cyrilzakka/clinical-trials huggingface dataset:
Millimeter Wave Therapy (MWT) for Analgesia After Total Knee Replacement

The aim of the study was to test whether the exposure to electromagnetic millimeter waves - Millimeter Wave Therapy (MWT) is effective for relief of acute postoperative pain in patients after elective unilateral total knee arthroplasty (TKA)


Eligibility Criteria:
Inclusion Criteria:

* patients with an American Society of Anesthesiologists physical status of II or III scheduled for elective TKA
* without previous opioid medication
* patients 35-80 years old able to use PCA pumps and Visual Analogue Scale for pain intensity measurement
* patients who have signed consent form

Exclusion Criteria:

* pregnant or nursing females
* recidivist alcoholics
* extremely obese patients (body mass index \> 35)
* inability to operate PCA-pump.
* females with the history of unstable angina pectoris (s. Risks for participants)
* patients who are unable to understand the consent form
* systemic infection
* history of psychiatric disease
* necessity to change postoperative analgesic scheme for particular patient
* severe intercurrent disease during the course of MWT
Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards

As part of everyday clinical practice, messages about preventing Shaken Baby Syndrome are delivered to young parents in maternity wards. The modality of these messages changes regularly. For example, in the near future, the messages will be delivered by video in addition to the usual practice. The investigators are setting up a prospective observational cohort study in order to evaluate and then monitor the state of knowledge of young parents on shaken baby syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Parents of newborns in maternity wards

Exclusion Criteria:

* Single parent
Study of Recombinant Interleukin 21 in Combination With Rituxan for Non-Hodgkin's Lymphoma

The purpose of the study is to evaluate whether recombinant IL-21 used in combination with rituximab is safe for patients with non-Hodgkin's lymphoma (NHL).

This is a Phase 1 open-label dose-escalation study of rituximab + rIL-21 combination therapy, administered once weekly for 4 weeks following an initial treatment with one dose of rituximab alone to patients with B-cell non-Hodgkin's lymphoma (NHL) who have failed prior therapy(ies). A standard dose of rituximab will be used. Increasing doses of rIL-21 will be studied sequentially in different groups of patients, starting with 30 μg/kg.

Before starting treatment with rituximab + rIL-21, patients will be treated with one dose of rituximab alone to look for rituximab infusion-related symptoms (such as fever, chills, and rigors). Patients who have severe infusion-related side effects after the first dose of rituximab will not go on to receive IL-21. Those who do not have unacceptable rituximab-related side effects will receive intravenous rIL-21 at least 60 minutes after completing the rituximab infusion at the rest of the weekly dosing visits. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed 2 weeks following completion of the first 4-week treatment cycle. Patients with stable disease or better at this evaluation may go on to receive a second 4-week treatment cycle of rituximab + rIL-21. Patients may be in the study for 2 to 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CD20+ B-cell NHL
* Disease measurable by computed tomography (CT) scan
* Has failed at least one prior systemic therapy for NHL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hepatic and renal function
* Adequate bone marrow function

Exclusion Criteria:

* Presence of acute infection or other significant systemic illness
* White blood cell (WBC) count \> 50,000/mm3 in peripheral blood
* Central nervous system involvement by malignancy
* Previous allogenic transplant or autotransplant within 6 months of enrollment
* Other current malignancy or known history of cancer within 5 years
* Received systemic corticosteroids, chemotherapy, immunotherapy, biologic therapy, antibody therapy (e.g., rituximab), radiation therapy, and/or investigational agent(s) within 1 month of enrollment
Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.

This pilot feasibility trial is a Phase IV, 12-week, single center, randomized, double blind, parallel group comparison of low (0.5 mg twice daily with slower titration over one full week) versus standard dose (1.0 mg twice daily with standard titration) varenicline in individuals with DSM-V Bipolar Disorder (BD) or Schizophrenia Spectrum Disorders (SSD) with a 12-week, post-treatment follow-up. The 16 visits after screening (Weeks 0-24) include 11 in-person (with medications dispensed at weeks 0, 2, 4, 6, 8 and 10\] and 5 via telephone. Plasma will be obtained at baseline to measure participants' Nicotine Metabolite Ratio (NMR) and to identify slow versus normal nicotine metabolisers. A flexible quit date (between days 8-35) will be employed allowing varenicline preloading to occur prior to the Target Quit Date. Ten sessions of Acceptance \& Commitment Therapy (ACT) for smoking cessation will be delivered by trained counselors.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* Outpatients with a DSM-V diagnosis of Bipolar Disorder or Schizophrenia Spectrum Disorder
* Smoke at least 10 cigarettes per day and have an expired carbon monoxide (CO) breathalyzer of ≥ 10 ppm at screening and baseline visits
* Are motivated to quit smoking
* Have access to a mental health provider

Exclusion Criteria:

* Females who are pregnant, planning to become pregnant, or lactating
* Test positive for any non-prescribed medications or illicit drugs
* Have made a suicide attempt or engaged in self-mutilatory behavior in the past year
* Meet criteria for another Substance Use Disorder in the past month
* In the investigators' judgement, are either psychiatrically or medically unstable to safely participate
* Are currently using any other form of treatment for smoking cessation
Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects

Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic solution compared to placebo in healthy subjects

The primary objective of the study is to establish the ocular safety and tolerability, and systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects. Safety and tolerability will be compared to those of a placebo.The PHMB bioavailability in plasma will also be assessed

Eligibility Criteria:
Inclusion Criteria:

* able and willing to give informed consent.
* man or woman of any race and 18 to 55 years of age, inclusive.
* Body Mass Index of 20-30 kg/m2
* willing and able to attend required study visits.
* bilateral visual acuity \>6/10.
* intraocular pressure (IOP) of 14-21 mmHg.
* ophthalmologic examination without abnormalities.
* medical history without major pathology.
* laboratory test results without deviations from the normal range.
* female subjects of childbearing potential with negative urine pregnancy test and using effective contraception during the study.

Exclusion Criteria:

* presence of bacterial ocular infections.
* presence of any concomitant ocular pathology.
* performing activities likely to result in an irritated conjunctiva during the study (including heavy alcohol intake, swimming in chlorinated water and heavy smoking).
* contact lenses wearing .
* ocular surface fluorescein staining score \>3.
* use of topical or systemic antibiotics, antihistamines, decongestants and non-steroidal anti-inflammatory agents as well as steroids within 7 days before screening.
* known or suspected allergy to biguanides or intolerance to any other ingredient of the test treatments.
* ocular surgery performed within 12 months before screening.
* participation in another clinical study in the preceding 30 days.
* one functional eye.
* pregnancy or breastfeeding.
* use of recreational drugs.
A Study of Taspoglutide in Type 2 Diabetic Patients

This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age;
* type 2 diabetes mellitus;
* treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* type 2 diabetes duration of \<3 months;
* treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
* treatment with insulin for \>7 days within 6 months prior to screening.
Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)

The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.

The study period will consist of a single time point retrospective medical chart abstraction with no required study visits or procedures. Data collection for this study is expected to last up to approximately five months.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of RRMS per McDonald criteria
* Received at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Note: continuous treatment with Tysabri is defined as treatment uninterrupted by other disease-modifying treatment.
* Initiated treatment with Tecfidera at least 12 months prior to enrollment into the study
* Patient has sufficient available medical records for data abstraction to meet the objectives of the study

Key Exclusion Criteria:

* Diagnosed with a progressive form of multiple sclerosis (MS) (progressive-relapsing, primary progressive, secondary progressive)
* Received treatment with any of the following after discontinuation of Tysabri and before initiation of treatment with Tecfidera (i.e., during washout period): interferon-beta, glatiramer acetate, fingolimod, teriflunomide, rituximab, alemtuzumab, ocrelizumab or any investigational compound for the treatment of RRMS
* Received BG00012, or other formulations of dimethyl fumarate, or Fumaderm® or compounded fumarates at any time prior to initiation of treatment with Tecfidera
* History of progressive multifocal leukoencephalopathy (PML) while on Tysabri or within 6 months of discontinuing treatment with Tysabri

NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Invasive Candidiasis in Saudi ICUs

Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in Saudi Arabia is not well studied. This observational study objectives include to determine the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill patients in Saudi Arabia.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\> 18 years)
* develop invasive candidiasis as per prespecified definitions during ICU stay
* In addition, patients who had invasive candidiasis within 72 hours of ICU admission will be included

Exclusion Criteria:

* Diagnosis of invasive candidiasis (definite or probable) more than 72 hours before ICU admission.
* Diagnosis of invasive candidiasis (definite or probable) within 72 hours of ICU admission, but the admission to ICU for an unrelated reason.
* Readmission to the ICU during the same hospitalization with invasive candidiasis occurring during one of the previous admissions.
An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250 patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up to 48 weeks.


Eligibility Criteria:
Male or Female

Idiopathic Pulmonary Fibrosis

20-79 years

Must have participated in the InterMune protocol GIPF-001 study.
Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer

The aim of this post-Market Clinical Follow-up (PMCF) study for a class IIb medical device is to confirm th efficacy and safety of Mucogyne Gel as a moisturizer in women with vaginal dryness irrespective of the cause; when used in accordance with its approved labelling.


Eligibility Criteria:
Inclusion Criteria:

Women with the following conditions:

* ≥ 18 years of age at inclusion with vaginal dryness, irrespective of the cause (which may or may not be accompanied by irritation of the vulva, discomfort, or itchiness).
* Having a Vaginal Health Index Score (VHIS) \<15 associated to pain and/or dyspareunia feeling.
* Subject agrees to not use any lubricant, local estrogens, or other vaginal product during the study.
* Subject agrees to not modify their intimate hygiene products.
* Able to understand and sign the informed consent form for study enrolment.
* Subject able to comply with study requirements, as defined in the protocol.
* Subject affiliated to a health social security system.

Exclusion Criteria:

Women with the following conditions:

* General:

  * Pregnancy (subject of childbearing potential must not be pregnant and must agree to avoid pregnancy during the study by using an effective birth control method from at least one month before D0 (V0) and throughout the duration of the study).
  * Participating at the same time in another interventional trial within the four previous weeks and during the study period, being in an exclusion period for a previous study.
  * Deprived of freedom by administrative or legal decision or under guardianship.
  * Subject in a social or sanitary establishment.
  * Subject suspected to be non-compliant according to the investigator's judgment.
  * Subject in an emergency situation.
* Linked to subject's status:

  * Known hypersensitivity to one of MUCOGYNE® Gel components.
  * Subject with a known vaginal pathology (clinical diagnosis only) other than vaginal dryness/atrophy.
* Linked to previous or ongoing treatments:

  * Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
  * Subject suffering from systemic diseases and/or using concurrent therapy that may interfere with the evaluation of the study results.
  * Subject undergoing a topical treatment on the test area or a systemic treatment: corticosteroids during the 2 previous weeks and during the study; retinoids and/or immunosuppressors during the 1,5 previous months and during the study; subject having started or changed her oral contraceptive or any other hormonal treatment during the one previous month.
Effects of Red Blood Cells Transfusion on Renal Blood Flow

The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. It is associated with the occurrence of acute kidney injury (AKI). Many parameters have been described as influential on the values of renal RI. Red blood cell (RBC) transfusion were shown to be able to increase renal oxygenation in animal model, whereas crystalloid resuscitation did not. We sought to describe the different effect of crystalloids infusion and RBC transfusion on renal blood flow, as evaluated with doppler ultrasound


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 90
* Hemoglobin ≥7 and ≤ 10 g/dl

Exclusion Criteria:

* Ultrasound RRI evaluation non available
* Patients with arrhythmia
* Pregnancy
* Refusal to give consent
* History of renal transplantation
* Central venous access in superior vena cava not available Critical active bleeding
Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers

To determine whether Moving Together improves quality of life in people with memory loss (PWML) and caregivers (CG) by performing a randomized, controlled trial (RCT) with a waitlist control group in 224 dyads.

The investigators will perform an RCT with a 12-week delayed start control group in 224 dyads of PWMLs and CGs. The primary outcome in PWML will be self-rated quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Secondary outcomes will include: a) self-reported emotional well-being; b) self-reported social isolation; c) self-reported mobility; and d) directly assess cognitive performance. In CGs, the primary outcome will be self-rated quality of life (SF-12). Secondary outcomes in CGs will include: a) healthy days; b) self-efficacy; c) burden; d) social isolation; e) ability to self-regulate; f) positive affect; and g) sleep quality. In addition, the investigators will ask CGs to report sleep quality, mobility, and cognitive function for PWML. Additional exploratory outcomes will include health services utilization (hospitalizations, emergency department visits) and falls.

In addition to the RCT, the investigators propose to compare health utilization outcomes in study participants to a matched 'no contact' comparison sample of patients with dementia diagnoses who receive care in the University of California San Francisco (UCSF) Health system.

Eligibility Criteria:
Inclusion Criteria:

* People with memory loss (PWML):

  * U.S. resident;
  * English language fluency;
  * diagnosis of Alzheimer's disease or other dementia; mild severity, assessed using the Quick Dementia Rating System.
* Caregivers (CG):

  * U.S. resident;
  * English language fluency;
  * Primary caregiver for PWML;
  * own one or more devices that can be used to participate in two-way livestreaming video classes (e.g., smart phone/tablet + TV, laptop or desktop with webcam, smart TV);
  * willing and able to participate in two-way livestreaming group movement classes with person with PWML.

Exclusion Criteria:

* Age \< 18 years;
* primarily use wheelchair inside home;
* limited life expectancy (e.g., enrolled in hospice, meta-static cancer);
* physical limitations that could affect ability to participate (e.g., difficulty sitting for 1 hour, chronic pain, vertigo);
* severe visual impairment (e.g., unable to observe instructor's movements on screen);
* severe hearing impairment (e.g., unable to hear instructor's requests);
* behavioral or psychiatric issues that could be disruptive in group setting (e.g., history of physical or verbal abuse, schizophrenia, bipolar disorder, substance abuse);
* unable to provide consent/assent;
* planning to travel for \>1 week during initial 12-week study period.
Observatory of the Quality of Surgical Procedures for Digestive Cancers

Surgery for digestive cancers is managed according to quality standards, validated by the scientific community. Despite the diffusion of these standards through the benchmarks of good practice, the results of the surgery remain disparate.

In many countries, this "inequality of opportunity" has justified the establishment of quality assurance systems to measure the results of surgery for one or more localizations of digestive cancer.

These surgical audit experiments have shown a positive, rapid and cost-effective impact on complication rates, recurrence rates and overall survival even in the absence of interventional measures. The data collected also helped to improve the management of subgroups of patients usually excluded from clinical trials.

In Morocco, the National Cancer Prevention and Control Plan provides for the establishment of a quality assurance system with the introduction of a system for monitoring and evaluating the care of patients. This pilot project is part of this framework, for the group of patients who are candidates for surgery for digestive cancers.


Eligibility Criteria:
Inclusion Criteria:

* patients operated for a digestive cancer, proven or suspected, in a curative or palliative intent In elective situation: inclusion from surgery programming In emergent situation: inclusion no later than 72 hours after surgery
* Cancer proven or suspected in the following digestive tract: colon, appendix, anus, rectum, esophagus, stomach, eso-gastric junction, bile ducts, ampulla of Vater , pancreas, duodenum, small intestine and liver.
* Patient willing and able to agree to participate in the study

Exclusion Criteria:

* Patient whose surgical intervention is indicated for:

  * a condition that is not a digestive tract cancer, including whether retrospectively surgical exploration and / or histological examination reveals digestive localization cancer
  * proven or suspected cancer of non-digestive location
  * a proven or suspected cancer of peritoneal localization
* Patient whose surgical intervention is indicated for a progressive disease or a local recurrence proven or suspected of a digestive localization cancer having already been the resected (with the exception of situations of iterative liver resection for liver metastasis hepatic and recovery of the tumor bed after the discovery of vesicular cancer on cholecystectomy specimen)
* Patients whose intervention is for diagnostic purposes without any curative or palliative intention
* Patients whose surgery is a liver transplant
* Patients whose surgical intervention is local destruction (radiofrequency, microwaves) exclusively by percutaneous approach (without laparotomy or laparoscopy)