cyrilzakka/clinical-trials huggingface dataset:
Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

One hundred forty patients with male factor infertility are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid with granulose cells will be performed using an IUI catheter after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.

This study is a randomized clinical trial to investigate implantation rate and clinical pregnancy after intrauterine flushing of infertile patients with follicular fluid plus granulosa cells - Randomized controlled trials. The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute and all participants provide informed consent.

The main objective of this study is evaluation of implantation rate and clinical pregnancy after flushing of uterine in infertile patients with follicular fluid plus granulosa cells in IVF/ ICSI cycles.

Material and methods: In a randomized clinical trial, 140 patients with Male factor infertility referring to infertility clinic of Royan Institute, Iran, who received ovarian stimulation with antagonist and agonist protocol, will be randomly assigned to two groups: in case group, if the follicular fluid of two clear dominant follicles contain at least 2 COC, after removal of the COCs, follicular fluid will be collected Endometrial cavity flushing with 2 ml of follicular fluid will be performed by IUI caterer. In control group only catheterization of uterine cavity will be performed. Primary outcome is comparison of implantation rate between case and control group. Secondly outcome is assessment of clinical pregnancy rate in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Normal Hormonal profile (FSH, LH, AMH) and normal AFC
2. Normal ovarian reserve
3. Age 20-38 years
4. Regular menstrual cycle
5. IVF / ICSI or IVF or ICSI cycles with agonist and antagonist protocol
6. Existence of at least 2 oocytes in dominant follicular fluids

Exclusion Criteria:

1. Presence of Endometriosis and Endometrioma
2. Hydrosalpinx
3. OHSS (Ovarian Hyper Stimulating Syndrome)
4. Tubal factor infertility
5. Male factor infertility with azoospermia
6. Low/Poor Response
7. Myoma with a compression effect or submocusa myometrium
8. Intra mural or subserouse Myoma \> 5cm
9. Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection.
10. Endometrial tuberculosis
11. The follicular fluid which contains any oocyte or contaminated with blood will be discarded
Ultrasound Based Acoustic Radiation Force Impulse Imaging

ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or younger
* Scheduled to have a needle biopsy of the liver at

  1. C.S. Mott Children's Hospital or
  2. Dept. of Radiology at the Univ. of Michigan Hospital
* Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)

Exclusion Criteria:

* None to list
The COMUNICARE Study: the Effectiveness of a Multimodal Intervention Based on Person-centered Communication

Pragmatic cluster-randomized clinical trial. An open, multicentric, parallel-group trial with a control group, and with a follow-up period of 1 year.

Pragmatic cluster-randomized clinical trial. An open, multicentric, parallel-group trial with a control group, and with a follow-up period of 1 year. Randomization unit: health care professionals. Analysis unit: patients and health care workers. Scope: primary care (PC) health centers in the Community of Madrid (Spain). Population sample: patients of 40 to 75 years of age with DM2, HbA1c ≥7.5%, on oral antidiabetic drugs (OAD) treatment, who had attended PC consultation during the last year. Sample size: 250 patients (125 per group). Main objective: assess the effectiveness of an intervention based on person-centered interviewing (PCI) to improve metabolic control and increase OAD treatment adherence in patients with DM2. Intervention: four-component intervention including 1) Training of health care professionals (doctors and nurses) on PCI, 2) Practice of PCI techniques, 3) Information card for patients and family members, 4) Instructions sheet on drug prescription. Control arm: usual clinical practice. Variables: 1) Patients: Main: metabolic control (difference of HBA1c ≥0.5%), and OAD treatment adherence (average increase of 50-75%); Secondary: cardiovascular risk, compliance with clinical practice guidelines, complications related to DM2, satisfaction with treatment, adverse effects of medication, usage of health care services. 2) Healthcare workers: professional burnout. Follow-up period: 1 year. Analysis: multi-level models.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 40 and 75 years.
* Patients with DM2 undergoing regular treatment with at least one type of OAD for the last 6 months.
* HbA1c ≥7.5% in the last laboratory test.
* PC patients that have attended consultation in at least 2 occasions for reasons related to their diabetes.
* Patients that will remain in the HC area during the follow-up period.
* Patients willing to provide Informed Consent to participate in the study.

Exclusion Criteria:

* Patients whose diabetes is monitored in specialized care consultations or private clinics, and attend the HC only for medical prescription.
* Patients diagnosed with a terminal disease and a survival prognosis of less than 1 year.
* Patients already taking part in another clinical trial.
* Patients on a surgery waiting list and/or not expecting to complete the follow-up period.
* Pregnant women.
* Patients with cognitive impairment.
* Patients suffering from severe chronic pathologies (kidney failure requiring hemodialysis; cardiac insufficiency of a degree equal to or higher than III/IV according to the classification by the New York Heart Association; respiratory insufficiency requiring treatment with continuous oxygen therapy and/or chemotherapy).
* Patients suffering from a psychiatric disorder that requires neuroleptics treatment.
* Drug use or alcohol abuse (\>60 gr/day).
Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention

We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being.


Eligibility Criteria:
The target population will be: immigrants to the U.S. of Hispanic origin whose native language is Spanish, who have been living in the U.S. (intermittently or continuously) for less than 10 years, who are over 18 years of age, who have a PHQ4 score that is three or more, who would be interested in using a well-being phone app, who do not have a graduate degree and have access to a smartphone.
Collect Breast Cancer Patients' Digital Mammography Images With Corresponding Reports for the Development of Software

The purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.

The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. The information will be used to develop algorithms that will foster development of CAD software. The information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events

Eligibility Criteria:
Inclusion Criteria:

* subjects with known breast cancer ages 18 and over
* case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image
* source documents or mammographic interpretation must be available

Exclusion Criteria:

* 17 or younger
Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

This is a single-arm, open, single-center, prospective and exploratory clinical study. We planned to enroll 29 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));
* Have at least one measurable lesion according to RECIST v1.1;
* ECOG performance status: 0-1;
* Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;
* Urine protein \< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
* Expected survival time \> 3 months;

Exclusion Criteria:

* Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);
* Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;
* Have uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mm Hg, while under anti-hypertension treatment;
* Patients with active ulcer, intestinal perforation and intestinal obstruction;
* With active bleeding or bleeding tendency;
* Severe history of cardiovascular and cerebrovascular diseases;
* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers

This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive
* Weight 40 to 100 kg
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
* Volunteers agree to use acceptable contraceptive measures

Exclusion Criteria:

* History or clinically significant manifestations of disorders
* History of anaphylaxis, hypersensitivity or drug allergies
* History or presence of an abnormal ECG
* History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
* History of significant drug abuse within 1 year prior to screening
* Current tobacco smokers
* Positive drug screen at screening or at check-in
* Positive pregnancy test result at screening or Day -1 or breast feeding during the study
Aerobic Exercise and Brain Health in Parkinson's

The purpose of the project is to investigate how moderate to high intensity aerobic exercise affects brain health in patients with Parkinson's disease. Assessments include MRI, blood markers, cognition, functional tests, questionnaires, and cardiorespiratory fitness.

The study will be a single blinded randomized controlled trial with a 6-month long intervention.

Background: No approved medical treatments preventing, delaying or stopping Parkinson's disease (PD) exist, making identification of interventions having this potential a major priority. Exercise studies have demonstrated beneficial effects of aerobic exercise (AE) on aerobic capacity, cognition, depression and the Unified Parkinson's Disease Rating Scale (UPDRS). Animal studies show that AE can reduce α-synuclein aggregation and toxin-induced lesions in the nigrostriatal pathway while improving motor and cognitive function. Consequently, AE possesses neuroprotective potentials and thus represents a potentially inexpensive and easily accessible disease modifying therapy in PD. Evolving magnetic resonance imaging (MRI) techniques offer valid and reliable biomarkers to monitor disease progression, but no longitudinal MRI study has assessed the neuroprotective potentials of AE in PD.

Aim: To investigate whether 24 weeks of AE can delay PD progression markers and improve motor/non-motor symptoms in PD.

Methods: 70 PD patients will be randomized 1:1 to 24 weeks of supervised AE (60 sessions, moderate to high intensity) or standard care. Neuroprotective effects will be determined by MRI scans (R2\*, quantitative susceptibility mapping, diffusion kurtosis imaging, neuromelanin-weighted MRI, volumetry), blood markers and Levodopa equivalents. Clinical (MDS-UPDRS III) and subjective (MDS-UPDRS I) outcomes are also assessed.

Perspectives: By combining expertise from exercise physiology, radiology, endocrinology and neuropsychology a novel approach is taken aiming to understand the possible neuroprotective effects of AE in PD. This would be of high relevance to PD patients and their relatives. From a societal perspective it may lower disability-related costs by optimizing PD rehabilitation. In case of positive findings, this would provide the first convincing human evidence of a disease modifying effect of AE in PD potentially changing clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age ≥ 40 years
* Idiopathic PD diagnosis (within the previous five years)
* Patients in symptomatic therapy / not in therapy. Patients who are not already taking medication are not expected to need medication within 6 months of inclusion (in case of drug startup, this is noted)
* Hoehn \& Yahr ≤ 3
* Ability to transport oneself to and from exercise and testing

Exclusion Criteria:

* Alcohol abuse, depression, pacemaker
* Comorbidity/competing (neurological) disorder preventing participation in the intervention
* Pregnancy
* Metallic implants that prevent MRI.
* Expected exercise adherence below 85% of all planned sessions.
* Systematic moderate-high-level AE more than twice per week prior to start-up in the project
Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA

In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) \> 20 mmHg or a drop \>10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation.

Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery.

This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and
* Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting.
* Patients that speak and understand Danish
* Written informed consent

Exclusion Criteria:

* Pre-existing orthostatic hypotension or intolerance
* Alcohol or substance abuse
* everyday treatment with either anxiolytic or antipsychotic medicine
* Cognitive dysfunction
* If surgery was converted to general anesthesia or total knee arthroplasty.
Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity

Verify the reliability of VA measured every week at home, by the patient using a TC, compared to the reliability of VA also measured by the patient using a TC but every 2 month at the hospital, during standard DME follow-up visits


Eligibility Criteria:
Inclusion Criteria:

Will be included in the study, patients with all of the following criteria:

* aged ≥ 25 years old (the minimum age is set at 25 years old in order to include patient with controlled diabetes);
* diagnosed with DME;
* followed and treated by anti-VEGF IVT in the ophthalmology debarment at Hopital Saint Joseph Marseille;
* having a VA score ≥ 20/100;
* able to understand the study and to use a TC;
* having an internet access at home;
* having given free and informed written consent;
* being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

Will not be included in the study, patients with one of the following criteria:

* treated for another pathology that DME;
* already participating to another research study;
* pregnant or breastfeeding woman;
* subject to a measure for the protection of justice.
First-in-human, Safety, Tolerability and Pharmacokinetics Study of LRX712 in Osteoarthritic Patients

This study is designed to evaluate, for the first time in humans, safety and tolerability of single ascending doses of intra-articular (i.a.) injections of LRX712 into the knee of patients with moderate osteoarthritis (OA), in order to support the further clinical development. This study will also allow establishment of the systemic and local pharmacokinetics (PK) of LRX712 and the exploration of biomarkers of cartilage breakdown and regeneration in OA patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, 30 to 65 years of age inclusive, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* At screening, and at baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position as outlined in the SOM.

Sitting vital signs should be guided by the following ranges:

* body temperature between 35.0-37.5 °C
* systolic blood pressure 90-139 mm Hg
* diastolic blood pressure 50-89 mm Hg
* pulse rate, 40 - 90 bpm • Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]

Exclusion Criteria:

* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Pregnant or nursing (lactating) women
* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
* A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening and baseline

  * PR \> 200 msec
  * QRS complex \> 120 msec
  * QTcF \> 450 msec (males)
  * QTcF \> 460 msec (females)
* Known family history or known presence of long QT syndrome
A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis

The goal of this clinical trial is to learn about the safety and effectiveness of Novabel bioabsorbable steroid-releasing stent in chronic sinusitis. The main questions it aims to answer are:

* The safety of this device for the chronic sinusitis
* The effectiveness of this device for the chronic sinusitis Participants will be implanted bioabsorbable steroid-releasing stents after FESS surgery. Participants will be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and 360 days after procedure.

Researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.


Eligibility Criteria:
Inclusion Criteria:

* Diagnose with CRS based on Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018), who were scheduled to undergo primary or revision bilateral ESS.
* Have evidence of bilateral sinus based on computed tomographic (CT) scan (Lund-Mackay \[L-M\] score of \<=3 on each side).
* Can understand the purpose of this study and will to join and finish all the follow up according to the study. Sign the ICF.

Exclusion Criteria:

1. Know history of allergy or intolerance to corticosteroids or mometasone furoate.
2. The subject has a known allergic reaction or contraindication to the device material and its degradation products (L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid).
3. Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
4. Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis.
5. Glaucoma, ocular hypertension, posterior subcapsular cataracts.
6. Known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease.
7. Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 360 day follow-up period.
8. Current ESS including frontal sinus surgery is aborted for any reason.
9. Pregnant or lactating female
10. Investigator determination that the potential study subject is unable to comply with study procedures and/or follow-up, or provided informed consent.
11. Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.