cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.

The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.

This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women.

A total of 80 eligible participants will be randomized to receive either 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 and standard of care (treatment arm) or standard of care alone (control arm). Participants in the treatment arm will receive 2 units of convalescent plasma on Study Day 1 in addition to standard of care.

Participants will be assessed on study Day 1 (pre-dose), 30 minutes after each unit of plasma, on all Study Days while hospitalized, and Study Days 15, 22, 29, and 60. All participants will undergo a series of safety and efficacy, assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 8, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥18 years of age
2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment.

   Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.
3. Hospitalized in participating facility.
4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
5. Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:

   * Room air saturation of oxygen (SaO2) \< 93%, OR
   * Requiring supplemental oxygen, OR
   * Tachypnea with respiratory rate ≥30
6. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion Criteria:

1. Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
2. Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
3. Receipt of other investigational therapy as a part of another clinical trial. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
Functional and Performance Effects of a 4-week Weightlifting Program in Highly Trained Adolescent Basketball Athletes

Weightlifting is an increasingly used intervention in the sport field to improve both function and performance outcomes. However, the effects in a pediatric and adolescent population are not well described, and require further research to elucidate the benefits and potential adverse effects compared to other strength training methods, such as plyometric training.

Highly trained male and female adolescent basketball athletes aged 12-16 years will be recruited for the study. Participants will be randomly assigned to a 4-week program (12 sessions) of weightlifting or plyometric training. The training programs will be identical in sets and repetitions, progressively evolving each week towards fewer sets and fewer repetitions. The training intensity will be the same in both groups, calculated from the RM, starting at 70% in the first week and progressing by 5% each week until a final intensity of 85% in the last week. Therefore, both interventions evolve towards sessions with fewer sets and repetitions and higher loads.

The weightlifting intervention refers to the performance of highly technical and explosive multi-joint strength exercises. The program consists of six basic weightlifting maneuvers (hang power clean, overhead squat, hang power snatch, clean, split jerk, snatch), two of which are performed in each of the three weekly sessions. The order of execution of the exercises in the weekly sessions is always the same. To ensure the correct execution of the maneuvers, before starting the intervention, a brief familiarization program will be carried out. This consists of an explanation of the exercises by the research staff and practice by the participants with simultaneous correction.

The plyometric program follows the same structure, consisting in a total of 6 exercises (Max countermovement jump, double leg side jump, maximum squat jump, dropjump (20cm), single leg hurdle jump, doble leg multi hop) performed in groups of 2 for each weekly training session.

The design of the intervention program is based on previously published related articles.Training sessions will be supervised by a member of the research team with expertise in strength and conditioning in basketball athletes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy highly-trained basketball athletes

Exclusion Criteria:

* Current injury or complaining limiting sports activity
* No histoy of injury receiving non-operative treatment in the last 3 months
* No history of injury receiving operative treatment in the last 9 months
* Subjects who have previously carried out weightlifting training for at least 4 weeks of duration.
* Subjects physically unable to perform a strength training program
A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old.
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
5. Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.
6. No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
7. Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator.
8. Has adequate organ function.

Exclusion Criteria:

1. Undergone major surgery within 30 days prior to the first dose of study treatment.
2. Active central nervous system (CNS) metastases.
3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
4. Active Hepatitis B or Hepatitis C.
5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
6. Has received treatment with docetaxel.
7. History of severe bleeding tendency or coagulation disorder.
Herbal Ointment in Treating Atopic Dermatitis Topically

Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin disorder. The current first-line recommended treatment for AD is the use of emollients, topical corticosteroids (TCS), and oral antihistamines if necessary. However, patients often have side effects like skin atrophy and telangiectasia. And there were plenty of herbal medicine which are beneficial to atopic dermatitis in ancient Chinese medicine books and records. Therefore, the purpose of this study is to develop a new topical application of traditional Chinese medicine and evaluate its clinical efficacy in AD patients. In human trial, 66 Subjects diagnosed as AD will be enrolled and treated with Sophora flavescens Aiton topical ointment. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.

The 1st year project: (1) Expect to enroll 66 clinical subjects of AD. (2) Evaluate subjects 'symptom and proceed herbal ointment treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.

The 2nd year project: (1) Completing enrollment of 66 clinical subjects of AD. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 65 years old, female or male.
2. Atopic dermatitis fulfilling the diagnostic criteria of Hanifin\&Rajka.
3. Atopic dermatitis involving \<10% of BSA. (Base on the BSA result of Screening)
4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)
5. Female patients of child-bearing age with negative pregnancy test at screening.
6. Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.

Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0) Willing to comply with study protocol and agree to sign an informed consent form.

Exclusion Criteria:

1. Having a history of topical or systematical hypersensitivity to herbal or its excipient (e.g. vehicle) in ointment
2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
3. Having used topical or oral therapy (e.g. topical corticosteroids, antibiotic, TCM) for dermatitis within 7 days before the first application of the study medication.
4. Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
5. Having abnormal liver or renal function (AST/ALT \>3 x ULN, creatinine \>2.0 mg/dl).
6. Women who are lactating, pregnant or preparing to be pregnant.
FlexED: A Digital, Gamified Early Intervention for Eating Disorders

The goal of this multiple baseline experiment is to test the effect of a digital, gamified early intervention for eating disorders on body image flexibility and determine treatment dose. Twenty-four young women and girls (between the ages of 15-25) with eating disorder (ED) symptoms will be randomized to different baseline durations (varying between 2-6 weeks). Participants will complete eight 20-30 minute sessions of a multimedia application over 10 weeks using their home computer or mobile device. Body Image Flexibility (BIF) will be measured repeatedly using a multimodal assessment strategy (behavior, physiological and self-report) during baseline and treatment phases. The investigators will estimate the effect of the intervention on BIF and examine when change occurs and plateaus (with no discernable benefit for additional sessions) to determine treatment dose.


Eligibility Criteria:
Inclusion Criteria:

* Female identified 15-25 years old
* Weight Concerns Scale score of \>47
* Maladaptive weight control behaviors with onset \<3 years

Exclusion Criteria:

* Currently meets full diagnostic criteria anorexia or bulimia nervosa or has in the past.
* Psychosis, substance use disorder or current suicidal ideation or self-harm.
* Start or change in psychiatric medications within the past month.
* NonEnglish Speaking.
* Presents with other specified feeding or eating disorder (OSFED) that does not have weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
Self-discontinuation of a Transurethral Catheter

This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following impatient pelvic organ prolapse surgery is non-inferior to office-discontinuation.

Postoperative urinary retention (POUR) is a common issue following urogynecologic surgery, with incidence rates of 1.4-43%. The wide range of incidence is due to the lack of a standardized definition of POUR. Generally speaking, POUR can be characterized by any impairment in bladder emptying following surgery. While the gold standard for assessing voiding function remains measurement of a postvoid residual (PVR), there are many voiding trial (VT) methods being used across institutions.

Historically, the most widely accepted postoperative VT for the assessment of voiding function was the backfill method. An alternative assessment of voiding function is the spontaneous VT, where the indwelling catheter is removed and a patient is asked to void spontaneously when a patient has the urge. It is controversial which of these methods are superior, and studies are conflicted. Nevertheless, both of these methods were studied in a clinical setting, and we lack information on self-discontinuation efficacy at home.

Managing an indwelling urinary catheter and returning to the outpatient clinic only a week after discharge from the hospital can be overwhelming for patients and their involved caregivers. Given the low incidence of POUR at one-week postoperative and patient dissatisfaction with urinary catheter management, home self-removal of indwelling urinary catheters is an important topic of investigation.

We are trying to compare the incidence of POUR between self-discontinuation and office-discontinuation of urinary catheters. The results of this study could impact on the decision regarding catheter use following inpatient pelvic organ prolapse surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a physician at Cincinnati Urogynecology Associates, TriHealth Inc.for the treatment of pelvic organ prolapse
* Failed voiding trial prior to discharge
* Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy

Exclusion Criteria:

* physical or mental impairment that would affect the subject's ability to self-remove indwelling urinary catheter, including patient's with Multiple Sclerosis, Dementia, Parkinsonism, or those who have impaired mobility or are wheelchair bound
* Bladder injury, fistula repair or other need for prolonged catheterization
Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy

The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.

The pin fixation and the risk for pin loosening and pintract infection is intimately connected Moroni et al., Magyar et al. Toksvig-Larsen and W-Dahl) The pin performance ratio for insertion to extraction torque (PPI) varies significantly between screw types.

The extraction torque force is the most important value and it is estimated that a removal torque around 300 Nm probably will be the best bon-pin fixation in clinical practice.

In animal studies and even in clinical studies the hydroxyapatite (HA) coated screw retained the highest level of osseointegration. However, the fixation for HAscrews is, especially in diaphyseal bone, the risk for too tight fixation, with extreme difficulties to remove the screws in few cases as a result ( high pain and seldom it is impossible to remove the screw) Coating by biphosphonate is a new novel technique with preclinical appealing performance, which theoretically should make this coating very appealing in clinical practice. The theory behind this technique is that it create a good pinfixation reasonable easy to remove.

The current most used cortical screw designs performed poorest in terms of fixation (PPI)

Method

Using the hemicallotasis technique for correction in high tibial osteotomies today, HA coated (Osteotite) conical 130/50 screws is used in the proximal tibia - the metaphysic - and plain (standard) cortical conical screws 110/40 is used in the diaphysis.

To study the effect of an improved pin coating a study including 30 patients randomised to the standard procedure today or the novel technique using biphosphonate coated screws.

In the metaphysic, the randomisation will be between the HA coated (Osteotite) screws and the biphosphonated coated screws 130/50 (screw thread 50mm) In the diaphysis the randomisation will be between the plain standard 110/40 screws and the biphosphonate 110/40 coated screws

Totally 30 patients will be studied which means totally 120 pins. This has been based on power calculations resulting in 23 patients in each group and calculated on extraction torque force. This is a clinical study and 30 patients is estimated due to expected drop out.

Eligibility Criteria:
Inclusion Criteria:

* All patients which are diagnosed with arthr and needs an operation.
Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.

This study was designed as a prospective single-arm intra-individual comparison multicenter study

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-year old and 85-year old
* Patients with a history of curative treatment for HCC including surgical resection or local ablation
* No recurrence after curative treatment of HCC for more than two years
* Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)

Exclusion Criteria:

* Estimated GFR less than 60
* Previous history of severe allergic reaction to the iodinated contrast agent
* Patients with claustrophobia who can't undergo MR examination
* Patients having cochlear implants or cardiac pacemaker
A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

The purpose of this study is to find out whether people with CLL or SLL who are currently receiving treatment with ibrutinib can stop treatment and remain off-treatment for at least 12 months, if they have achieved complete or partial remission of their disease.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18-years-old
* Diagnosis of CLL or SLL confirmed by the enrolling institution
* Negative del(17p) test confirmed by FISH testing prior to initiating treatment with ibrutinib
* Receiving commercial treatment with an ibrutinib-based regimen in the front-line setting as defined below with the intent to discontinue therapy on C1D1:

  1. Ibrutinib monotherapy
  2. Ibrutinib in combination with anti-CD20 monoclonal antibody (Patients must have completed the anti-CD20 monoclonal antibody portion of the regimen prior to signing consent)
* Patients must have received ibrutinib-based therapy for at least 15 months. Dose interruptions and reductions during this treatment period may have been carried out per treating provider discretion.
* Response evaluation performed by radiology assessment (CT or MRI imaging of neck / chest / abdomen / pelvis) confirming complete remission or partial remission by iwCLL criteria.
* Peripheral blood (by flow cytometry per institutional standards) testing for MRD confirming U-MRD to a sensitivity of 10\^-4. MRD testing must be confirmed to follow ERIC consensus criteria.

  1. CR with or without U-MRD in peripheral blood
  2. PR with U-MRD in peripheral blood

Exclusion Criteria:

* Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk..
* Unwilling or unable to participate in all required study evaluations and procedures. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).
A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer

Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous histology
* Patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Adequate organ function

Exclusion Criteria:

* Concurrent administration of any other anti-tumor therapy
* Other co-existing malignancies
* Pregnancy or breast feeding
* Serious concomitant disorders
* Inability or unwillingness to take folic acid or vitamin B12 supplementation
Natural History Study for Patients with Angelman Syndrome

This study is a 9-year natural history study for patients with Angelman syndrome in Belgium (a genetic neurodevelopmental disorder, affecting 500,000 individuals in the world). It includes a 3-year recruitment phase, a 5 year follow-up and a year to analyze the collected data. The investigators plan to include 30 patients with a semi-annual follow-up for 4 years.

The investigators will collect relevant retrospective and prospective data using age-standardized scales and questionnaires for functional motor assessments and global developmental assessment.

Patients are seen every six months for five years. In these visits, patient have medical review (general medical examination, neurological examination), vital signs (height, weight, respiratory rate, heart rate, blood pressure), cognitive assessment (Bayley-IV), language assessment and questionaire (Bayley-IV, ORCA), motor assessments (Bayley-IV, FMS, Developmental milestones and HINE), quality of life questionnaire (PedsQL, CGI-CASS) and general development questionnaire (Vineland-II).

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of AS
* 0-99 years
* Male or Female
* Participant's carer is willing to give IC/sign a "record of consultation" for participation in the study

Exclusion Criteria:

* comorbidity that could potentially affect the results of the study coexists. This