fevers, chills, cough, shortness of breath, fatigue, gastrointestinal symptoms, etc. They will also take their temperature twice daily during the recovery period, which will help determine the effectiveness of screening based on symptoms and/or thermometer readings.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Tested positive for COVID-19

Exclusion Criteria:

* Prisoners
* Unable to provide own informed consent
Postoperative Atelectasis in Pediatric Patients With Prone Position

This study evaluates the incidence of postoperative atelectasis after general anesthesia with prone position using lung ultrasound in children age \< 3 years.

Atelectasis is common in pediatric patients after general anesthesia. Particularly, infants are more likely to develop atelectasis or ventilation-perfusion imbalance after general anesthesia because of the immature ribs and respiratory muscles, the high compliance of the rib cage and a significant reduction in functional residual capacity (FRC) during general anesthesia. Previous studies have reported that alveolar recruitment and positive end-expiratory pressure (PEEP) can be used to reduce atelectasis in children. Also, previous studies have shown that the lung ultrasound can be used to evaluate the degree of atelectasis during general anesthesia in children.

However, none of the previous studies investigated the incidence of atelectasis, the effect of alveolar recruitment, and the PEEP in pediatric patients under general anesthesia with prone position. The purpose of this study was to evaluate previously described parameters using lung ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing general anesthesia with prone position
* Endotracheal intubation and mechanical ventilation during general anesthesia
* Operation time is more than 2 hours

Exclusion Criteria:

* Previous lung surgery
* Any abnormal findings such as atelectasis, pneumothorax, pleural effusion, or pneumonia on preoperative chest X-ray
* Researchers judge (to be inappropriate)
Effect of Different Remineralization Gels

The aim of the study is to treat white spot lesions that occur after orthodontic treatment.

Different gels will be used for remineralization. The study will consist of 45 people between the ages of 15-18. 45 people will be divided into 3 groups.

Oral hygiene training will be given to each group and a toothpaste containing 1450 ppm fluoride will be given to brush their teeth twice a day.

Essix appliance with reservoir will be made by taking impressions from 30 patients. Remineralization gel will be put into the Essix appliance for 5-7 minutes twice a day for one month.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 15-18 years,
* Presence of white point lesions,
* Volunteering to participate in the research.

Exclusion Criteria:

* Not having received orthodontic treatment,
* Having a developmental anomaly affecting the enamel,
* Being allergic to milk,
* Having a syndrome affecting the oral cavity.
Seguimos Avanzando - Latino Youth Coping With Discrimination

The overall objective of this study is to investigate mediators and moderators at multiple ecological (individual, family/peer and school/neighborhood levels) and time-scale (micro- and macro-time) levels in the link between discrimination-related stressors and mental health among 340 Mexican-origin youth.

The project's long-term goal is to improve the mental health of Mexican-origin youth by reducing the deleterious effects of racism, "othering," and negative neighborhood interactions. Community based collaboration will be used to recruit a sample of 340 Mexican-origin adolescents, mothers, and fathers in Indiana. The inclusion of fathers will be a valuable contribution to the literature, given the dearth of studies on Latinx fathers/stepfathers. A combination of annual surveys administered over three waves to parents and youth ("macro-time") and a 21-day daily diary ("micro-time") administered in wave 1 to youth is employed to assess important questions about how mediating and moderating processes unfold over time. Specific aims of the project include determination of within-person discrimination-related stressors that impact youth's mental health outcomes and the mechanisms of action at both micro- and macro- time levels; identification of protective factors that could help coping with discrimination related stressors and conditions under which they work; and elucidating youth, parent, and neighborhood risk factors that moderate the link between discrimination-related stressors and mental health outcomes in youth. This research is highly translational in that it will facilitate the development of more effective, culturally sensitive prevention and intervention strategies for Latinx youth and their families.

Eligibility Criteria:
Inclusion Criteria:

Adolescent Inclusion Criteria:

* The adolescent has two eligible caregivers (as defined in the following criteria)
* The adolescent resides with at least one of the two caregivers.
* One of the caregivers is a parent or legal guardian who is eligible to give consent for the child's participation.

Caregiver Inclusion Criteria:

* Biological Parents of Mexican origin
* Legal guardians of Mexican origin
* Step-parents of Mexican origin
* A caregiver of Mexican origin identified by the parent/guardian who is 18 or older (e.g., grandparents, uncles/aunts, older siblings, godparents)

Exclusion Criteria:

* A parent reports that the adolescent has a severe learning or developmental disability which would prevent understanding/survey response
Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma

This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
* At least one measurable or assessable tumor lesion.
* Adequate organ and hematologic function.
* Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
* All adverse events from prior treatment must be CTCAE v5.0 grade \<= 1

Exclusion Criteria:

* Active central nervous system (CNS) lymphoma.
* Systemic steroid therapy (dose equivalent to \> 10 mg prednisone / day).
* History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade \>=3).
* Have evidence of severe uncontrollable active infection.
* Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* 18 years of age, or older.
* Capable of completing the diary card.
* Ability to complete the HRQL questionnaires.
* A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (\>325 mg/day).
* Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)
* Hp negative by UBT, serology or biopsy based test, at visit 1.

Exclusion Criteria:

* Current, or history of, gastric or duodenal ulcer
* Current, or history of, esophageal, gastric or duodenal surgery.
* History of GERD, not associated with NSAID use.
* Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
* Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
* Endoscopic Barrett's esophagus(\>3 cm) or significant dysplastic changes in the esophagus.
A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System

The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.

Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater.

The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged between 45 and 75 years inclusive.
* Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
* Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º.
* Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
* Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the P.F.C.® Sigma RPF knee, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
* Subjects who are currently involved in any personal injury litigation claims.
* Subjects with a known history of poor compliance to medical treatment.
* Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis.
* Subjects who have morbid obesity i.e. BMI ≥40.
A RETROspective Study of Patients With TK2d

This is a medical chart review study to collect information for patients who have been taking pyrimidine nucleosides for treatment of TK2 deficiency. Information from the time of onset of symptoms will be collected to describe the pre treatment course of TK2 deficiency.

Data to be collected from the time of onset of symptoms related to TK2 deficiency includes medical conditions and/or adverse events (AEs); these should include relationship to TK2 disease and/or pyrimidine nucleosides, as appropriate, as well as date of onset and severity, when available. When available, test reports may be obtained as well as available research biological samples (eg, blood or tissue samples that may be tested for biomarkers of disease and/or effects of medications to treat the mitochondrial disease).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by the patient or parent(s)/legally authorized representative (LAR) and/or assent by the patient (when applicable), unless the associated institutional review board (IRB) or ethics committee (EC) provides an appropriate consent waiver
2. Confirmed genetic mutation in the TK2 gene
3. Availability of medical records for each patient from the time of onset of symptoms
4. Patient has taken pyrimidine nucleos(t)ides (dCMP/dTMP and/or dC/dT) as substrate enhancement therapy for TK2 deficiency
5. Most recent patient visit at which efficacy and/or safety parameters were collected occurred between 01 June 2018 and 15 December 2018

Exclusion Criteria:

1. Presence of other genetic disease or polygenic disease
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)

"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)

This international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on TiLOOP® Bra Pocket surgical meshes for a period of up to two years. In particular, on patient reported satisfaction (BreastQTM), cosmetic outcome and the rate of complications.

The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket.

The Investigation will be performed in ten clinical centres in Germany and Austria.

Eligibility Criteria:
Inclusion Criteria:

Age \[≥ 18\]

Indications of breast reconstruction: histologically confirmed breast cancer, precancerous lesions (DCIS, LCIS), mutation carrier with increased breast cancer risk, strong family history (lifetime risk \> 15%)

The patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1)

Patient information has been provided and all written consents of the patient are available

Exclusion Criteria:

Metastatic breast cancer

Patient with known contraindications against mesh-assisted or plastic-reconstructive breast surgery according to the instruction for use

Patient is kept in an institution under judicial or official orders (MPG §20.3)

Participate in another operative clinical trial, if it relates to the area of reconstructive breast surgery and/or influences the primary endpoint of the clinical trial
Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")

Based on early bench-testing data and subsequent clinical case studies in the U.S., "Intrinseque Health" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available oxygen first into the alveolar spaces by sequential opening of valves in its controller manifold, even at oxygen flow as low as 10 LPM, patient can attain high alveolar oxygen concentration of 75% or more-far higher than attainable with face mask or nasal cannula.

Numerous intubated patients emerging from the operating room require intensive critical care specialist supervision in order to transition to the regular care. This would enable higher patient turnover and more efficient utilization of hospital resources, if patient can be transited to the regular care earlier by using a device that supports high oxygenation. This will enable a faster, safe and smooth extubation in critical care, and earlier discharge from intensive care ward.

This study is anticipated to take only around 2.5 hour per patient to complete. Patients meeting the inclusion and exclusion criteria of this study are placed on IHNRM and monitored until steady state of SpO2 of 95% or higher on 7-10 LPM has been maintained for at least 2 hours, when they can be discharged from the post-anesthesia care unit (PACU) to the regular care ward.

The study is the parallel design study. 60 patients will be randomly selected to use the IHNRM, and 30 subjects will be placed on HFNC. Blood oxygen concentration (SpO2), respiratory rate, end tidal CO2 concentration (EtCO2), and vital sign will be recorded in the study. The endpoint of the study is to compare the effect after using between "IHNRM" and HFNC.


Eligibility Criteria:
Inclusion Criteria:

1. ANY hospitalized patient in moderate to moderately severe respiratory distress and able to breathe spontaneously, and with SpO2 (oxygen saturation by pulse oximetry) reading of:

   (i) 90% or less on room air, or (ii) \<95% in spite of oxygen supplementation on another form of oxygen supplementation.
2. Has minimum ideal body wt. of at least ≥15 kg., and at least 3 years old.
3. Self/guardian-able to consent to study participation and monitoring.

Exclusion Criteria:

Patient with any of the following present will be excluded:

1. Agitated or confused or somnolent mental state.
2. Any impairment of gag reflex.
3. Multi-organ failure that may decompensate rapidly, with or without hypoperfusion secondary to cardiogenic, hypovolemic, or septic shock.
4. Acute MI, pulmonary embolism, pneumothorax or stroke
5. Inability to pull mask off (or to side of) face in emergency.
6. ICP (intracranial pressure) \> 15mmhg. If ICP unknown but clinically may have elevated ICP (such as head trauma or CNS tumor), patient should be excluded.
Defocused Shock Wave Therapy for Chronic Wounds

Chronic soft tissue wounds of the lower limbs are painful and debilitating condition that significantly reduce the quality of life of the patient. They often do not respond to conservative treatments or advanced wound managements. Focused and defocused extracorporeal shock wave therapy can be a viable alternative therapeutic strategy.

The purpose of the study was to examine the effects of defocused extracorporeal shock wave treatment on chronic soft tissue wounds of the lower limbs, in terms of the rate of wound healing and pain control.


Eligibility Criteria:
Inclusion Criteria:

* chronic post-traumatic, venous, arterial, diabetic, or mixed wound of the lower limb
* wound persisting for longer than three months
* a wound surface bigger than 0,5 cm2
* a wound diameter between 0.5 and 5 cm
* unresponsiveness to conservative treatments and advanced wound managements in the 3 months prior to enrollment
* no changes in wound managements during the study.

Exclusion Criteria:

* an ankle brachial index (ABPI)\<0.7 and TcPO2\<40 mmHg
* arrhythmias, presence of pacemaker, or coagulation disorders
* use of anticoagulant drugs
* neoplasia
* pregnancy
* soft tissue wound infections and/or osteomyelitis
* patients with full-thickness loss of soft tissue and extension into muscle, bone, tendon, or joint capsule.