cyrilzakka/clinical-trials huggingface dataset:
Systematic Quality Improvement With Realtime Event Support

The goal of this study is to improve perioperative quality metric performance in patients receiving anesthesia care provided by Washington University Department of Anesthesiology. In this protocol, we describe (1) the use of telemedicine-augmented quality improvement interventions to enhance on-time dosage of surgical prophylactic antibiotics, while (2) carrying out large scale monitoring of surgical site infection incidence in the target population. If this quality improvement framework is found to be feasible and successful, we plan subsequently to study its application to additional perioperative quality metrics, including many pertinent to surgical site infection incidence such as perioperative glucose monitoring and management, and intraoperative temperature management.


Eligibility Criteria:
Inclusion Criteria:

* Patients having procedures at Barnes-Jewish Hospital in suites not part of the TECTONICS trial will be included.

Exclusion Criteria:

* Patients enrolled in the ongoing TECTONICS intraoperative Anesthesiology Control Tower telemedicine trial at Barnes-Jewish Hospital will be excluded from this study
UCSD Take Charge Study

The purpose of the Take Charge Study is to determine among overweight and obese men and women with type 2 diabetes whether 1) participating in a commercial weight loss program promotes great weight loss and weight loss maintenance at one year compared to usual care conditions and 2) whether there is a differential weight loss response to different dietary macronutrient composition (lower carbohydrate/higher fat diet versus a higher carbohydrate/lower fat).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Type 2 diabetes
* BMI 25-45 kg/m2
* Willing to participate in any of the study diet arms (higher or lower carbohydrate diet or usual care) over a one-year period
* Able to comply with all required study procedures and schedule
* Must live within the San Diego or Minneapolis area

Exclusion Criteria:

* Pregnant, breastfeeding or planning to become pregnant in the next year
* Serious medical condition or psychiatric illness
* History of having an eating disorder, food allergy or food intolerance
* Have food restrictions or requires a special diet
* Objects to frozen, processed or prepackaged foods
* Inability to be moderately physically active
* Currently enrolled in a weight loss program or another diet intervention
* Current use of weight loss medication or supplements
* Planned surgical procedure that can impact the conduct of the study
* Previous surgical procedures for weight reduction
* Does not have own transportation
* Have plans to relocate from area within 1 year
* HbA1C \>11%, fasting triglycerides \>600 mg/dL, serum creatinine \>1.4 mg/dL (women) or 1.5 mg/dL (men) -- to be screened at baseline visit
Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

In patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. In addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 patients who complained of dizziness
* Orthostatic hypotension after 3-minute standing (systolic blood pressure drop \>=20 or diastolic blood pressure drop \>=10

Exclusion Criteria:

* Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
* Heart failure or Chronic renal failure
* Patients who cannot or do not want to write questionaires.
* Poor drug compliance
Infusion Laboratory: Protocol 5 (Flupenthixol) - 14

The purpose of this study is to evaluate clinical safety issues pertaining to flupenthixol, to cocaine, and to their interaction, and to determine how pretreatment with flupenthixol modifies the subjective as well as physiological effects of cocaine. Taken together, these relatively D-1 selective agents can help determine the extent to which DA-1 binding affects the reinforcing effects of stimulants.


Eligibility Criteria:
Inclusion Criteria:

M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK44459 in Healthy Subjects

This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK44459 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
2. 18 years to 55 years (inclusive), male and female;
3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 19-26 kg/m2 (inclusive) ;
4. Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.

Exclusion Criteria:

1. Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
2. Have an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;
3. Have a history of any malignant tumors;
4. The abnormalities were clinically significant during the screening period, such as physical examination, vital signs, blood biochemistry, blood routine, coagulation, urine routine, blood pregnancy test, infectious diseases and X-ray;
5. Subjects whose results of routine 12-lead electrocardiograms were inconsistent with normal heart conduction and function;
6. Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
7. Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study;
8. Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening, or positive urine drug screen at screening;
9. Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice;
10. Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;
11. Subjects who have a allergic to any component of HSK44459 or allergic history to opiates;
12. Have participated in any clinical investigator within 3 months prior to screening;
13. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
14. Not suitable for this study as judged by the investigator.
Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Advanced, EGFR-positive NSCLC
* ECOG Performance Status 0, 1 or 2
* Measurable disease

Exclusion Criteria:

* Known CNS metastasis
* Pre-existing autoimmune or antibody mediated disease
Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India

The purpose of this study is to assess the effect of vitamin D and/or zinc supplementation on improving COVID-19 treatment outcomes. The effects of vitamin D, zinc, and both vitamin D and zinc together will be investigated among COVID-19 patients in India.

This study is a 2x2 factorial randomized double-blind, placebo-controlled trial to examine the effectiveness of vitamin D and zinc supplements as immune-based therapy among COVID-19 patients in India. The study is also examining the immunological response to COVID-19 and the effect of the intervention on specific biomarkers of immune and endothelial activation that are independent and quantitative predictors of severity and mortality in other severe infections. The primary aims are to determine the effect of vitamin D supplementation versus placebo on time to recovery among patients hospitalized with COVID-19; and to determine the effect of zinc supplementation versus placebo on time to recovery among patients hospitalized with COVID-19. As secondary aims, this study is also investigating the effect of vitamin D or zinc supplementation on all-cause mortality. necessity for assisted ventilation, individual symptoms duration, duration of hospital stay and biomarkers including vitamin D, Zinc, Interleukin 6 (IL-6), Angiopoietin-2, sTREM-1, immunoglobulin G (IgG) and immunoglobulin M (IgM).

Eligible individuals are randomly assigned to one of four groups: (1) Vitamin D (180,000 IU bolus at enrollment, followed by 2000 IU daily); (2) Zinc (placebo at enrollment followed by one daily dose of 40 mg); (3) Vitamin D and Zinc; or (4) Placebo. Daily supplements start at the hospital and continue after discharge for a total of 8 weeks. Active data collection occurs daily while patients are hospitalized and at least twice per week via telephone after discharge. A clinical exam occurs at 8 weeks and longer-term symptoms are assessed at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>=18 years old
* Polymerase chain reaction (PCR) or Rapid Antigen Test (RAT)-confirmed infection with SARS-COV2
* Provide informed consent

Exclusion Criteria:

* Pregnancy
* Enrollment in other clinical trials
Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Students

The study is a randomized, controlled trial comparing music therapy associated to NRT versus NRT alone to evaluate the value of music therapy in improving the management of craving among 120 student smokers (18 to 25 years old). This pilot multi-method study will combine the methodology of clinical trials with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a young audience.

The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers. At baseline visit, they will be randomly 1:1 assigned to receive either music therapy and NRT or NRT alone for 3 months.

During the 3 months after TQD (Target Quit Date), 3 visits will be performed by practitioners at the CIC. Practitioners will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12, HAD, MNWS, UPPS).

Eligibility Criteria:
Inclusion Criteria:

* students, age \>=18 and \<=25 years,
* smoking more than 5 cigarettes per day for at least 6 months,
* motivated to quit smoking,
* without legal tutors or subordination,
* affiliated to a health insurance system as required by the French law on biomedical research,
* written informed consent for participation in the study.

Exclusion Criteria:

* Roommates and couples,
* NRT contraindication
* with depression and/or psychosis and/or cognitive disorder and/or mental retardation,
* substance misuse or alcohol dependence,
* smoking-cessation medication (NRT, bupropion, varenicline) or undergoing cognitive-behavioral therapy or hypnotherapy in the last 3 months,
* electronic cigarette for smoking cessation in the last 3 months,
* Persons benefiting from enhanced protection, i.e. persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.
Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment

The Thoraco-Brachial Outlet Syndrome (T-BOS) corresponds to the entirety of clinical manifestations related to the compression of the branches of the brachial plexus and/or the subclavian vessels during their passage through the cervico-thoracic region.

Following surgery, a recurrence of symptoms occurs in 5% to 30% of operated patients. The treatment of these recurrences primarily relies on conservative therapies, and in case of failure, surgical intervention, particularly neurolysis of the brachial plexus.

In order to prevent a new recurrence, it is desirable to cover the neurolyzed brachial plexus with a flap, providing better local vascularization. However, fatty perforating flaps, by avoiding muscle harvesting, reduce donor site sequelae. We aim to investigate, through validated and recommended questionnaires, the impact of covering the neurolyzed brachial plexus with a free fatty flap after neurolysis in the context of recurrent neurological Thoraco-Brachial Outlet Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent brachial plexus neurolysis and free fat flap coverage in the context of recurrence of neurological thoraco-brachial outlet syndrome

Exclusion Criteria:

* Patients were unable to express their non-opposition to participating in the study.
* patients under guardianship or trusteeship.
* patients whose mother tongue is not French.
* patients who cannot read and/or write.
Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be eligible for an OSA diagnostic or surgical procedure.
* Subject suffers with moderate to severe OSA based on history and a physical exam.
* Subject has failed, refused or has not tolerated CPAP treatment.
* Subject is willing and capable of providing informed consent.
* Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.

  --Subject is willing to participate in the designated follow-up visits.
* Subject must be in good general health.
* Subject is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
* Subject must be minimum of 21 years and maximum 80 years of age.
* Subject's Hypoglossal Nerve must be able to be visualized using ultrasound

Exclusion Criteria:

* Subject has Body Mass Index above 38kg/m2.
* Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
* Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study.
* Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.
Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis

An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-70 years;
* Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy;
* High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN);
* High levels of IgG(1-1.5 X ULN);
* Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);
* Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

* The presence of hepatitis A, B, C, D, or E virus infection;
* Patients with presence of liver cirrhosis or portal hypertension;
* Patients with presence of fulminant liver failure;
* Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
* Pregnant and breeding women;
* Severe disorders of other vital organs, such as severe heart failure, cancer;
* Parenteral administration of blood or blood products within 6 months before screening;
* Recent treatment with drugs having known liver toxicity;
* Taken part in other clinic trials within 6 months before screening.
WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.


Eligibility Criteria:
Inclusion Criteria:

For inclusion in this study, subjects must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis will be conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis", issued by the Japanese Dermatological Association.

* 15 years of age or younger
* Body weight of 14 kg or more
* Outpatients
* The patient has been undergoing treatment with a "very strong" or lower-grade external steroid preparation for \>= 1 week at the time informed consent is obtained
* Pruritus with "2" or higher grade at the start time of administration

Exclusion Criteria:

* Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
* Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
* Use of any external steroid preparation at "Strongest" in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
* Undergoing phototherapy
* Undergoing specific desensitization therapy or modulation therapy
* Past history of contact dermatitis caused by external steroid preparation
* Possibility of exacerbation by an external steroid preparation of infectious skin disease caused by bacteria, fungi, or virus
* Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient was ineligible for inclusion in this study. Patients must be excluded from the study if the patients fell under Grade 2 or more, in the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria
* Past history of allergy to any drug
* Participation in any other clinical study, or history of participation in any other clinical study within 6 months before the date when the patient gave consent to participate in this study
* Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study
Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center

The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in one of the investigating centers after acute/subacute stroke.
* Affiliated to a social security scheme

Exclusion Criteria:

* Opposed to its participation in this study
* Neurodegenerative disease impacting gait prior to stroke onset
* Patient not walking before stroke
* Progressive pathology with life-threatening consequences within 6 months
* Patient under legal protection
Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).


Eligibility Criteria:
Inclusion Criteria:

* Female SLE patients
* Age 18-60 years
* If premenopausal using a reliable method of contraception
* Clinically stable disease
* Taking hydroxychloroquine and up to 15mgs of prednisolone daily

Exclusion Criteria:

* Smokers
* Pregnancy or breast feeding
* Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
* Use of any investigational drug within 1 month prior to screening
* Acute infections 2 weeks prior to Visit 1
* History of ischaemic heart disease or end stage renal disease
* Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease
Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients

Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.

Objectives

1. To explore if acute radiation response can be predicted in patients, by analyzing a single nucleotide polymorphism (SNP rs1801516) sampled prior to radiotherapy.
2. If acute radiation response can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled prior to radiotherapy.
3. If late side effects from radiotherapy can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled before and after radiotherapy.
4. If there is a correlation between genetic and inflammatory markers in blood and patient reported outcome measures (PROM) and quality of life (QoL).
5. To train an algorithm to correlate the appearance of skin before radiotherapy and the extent of skin reaction to radiotherapy

Outline This study is a non-randomized clinical cohort study. Adults with breast cancer will be invited to participate in the study. Blood will be collected before start of treatment and after radiotherapy is completed. Quality of life (QoL) and symptoms will be assessed before and weekly during treatment, at the end of treatment and after one year. A total of 550 patients is expected to be recruited.

Eligibility Criteria:
Inclusion criteria:

* Patients receiving adjuvant radiotherapy for breast cancer 2,67 Gy x 15 (or a radio biologically equivalent dose)
* \> 18 years
* Being able to read and understand patient information in Swedish
* Signed informed consent

Exclusion criteria:

* Ongoing infection
* Fever \>37,9 degrees Celsius
* Unable to follow study protocol