cyrilzakka/clinical-trials huggingface dataset:
Weight Management & Wellness for People With Psychiatric Disabilities

The purpose of this study is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients.

Weight management is a serious issue for individuals with mental health conditions, especially those who are taking psychiatric medications. The latest estimates are that over half of individuals receiving community mental health services are overweight or obese. This project's objective is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients living and working in the community. It is an 8-week, recovery-oriented intervention that is co-led by a trained health educator and a certified mental health peer specialist. The study will take place at the UIC Department of Psychiatry in Chicago. Research participants will be recruited from the Department's outpatient clinics and other community programs, and randomly assigned to receive NEW-R along with services as usual or services as usual alone.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with a mental health disorder
* Patient of outpatient program
* Age 18 or older
* Being overweight or obese defined as BMI\>=25
* Ability to understand spoken English

Exclusion Criteria:

* Residing in a nursing home
* Cardiac event in past 6 months
* Past episode of anorexia or bulimia
* Pregnancy
* Diagnosis with a terminal illness expected to result in death within 1 year
* Active alcohol or substance abuse or dependence
* Inability to provide informed consent due to diagnosis of dementia or cognitive impairment
* Inability to understand spoken English
Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge

The investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load. This phenotype is associated with healthy metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content. Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous glucose production, also reduces appetite and increases basal energy expenditure. The aims of this study are to i. detect functional differences in the appetite-related central nervous system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick the non-suppressed glucagon phenotype in those participants who suppress glucagon by administering a very-low-dose glucagon infusion and retest them.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5- 29.9 kg/m2
* written informed consent

Exclusion Criteria:

* Current

  1. febrile infection with temperatures\> 38.5 ° C in the last 14 days
  2. Blood donation within the last 12 weeks Pre-study Inclusion
* Chronic diseases:

  1. Diabetes mellitus
  2. Known liver diseases (hepatitisB/C, hemochromatosis, NASH)
  3. Chronic inflammatory diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis) chronic renal insufficiency
  4. Cancer (known malignant disease)
  5. psychiatric diagnoses (bipolar disorder, schizophrenia, psychoses, depression, agoraphobia)
  6. Persons with non-removable metal parts, e.g:

     * pacemaker
     * artificial heart valves
     * metal prostheses
     * implanted magnetic metal parts (screws, plates of operations)
     * spiral
     * metal slivers / garnet splinters
     * fixed braces
     * Acupuncture needle
     * Insulin pump
     * totally implantable venous access device (port)
     * tattoos, metallic eye shadows
  7. Persons with impaired sensitivity and / or increased sensitivity to heating of the body
  8. Medical history of venous thromboembolism
  9. alcohol consumption of more than 50g / day
  10. In physical examination:

      blood pressure \> 160/100 mmHg pathologic cardiac murmurs (diastolic or systolic louder than 2/6)
  11. in the blood test: fasting glucose ≥ 125 mg/dl or HbA1c ≥ 6.5% AST or ALT\> 2.5x upper limit of the reference range (\> 125 U/l) Hb \<12 g/dl C reactive protein (CRP) \> 5 mg / dL or leukocytes\> 15000/μl
The Effect Of Olive Oil on Diaper Rash

Objective: Diaper rash is an irritating, common skin problem in newborns and young children and occurs in the skin rubbed by wet diapers and in the armpits due to heat, moisture and irritation. This experimental study was planned to investigate the effect of olive oil use on the healing of diaper rash in infants with first-degree diaper rash undergoing treatment in an infant ward.

Methods: The study conducted between September 2020 and December 2020 included 37 infants aged 0-24 months who were treated for any reason in the Infant Clinic of a medical school and had first-degree rash. The infants in the experimental and control groups were "treated with olive oil and X brand cream" respectively. The X brand cream and the effects of olive oil and X brand cream use on the improvement of diaper rash were compared.


Eligibility Criteria:
Inclusion Criteria:

* Having a first-degree diaper rash
* Being 0-24 months old
* Having the family's consent indicating that they allow their child to be included in the study

Exclusion Criteria:

* The baby's having anorectal congenital anomaly
* The baby's having an obstacle to the application of olive oil (allergy, etc.)
* Having a second-degree or third-degree rash
Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy. (TORSIV)

Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation...) as well as endobronchial therapeutic procedures.

Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous.

We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged between 18 and 80, who will undergo bronchoscopy
* FEV1≥ 50% of theorical value
* Ambient air saturation at rest ≥ 94%
* No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one of their compound
* fasting for at least 6 hours
* No indication against bronchoscopy, nor to premedication
* Informed consent signed

Exclusion Criteria:

* Pregnant or lactating, women
* PAH patients
* patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy
* Patients with oral anticoagulants
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies

SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.

SHR-1603-I-101 is a single-arm, open-label, dose finding, first-in-human(FIH) clinical trial of SHR-1603 intravenous infusion in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases.

The primary objective of this study is to evaluate the safety and tolerability of SHR-1603, as well as to determine the maximally tolerated dose(MTD) and define the recommended Phase 2 dose(RP2D) of SHR-1603.

The study is consisted of a dose-escalation Part 1 followed by a dose expansion Part 2 and a clinical expansion Part 3.

Part 1 will use accelerated titration and 3+3 dose-escalation design to determine MTD.

Part 2 will further evaluate the safety, tolerability and PK/PD features of SHR-1603 based on the results of Part 1.

Part 3 will include several cohorts of malignancies to collect preliminary efficacy information of SHR-1603.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 years or older;
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
3. Life expectancy no less than 12 weeks;
4. Pathologically confirmed advanced solid tumor or relapsed/refractory lymphoma with measurable target lesions;
5. Adequate bone marrow, haptic, renal and coagulation function.

Exclusion Criteria:

1. Evidence of central nervous system (CNS) involvement;
2. Previously treated with similar agents;
3. History of anticancer treatment within 4 weeks of enrollment (6 weeks for subjects treated with nitrosoureas or mitomycins);
4. Anticipated to be involved in other anti-cancer treatments expect for palliative care during the trial;
5. History of anti-cancer vaccination; or history of vaccination using attenuated vaccines within 4 weeks of enrollment;
6. History of Red blood cell (RBC) transfusion within or treatment with erythropoitin(EPO) within 3 months of enrollment;
7. History of grade 3 or higher thrombolic incidence within 2 years of enrollment, or using antithrombotic/anticoagulant agents;
8. With confirmed immunodeficiency, uncontrolled auto-immune disease, uncontrolled cardiovascular disease, uncontrolled or active infection;
9. Substance abuse.
Differentiation Induction in Acute Myelogenous Leukemia

Hypothesis: Differentiation induction therapy in acute myelogenous leukemia (AML) can be used to achieve disease control and stabilize peripheral blood counts in patients with acute myelogenous leukemia.

Adult patients (\<18 years of age) who can be included: Elderly patients (\>60 years of age) with newly diagnosed AML who cannot achieve standard chemotherapy, patients with relapsed or resistant AML. Patients with relapsed or resistant AML who cannot receive intensive chemotherapy.

Treatment: Patients will be treated with all-trans retinoic acid (oral administration), valproic acid (7 days intravenous administration and later oral administration)and theophyllamine (7 days intravenous administration and later oral administration). Duration of treatment at least 2 months or until disease progression. Maximal duration of treatment 2 years.

Followup: Clinical evaluation, peripheral blood samples, bone marrow samples.

Patients to be included:

1. Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (AML) who cannot receive conventional intensive chemotherapy.
2. Adult patients of any age (\> 18 years of age)with relapsed or resistant AML who cannot receive conventional intensive chemotherapy or allogeneic stem cell transplantation.

We plan to include at least 20 patients, but if possible 30 patients during a 3 years period. The first patient was included November 2004.

Treatment:

All-trans retinoic acid (ATRA) administered orally 22.5 mg/m2 twice daily for 14 days, repeated every third month.

Valproic acid started on day 3 of ATRA therapy, the first week as intravenous administration and later oral administration.

Theophyllamine started on day 3 of ATRA therapy, the first week as intravenous administration and later oral administration.

Duration of treatment at least 2 months unless side effects,until disease progression or an overall duration of treatment of 2 years.

Supportive therapy according to the hospitals general guidelines.

Followup:

The first week treatment in hospital. Later out-patient treatment with regular controls including clinical examination, peripheral blood parameters (including serum valproic acid and theophyllamin levels), bone marrow samples.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed acute myelogenous leukemia (AML)
* Patients above 60 years of age
* Patients who cannot receive conventional chemotherapy
* Patients with relapsed or refractory AML independent of age

Exclusion Criteria:

* Chronic myelogenous leukemia in blast phase
* Intolerance to the study drugs
* Serious liver disease
* No informed consent
Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy

This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.

This is a randomized control study with an elective cross over. In part 1 of the study participants will be randomized into one of three treatment arms: 1) physical therapy only; 2) physical therapy and shockwave therapy; 3) physical therapy, shockwave therapy and photobiomodulation. At 3 months, patients can choose to switch to a different treatment arm than they were initially randomized.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral)
* Running is the pre-injury primary form of physical activity and pre-injury would complete on average 10 miles per week or more of running
* VISA-A \<80 at baseline to be eligible

Exclusion Criteria

* Less than 3 months of symptoms
* Primary insertional Achilles tendinopathy
* Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside Achilles tendinopathy, other contraindications to PBMT or SWT
* Have received SWT within the past 3 months to their Achilles
* Prior injection within 3 months
* Currently enrolled in PT for more than 4 weeks for their condition
* Women who are pregnant.
* known history of Achilles tendon tear
* currently taking oral steroid or fluoroquinolone class of antibiotics
A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH


Eligibility Criteria:
Inclusion Criteria:

* Adequate complete blood counts, liver and renal function
* 12-lead electrocardiogram (ECG) within normal limits
* Female subjects of child bearing potential agreeing to use a protocol specified method of contraception
* Male subjects agreeing to use protocol specified methods of contraception
* Willing to provide written informed consent and willing to comply with study requirements

Exclusion Criteria:

* Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
* Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
* History of multiple drug allergies or intolerance to subcutaneous injection
* Parts A and B of the study: Used prescription medications within 14 days or 7 half-lives of administration of the first dose of study drug.
* History of meningococcal infection
Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study

Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Early diagnosis and appropriate treatment have been shown to reduce mortality from this disease.

In a context of limited resources, it is therefore important to be able to quickly stratify patients presenting to the emergency department with a suspected infection into those who require rapid and intensive management because they are at risk of developing sepsis and septic shock and those who can be managed conventionally The objective of this study is to compare the clinical intuition of emergency room physicians and nurses with the qSOFA score to predict the clinical course of patients presenting to the emergency room with potential sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to one of the participating emergency departments with suspected infection, defined as the presence of at least one of these parameters:

Temperature ≥ 38°C ou \< 36°C measured in the emergency room Chills (in the emergency room or on recent history)

* No objection to participation in the study

Exclusion Criteria:

* Minor patient (\<18 years)
* Patient under guardianship or other protective measure
* Patient unable to understand research information
* Patient refusing the use of their data for research purposes
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica

Background: Polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Treatment with prednisolone has several adverse effects. PMR is an exclusion diagnosis, and methods to diagnose and monitor the disease are lacking.

Objective: To investigate if ultrasound and PET/CT can be used to diagnose and monitor PMR. In addition, the importance of prednisolone induced adrenal insufficiency is investigated.

Methods: It is a prospective observational study in patients suspected of PMR. Patients diagnosed with PMR continue in the study. Ultrasound and PET/CT are performed at baseline, after 8 weeks on prednisolone, and after 10 weeks during a short prednisolone break. Adrenal insufficiency is investigated five times throughout the study. After one year the PMR diagnosis is confirmed.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of PMR.
* Age above 50
* Pain of the proximal muscles.

Exclusion Criteria:

* Peroral, intraarticular, intramuscular and dermal application of glucocorticoids within the last 3 month.
* Previous prednisolone treatment for GCA/PMR
* Unable to give consent.
* Symptoms of GCA (headache, jaw claudication, vision disturbances).
* Active malignant cancers within the last 5 years (except basal cell carcinoma).
* Other inflammatory rheumatic diseases (eg. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritits, gout).
* Uncontrolled diseases (eg severe active astma, cardiac disease with NYHA class IV)
* Treatment with peroral oestrogens, aminogluthethimid, trilostan, ketoconazole, fluconazol, etomidate, phenobarbital, phenytoin, rifampicin, metyrapon, mitotane.
* Known primary or secondary adrenal insufficiency.
Photoplethysmography (PPG) Algorithm With Smartwatch in Evaluation of Atrial Fibrillation Burden

The purpose of this study is to evaluate the monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.


Eligibility Criteria:
Inclusion Criteria:

1. Atrial fibrillation patients diagnosed by electrocardiogram
2. Willing to use long-range electrocardiogram monitoring equipment

Exclusion Criteria:

1.Patients who are allergic to electronic devices or unable to wear watches
Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients

The ADAPT study is an observational study of apalutamide, which can be given to patients with hormone sensitive metastatic prostate cancer as standard of care. The clinical decision for patients to have apalutamide as part of their management plan will be decided by the clinician. The patient will only be approached about the ADAPT study if they decide they want to have apalutamide as part of their management.

The aims of the ADAPT study include documenting the biochemical effectiveness, as determined by the Prostate-Specific Antigen (PSA) and impact of apaluatmide on health related quality of life. The blood test for PSA is regularly monitored as standard of care.

Additionally, the impact of apalutamide on fatigue, cognitive function, patients reported outcomes, health related quality of life will be evaluated using patient questionnaires answered at defined timepoints. The questionnaires will be sent either electronically or via post at week 12, 24, 36, 48, 72 and 104 weeks after commencement of apalutamide.

Currently, the majority of data regarding tolerability and biochemical response to apalutamide has been from large phase III trials, where there are strict eligibility criteria. Real-world data as from the ADAPT study can provide valuable complementary data to randomised controlled trials, which can be used to address the 'generalizability' limitations of randomised control trials and can provide evidence on the external validity of their findings. This information can advance knowledge of patterns of care, treatment effectiveness and side-effects and inform clinical practice to improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Male 18 years of age or older
* Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:
* Metastatic hormone sensitive prostate cancer
* Treatment decision for apalutamide by clinician

Exclusion Criteria:

* Non-metastatic prostate cancer
* Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
* Unable to complete patient reported outcome questionnaires
GLP1R Polymorphisms and Response to GLP1

Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor (GLP1R) is the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains numerous non-synonymous Single Nucleotide Polymorphisms (nsSNPs) which could potentially alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of genetic variation in GLP1R on response to GLP-1.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40
* fasting glucose concentration of less than 95 mg/dl.

Exclusion Criteria:

* Individuals with a BMI \< 19 or \> 40 kg/m\^2
* active systemic illness
* medication that can alter gastric emptying, insulin secretion \& action
* history of abdominal surgery (other than appendectomy or tubal ligation).
Pivotal Study of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (DIAMOND-2)

The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).

A Phase 3 Pivotal Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema

Eligibility Criteria:
Inclusion Criteria (selection):

1. Have a signed informed consent form before any study-specific procedures are performed.
2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1).

Exclusion Criteria (selection):

1. Have macular edema considered to be because of a cause other than DME.
2. Have a decrease in BCVA because of causes other than DME.
3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.