cyrilzakka/clinical-trials huggingface dataset:
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability

The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer and Doppler ultrasound.

The majority of obstetric deliveries in the US undergo electronic monitoring and continuous uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically, external transducers are employed, the reliability of which depends on their proper positioning, which may be disturbed by patient or fetal movement. The tocodynamometer (strain gauge, toco for short) provides frequency and timing of contractions, but requires transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an external Doppler ultrasound transducer. The reliability of this monitor depends on the ability to obtain a window to the fetal heart.

In some patients, particularly the obese, the toco and ultrasound may fail to monitor consistently. In others both transducers require frequent repositioning by the nursing staff, and the Doppler may erroneously report maternal heart rate instead of fetal.

The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which is placed through the cervical os in the adequately dilated patient with ruptured membranes. While this monitor usually provides a more reliable signal than the toco, as well as quantitative information regarding intrauterine pressure, it is invasive and there is an increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE), which is applied transvaginally to the fetal presenting part, also requiring adequate cervical dilation and ruptured membranes. While the FSE usually provides a more reliable signal, it is similarly invasive and increases risk of infection.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 50 years old
* \>/= 34 weeks gestation
* Single viable fetus in cephalic presentation

Exclusion Criteria:

* Bleeding or uterine scarring
Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques

In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence, especially following tourniquet deflation. The resulting cardiopulmonary emboli can potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive dysfunction due to emboli. The standard surgical technique involves placing an intramedullary rod in the femur to determine the angle and degree of resection from the end of the femur. A new surgical technique utilizes computer navigation system to perform the desired cuts in the appropriate position. The investigators hypothesize that the avoidance of intramedullary instrumentation in computer assisted total knee replacement will result in fewer thromboembolic events compared with the standard technique using manual instrumentation in the femur. The present study will test this hypothesis by quantifying the extent of thromboembolism during both surgical techniques.

Currently, Transesophageal Echocardiography (TEE) is routinely used intraoperatively to monitor patients undergoing total knee arthroplasty for thromboembolic events. Video recording (without any patient identifiers) of the TEE loops before and after tourniquet release, offline analysis to quantify the extent of thromboembolism and the two surgical techniques will be compared. Patients are assigned to a particular technique according to some non-rigid criteria. This study has no impact on their selection into one group or the other. Participation in this study does not influence the choice/selection. We will simply record and analyze the echo loops in twenty patients already assigned to each surgical technique.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled to undergo Total Knee Arthroplasty at UC Davis Medical Center
* 18 years and above

Exclusion Criteria:

* Any contraindication to perform TEE
DSP-3025 A Phase 1 Study of Healthy Male Volunteers

Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
* No clinically relevant abnormal findings

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
* Clinical relevant disease or disorder (past or present)
* A history of respiratory disorder(s) such as asthma
MSC Infusion for Anti-aging and Regenerative Therapy

To evaluate the safety and efficacy of human Mesenchymal Stem Cell (hMSC) infusion therapy, in preserving general wellness and ameliorating or reversing the effects of aging in our study population

100million human mesenchymal stem cells will be infused into study subjects. They will be followed up for both objective and subjective measures of 'anti-aging'. Biochemical markers such as male and female hormones and other parameters of well being will be measured. A questionnaire will also be filled pre and post infusion to ascertain one's well-being (Adapted from SF-36).

Source of MSCs - Autologous (Adipose tissue) or Allogenic (Adipose tissue or umbilical cord)

MSC production and storage will be performed in a GMP certified laboratory setting.

Eligibility Criteria:
Inclusion Criteria:

1. All patients \>18yrs old, who are able to read, write and understand Informed Consent form, regarding the experimental nature of this therapy.
2. All Healthy Subjects are eligible for this study
3. Subjects with stable pre-morbid medical conditions, not requiring changes to their current medical therapy for \>6 months prior to enrolling in this study, are eligible.

Exclusion Criteria:

1. Uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmHg and/or diastolic blood pressure \> 100 mmHg.
2. Having evidence related to renal dysfunction: creatinine \> 1.5 mg/dl or (\>133 mmol/L) for men. creatinine \> 1.4 mg/dl or (\>124 mmol/L) for woman. eGRF \< 40 ml/ min Proteinuria \> 300 mg/day
3. Severe heart disease (NYHA 3/4 or congestive heart failure)
4. Severe liver disease (liver enzymes \>2x baseline, or evidence of coagulopathy)
5. Evidence of ketoacidosis at the time of selection.
6. Evidence of ongoing or frequent hypoglycemia.
7. Severe infection at time of selection
8. Infected with hepatitis B virus or hepatitis C or tuberculosis.
9. Serious allergic constitution
10. Neoplasm detected before/during screening or raised tumour markers CA125 (Females), CA15.3 (Females), CEA, CA19.9, Alpha Fetoprotein (AFP), PSA (Males)
11. Patients who are currently participating in another clinical study involving experimenting drugs and/or medical equipment.
12. Pregnant or Breastfeeding
13. Patients who are unable to perform the tests and assessments needed for the study
14. Patients who do not agree to participate in the study.
15. Patients with pre-morbid medical conditions, who have recently had alterations in their treatment regime (\<6 months).
Lived Experiences of Black Girls in Richmond

This study is to understand the quality of life of Black Girls in Richmond, Virginia, which includes generating a report about the status of Black girls in Richmond. Research or reports about the state of the girls are growing more common across the country in cities like Los Angeles, Chicago, and Philadelphia. Most of these studies generate deficit narratives focusing on these groups' problems, needs, and deficiencies. Fewer studies focus solely on the experience of Black girls specifically. This study proposes a new approach and explores the quality of life of Black girls using an asset-based approach that thinks differently about the subject of these studies and how to address their needs appropriately.


Eligibility Criteria:
Inclusion Criteria (Online Survey and focus groups):

* Self-identify as Black/African American adolescent cisgender girls, between the ages of 12-17, and reside in the City of Richmond.

Exclusion Criteria (Online Survey and focus groups):

* Girls who are not between 12 to 17 years of age, do not self-identify as Black, does not identify as cisgender, legal residence is not located in the city of Richmond, and/or who do not read English.

Inclusion Criteria (Interviews):

* Parents/guardians (any sex; no age range for parent/guardian) of Black girls (ages 12-17) who reside in the City of Richmond; and
* Black emerging adult women (ages 18-22) who resided in the City of Richmond when they were under 18.

Exclusion Criteria (Interviews):

* Parent/Guardian - Does not have a child (daughter) between the ages of 12-17; child does not self-identify as cisgender and Black/African American; legal residence is not in the city of Richmond; unable to read, write, or speak in English.
* Emerging adult women - does not self-identify as Black/African American, under 18 or over the age of 22, did not reside in the City of Richmond under 18, and unable to read, write, or speak in English.
Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study

The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous trials of similar study design.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign the Informed Consent.
* Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations.
* Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery.
* Patients requiring a primary total knee replacement.
* Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* Patients with intact collateral ligaments.

Exclusion Criteria:

* Patients with inflammatory arthritis.
* Patients that are morbidly obese, body mass index (BMI) \> 40.
* Patients with a history of total or unicompartmental reconstruction of the affected joint.
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
* Patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers.
* Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
* Patients with knee fusion to the affected joint.
* Patients with an active or suspected latent infection in or about the knee joint.
* Patients whose surgery will utilize computer-assisted surgical navigation (CAOS) techniques.
* Patients whose surgery will utilize minimally invasive surgical techniques.
* Patients that are prisoners.
The PRE-OP ENERGY Trial

The PRE-OP ENERGY Trial proposes to test the overarching hypothesis that a pre-surgery high energy diet will protect patients against organ damage during cardiac surgery with cardiopulmonary bypass.

PRE-OP ENERGY is a single centre, unblinded, parallel group, randomised controlled trial of a pre-operative high energy diet, versus a control group receiving standard care.

The trial will test a number of specific hypotheses:

1. A pre-surgery high energy diet will protect against post-cardiac surgery organ failure by altering the pre-surgery cardiometabolic state, a process referred to as 'metabolic preconditioning'.
2. The effects of the trial intervention will not be attributable to changes in frailty, activity or baseline organ dysfunction.
3. The trial intervention will not result in long-term adverse changes in cardiometabolic status.
4. Metabolic preconditioning will confer protection against post-cardiac surgery kidney injury by increasing the expression of genes that promote renal tubular homeostasis.
5. Metabolic preconditioning will confer protection against post-cardiac surgery myocardial injury by increasing the expression of genes that promote myocardial mitochondrial homeostasis via effects on chromatin histone deacetylation.
6. Metabolic preconditioning will confer protection against post-cardiac surgery endothelial dysfunction by increasing the expression of genes that promote endothelial homeostasis.

Eligibility Criteria:
Inclusion Criteria:

ALL of the following:

* Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery (CABG, Valve, or CABG and Valve) with cardiopulmonary bypass.
* BMI\<30
* Able, in the opinion of the investigator, and willing to give informed consent.
* Do not have diagnosed coeliac disease
* Able to understand English

Exclusion Criteria:

Any of the following:

* Urgent, emergency or salvage procedure
* Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) \<15 mL/min/1.73 m2 calculated from the Modification of Diet in Renal Disease equation,1 or patients who are on long-term haemodialysis or have undergone renal transplantation.
* Patients with persistent or chronic atrial fibrillation.
* Patients with severe liver dysfunction; hepatitis, cirrhosis, jaundice.
* Women who are pregnant or who may become pregnant in the intraoperative period.
* Patients who are participating in another interventional clinical trial.
* Unable, in the opinion of the investigator, or unwilling to give informed consent.
* Have diagnosed coeliac disease
* Unable to understand English

Exclusion criteria for optional MRI research procedure:

* Permanent pacemaker or ICD
* Brain Aneurysm Clip
* Implanted neural stimulator
* Cochlear implant (specific implant must be checked that it is MR safe)
* Ocular foreign body (e.g. metal shavings) unless removed
* Other implanted medical devices: (e.g. Swan Ganz catheter)
* Insulin pump
* Retained metal shrapnel or bullet
* Claustrophobia
Uterus Transplantation From Deceased Donor - Gothenburg III

Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II


Eligibility Criteria:
Inclusion criteria recipient

* initially included with IVF and excluded by donor issues of Gothenburg I or II
* initially included and excluded by early graft failure of Gothenburg I or II
* age \< 40 years
* no systemic disease
* no standing medication
* satisfactory ovarian reserve
* BMI \<35 and at BMI 30-35 waist circumference of \< 82 cm
* absolute uterine factor infertility
* psychological stable

Inclusion criteria donor

* brain death and suitable as multiorgan donor
* acceptance for donation of uterus from family or previously by patient
* age \<55 years
* at least one normal pregnancy and childbirth
* no previos malignancy
* no systemic disease
* no previous major surgery inn abdomen or on uterus
Childhood Origins of Asthma (COAST)

Although asthma is likely to be a heterogeneous disease or syndrome, three factors and/or events repetitively emerge for their ability to significantly influence asthma inception in the first decade of life: immune response aberrations, which appear to be defined best by the concept of cytokine dysregulation; lower respiratory tract infections (in particular RSV); and some form of gene by environment interaction that needs to occur at a critical time period in the development of the immune system or the lung. It remains to be firmly established, however, how any one or all of these factors, either independently or interactively, influence the development of childhood asthma. Thus, our efforts to determine and define the importance of these three factors to asthma pathogenesis are the focus and goal of this current grant application.

No more description necessary.

Eligibility Criteria:
Inclusion Criteria:

* children who had one or more parent with a history of allergy or asthma

Exclusion Criteria:

* pre term infants
* low birth weight infants
* respiratory distress at birth
Phase I/II Study of FR104 First Administration in Patient with Renal Transplantation: FIRsT Study

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) of FR104 as well as its potential clinical effect on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years old
2. Signed and dated written informed consent prior to any study procedure
3. First kidney transplantation
4. Willing and able to participate to the study
5. Women of childbearing potential must use appropriate method(s) of contraception during the clinical trial (oral contraception, implant or intrauterine device) throughout the study period and for 90 days after the last dose of FR104
6. Women of childbearing potential must have a negative urinary pregnancy test the day of transplantation
7. All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of FR104, whichever is longer
8. Recipient of a kidney from deceased donor -
9. Recipient of a de novo kidney transplant able to start the immunosuppressive regimen at the protocol-specified time point
10. Recipients of a kidney with a cold ischemia time \< 36 hours
11. Patients with French social security

Exclusion Criteria:

1. Recipient of a kidney from living donor
2. Patient at high immunological risk of rejection as determined for assessment of anti-donor reactivity:

   High TGI \>20% or Presence of pre-formed DSA with MFI\>500 (results 12 weeks prior to enrollment are acceptable if no blood transfusion or abortion occurred during this period)
3. Any retransplantation and combined transplantations
4. ABO incompatible transplantation
5. HIV-positive, EBV-negative or suffering active viral hepatitis B (AgHbs positive excluded) or hepatitis C, syphilis serology- positive recipient
6. CMV negative recipients of CMV positive donors (R-D+)
7. Patient with known history of tuberculosis
8. Uncontrolled concomitant infection or any other unstable medical condition (heart failure, severe liver disease, psychiatric disorders, substance abuse) that could interfere with the study objectives
9. A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components
10. Previous history of cancer (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured)
11. Pregnant woman or likely to become pregnant or nursing
12. Patient under guardianship or trusteeship
13. Patient participating in another interventional clinical trial
14. Live viral or bacterial vaccines/treatment agents given from 3 months prior to FR104 administration (12 months for BCG vaccine)
Children's Familiarity With Snack Foods Changes Expectations About Fullness

The purpose of this study was to measure and quantify children's beliefs about the satiating properties (i.e. expected satiation)of snack foods. The investigators predicted that children who were especially familiar with snack foods would expect them to deliver greater satiation.

Palatability is regarded as a major determinant of children's energy intake. However, few studies have considered other "non-hedonic" beliefs about foods. In adults there is emerging evidence that expectations about the satiating properties of foods are an important determinant of meal size, and that these beliefs are learned over time.

In the current study, we measured and quantified children's 'expected satiation' across energy-dense snack foods using a psychophysical technique known as method of adjustment. Participants changed a comparison-food portion (pasta and tomato sauce) to match the satiation that they expected from a snack food. We predicted that children who were especially familiar with snack foods would expect them to generate greater satiation, and that children who were unfamiliar would match expected satiation based on the physical characteristics (perceived volume) of the foods.

In our study, seventy 11- to 12-year-old children completed computerised measures of expected satiation, perceived volume, familiarity, and liking across six snack foods. Our analyses focused on the associations between these measures. This approach enabled us to establish differences in healthy behaviours that are evident across individuals.

Eligibility Criteria:
Inclusion Criteria:

* aged 11 to 12 years
* English speaking
* normal or corrected-to-normal vision

Exclusion Criteria:

* None
Validation of the Hebrew Version of the Montreal Affective Voices.

Today, no non-verbal auditory stimuli that assess mental processing are available in Israel. The goal of this study is to make available a validated set of auditory stimuli in Israel. We created a computerized Hebrew version of the Montreal Affective Voices (MAV). The MAV is a novel tool for assessing mental processing. The MAV consists of 90 nonverbal affect bursts corresponding to nine different emotions (such as anger, fear, happiness etc.) recorded by ten different actors. The uniqueness of these affective bursts is that they do not contain verbal context, but rather express affective moods using the vowel /a/ (as in "apple"). In this study, the investigators will verify the new Hebrew version of MAV in healthy control groups. Next, the investigators will compare the mental processing ability in young vs. old population, using the MAV test. In addition, the investigators will assess mental processing in two pathologic study groups (Parkinson's disease, major depressive disorder) using the MAV test. The investigators intend to use the MAV tool in future research in Parkinson's disease and depression.


Eligibility Criteria:
Inclusion Criteria:

* Healthy group
* Parkinson's disease
* Major depressive disorder
* All participants will be competent and willing to give written informed consent. Patients over 65 and/or suspected to have a cognitive decline will be tested by the Mini-mental test and will be included in the study only if the score is above 26.

Exclusion Criteria:

* Non-competent or unable to give written informed consent