cyrilzakka/clinical-trials huggingface dataset:
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)

Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2). Near infrared spectroscopy (NIRS) is a technique available to non-invasively and safely monitor the tissue oxygenation status (StO2), which can be beneficial or live saving for this fragile patient population. Unfortunately, traditional NIRS devices show a broad variability when applied to the abdomen (Bailey \& Mally 2016). The novel device is designed especially for application of NIRS on the abdomen of preterm infants.

Each child will be measured over a time span of three days with the novel NIRS device.

1. A two-hour measurement is performed in measurement phase 1
2. Additionally, the sensor will be placed five times onto the abdomen for 1-minute measurements, which constitutes measurement phase 2.
3. The final measurement phase 3 lasts for up to 70 hours.

A total of two ultrasound (US) examination on the abdomen are performed during the first two measurement phases to assess the presence of air and stool in the abdomen.

Additional assessment of SpO2 is performed throughout. Aside from the US and SpO2 measurement, no additional procedures will be performed.

The NIRS measurement will not disturb necessary clinical and nursing procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants with Gestational age less than 35 0/7 weeks
2. Signed Informed consent of the legal representative(s) is received after being informed. The consent form is signed by one legal representative, which is likely to be either the mother or the father. Only married fathers or those listed on the birth certificate are considered under UK regulations. In the case of non-married father, the mother must provide consent.
3. Clinically stable condition. The clinical stability is to be reconfirmed before the start and checked during the measurement.

Exclusion Criteria:

1. Injured, hypersensitive or bruised skin present on the abdomen,
2. Existence of clinical instability at any time during the investigation leads to exclusion, if ordered so by the physician entrusted with the investigation,
3. Any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors,
4. Severe Congenital malformations,
5. Clinical abdominal concerns
6. Severe metabolic disorders,
7. Early onset sepsis,
8. Inability of legal representatives to understand the purpose of the clinical trial due to language barriers such as the insufficient ability to understand the spoken or written language,
9. The treatment of newborn jaundice with light during measurement time phase 1 and 2,
10. Previous enrolment into the current study,
11. Family members, employees and other dependent persons of the investigator,
12. Participation in another study with investigational drug/device within the preceding days and during the present study which may influence abdominal oxygen saturation.
13. Known silicone allergy
Fingolimod for Type 2 Diabetes Mellitus

The aim of this study is to explore the efficacy and safety of Fingoland in the treatment of type 2 diabetes. A total of 40 patients were randomly divided into two groups. One group was treated with fingolimod, another group was given guideline based treatment. The changes of islet function in patients with glycosylated hemoglobin, insulin and C-peptide were observed .


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years old;
2. clinically diagnosed type 2 diabetes.
3. Glycosylated hemoglobin: 6.5% - 9.5%;
4. No drug treatment or only one oral hypoglycemic drug within 6 months;
5. Fasting blood glucose: \< 13.9mmol/l for those without medication, or \< 13.3mmol/l for those with medication;
6. if the antidiabetic drugs are taken, the dosage and the drug must be stable in the past 3 months.
7. Body mass index (BMI) ≤ 45 kg / m2;
8. Sign informed consent

Exclusion Criteria:

1. patients with type 1 diabetes;
2. diabetic complications (ketoacidosis, hypertonic state, lactic acidosis).
3. Allergic to the study drug;
4. Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L);
5. Complicated with other serious organ diseases;
6. Recent disease history (within the past 6 months): myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III / IV heart failure;
7. Presence or history of mobitz type II second or third degree AV block or sick sinus syndrome, unless the patient has a pacemaker;
8. Baseline QT interval extension (male \> 450ms or female \> 460ms);
9. Treatment with class IA or class III antiarrhythmic drugs;
10. Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.);
11. Participating in other clinical trials within 3 months;
12. Other circumstances that the investigator considers unsuitable for participating in this clinical study.
Natural Killer Cells in Older Patients With Acute Myeloid Leukemia

RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy.

PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia.

OBJECTIVES:

Primary

* Determine the evolution of functional receptors of natural killer (NK) cells after completion of chemotherapy in elderly patients with acute myeloid leukemia in first remission.

Secondary

* Measure the kinetics of cytotoxic functional recovery of NK cells.
* Determine activation markers of NK cells.

OUTLINE: This is a multicenter study.

Patients receive 1 course of consolidation therapy comprising an anthracycline and cytarabine to induce first remission.

Blood is collected on day 0 of the consolidation course and then every 2 weeks for 8 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia

  * No promyelocytic leukemia
  * No prior therapy

PATIENT CHARACTERISTICS:

* Hemoglobin \> 10 g/dL

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Evaluating a New Mental Health Group for Asians and Asian Americans

This study's overarching aim is to evaluate a new psychoeducation and process group for Asian and Asian American psychiatric outpatients. This is a 12 week mental health group which will focus on both educational content related to Asian mental health as well as increasing connection between group members. We hypothesize that participants in the group will experience a decrease in psychiatric symptoms at the conclusion of the group compared to their symptoms at the beginning of group. We also hypothesize that participants will feel more socially connected after the group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Participants must identify as Asian or Asian American
* Sufficient English proficiency to participate in a psychotherapy group conducted in English

Exclusion Criteria:

* Unable to provide written informed consent
* Elevated suicide risk (e.g. recent active suicidal ideation, past-year suicide attempt) without a current individual mental health provider
* Any other challenges that would preclude participation in group psychotherapy
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery

A prospective observational study to assess the energy needs of Ulcerative Colitis patients undergoing total proctocolectomy with ileoanal j-pouch anastomosis.

Total proctocolectomy with creation of ileoanal j-pouch anastomosis is the gold-standard surgical procedure for familial polyposis, for ulcerative colitis unresponsive to medication and for colitis associated with dysplasia requiring total colectomy.

Patients postoperatively face difficulties in maintaining their physical condition and quality of life due to potential complications such as surgical, mechanical, inflammatory and functional disorders increasing the rates of malnutrition. Postoperative changes as regards anthropometric characteristics and nutritional status have not been fully elucidated.

Therefore, the need arises to calculate the energy needs of patients with ileoanal j-pouch anastomosis, given the lack of corresponding data and the possible differentiation of energy needs from a similar group of patients undergoing colorectal surgery.

Of particular interest is the body composition of ileoanal anastomosis patients, which has been studied very little ), and the extent to which their energy needs are met, given dietary restrictions both preoperatively and postoperatively.

It is therefore necessary to determine the energy needs, as well as the degree of their coverage by the diet, of UC patients undergoing proctocolectomy with creation of ileoanal j-pouch anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ulcerative colitis and planned proctocolectomy with ileoanal j-pouch anastomosis surgery or patients who are to undergo subtotal colectomy.
* Age over 18 years.
* Written informed consent to take part in the study.
* Speaking ability in Greek or English.
* Able to get tested fasted;

Exclusion Criteria:

* Age under 18 years.
* Existence of pregnancy.
* Inability to breathe inside the indirect calorimetry mask for the time required for the measurement.
* Use of medications that may affect body metabolism will be evaluated individually (e.g. cortico-steroids etc.)
Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs.

23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Age 6 years and older at the time of enrollment
* Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search).
* Hair must be at least 3 cm long.
* Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age).
* For females of childbearing potential, a statement declaring that she is not currently pregnant.

Exclusion Criteria:

* Used any chemical head lice treatment in the 7 days preceding the trial treatment
* Used antibiotics in the week preceding treatment
* Open wounds in the treatment area
* Skin irritation in the treatment area
* Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation
* Known allergies to any of the gel's components
* Participant that is already enrolled in another study
* Participant who can't be combed with fine Comb dense ASSY2000
Use Of Fragmin In Hemodialysis

The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.


Eligibility Criteria:
Inclusion Criteria:

* chronic renal failure on hemodialysis

Exclusion Criteria:

* significant comorbidities that would prevent a patient from completing the trial
Post Intensive Care Syndrome in COVID19 Patients

This project is based in the implementation of a combined monitoring system (technological solutions and medical visits) in survivors of the critical illness due to the infectious disease by COVID-19. The main objective of the project is to characterize the Post-Intensive Care Syndrome (PICS) and detect early needs for specific treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU for COVID 19

Exclusion Criteria:

* Mental health diagnosis previous to the COVID19 infection
* Acquired brain damage or neurological disease previous to the COVID19 infection
TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

Athletic tendinopathies of the upper and lower extremity are often therapeutically challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in painful tendons, which are associated with pain-mediating nerve fibres in such tendinopathies. These neovessels are represented by an increased capillary blood flow at the point of pain. Painful eccentric training reduces pain and improves function in Achilles tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with eccentric training is superior to eccentric training alone (evidence level Ib). Long-term results suggest a collagen induction and reduced pain following topical glyceryl trinitrate (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence level Ib). The role of proprioceptive training in tendinopathy has to be determined in future randomized-controlled trials (evidence level II).

The investigators thought to evaluate the combination of the aforementioned individually successfully therapeutic options in athletes to shorten the recovery period and return to play interval.

Interventions:

Combined Power-Doppler-guided sclerosing therapy using Polidocanol (0.5%, 2ml) in 6-8 week intervals combined with extracorporeal focused shockwave therapy (STORZ Duolith 2000impulses 0.25mJ/mm2) every 6-8weeks plus painful daily eccentric training plus daily topical NO

Eligibility Criteria:
Inclusion Criteria:

* Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)
* patella tendinopathy
* elbow tendinopathy
* informed consent

Exclusion Criteria:

* no informed consent
* no painful tendons
* allergy against Polidocanol
* current treatment with Marcumar
Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects

The primary objective of the study was to evaluate the safe and effective use of the single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon beta-1a) in participants with multiple sclerosis (MS).

The Main Study was a 4-week treatment period which consisted of 1 Avonex manual injection using a prefilled syringe, followed by 3 Avonex injections using the single-use autoinjector. The Extension Study was designed to provide continuation of treatment with the Avonex single-use autoinjector to eligible participants who completed the Main Study for up to an additional 12 weeks, and to obtain additional safety and preference data for the Avonex single-use autoinjector.

Participants were enrolled under the initial study protocol (Initial Subject Subset); the study was subsequently suspended. Changes were made to the protocol (including modifications to the autoinjector needle), and additional participants were enrolled (Main Subject Subset).

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Must be 18 to 65 years old, inclusive, at the time of informed consent.
3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the Screening Visit.
4. In the investigator's opinion, subjects must be willing and able to self-administer all injections required by the protocol.
5. Must speak English.
6. All male subjects and female subjects of child-bearing potential must practice effective contraception during the study.

Exclusion Criteria:

1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to the Screening Visit.
2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1. Severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy. NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the study unless the dose has been increased within the 3 months prior to the Screening Visit.
3. Clinically significant local infection (for example cellulitis, abscess) or systemic infection (pneumonia, septicemia), at the discretion of the Investigator.
4. Known history of Human Immunodeficiency Virus (HIV).
5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody \[HCV Ab\]) or Hepatitis B virus (test for Hepatitis B Surface Antigen \[HBsAg\] and/or Hepatitis B Core Antibody \[HBcAb\]).
Automated Insulin for Management of Intrapartum Glycemia

The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are

* What are the neonatal glycemic outcomes with use of AID systems during labor/delivery?
* Do patients report higher birth satisfaction with use of AID systems during labor/delivery?
* Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery?

Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.


Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of type 1 diabetes ≥ 1 year
* Current use of commercially available AID system ≥ 6 months
* Currently pregnant at ≥ 34 weeks
* Singleton pregnancy
* English- or Spanish-speaking

Exclusion Criteria:

* Planned cesarean delivery
* Use of medications known to interfere with glucose metabolism
* Intrauterine fetal demise
* Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants

The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.

The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet formulation.

The study will enroll approximately 16 participants. Participants will be randomly assigned (by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:

* T2 50 mg Fasted + T3 50 mg Fasted + T3 600 mg Fasted + T2 600 mg Fasted + T3 600 mg Fed
* T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
* T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed
* T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed

All participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment period.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 70 days. Participants will make multiple visits to the clinic and will be contacted by clinic approximately 14 days after the last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 30.0 kilogram per square meter (kg/m\^2), at Screening.

Exclusion Criteria:

1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
2. Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing products during the confinement period(s) of the study.
3. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
4. Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.
5. Donation of blood or significant blood loss within 56 days prior to the first dosing.
Treatment Of Chronic Pain Using Real Time fMRI

The purpose of this study is to test a new investigational method for treatment of chronic pain using cognitive training guided by functional magnetic resonance imaging (fMRI).

Chronic pain is a substantial medical and economic problem, and is often unresponsive to conventional treatment. In this study, scientists will seek to decrease pain by increasing control over pain using newly-developed brain imaging methods to train people to control their own brain activation. This is the first clinical application of a recently-developed technology allowing a person to watch their own brain activation second-by-second and to learn to control it. It may provide a means to train people to control chronic pain by controlling their own brain states.

The purpose of the study is to evaluate real-time functional magnetic resonance imaging (fMRI) feedback for treating chronic pain diagnoses, including fibromyalgia, neuralgia, neuropathy, migraine, and complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD). The study will also measure the impact of cognitive training for pain control on activations from the areas of the brain involved in pain.

All participants in this study will receive a new form of cognitive training for controlling pain. Participants will be scanned using fMRI while they employ the cognitive training strategies-allowing them to view their brain activity. Some participants will see their own brain activation during this process while other participants will see very similar but simulated data that does not come from their own brains.

Participation in the study will last about 6 months with 12 visits that includes 6 sessions in an MRI scanner. Recruitment for this trial is limited to persons in the San Francisco Bay area. Participants must be able to attend sessions in Menlo Park, CA. Participants will be reimbursed for travel time within the Bay area.

Information gained from this study may help in developing potential future treatments for chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed chronic pain. Some example diagnoses include: CRPS, RSD, neuropathy, neuralgia, fibromyalgia, or migraine.
* No implanted medical devices that are not compatible with MRI (spinal cord stimulator/pump, pacemaker, surgical aneurysm clip, etc)
* No recent history of severe psychiatric illness
* Weight less than 220 lbs.
* Able to be scanned in MRI without claustrophobia
* No facial tattoos, non-removable metal implants, piercings, or extensive dental work.
* Not pregnant or having fertility treatments
Clustering Among the Clinical Profiles of Patients With Pectus Excavatum

The primary objective of this study is to describe the relative distances between patient clinical profiles (i.e. patient clustering) in multivariate space.

Observational data will be collected from patient files and submitted to clustering analyses. Then clusters will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with pectus excavatum
* The patient has had corrective surgery

Exclusion Criteria:

* The patient has expressed opposition to the study