cyrilzakka/clinical-trials huggingface dataset:
The Integration of Sensor Technology in Disposable Pads: a Needs Assessment in Nursing Homes

The aim of the study is to explore the criteria and conditions for the integration of sensor technology in disposable pads according to the needs and opinions of residents with incontinence, healthcare workers, and policymakers in nursing homes.


Eligibility Criteria:
Inclusion Criteria:

* Residents

  1. if they have worn absorbent incontinence products minimum one time for more than one week
  2. if they have a Mini-Mental State Examination (MMSE)-score of \>23
  3. if they are able to communicate verbally
* Health care workers
* if they are health care assistants or nurses
* Policymakers if they have a role in the financial decisions regarding incontinence material.

Exclusion Criteria:

-
The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery

The purpose of this study is to evaluate the differences in blood clotting seen in healthy patients given two different doses of oxytocin following cesarean delivery. The secondary objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and differences in blood loss with the two separate doses of oxytocin.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Age \> or = 18 yrs
* Non-laboring women
* cesarean delivery under spinal anesthesia with pfannenstiel incision
* ASA I-III

Exclusion Criteria:

* Height \<5'0"
* Allergy to phenylephrine
* Severe cardiac disease in pregnancy with marked functional limitations
* Women receiving NSAIDS, aspirin or other anticoagulants
* Subject enrollment in another study involving a study medication within 30 days of cesarean delivery
* Other physical or psychiatric condition which may impair the ability to cooperate with study data collection
Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke patients.Half of participants will receive "Huo Xue San Feng" acupuncture combining 1 antihypertensive medication on the routine ischemic stroke treatments' basis. While the other half will receive 1 antihypertensive medication and basic treatments for ischemic stroke.

Under recuiting 480 patients come from 5 hospitals in China.Eligible patients will be randomly assigned into 2 groups: treatment group and control group. The treatment group will receive "Huo Xue San Feng" acupuncture combining 1 antihypertensive medication on the routine ischemic stroke treatments' basis. The control group will receive 1 antihypertensive medication and basic treatments for ischemic stroke. "Huo Xue San Feng" acupuncture will be given six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will thereafter be conducted. Antihypertensive medications will be adjusted based on BP levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the first time ischemic stroke
* Patients meet the TCM diagnosis standard of Stroke
* Patients meet the diagnosis standard of hypertension, taking only 1 type of antihypertensive drugs for at least 2 weeks before admission,corresponding to systolic pressure ranging from 140 to 160mmHg and Diastolic ranging from 90-100mmHg.
* The course of Ischemic stroke ranging from 2 weeks to 6 weeks .
* Men or Women Aged between 35 and 70 years old.
* Patients who are willing to participate in our clinical trial agree to sign the informed consent form.

Exclusion Criteria:

* Patients who have been diagnosed with secondary hypertension.
* Patients have taken beta blockers or diuretics or non dihydropyridine calcium channel blocker （NDHP-CCB）for a long time because of cardiovascular disease.
* Patients who taking 1 type of antihypertensive drugs,blood pressure under 140/90mmHg.
* Patients accompanied with other neurological disorders,such as epilepsy, peripheral nerve injury,
* Patients accompanied with severe medical condition such as severe hematopoietic system disease, coagulation dysfunction and malignant tumor.
* Patients accompanied with diabetic nephropathy,severe liver and renal insufficiency,severe cardiac or pulmonary dysfunction,severe arrhythmia.
* Patients who have occured skin infections near the acupoint location.
* Pregnant or breast-feeding women.
* Patients who currently participate in another clinical trial.
Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+ lymphoma.
* Patients must be between 2-6 months post-transplantation at the time of study registration.
* Patients must have at least stable disease (no overt progressive disease) at the time of study registration.
* Laboratory values must be within protocol specified ranges.
* Females of childbearing potential must have a negative pregnancy test.
* Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy.

Exclusion Criteria:

* Patient must not have obvious clinical progression of lymphoma after PBSCT as determined by the treating physician.
* Cannot be positive for hepatitis B surface antigen, hepatitis B core antibody or HIV antibody.
* No major or uncontrolled comorbid conditions as determined by the treating physician: history of ventricular arrhythmias requiring drug or device therapy; uncontrolled angina or symptomatic congestive heart failure; • severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection; severe or uncontrolled psychiatric illness.
* No known leptomeningeal involvement by lymphoma or current metastatic brain disease.
* No Corrected QTc interval \> 480 msec.
* No known or suspected hypersensitivity to ofatumumab or SB-485232 that in the opinion of the investigator is a contraindication to their participation in the study.
* No systemic (oral or parenteral) corticosteroids within 14 days of study entry.
* Not receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy.
* No previous treatment with SB-485232 or ofatumumab.
* No history of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
* No diabetes mellitus with poor glycemic control (documented hemoglobin A1c \>7% within 4 weeks prior to study entry).
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids

Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Study was terminated by clinical hold.

Eligibility Criteria:
Inclusion Criteria:

* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
* Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
* Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
* Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria:

* Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

  * Six months or more (immediately prior to Screening Visit) without a menstrual period, or
  * Prior hysterectomy, or
  * Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
* Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
* Documented endometriosis or active pelvic inflammatory disease (PID);
* Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
* Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
* Use of prohibited concomitant medications:

  1. Depo-Provera use must cease ten months prior to first dose of study drug, or
  2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
  3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
OTIS Humira Pregnancy Registry

The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant
Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 and 45 years, inclusive;
* 19.0≤BMI≤26.0 kg/m2. Weight of male ≥50 kg and Weight of female ≥ 45 kg.

Exclusion Criteria:

* History of clinically significant allergy or atopic allergic disease, or allergy to the study drug;
* Previous surgery may affect drug absorption, distribution, metabolism and excretion; or have suffered from gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism in the past 6 months;
* History of tuberculosis;
* Frequent infection history in the past year, or serious infections leading to hospitalization within 3 months before administration;
* untreated diarrhea, or diarrhea within 7 days before administration;
* Any drugs, vitamin products or herbal medicine used within 1 month before administration;
* History of drug abuse;
* Participated in clinical trial within 3 months before administration;
* Blood donation or massive blood loss within 3 months before the first administration;
* Pregnant or lactating women;
* Regular drinking history; or took any alcoholic products within 48 hours before administration; or positive alcohol test;
* Regular smoking history within 3 months before administration or cannot quit smoking during the trial;
* GFR\<80 mL/min;
* Abnormal results of laboratory examination,vital signs, 12 lead ECG, physical examination and chest X-ray;
* Systolic blood pressure\<90 or ≥ 140 mmHg, diastolic blood pressure\<60 or ≥ 90 mmHg;
* Other situations that are not suitable for participate the study.
The Effect of Deep Tissue Massage on Respiratory Parameters in Healthy People

Deep tissue massage (DTM), based on deep palpation and elimination of fascia restrictions, can reduce symptoms resulting from fascial disorders. The goal of this study was the analysis of the DTM effect on respiratory parameters in healthy people. People of both sexes living in the city of Cracow were recruited to the study by the authors personally and through social media. An original questionnaire was completed in the presence of the examiner in order to collect the participants characteristics data. Questions about past diseases, previous surgical procedures or injuries, currently taken medications or the level of physical activity were asked to check the inclusion/exclusion criteria. The study involved a group of 40 people divided into two subgroups. The experimental group underwent a single DTM session. Classic massage was performed in the control group. Before and after treatment the lung vital capacity, chest circumference and oxygen saturation were measured and a spirometry test was performed. The main hypothesis assumed that static respiratory parameters should increase after the treatment session more in the experimental than in control group while the dynamic respiratory parameters would not differ significantly in both groups before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Physical activity of minimum 30 min. duration, at least 3 times a week.
2. No chest injuries.
3. No contraindications for DTM/classic massage.
4. No serious diseases of the respiratory and/or cardiovascular systems.
5. No tobacco products smoking (incl.e-smoking).
6. No posture defects that could affect the chest mobility.

Exclusion Criteria:

1. Contraindications to DTM/classic massage of the chest.
2. Occurrence of serious diseases of the respiratory/cardiovascular system now or in the past.
3. Lack of or low physical activity (\< 30 min min. 3 times per week).
4. Tobacco smoking (incl.e-smoking).
5. Chest injuries.
6. Posture defects that may affect the chest mobility.
Beta-glucan and Fatigue in HSCT Survivors

This is a single-center, randomized, double-blind, placebo-controlled study exploring the effects of a yeast-derived β-glucan on clinically significant fatigue among survivors of autologous HCT due to multiple myeloma. The primary aim is to evaluate the effect of β-glucan supplementation on changes in fatigue symptoms, as assessed by the Brief Fatigue Inventory (BFI) global fatigue score, by testing the differences in changes in scores from baseline to the mid-point (mean of weeks 1-4) and to the end of the intervention (mean of weeks 5-8).

Fatigue is one of the most prevalent and distressing complications among hematopoietic cell transplantation HCT survivors, affecting up to 80% of patients. Fatigue has a significant negative impact on the physical, functional, social, and emotional domains of quality of life. Therefore, special attention should be directed toward therapeutic interventions in reducing persistent fatigue, which in turn improves quality of life of this patient population. Research is needed to determine if yeast-derived β-glucan regulates inflammatory disruption and fatigue in patient populations. This study will investigate the efficacy of β-glucan supplementation on fatigue symptoms in autologous HCT survivors due to multiple myeloma. The primary aim is to evaluate the effect of β-glucan supplementation on changes in fatigue symptoms, as assessed by the BFI global fatigue score, by testing the differences in changes in scores from baseline to the mid-point (mean of weeks 1-4) and to the end of the intervention (mean of weeks 5-8). Secondary objectives will be to evaluate tolerability, adverse events, inflammatory cytokines, quality of life, sleep disturbance, pain, anxiety, and depression.

Eligibility Criteria:
Inclusion Criteria:

* Be ≥ 18 years of age.
* Be an autologous HSCT survivor with clinically significant fatigue (determined post-consent). Clinically significant fatigue is defined as BFI global score greater than 3.0.
* Have a medical history of the first autologous HSCT due to multiple myeloma approximately 30 days before starting the study intervention.
* Be willing and able to provide written informed consent.
* Be willing and able to comply with all the study-related procedures, including attending study visits for the blood draws, intake of the study supplement, and completing study questionnaires.

Exclusion Criteria:

* Have an active infection.
* Have disease relapse.
* Have absolute neutrophil count less than 500.
* Have anemia and thrombocytopenia requiring transfusions.
* Have an untreated medical condition that could clinically explain fatigue in this population (i.e., untreated hypothyroidism).
* Have begun to take antidepressants less than 30 days from enrollment.
* Demonstrate an inability to comply with the study and/or follow-up procedures.
* Use probiotic supplements. The subjects can participate if they are willing to stop taking probiotics. A one-month withdrawal from probiotics is required
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

To compare the efficacy of fluconazole versus placebo for the prevention of Candida esophagitis and vaginal/oropharyngeal candidiasis, including a comparison of the development of clinical resistance.

Fluconazole has been shown to be effective in preventing or suppressing candidiasis in HIV-negative women. An increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons.

Fluconazole has been shown to be effective in preventing or suppressing candidiasis in HIV-negative women. An increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons.

Four hundred HIV-infected women are randomized to receive fluconazole or placebo weekly for up to 2 years. Patients undergo follow-up every 3 months or more often if signs and symptoms of mucosal candidiasis occur.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Evidence of HIV infection.
* CD4+ count \<= 300 cells/mm3 or \<= 20 percent of total lymphocyte count.
* Reasonably good health with a life expectancy of at least 6 months.
* Pelvic exam including Pap smear or colposcopy performed within the past 90 days.

Prior Medication:

Allowed:

* Topical or systemic treatment or prophylaxis with an antifungal agent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Current diagnosis of Candida esophagitis.
* Known intolerance to azoles.

Concurrent Medication:

Excluded:

* Systemic treatment or prophylaxis with an antifungal agent.

Patients with the following prior conditions are excluded:

* Past history of Candida esophagitis.
Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis

Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis

Hepatic steatosis is an increasingly frequent pathology, which can lead to severe complications (Cirrhosis, Hepatocellular Carcinoma).

The poor quantification of steatosis by ultrasound or scanning and the invasiveness of the reference method (liver biopsy) make MRI a measurement tool of choice.

Recent techniques such as proton density measurement with several echoes or spectroscopy are increasingly used for the measurement of steatosis.

At the time of the development of therapeutics to reduce fatty liver disease, the use of MRI seems an interesting alternative for longitudinal follow-up in these patients.

Our study aims to ensure the reliability of these different MRI techniques for accurate quantification of liver steatosis and to compare them.

* Measurement and influence of hepatic fibrosis
* Measurement and influence of intrahepatic iron
* Influence of intercurrent liver disease
* Comparison of the fat measurement of the different hepatic segments
* Reproducibility by measurement of inter-observer concordance

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
* signature of written consent

Exclusion Criteria:

* Contra-indications to MRI
* Refusal of protocol
* underage patients and protected adults
A Study to Assess Regional Cerebral Blood Flow as an Alzheimer's Disease Biomarker Compared to Positron Emission Tomography in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects (Study MK-0000-068)(COMPLETED)

The aim of the study is to determine if regional cerebral blood flow, measured by dynamic arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's disease, and participants with normal cognition. Various imaging studies will be done using magnetic resonance imaging (MRI) and positron emission tomography (PET) along with neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8 study visits. Repeat imaging studies may be required if the initial data are incomplete or un-interpretable. The maximum number of PET scans during the study will be limited to four.


Eligibility Criteria:
Inclusion Criteria:

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.

The participant:

* Has mild-to-moderate Alzheimer's Disease (AD), OR is considered cognitively normal;
* Has been on stable doses of any regularly used medications for 4 weeks prior to study start;
* Must have been on a stable dose for 12 weeks prior to study start, of any medications taken for AD.

Exclusion Criteria:

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

* Is living in a nursing home or skilled nursing facility;
* Has severe AD;
* Cannot undergo MRI;
* Cannot undergo PET scans;
* Has a history of neurological or neurodegenerative disorders, other than AD within 2 years prior to study start;
* Has taken Tacrine or anti-parkinsonian medications within 3 months of study start;
* Has taken corticosteroids, blood thinners, narcotic analgesics, benzodiazepines, or certain antihistamines within 1 month of study start;
* Initiates, discontinues, or changes the dose of any AD treatment during the study.
Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering

The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

- American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.

Exclusion Criteria:

* history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever \&gt;38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake