cyrilzakka/clinical-trials huggingface dataset:
Neonatal Pulse Oximetry Sensor Study

To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.

Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red and infrared light-absorption characteristics of oxygenated and deoxygenated hemoglobin. Uses of pulse oximetry include detection of hypoxia, avoidance of hyperoxia, titration of fractional inspired oxygen, and enabling weaning from mechanical ventilation. Arterial blood gas (ABG) analysis, such as by the use of CO-oximeter, provides a direct measurement of SaO2. However, ABG analysis requires time, expense, and arterial access. Therefore, this study aims to validate the SpO2 accuracy of pulse oximetry sensors (manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in neonates as compared to ABG measurements as part of their clinical standard of care (SOC), as assessed by CO-oximetry.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are postnatal 28 days or younger (neonates)
* Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC
* Subjects who weigh less than 5 Kg (weight range for thesensors)

Exclusion Criteria:

* Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement
* Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study
* Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study
* Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)
Acupuncture Therapy on Dysphagia in Parkinson's Disease

From June 2019 to May 2021, we conducted a randomized controlled study, including dysphagic patients with Parkinson's diseases who were admitted to the department of rehabilitation medicine in 3 hospitals in China. The participants were divided randomly into the experimental group and the control group, with 56 in each one. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.

From June 2019 to May 2021, we conducted a randomized controlled study, including dysphagic patients with Parkinson's diseases who were admitted to the department of rehabilitation medicine in 3 hospitals in China. The participants were divided randomly into the experimental group and the control group, with 56 in each one. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy. The study lasted 42 days (6 weeks) for each participant.

Specifically, our main focus is on the study of Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng, Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible), Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Water swallow test\> Level 3.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* History of mental diseases or use of antipsychotics.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health

The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D as achieved by oral supplementation higher than the current recommendations are associated with a less negative bone calcium balance in post-menopausal Swiss women.

In a substudy - not related to the vitamin D intervention - spot and 24 h urine samples are compared with regard to the assessment of iodine status in Swiss post-menopausal women.

In an short subsequent study using five of the subjects who participated in the original trial, the effect of a 40 d-exercise program (rebounding on a trampoline) on Ca-41 excretion will be observed.

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy women, at least 5 years post-menopausal
* BMI 18-30
* no HRT
* no regular intake of Ca or vit D supplements
* wiling and able to give written informed consent and to understand, participate and comply with study requirements
* non-smokers
* no long travels (\>3 wk) planned within study period

Exclusion Criteria:

* diseases that predispose to osteoporosis
* history of fragility fractures
* currently on a weight reduction program
* excessive physical activity
* diseases influencing calcium metabolism (thyroid, parathyroid, adrenal disorders etc.)
* regular intake of medication affecting calcium metabolism
* osteoporosis (T-score below -2.5)
* history of psychological illness likely to interfere with the subject's ability to understand the requirements of the study
* participation in concurrent studies
Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?

To determine if a balloon tamponade catheter filled with cold saline is more effective than a catheter filled with room temperature saline in controlling post partum hemorrhage.

When post partum hemorrhage occurs one mode of therapy is to place a balloon tamponade catheter into the uterus to compress the bleeding vessels. When this mode of therapy has been chosen by the attending physician the patient will be randomized to either the room temperature arm (control) or the cold arm (study). The balloon catheter is placed through the vagina into the uterus and inflated using normal saline; room temperature for the control group and approximately 32 degrees F for the study group. Traction is placed on the catheter to tamponade the vessels in the lower uterine segment. Blood from the uterus passes through a central lumen of the balloon and will be collected and measured. Total measured blood loss for each group will be compared.

Eligibility Criteria:
Inclusion Criteria:

* women 18-45 years old who have just delivered they baby vaginally who now have uncontrolled bleeding from their uteri

Exclusion Criteria:

* anyone outside of the specified age group
* anyone who declines to participate in the study
Coordinating Access to Care for People Experiencing Homelessness (CATCH-FI)

Coordinating Access to Care for the Homeless (CATCH) initiative is a multidisciplinary brief intervention for homeless adults with mental health needs discharged from hospital in Toronto, Canada. The study aims to evaluate the effect of financial incentives in facilitating treatment engagement of homeless people with mental illness, as well as in improving health, health service use and housing outcomes, compared to usual CATCH care, over 6 months, a critical time of transition from hospital to community care.


Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* a new client of the CATCH team, recently admitted or readmitted
* at least one contact with the CATCH team

Exclusion Criteria:

-
Increase Breastfeeding Duration Among Puerto Rican Mothers

This study is to determine preliminary effects of home-based individual breastfeeding consultation with and without cash incentives to increase breastfeeding (BF) duration among low-income Puerto Rican mothers enrolled in a Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

This study is to determine feasibility, acceptability, and preliminary effect sizes of home-based individual breastfeeding consultation alone and combined with financial incentives to increase breastfeeding (BF) duration among low-income Puerto Rican mothers. These interventions will be tested in a Women, Infants, and Children (WIC) program, which capitalizes on the current goals of WIC and on the current practice of using incentives to support BF - factors that are likely to increase potential for sustainability and dissemination of the intervention. We will follow a three phase strategy. During the Formative Phase we will consult WIC staff, Puerto Rican postpartum mothers, and experts in BF, behavioral health incentives, and WIC populations and settings to develop intervention and research manuals. During the Implementation Phase, we will pilot the interventions and research procedures. We will randomly assign 60 Puerto Rican women who initiate BF to: Treatment-as-Usual (TAU) or TAU with financial incentives (also known as Contingency Management; (CM). A bilingual breastfeeding counselor visits participants at home for problem solving issues around breastfeeding. Participants also receiving CM will receive cash incentives if they show breastfeeding. We will conduct assessments at baseline, 1, 3, and 6 months postpartum, measuring BF duration, BF exclusivity, BF self-efficacy, and infant weight gain. In the Evaluative Phase, we will examine monthly recruitment, consent, and enrollment rates, as well as attendance and retention rates for the interventions and for research participation (i.e., feasibility and acceptability).

Eligibility Criteria:
Inclusion Criteria:

1. Identify as Puerto Rican or of Puerto Rican descent
2. be able to read Spanish or English
3. currently live in the area and plan to stay until 12 months postpartum
4. be able to participate in Spanish-speaking peer-support group meetings
5. consent to participate
6. pass an informed consent quiz
7. successfully initiate BF
8. be within 15-44 years of age

Exclusion Criteria:

1. Have ongoing illicit drug use
2. have current active suicidal thoughts or a past suicide attempt, or a psychiatric hospitalization within the last 3 months
3. have untreated HIV (BF contraindicated)
4. are currently prescribed psychotropic medication (i.e., antidepressants, antipsychotics, mood stabilizers, anxiolytics)
5. have serious postpartum medical problems (e.g., postpartum hemorrhage, infections and serious jaundice requiring exchange transfusion)
Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes

Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to complete a 3-week wash-out of current anti-diabetic medication
* Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
* Must discontinue beta-blockers and lipid lowering drugs
* Blood glucose criteria must be met
* BMI in the range 30-35

Exclusion Criteria:

* History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Need for insulin within 3 months or patients on thiazolidinediones
* Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
* Significant concomitant disease or complications of diabetes
* Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
* High tryglycerides as defined by the protocol
* Smokers who cannot abstain from smoking during the treatment periods
Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for \~20% of the entire AF population, which is \~300K/year in the United State and EU. The implant is designed to exclude emboli \> 1.4mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is \> 1.5 mm

Eligibility Criteria:
Inclusion Criteria:

* Documented AF
* CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging)
* No contra-indication for patient to receive an OAC, either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC) for the duration of the study
* Age \> 50 years
* Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm
* CCA accessibility: up to 40mm from skin to CCA center, safe approach
* Implantation segment free of atherosclerotic disease as determined by ultrasound imaging
* Patient is able and willing to provide informed consent

Exclusion Criteria:

* Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)\]
* Evidence of carotid dissection
* Pre-existing stent(s) in CCA
* Female who is pregnant or who is planning to become pregnant during the course of the study
* Life expectancy of less than two years
* Active systemic infection
* Known sensitivity to nickel or titanium metals, or their alloys
* Known hereditary or acquired coagulation disorders
* Any planned surgical or endovascular treatment within 30 days after the implantation procedure
* A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments\* Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day)
* Active participation in another investigational drug or device treatment study
* Inability to complete all scheduled follow-up
* Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study
* History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke
* Event of stroke/TIA in the past 14 days
Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

The purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery.

This is a retrospective chart review study. Patients who underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist will be identified and their chart reviewed for demographic data of age, race, BMI, comorbidities, and type of surgery. Those patients who had a deep organ/space surgical site infection within 30 days postoperatively will be identified. The numbers of these infections before and after August 2020, at which time all patients moving forwards were prescribed antibiotic bowel preparation, will then be statistically analyzed and compared to see if the institution of the antibiotic bowel preparation was associated with a reduction in surgical site infection.

Eligibility Criteria:
Inclusion Criteria:

- Underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist

Exclusion Criteria:

* Unscheduled surgery
* Intraoperative consult by a WellSpan gynecologic oncologist
Therapy of Obesity and Diabetes Mellitus Type 2

To evaluate a standardized weight-loss program as treatment option for obesity and type 2 diabetes, changes in body composition and metabolic control are investigated in obese patients with diabetes.

Men and women with obesity and diabetes mellitus type 2 are invited to join a standardized weight-loss program (six weeks of formula diet, followed by the reintroduction of regular food with gradually increasing energy intake over nine weeks) for a duration of 15 weeks. All subjects undergo bioelectrical impedance analyses to investigate body composition and magnet resonance imaging to measure fat mass and fat fractions of abdominal organs, at three time points: first before the program, then at the end of the six weeks of formula diet and finally, at the end of the program after 15 weeks. Laboratory data are measured before and after the program.

Eligibility Criteria:
Inclusion Criteria:

* known type 2 diabetes
* body-mass-index between 27 and 45 kg/m²

Exclusion Criteria:

* treatment with incretin mimetic drugs \< 3 month
* pregnancy
* immobilization
* severe heart, liver or renal failure
* dementia
* eating disorder
* alcoholism
Green Tea in Crohn's Disease

The purpose of this study is to assess whether green tea or coffee influence the course and life quality of patients with mild to moderately active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Women and men ≥ 18 years with signed informed consent,
* Patients with proven Crohn's disease,
* Chronic-active course ≥ 3 months,
* Current CDAI ≥ 150 and ≤ 350,
* All medications for Crohn's disease have to be on a constant dosage for at least 4 weeks prior to study entry (i.e. 5-ASA, steroids),
* Ability of the participant to understand character and individual consequences of the study.

Exclusion Criteria:

* Pregnancy or the wish to become pregnant, breastfeeding,
* Concomitant treatment with methotrexate, azathioprine or 6-mercaptopurine for \< 3 months,
* Treatment with TNF-alpha-antagonists, cyclosporine or tacrolimus \< 4 weeks prior to study entry,
* Participation in another study within the last 4 weeks,
* Ulcerative colitis or indeterminate colitis,
* Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
* Colitis for other reasons like known diverticulitis, radiation colitis, ischemic colitis or microscopic colitis,
* Malabsorption syndromes, lactose intolerance, celiac disease, exocrine pancreas insufficiency,
* Bleeding hemorrhoids,
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
* Intolerance / aversion to tea and/or coffee,
* Current treatment with antibiotics.
A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).

In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13 levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global haemostasis will be assessed using thrombin generation and the relation between increase thrombin generation and VWF explored. Thrombin generation will be performed pre and post filtration for the presence of procoagulant microparticles. These parameters will be investigated acutely, at presentation and in convalescence; in addition, the effect on these parameters of treatment such as thrombolysis may be informative. Correlation between measured parameters and adverse clinical outcome would be used to identify markers of severity and progression of ischaemic stroke and identification of potential novel approaches to therapy that might improve outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years of age presenting within 9 hours of onset of symptoms will be recruited from the hyperacute stroke unit at UCLH.
* Patients in whom stroke has been excluded or in whom intracerebral haemorrhage has been diagnosed are to be included as 'controls'. The definitive diagnosis will not be immediately obvious at presentation.
* Written consent will be obtained from patients or their nearest relative, particularly in patients with aphasia/dysphasia.

Exclusion Criteria:

* Patients \<18 years old
* Patients with systemic vasculitis or active malignancy will be excluded.
* Patients not wishing to participate
Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant prostate cancer.

This research is being done because the standard treatments for metastatic prostate cancer that is growing despite medical or surgical therapies are not curative. Existing treatments, such as the docetaxel used as part of this study, may work temporarily, but unfortunately the cancer continues to grow. This test drug, 177Lu-J591, is designed to seek out prostate cancer cells and deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of prostate adenocarcinoma.
* Patient must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy.
* Serum testosterone \< 50 mg/ml.
* Patients who have previously received docetaxel must meet BOTH of the the following criteria:

  * reason for docetaxel discontinuation must NOT have been progression of disease while receiving drug (i.e. progression of cancer must have been AFTER docetaxel discontinuation) AND
  * All docetaxel-related toxicities must have resolved to \< grade 1 (with the exception of alopecia) and the pt must be eligible by other criteria

Exclusion Criteria:

* Use of red blood cell or platelet transfusions within 4 weeks of treatment.
* Use of hematopoietic growth factors within 4 weeks of treatment.-Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
* Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton ("superscan").
* Prior radiation therapy encompassing \>25% of skeleton.Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
* Platelet count \<150,000/mm3.
* Absolute neutrophil count (ANC) \<2,000/mm3.
* Hematocrit \<30 percent or Hemoglobin \< 10 g/dL.
* Abnormal coagulation profile (PT or INR, PTT) \> 1.3 x upper limit of normal (unless on therapeutic anticoagulation).
* -Serum creatinine \>2.5 mg/dL.
* AST (SGOT) \>2.5x ULN.
* Bilirubin (total) \>1.5x ULN.
* Serum calcium \>11 mg/dL.
* Active serious infection.
* Active angina pectoris or New York Heart Association Class III-IV.
* ECOG Performance Status \>2.
* Life expectancy \<6 months.
* Deep vein thrombosis and/or pulmonary embolus within 1 month of study entry.
* Other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
* Prior anti-PSMA monoclonal antibody therapy with the exception of ProstaScint®.
* Prior investigational therapy within 6 weeks of treatment.
* Known history of HIV.
* Known history of myelodysplastic syndrome or leukemia