cyrilzakka/clinical-trials huggingface dataset:
Effects of Hemofiltration and Mannitol Treatment on Cardiopulmonary-Bypass Induced Immunosuppression

After cardiac surgery with cardiopulmonar bypass, the LPS-stimulated cytokine response has been previously shown to be depressed. Therefore, in this trial the hypothesis was tested, whether simple immunomodulting interventions like the i.v. adminstration of mannitol of hemofiltration during cardipulmonary bypass can attenuate this immunosuppressing effect.

Background Cardiac surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. In addition to this immune response to CPB, a significant impairment of the responsiveness of peripheral blood mononuclear cells (PBMC) to further immunological stimuli has been observed. The aim of our present study was to evaluate the ability of antioxidant therapy with mannitol or hemofiltration during CPB to modulate the observed immunosuppression after CPB.

Methods With ethics committee approval, 52 patients undergoing elective CABG-surgery were prospectively enrolled and randomized into 3 groups (control, 50 g mannitol iv, hemofiltration during CPB). Blood samples were taken after induction of anesthesia (T1), 20 min after separation from CPB (T2) and 24 h postoperatively (T3). Expression density of the monocytic surface receptor CD14, HLA-DR expression and cytokine release (TNF- and IL10) after LPS-stimulation were evaluated.

Results At T2, the CD14dim cell population was maintained in both intervention groups while in the control group there was a significant decrease of this proinflammatory monocytic phenotype. At T3, all groups developed a significant shift towards the antiinflammatory CD14bright population. No significant differences regarding HLA-DR expression or cytokine release could be demonstrated.

Conclusion This study shows that the suppression of the stimulated immune response after CPB can be alleviated by iv administration of mannitol or hemofiltration. In the light of data showing that this depression of the immune response might affect the postoperative course of patients, these results could lead to an improvement of the management of patients undergoing cardiac surgery with CPB.

Eligibility Criteria:
Inclusion Criteria:

* male patients
* aged 35-80
* elective CABG surgery

Exclusion Criteria:

* previous cardiac surgery
* ejection fraction \< 40%
* valvular heart disease
* myocardial infarction during the last 3 months
* evidence of concomitant malignant or immunologic diseases
* antecedent medication with corticosteroids or methylxanthines
* hemoglobin \< 12 g/dl
* body mass index \> 30
Impact of Probiotics on Children With ADHD

This study investigates WecProB (Bifidobacterium animalis subsp. lactis and Lacticaseibacillus rhamnosus) to evaluate their potential to improve symptoms and safety in children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ADHD per DSM-5 criteria;
2. Age 6-12 years, gender-neutral;
3. IQ \>70 on intelligence testing;
4. Participant/guardian comprehension and voluntary consent.

Exclusion Criteria:

1. Those with a clear history of other serious neurological diseases, such as epilepsy, head trauma, encephalitis or meningitis, etc.;
2. Have taken antibiotics, probiotics or immunosuppressants within one month before starting the experiment;
3. Ongoing special diet, such as ketogenic diet, etc
4. BMI higher than the 90th percentile or lower than the 10th percentile for children of the same age and sex;
5. Those who have had symptoms of respiratory or digestive tract infection in the past month, such as fever, cough, diarrhea, etc.;
6. Those who have had inflammatory bowel disease in the past, such as ulcerative colitis, Crohn's disease, etc.;
A Cohort Study of Uterine Malignancies

The purposes of current study were to explore the relationship between cervical cancer/endometrial cancer and demographic information, behavior and life style, pregnancy-related factors, and disease history, and to study the factors affecting the prognosis of cancers. In addition, omics tests were performed on the biological specimens to identify the diagnostic markers and prognostic biomarkers.

After being informed about the study and potential risks, all patients who meet the eligibility requirements will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years;
* Women with cervical cancer or endometrial cancer with a definite pathological diagnosis for the first time;
* Women attending a health check-up;
* Obtain informed consent and sign an informed consent form.

Exclusion Criteria:

* Patients who are unable to cooperate with the investigations such as mental disorders or cognitive impairment；
* Patients with cancer other than cervical cancer or endometrial cancer;
* Women who have received hysterectomy or pelvic radiation therapy previously.
ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024)

This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared to a cohort of unvaccinated participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants with continuous Kaiser Permanente Northern California (KPNC) membership since becoming age-eligible for ZOSTAVAX™ and with 12 months of continuous enrollment in KPNC before their study start date

Exclusion Criteria:
Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction

The purpose of this study is to assess the safety of IW-6118 when administered as a single oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an exploratory manner.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 30 years old at time of screening;
* BMI \> 18.5 and \< 30.0;
* In overall good health with no clinically-significant laboratory, ECG, or physical exam findings;
* Patient requires two ipsilateral third molar extractions of which one must be a full or partial bony mandibular impaction;
* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
* Other inclusion criteria per protocol.

Exclusion Criteria:

* History of any clinically-significant medical condition;
* Previous usage of prescription, OTC, or investigational drugs as per protocol requirements;
* Inadequate levels of pain to be included in the study;
* Other exclusion criteria per protocol.
The Conveyor Study

To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral valve replacement or repair (failing bioprosthetic mitral valve) who are candidates for mitral valve-in-valve procedure.

This is a prospective, non-randomized, multi-center early feasibility study designed to demonstrate that the Conveyor System can safely provide left ventricular access to deliver an Edwards SAPIEN 3 TAVR valve into the mitral valve position in a valve-in-valve procedure. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed insufficient, or combined).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is able and willing to comply with all assessments in the study.
2. Subject or subjects' legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
3. Age of Subject is ≥18.
4. Estimated life expectancy \>6 months.
5. Patients demonstrated to have symptomatic post-therapeutic mitral valve dysfunction as determined at diagnostic cardiac catheterization, echocardiography, and/or MR and a mitral valve annulus suitable for a "valve in valve" transcatheter valve replacement procedure using the Edwards SAPIEN 3™ TAVR device based on diagnostic cardiac catheterization, echocardiography and/or MR imaging.
6. Patient has been evaluated by a Heart Team and judged to be a candidate for mitral valve in valve procedure.
7. Patient has femoral and iliac artery dimensions sufficient to accept the study device (\>6 mm).
8. Patient is potential surgical candidate.

Exclusion Criteria:

1. Patients with any clinical presentation that will exclude them from receiving a Edwards SAPIEN 3™ percutaneous valve.
2. Patients with vascular disease that would preclude navigation of the Conveyor System.
3. Patients who do not desire to participate in the study.
4. Patients who are judged to be mentally incapable of fully understanding the risks or potential benefits of participation in the study.
5. Patients with visible thrombus in the left atrium or on the mitral valve apparatus/replacement.
6. Patient requires urgent or emergent treatment.
7. Patient has significant aortic valve disease or previous aortic valve replacement.
8. Pregnant patients (must have negative pregnancy test).
A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer

To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 18 years, ≤75 years
2. Her2-positive recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
3. Did not receive any systemic antitumor therapy in the advanced stage;
4. At least one measurable lesion was present according to RECIST1.1 criteria.
5. The ECOG score is 0 to 1
6. The functional major organs must be normal
7. Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up

Exclusion Criteria:

1. Have received any systematic antitumor therapy at the recurrence/metastasis stage;
2. Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any stage of breast cancer
3. Patients judged by the investigators to be unsuitable for systematic chemotherapy.
4. Patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases);
5. Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment.
6. Serious heart disease or discomfort
7. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the use and absorption of medications.
Plantar Fascitiis: Comparison of ESWT and Collagen Hydrolyzed Peptides

Patients suffering from Plantar Fasciitis were randomized into three groups:

the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

Patients suffering from Plantar Fasciitis were randomized into three groups:

the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

Aim of the study was to consider any difference in the outcome of the three groups of patients. The NRS and the AFAS score were considered for the outcome measurement.

Eligibility Criteria:
Inclusion Criteria:

Plantar fascitiis Aged between 18 and 80 years old

Exclusion Criteria:

* Previous surgery of the foot
* Contraindications to ESWT
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia.

In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 or 2 patients patients scheduled for thyroidectomy

Exclusion Criteria:

* Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment

The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.

This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being.

The present study was designed as a single-arm pilot scale to understand the temporal changes in both gut and oral microbiome of the practitioners at a meditation-cum-spiritual retreat in a controlled environment. There was open communication between all the participants before, during and after the retreat. As all the practitioners followed group practices in one location under the supervision of the senior instructors, separate assessment of the adherence of the practitioners to the protocol was not performed. Oral and fecal samples of practitioners were collected at the start (Day0: T1), middle (Day3-5: T2) and end (Day7-9:T3) of the retreat in a sterile containers. Amplicon sequencing was performed from extracted DNA to study changes in microbiome profile during retreat.

Eligibility Criteria:
Inclusion Criteria:

* must provide written informed consent prior to initiation of any study procedures
* was able to understand and agreed to comply with planned study procedures (agreed to the collection of specimens (saliva and fecal) before, during and after the study
* male or non-pregnant female greater than 18 years of age at time of enrolment
* must have a distinct Arhatic level (0-5 level) and performed meditation and MTH practices from once a week to more than 3 times a week prior to this retreat

Exclusion Criteria:

* concomitant disease that requires any medical treatment
* pregnancy
* any antibiotic treatment in the past two weeks
* pediatric population
* clinical apparent infectious disease
Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 18 years
* Diagnosis of T-cell large granular lymphocytic leukemia (T-LGLL)
* Meet any of the following indications for treatment：

  1. Hemoglobin \< 100g/L or RBC transfusion dependence
  2. Neutrophil count \<0.5×10\^9/L or neutrophil count decreased with recurrent infection
  3. Progressive splenomegaly and/or Massive Splenomegaly
  4. Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc.
  5. Severe B symptoms
* Failure or intolerance to a first-line therapy
* ECOG performance status ≤2
* Expected survival ≥ 6 months
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* History of other lymphoproliferative neoplasms
* Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
* Previously received organ or stem cell transplantation.
* Patients with active infection within 2 weeks before giving the first dose of medication
* Patients with HBV, HCV, HIV or other infections that require treatment
* History of immunodeficiency, or congenital immunodeficiency disorders
* Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
* Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
* Renal impairment: creatinine clearance \<60ml/min
* History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.
* Received attenuated vaccine 4 in weeks before enrollment
* Participation in another clinical trial within 4 weeks before the start of this trial
* Have an allergy to Linperlisib or any other part of this medicine.
* Previously treated with other PI3Kδ inhibitor.
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above
Manuka Honey Nasal Rinse Study

The purpose of this study is to evaluate whether high-volume nasal rinses with a manuka honey/saline mixture will improve symptom scores, nasal endoscopic findings and CT scan findings compared to nasal saline rinse without manuka honey in patients with chronic rhinosinusitis.

Manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in New Zealand. It has been shown to have antibacterial activity against common bacteria that cause chronic sinusitis.

If the subject chooses to participate in the study, the subject will be asked to fill out a symptom questionnaire at the beginning of the study and at each follow-up visit. The subject will be randomly assigned (much like the flip of a coin) to one of two treatment arms in addition to the prescribed medical treatments: 1) nasal rinses twice daily with a saline solution (standard therapy) or 2) nasal rinses with a saline solution mixed with manuka honey (the experimental therapy.) Subjects in the manuka honey/saline rinse arm will perform the experimental rinses twice daily for one month, and then will continue with saline rinses twice daily, with manuka honey added to the rinses only as needed. Nasal rinsing of some kind will be continued through the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Rhinosinusitis
* Nasal Polyposis stages 1-3

Exclusion Criteria:

* Nasal Polyposis stage 4-5
* Cystic Fibrosis
* Immunocompromised patients
* Allergy to bees or honey
CoMplete™ Acetabular Hip System

The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.

This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.

Eligibility Criteria:
Inclusion Criteria:

* 1. If the subject:

  1. Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
  2. Qualifies based on the approved labeling for the device; and
* 2. Is willing and able to provide informed patient consent for participation in the PAS study; and
* 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and
* 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has

  * consented to participate,
  * authorized release of Personal Health Information (PHI),
  * met all eligibility criteria through the operative stage, and
  * received the implant as noted in this protocol.

Exclusion Criteria:

* Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
Comparison of Theraband, Co-contraction and Isometric Exercises in Frozen Shoulder

This project was a Randomized control trial conducted to check the effects of in patients with chronic frozen shoulder theraband, isometric and co-contraction exercises so that we can have best treatment option for patients with chronic frozen shoulder. upper cross syndrome, duration was of 6months,convenient sampling was done, subject following eligibility criteria from DHQ hospital Sheikhupura, were randomly allocated in three groups via lottery method, baseline assessment was done, Group A participants were given baseline treatment along with theraband exercises , Group B participants were given baseline treatment along with co-contraction exercises and Group C were given baseline treatment along with isometric exercises on 3rd and 6th week, post intervention assessment was done via, Numeric pain rating scale(NPRS),Shoulder Pain And Disability Index (SPADI) and goniometric measurements of shoulder ranges ,3 sessions per week were given, data was analyzed by using SPSS version 26.

Frozen shoulder is among the most commonly reported problems to physicians, orthopedics and physical therapists. Even before reporting to clinics there is long history of using over the counter pain killers. Pain avoidance behaviors let the joint stiff so much that a clinician help is sought. Most times the cause of frozen shoulder is not known, therefore is termed as 'idiopathic frozen shoulder'.There is huge literature regarding the management of frozen shoulder and yet after the decades of research there are gaps in treatment options. In modern age of health care, it is common goal of every health care to make patient self-sufficient as early as possible. The self-care models have tremendous advantages. The current study has compared the use of theraband, co-contraction and isometric exercises. The current study was novel in a way that there is limited literature about treating shoulder hypomobility with physical strengthening exercises. All three methods were employed to see if they improve ranges along with accompanying pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic with 6 month chronicity.
* Patients with AROM/PROM less than or equal to 90 degrees.
* Affected shoulder has not more than 90 degrees of abduction \& 50% decreased external rotation as compared to normal side/normal ROM values.

Exclusion Criteria:

* Traumatic \& diabetic.
* Patient with any cervical or thoracic problem.
* Patients with any intra-articular injection in glenohumeral joint.
* Patients with rotator cuff complete tear.
* Patients with any other serious pathology/red flags