cyrilzakka/clinical-trials huggingface dataset:
New Stage 1 Formula on Gut Comfort and Gut Health

180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed in study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3 groups, including breast feeding, commercial and new formula group. Study intervention is 12 weeks.

Primary objective:

1. Improvement on gut health and infant comfort

Secondary objective：

1. Efficacy on easy digestion;
2. Changes on SCFA in feces(Baseline and Endpoint)
3. Improvement on gut microbiome strains(Baseline and Day 21); (bifidobacterium/lactobacillus/clostridium perfringens recommended)
4. Changes on sIgA in feces(Baseline and Endpoint)
5. Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk regurgitation/sleeping time;
6. Incidence of eczema and duration;
7. Infants growth

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 7-90 days;
* Fed by breast milk before enrollment;
* Parent or legal guardian fully understand the purpose and requirement, including the potential risks and side effects of the study;
* Willing to participate in the study and comply all the procedures;
* Concent form signed by parents.

Exclusion Criteria:

* Twins, multiple birth, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
* Think about the need to exclude C-section delivered infants? It's often the majority of births in Chinese tier-1 cities, so it will probably make the study recruitment slower, and postpone the study. The microflora of C-section infants in known to be different compared to normally born infants. At least, the mode of delivery should be noted and calculated into the primary and secondary outcome measurements as a potential confounding factor
* During pregnancy, the mothers had pregnancy complications or other disease that may affect the results;
* Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other disease;
* Having neonatal diarrhea or acute respiratory infections within 48hours before enrollment;
* Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results;
* Having taken any food containing prebiotics or probiotics tithing 15 days of enrollment;
* Having gluten allergy (celiac disease);
* Body weight-to-height Z-value\<-3 according to the standard of WHO;
* Receiving hormone therapy and intravenous nutrition;
* Lactose intolerance or allergic to ingredients of study product;
* Have participated in other clinical studies within 3 months prior to the date of screening;
* Unable to comply the study schedule.
NTS-WBRT in Brain Metastases

This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT).

This research study involves:

* NTS-WBRT (normal tissue sparing whole brain radiation therapy)
* Memantine standard of care drug

This is a Phase 2 trial testing the safety and effectiveness of NTS-WBRT (normal tissue sparing whole brain radiation therapy) in treating brain metastases.

NTS-WBRT is a targeted radiation therapy that further reduces radiation dose to tissue that does not need radiation therapy treatment.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

It is expected that about 41 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy
* Age ≥ 18
* Karnofsky Performance Status ≥ 70
* Prior stereotactic radiosurgery (SRS) permissible per physician discretion
* Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy.
* Prior partial brain radiation therapy permissible if target volume \< 50% brain and per physician discretion
* Expectant \> 6 months survival
* Ability to understand and the willingness to sign a written informed consent document.
* Fluency in English, able to complete questionnaires and neurocognitive testing
* Ability to undergo MRI with gadolinium examination
* Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion
* Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians
* Negative pregnancy test for premenopausal women

Exclusion Criteria:

* Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)
* Prior whole brain radiation therapy
* Pre-existing or current use of memantine or other NMDA antagonists
* Known allergy to contrast used in imaging studies and/or inability to have MRI imaging
* Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy
* Concurrent participation in an investigational systemic therapy protocol.
Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.

In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision(double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used.

Women will be followed for a subsequent pregnancy in the next average 6 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Term (\> 37 weeks) pregnancy
* Cervical dilatation \< 4 cm
* Kerr incision
* Age \> 18 years old

Exclusion Criteria:

* Being in active phase of labor
* Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )
* Having a history of uterine surgery (myomectomy, hysterotomy) other than CS
* Extension of Kerr incision
* Multiple pregnancy
* Maternal diabetes mellitus
* Maternal connective tissue disease
* Uterine malformation
* Uterine fibroids on Kerr incision line
* Chorioamnionitis
Oral Nutritional Supplements in Treatment of Elderly Mild-to-Moderate COVID-19

The coronavirus disease 2019 (COVID-19) pandemic has seriously threatened public health worldwide. Nutritional supplements may have a positive influence on the recovery of patients with viral infection. This study aimed to assess the influence of oral nutritional supplements (ONSs) on the biochemical parameters of elderly patients with mild-to-moderate COVID-19.

This clinical trial will be conducted on 145 elderly patients with mild-to-moderate COVID-19. Patients in the intervention group (n=74) received nutritional powder (vitamins, minerals, dietary fiber, polyphenols, omega-3, amino acids, and probiotics) for 14 days. Cases in the control group (n=71) took the placebo, except for nutritional powder, and they received the same treatment. Biochemical parameters were measured before and two weeks after intervention.

The coronavirus disease 2019 (COVID-19) pandemic has seriously threatened public health worldwide. Nutritional supplements may have a positive influence on the recovery of patients with viral infection. This study aimed to assess the influence of oral nutritional supplements (ONSs) on the biochemical parameters of elderly patients with mild-to-moderate COVID-19.

This clinical trial will be conducted on 145 elderly patients with mild-to-moderate COVID-19. Patients in the intervention group (n=74) received nutritional powder (vitamins, minerals, dietary fiber, polyphenols, omega-3, amino acids, and probiotics) for 14 days. Cases in the control group (n=71) took the placebo, except for nutritional powder, and they received the same treatment. Biochemical parameters were measured before and two weeks after intervention.

After 14 days, patients in the groups will be measured by C-reactive protein (CRP), creatinine (Cr), blood urea nitrogen (BUN), and interleukin-8 (IL-8) ,white blood cell (WBC), red blood cell (RBC), platelet (PLT), neutrophil percentage (NE%), prothrombin time (PT), D-Dimer (DD), blood glucose, sodium (Na+), potassium (K+), aspartate aminotransferase (AST), glutamate pyruvic transaminase (ALT), albumin, calcium (Ca), arterial blood gas (ABG) parameters, and interleukin-10 (IL-10).

Eligibility Criteria:
Inclusion Criteria:

1. COVID-19-positive was confirmed by reverse transcription-polymerase chain reaction (RT-PCR);
2. Mild-to-moderate COVID-19 patients who aged 60-90 years old;
3. Consistency with the indication of enteral nutrition;
4. The time from diagnosis of COVID-19 to hospitalization was less than 24 h.

Exclusion Criteria:

1. Oxygen saturation \< 93% or mechanical ventilation was required;
2. Systemic diseases (malignant tumors, autoimmune diseases, liver or kidney diseases);
3. Participation in other clinical trials within 3 months;
4. History of allergy to nutrients in the trial.
The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery

The purpose of this study is to determine whether the use of different dose of LMWH compared with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of esophageal carcinoma and planned for esophagectomy
* clinical diagnosis of lung carcinoma and planned for lung resection
* general anesthesia combined with epidural anesthesia

Exclusion Criteria:

* blood clotting disfunction before surgery
* anticoagulating or antiplatelet history before surgery
* low blood platelets count
* hemorrhagic disease
* cerebral hemorrhage
* cerebral,spinal,ophthalmologic operation history
* peptic ulcer
* bleeding\>400ml in operation
* bleeding\>100ml/h after operation
* blood transfusion in or after operation
* severe renal or liver disfunction
* severe hypertension
Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris

This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)

Researchers at the University of Washington are doing this study to find out if a commonly used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy under general anesthesia.

The investigators will administer routine anesthesia care including Ketamine, a commonly used anesthetic, during the patients surgery. During the patients surgery, the investigators will monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely non-invasive and collects data from the EKG monitor.

Eligibility Criteria:
Inclusion Criteria:

* ASA status I, II, or III
* 18 years or older
* Receiving GA with uncomplicated routine intubation
* Ability to provide informed consent
* English-speaking

Exclusion Criteria:

* Presence of coronary artery disease, cardiac arrhythmias, or ketamine allergy
* Patient refusal
* History of substance abuse
* Patients taking psychotropic and/or opiate drugs
* Having a history of psychiatric diseases or psychological problems
Lipid Lowering Agents to Limit Lipid Oxidation and Activation of Clotting System in Nephrotic Syndrome

The purpose of this research study is to learn if using statin in patients with nephrotic syndrome could lower the risk of blood clots. Nephrotic syndrome is a collection of signs and symptoms that occur when the glomeruli -the tiny filters that work in the kidney- leak protein in the urine.

One of the symptoms associated with nephrotic syndrome is hyperlipidemia: too much bad cholesterol (LDL). This bad cholesterol could be linked to the increased risk of blood clots in patients with nephrotic syndrome. The study doctors would like to see if taking a statin drug to reduce the amount of bad cholesterol could reduce the risk of blood clots.

Venous thromboembolic (VTE) events are common in the nephrotic syndrome (NS) occurring in up to 30% of patients when systematically screened. The investigator proposes to explore a novel mechanism for the increased clot formation in NS. To date, the only consistently identified underlying risk factor for VTEs is severe hypoalbuminemia related to the NS. The underlying pathophysiology related to VTE in NS remains poorly understood and has previously been ascribed to dysregulation of pro- and anticoagulant clotting factors due to urinary protein losses and reflected by the low serum albumin. However, the direct evidence for this mechanism is inconsistent and relatively poor. Another feature of NS is that of severe hyperlipidemia which also correlates with hypoalbuminemia. In other severely hyperlipidemic states (e.g. Familial Hypercholesterolemia), the level of oxidized low-density lipoprotein (oxLDL) is markedly elevated. Forms of oxidized LDL interact with monocytes and macrophages leading to expression of Tissue Factor (TF), a procoagulant molecule. Furthermore, monocytes and macrophages activated in this fashion also release microparticles, small cell-membrane derived vesicles, that also express TF and participate in initiating intravascular clot formation. the investigator hypothesizes that the hyperlipidemia of the nephrotic syndrome leads to elevations in oxidized LDL and in turn, elevations in microparticle Tissue Factor (MP-TF) and its activity. The investigator also hypothesizes that serum albumin levels will inversely correlate with hyperlipidemia as well as oxLDL levels and MP-TF activity. Here, the investigator will study the effect of treatment with HMGCoA reductase inhibitors (statins) on ox LDL and MP-TF activity patients with NS.

Eligibility Criteria:
Inclusion Criteria:• Prevalent or incident patients of either sex, ages 18-70, with Membranous Nephropathy (MN) , Focal Segmental GlomeruloSclerosis (FSGS), or Minimal Change Disease (MCD).

* Proteinuria ≥ 3.0 g/day by 24hr urine collection or urine protein/creatinine ratio ≥ 2.
* Hyperlipidemia as defined by fasting or direct LDL ≥ 150 mg/dl. -

Exclusion Criteria:Inability or unwillingness to comply with the study protocol and follow-up visits.

Patients unable to provide written consent will be excluded.

-
Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints

This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Creation of Auditory Processing Disorder Screening Tool in French

The objective of the study is to validate a screening tool for auditory processing disorder in children of 7 to 13 years old. This screening tool was created based on literature and combines a questionnaire and a mini-battery of tests composed of verbal and nonverbal assessments.

Hearing plays a vital role in the development of a child. Hearing is based on two main systems: the peripheral system and the central system. Peripheral hearing, which includes the outer, middle, and inner ear and the auditory nerve, can detect sound signals.

For its part, the central system, which is composed of auditory structures from the auditory nerve to the brain, makes it possible to process these sound signals and to analyze them. Peripheral hearing damage will result in deafness while a problem in the central auditory system will be called auditory processing disorder. Peripheral deafness can be detected from birth through neonatal screening for deafness. The symptoms of an auditory processing disorder can easily be confused with those caused by attention deficit disorder with or without hyperactivity and a specific language disorder. Auditory processing disorder is often unknown in the medical and educational worlds, and children are referred late for consultation. In addition, the lack of French screening tests for auditory processing disorder and the long waiting lists for specialized consultations help to delay diagnosis and hinder early intervention. Auditory processing disorder affects about 2 to 3% of school-aged children.

The objective of the study is to validate a screening tool for auditory processing disorder in children of 7 to 13 years old. This screening tool was created based on literature and combines a questionnaire and a mini-battery of tests composed of verbal and nonverbal assessments.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 7 to 13 on the day of enrollment.
* Child referred for assessment of central auditory skills, who did not have an auditory processing disorder -type assessment before.
* Hearing thresholds at both ears between 0 decibels Hearing Level (dB HL) and 15 dB HL at 250, 500, 1000, 2000, 4000 and 8000 Hz. Absence of auditory neuropathy.
* Child affiliated to a social security scheme.
* Holders of parental authority who do not oppose the patient's participation in research.

Exclusion Criteria:

* Known neurological disorder (epilepsy, cranial trauma, etc.).
* Non medicated attention deficit since the presence of such a deficit can affect the child's performance during the auditory processing disorder assessment.
* Intellectual disability since impairment of cognitive skills may also explain poor test performance (IQ \<80).
Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

This study is being done to evaluate intraosseous vascular access through the sternum.

The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older;
* healthy adult subjects

Exclusion Criteria:

* Weight \< 45kg;
* BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
* Imprisoned subjects;
* pregnant subjects;
* prior sternotomy;
* cognitively impaired subjects;
* fracture in target bone, or significant trauma to the site;
* excessive tissue and/or absence of adequate anatomical landmarks in target bone;
* infection in target area;
* IO insertion in past 48 hours or other significant orthopedic procedure in target bone;
* current use of anti-coagulants;
* previous adverse reaction to Lidocaine;
* current cardiac condition requiring pacemaker or anti-arrhythmic drugs
* previous adverse reaction to contrast dye
* Allergy to any food and drug
* History of impaired renal function
* History of impaired hepatic function
* History of cardiac disease
* History of pheochromocytoma