cyrilzakka/clinical-trials huggingface dataset:
Embryo Development in Microfluidics System of Culture

Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.

Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.

Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 35 years old
* No more than 1 previous IVF failure
* Absence of physical conditions that can interfere in oocyte quality
* At least 8 zigotes 24 hours after fertilization

Exclusion Criteria:

* Use of epididimary or testicular sperm
* Sperm or egg donation
* Untreated systemic diseases
Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis

The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic plaque-type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Must be able to understand and communicate with the investigator and comply with the requirements of the study
2. Chronic plaque-type psoriasis diagnosed for at least 6 months before screening
3. Stable plaque psoriasis
4. History of receipt of or candidate for therapy.
5. Moderate to severe psoriasis at screening and baseline
6. Must be willing and able to self-administer SC injections or have a caregiver available to administer injections
7. Male participants of childbearing potential must employ a highly effective contraceptive measure
8. Female participants must have a negative pregnancy test; are not planning to become pregnant; and must not be lactating. Female participants must also agree to employ a highly effective contraceptive measure.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type
2. Drug-induced psoriasis.
3. Other skin conditions which would interfere with assessment of psoriasis
4. Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
5. Other inflammatory conditions other than psoriasis or psoriatic arthritis
6. Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
7. Ongoing use of prohibited psoriasis treatments
8. Ongoing use of other non-psoriasis prohibited treatments
9. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
10. Laboratory abnormalities at screening deemed clinically significant by the investigator
11. Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
12. History of latex allergy
13. History of or current signs or symptoms or diagnosis of a demyelinating disorder
14. History of or current Class III or IV New York Heart Association congestive heart failure
15. Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
16. Current malignancy or history of any malignancy except adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ; no more than 3 lifetime basal cell and squamous cell carcinomas permitted
17. Chronic infections, recurrent infections; recent infection to be evaluated
18. History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV)
19. History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
20. Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study
21. Participant is a family member or employee of the investigator or site staff or study team
Longitudinal TSPO PET Imaging with [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)

The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval.

Primary Objectives

* To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers.
* To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.

Secondary Objectives

* To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes.
* To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes
* To acquire safety data following injection of \[18F\]DPA-714


Eligibility Criteria:
Inclusion Criteria:

* A prodromal PD and Healthy participant enrolled in PPMI Clinical protocol
* A PD participant enrolled in PPMI Clinical protocol who has not started symptomatic treatment at time of enrollment or in the first 2 years of participation.
* Able to provide informed consent
* Must have screening genetic testing documenting high binder at the at the known TSPO gene polymorphism (rs6971)
* Male or Female (Females must meet additional criteria specified below, as applicable)

  • Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \[18F\]DPA-714
* Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
* Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.

  * Females of childbearing potential must not be pregnant, breastfeeding or lactating.
  * Includes a negative urine pregnancy test prior to injection of \[18F\]DPA-714 on day of PET scan.

Exclusion Criteria:

* Exposure to a total effective dose equivalent of 50 millisievert (mSv) for the whole body, which is the annual limit established by the US Code of Federal Regulations , during the past year.
* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.
Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of CC-1088 in treating patients who have chronic lymphocytic leukemia that has not responded to previous therapy.

OBJECTIVES: I. Determine the toxicity of CC-1088 in patients with refractory, progressive, B-cell chronic lymphocytic leukemia. II. Determine the response rate to this treatment in these patients.

OUTLINE: Patients receive oral CC-1088 three times a day for 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 11-20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed refractory, progressive, B-cell chronic lymphocytic leukemia Failed prior first line therapy of chlorambucil or fludarabine (or their equivalent) Progressive disease as defined by at least one of the following: Greater than 50% increase in the sum of the products of at least 2 lymph nodes on two consecutive determinations 2 weeks apart (at least one lymph node must be greater than 2 cm) Appearance of new palpable lymph nodes At least a 50% increase in size of previously palpable liver or spleen Appearance of palpable hepatomegaly or splenomegaly not previously present At least a 50% increase in the absolute lymphocyte count to at least 5,000/mm3 Transformation to an aggressive histology (e.g., Richter's or prolymphocytic leukemia) High risk OR Intermediate risk with active disease, as defined by the following: Greater than 10% weight loss Extreme fatigue Fevers greater than 100.5 Fahrenheit for greater than 2 weeks without infection Night sweats Splenomegaly greater than 6 cm Lymphadenopathy greater than 10 cm Lymphocytosis with a doubling time less than 6 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG or Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 2 weeks after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea

This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.

   - somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
2. Patients who are willing to provide written informed consent.

Exclusion Criteria:

1. Patients with contraindication according to prescribing information for Lutathera in Korea.
A Pharmacovigilance Study of Brain Oedema

Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).

Brain oedema is a serious neurological condition, as it possesses a significant impact on the functional abilities of an individual by causing irreversible brain damage and potentiates the risk of mortality. Apart from a number of medical conditions causing brain oedema, evidence suggests the association of various drugs with brain oedema. Therefore, this study aims to provide a comprehensive disproportionality analysis of the drug-induced brain oedema reports in the FAERS database.

Eligibility Criteria:
Inclusion Criteria:

* Brain Oedema cases reported in the FAERS database till 31/03/2019
* Adverse event reported was included using the MedDRA term: Brain Oedema

Exclusion Criteria:

* Drugs with less than 19 brain oedema reports
Thromboelastography (TEG®) and Platelet Function in Patients on Anti-platelet Agents

Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding complications in patients on blood thinning (anti-platelet) agents?

Two hundred patients coming for surgery who are taking anti-platelet medications will be enrolled in this study as a pilot, to determine the feasibility for a larger study. A simple blood test for clotting function will be done after surgery. Patients will be assessed daily during their hospital stay to determine if they have any clotting or bleeding complications. For analysis, groups will be divided into normal and increased or decreased ability to make a blood clot based on the TEG® and PMA™ test done. Complications will be recorded for each group and analyzed to determine if there is any difference between groups.

Eligibility Criteria:
Inclusion Criteria:

* patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery

Exclusion Criteria:

* anemia (Hb \< 100) or thrombocytopenia (platelet count \< 80), having any known clotting abnormalities
* family history of clotting abnormalities
* concurrently on NSAIDs, warfarin therapy or other treatments affecting platelet function
* renal impairment (Cr \> 110 mg for females or Cr \> 125 mg) or INR \> 1.2
Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices

The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment and the cost of treatment during one year.

This randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the clinic at 5 scheduled occasions.

The study includes 2 arms. Secondary measures are obtained by respiratory analysis and questionnaires. Electromyography (EMG) of the masseter muscle is recorded and the influence of bruxism is evaluated in terms effect on efficacy and adverse events

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of obstructive sleep apnea with AHI \> 15
* Odontological status that allows retention of oral devices and with at least one molar in each quadrant
* Maximal protrusion \>6 mm
* Subject giving his/her informed concent
* Understands and can communicate in Swedish
* Subject understands the instruction on how to put on the polygraphy equipment at home
* Valid AHI data at baseline respiratory analysis

Exclusion Criteria:

* age\< 18 år
* BMI \>35
* Jaw complaints requiring treatment the past year
* Pain or locking of the jaw at the enrollment visit
* At the discretion of the investigator judged not being able to attach to the study directives
* Hypersensitive to the material of the devices
* Ongoing Continuous Positive Airway Pressure (CPAP) treatment or oral device treatment or such treatment terminated within a month from enrollment
Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

Still not well resolved access, execution and interpretation of spirometry in primary care medicine. This seriously affects the quality of care of chronic respiratory diseases.

OBJECTIVE: To compare the effectiveness of two methods for quality control in performing spirometry in primary care teams (EAP) participating in the "Healthcare Process Chronic Obstructive Pulmonary Disease (COPD )" (multidisciplinary program between primary care medicine and hospital for improved care COPD).

METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality control of spirometry in each EAP randomize into three branches:

1. Supervision from the pulmonary function laboratory of the Hospital ; computer.
2. Program incorporated into automated spirometer.
3. Spirometric usual practice (control group without any support on the quality ). Spirometry EAP participants include year follow-up study . All sites use the same model spirometer and have received the same previous training . In a 2nd phase results implementing the most effective method shown in the 1st phase was studied.

EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the quality spirometry.

POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early detection (secondary prevention ) , the diagnosis of the severity and developmental control of COPD.


Eligibility Criteria:
Inclusion Criteria:

* All patients seen in the participating primary care, requiring spirometry for both the diagnosis and control of any disease will be included.

Exclusion Criteria:

* Patients under 15 years
Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
* Patient is opioid naïve

Exclusion Criteria:

* Patients who are pregnant
* Patients with cognitive impairment
* Patients with psychological disorders
* Patients with prior thoracic surgery
* Patients with fibromyalgia
* Patients with redo ipsilateral thoracic surgery
* Patients undergoing bilateral thoracotomy
Cognitive/Physical Computer-Game Blended Training of Elderly: Neuroscientific LLM Studies

The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.

The study was conducted in the Thessaloniki (Greece), in various centers. It was part of the Long Lasting Memories (LLM) project (www.longlastingmemories.eu), which was funded by the European Commission (Information and Communication Technologies Policy Support Program (ICT-PSP) for a three year period (2009-2012). It used a pre-post-test design with the between-participant factor group \[intervention(s) vs. passive and/or active control\]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, and at participants' homes.

Centers had to provide 8 exercise weeks, with a frequency of at least 2 physical and 3 cognitive exercise sessions per week, resulting in at least 16 physical and 24 cognitive exercise sessions in total.

A similar trial was registered with Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02267499

Eligibility Criteria:
Inclusion Criteria:

* no severe cognitive impairment \[MMSE ≥ 18\]
* fluent language skills
* agreement of a medical doctor
* time commitment to the test and exercise protocol.

Exclusion Criteria:

* concurrent participation in another study
* severe physical or psychological disorders which precluded participation in the intervention (i.e., inability to follow instructions)
* unrecovered neurological disorders such as stroke, traumatic brain injury, unstable medication within the past three months
* severe and uncorrectable vision problems, or hearing aid for less than three months.
Penicillin Allergy Testing in STD Clinics

Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing

all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge

Eligibility Criteria:
Inclusion Criteria:

* Prior history of PCN allergy

Exclusion Criteria:

* No immunodeficiency or contraindication to skin testing
Tobramycin Tear Concentrations

To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.


Eligibility Criteria:
Inclusion:

* Visual Acuity (VA) of 0.6 logMAR or better
* Tear meniscus height of ≥ 0.3mm at Visit 1.
* No concomitant topical ocular medications, including artificial tears, during the study period

Exclusion

* ocular hypertension, iritis or uveitis, glaucoma
* ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
* epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
* lacrimal duct obstruction, dry eye, ocular allergies.
* contact lens within 7 days of Visit 1.
* ocular medications within 14 days of Visit 1.