cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.


Eligibility Criteria:
Inclusion Criteria:

W8M-MC-GN01:

* Assigned male at birth
* Assigned female at birth, who are of non-childbearing potential

W8M-MC-CWMM:

* Have a BMI of

  * ≥ 30 kilograms per square meter (kg/m²) or
  * ≥ 27 kg/m² and \< 30 kg/m² with at least one weight-related comorbidity
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria:

W8M-MC-GN01:

* Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus
* Have a history of acute or chronic pancreatitis
* Have renal impairment
* Individuals who are of childbearing potential

W8M-MC-CWMM:

* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have any of the following cardiovascular conditions within 3 months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure.
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have a lifetime history of suicide attempts.
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.


Eligibility Criteria:
Inclusion Criteria:

* Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
* Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects

Exclusion Criteria:

* Active malignancy
* Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
Effectiveness of a Self-rehabilitation Program

The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is most often based on analgesics combined with physical therapy. More recently authors have advocated the use of self-rehabilitation, that is to say, the use by the patient himself of physiotherapy exercises to perform at home regularly. However, if there are currently many studies on the effectiveness of self-rehabilitation for low back pain, there are few data on neck pain.

In this context we have chosen to implement a prospective, randomized study, on the effectiveness of self-rehabilitation in patients with chronic neck pain.

Patients included in the "self-rehabilitation" group will, in addition to conventional physiotherapy, to visit two training sessions in self-rehabilitation at the hospital. Each patient received a booklet including advices to perform different kinds of exercises at home. The patients learn the exercises with the help of the physiotherapist and have to traine daily at home.

Patients will have to answer questionnaires about their pain at follow-usual consultations of their disease at 2 months and 4 months after the start physical therapy and during a phone call after 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific neck pain \* ≥ 15 days / month for more than 3 months
* Consultation first line in the pain center
* Subject able to complete questionnaires
* Subject able to understand and perform exercises

Exclusion Criteria:

* History of stroke
* History of carotid or vertebral arterial dissection
* "Whiplash" for less than six months
* Cervicobrachial neuralgia for less than 3 months
* Syndrome of thoracic outlet diagnosed
* Tumor and infectious syndromes
* Polyarthritis or major cervical spondylosis against known-indicating active mobilization of the cervical spine
* Unbound bone trauma
* Patients with cognitive impairment prevents proper application instructions
Myopia Control With Orthokeratology Contact Lenses in Spain

The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.

The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.

Eligibility Criteria:
Inclusion Criteria:

* Be 6 to 12 years of age, both ages inclusive
* A low-to-moderate level of myopia (between -0.75 and -4.00 D) and of astigmatism (≤ 1.00 D)
* Neophyte contact lens wearer
* Be successfully fitted with spectacles or orthokeratology contact lenses
* Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
* Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
* White European ethnicity

Exclusion Criteria:

* Systemic or ocular disease affecting ocular health
* Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
* Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
* CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
* Aphakic, amblyopic, and atopic individuals
* Refractive astigmatism ≥ ½ spherical refraction
* Previous contact lens wear
Prone Position in Acute Bronchiolitis

Acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in France). Between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support.

Non-invasive ventilation, in particular the nasal Continuous Positive Airway Pressure (nCPAP), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. Nowadays, this technique is considered as the gold standard in the pediatric intensive care units (PICU) in France. High Flow Nasal Cannula (HFNC) has been proposed as an alternative to the nCPAP because of its better tolerance and simplicity of implementation. However, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the PICU.

In a physiological study (NCT02602678, article published), it has been demonstrated that prone position (PP) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis.

Investigators hypothesize that prone position, during High Flow Nasal Cannula (HFNC), would significantly reduce the use of non-invasive ventilation (nCPAP and others) or invasive ventilation, as compared to supine position during HFNC, in infants with moderate to severe viral bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* Infant under 6 months
* Hospitalized in critical care unit (continuous monitoring unit or intensive care unit)
* With a clinical diagnosis of acute viral bronchiolitis (criterion of the American Academy of Pediatrics 2014)
* m-WCAS score ≥ 3 and / or hypercapnic acidosis with pH \<7.35 and pCO2\> 50mmHg (6.7 kPa)
* Informed consent signed by at least one of the parents with oral consent of the other parent (and / or legal guardian) recorded in the medical file.

Exclusion Criteria:

* Infant admitted with criteria for invasive or non-invasive ventilation (hypercapnic acidosis with pH \<7.25 without ventilatory support and/or hypoxia with impossibility of maintaining SpO2\> 92% whatever the FiO2 and/or more than 3 significant apneas per hour and/or severe consciousness disorder)
* Patient already positioned in the prone position before randomization
* Significant comorbidities with a history of respiratory pathology (bronchodysplasia with ventilatory support), Ear Nose and Throat pathology (pharyngolaryngomalacia) or neuromuscular and / or hemodynamically significant congenital heart disease.
* Contraindication to Prone position : recent abdominal surgery (laparoschisis or omphalocele) or recent sternotomy
* Patient who is not affiliated (or does not benefit from) to a national social security system
Behavioral Economics of Human Drug Self-Administration

The objective of this protocol is to examine the utility of behavioral economics for understanding reinforcer interactions as they pertain to drug self-administration. In a series of 6 experiments, the researchers will attempt to quantify the effects of qualitatively different reinforcers (money, cigarettes, alcohol, nicotine gum) and their interactions. This work represents a continuation of research by this investigator in the area of addiction and pharmacology.


Eligibility Criteria:
Inclusion Criteria:

* Use of 20 or more cigarettes per day
* CO levels \>15 ppm
* More than 12 alcohol drinks per week and beer as preferred alcoholic beverage
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs

This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.

◊ Trademark of Smith \& Nephew

IODOSORB gel is a cadexomer iodine product indicated for use in wet ulcers and wounds. As the use of IODOSORB has an anti-microbial effect and removes exudate continuously from the wound, a reduction in pain, odour, oedema, exudate, pus and debris, and microbial load including biofilm can be achieved, hence providing an environment conducive to the normal healing process. While evidence exists to support the use of IODOSORB in diabetic foot ulcers (DFUs) for the reduction of planktonic bacteria, little evidence exits for the effect of any topical therapy on non-planktonic or biofilm bacteria in-vivo. The aim of this study is to explore the effects of IODOSORB on biofilm in the wound, wound healing, and associated factors, such as odour, pain, and reduction of slough.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is able to understand the study and is willing to consent to the study.
2. The patient consents to the ongoing use of their de-identified photos by the Sponsor for purposes outside of this study.
3. The patient must be at least 18 years of age.
4. Males and females - provided they are not pregnant or lactating and if of reproductive age are using contraception.
5. The patient has presented with a DFU which, according to the clinical judgement of the Investigator, has a suspected biofilm
6. The patient has a DFU of Grade 1 or 2 according to the Meggit-Wagner scale. Grade 1 - Superficial ulcers limited to the dermis Grade 2 - Ulcers are transdermal with exposed bone or tendon, and without osteomyelitis or abscess formation
7. The patient's ulcer is suitable to be dressed with IODOSORB or SOLOSITE.
8. The patient has an ABPI \>0.49; or toe pressure \>50mmHg.

Exclusion Criteria:

1. Patients with a known history of poor compliance with medical treatment.
2. Patients who have participated in this study previously and who healed or were withdrawn.
3. Patients who are participating in any other clinical study.
4. Patients that have received continuous treatment with Iodosorb (on any wound) in the past 8 weeks (Iodosorb must not be continuously used for more 3 months) or whose reference ulcer has been treated with Iodosorb in the past 2 weeks.
5. Patients with a history of any thyroid disorders, e.g. Hashimoto's thyroiditis, Graves disease or non-toxic nodular goitre.
6. Patients undergoing treatment with mercurial antiseptics, taurolidine or lithium.
7. Patients with a known sensitivity to iodine or any of the other ingredients in IODOSORB, SOLOSITE or ALLEVYN Non-adhesive
8. Patients with severe renal impairment
9. Patients with an ulcer less than 3cm diameter.
10. Patients with an ulcer that is not exuding.
Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Japanese participants with relapsed refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
* Previously treated with at least 1 prior line of multiple myeloma (MM) therapy and must have documented disease progression during or after their most recent therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Must have at least 1 aspect of measurable disease, defined as one of the following;

  1. Urine M-protein excretion \>=200 mg per 24-hour, or
  2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
  3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
* All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be \<=Grade 1 at the time of enrollment, except for alopecia.
* Adequate organ function

Exclusion Criteria:

* Intolerant to daratumumab.
* Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
* Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
* Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
* Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
* Prior allogenic stem cell transplant.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
* Corneal epithelial disease
Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases

This single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma of the colon or rectum (diagnosed at the time of colon or rectal resection or on endoscopic biopsy) with liver metastases (by liver biopsy or by history of biopsy-proven colon/rectal cancer with characteristic imaging findings):
* Imaging showing typical features of colorectal cancer liver metastasis;
* Cytologic/histologic diagnosis of colorectal cancer or colorectal cancer liver metastasis.
* No more than 3 hepatic metastatic lesions noted on preoperative imaging
* No lesion greater than 5 cm in maximal dimension
* Adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic liver resection or microwave ablation as treatment for colorectal cancer liver metastases
* Willing and able to give informed consent

Exclusion Criteria:

* Radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases
* Evidence of recurrent disease adjacent to a previous ablation or resection site
* Severe renal dysfunction (creatinine clearance of \<40 mL/min)
* Pregnant or nursing women
Nephrocare mHealth Project: Telemonitoring of Blood Pressure

The Nephrocare mHealth project supports patients with Chronic Kidney Disease with a mobile application and telemonitoring. The application includes the follow-up of blood pressure.

Patients that are included in the Nephrocare mHealth project send their blood pressure results through an app or online website.

The clinical decision support system will alert the patient, as well as the general practitioner and the hospital when the blood pressure is too high or low. In addition the clinical decision support will calculate monthly averages and all the data are connected with the electronic patient files.

Eligibility Criteria:
Inclusion Criteria:

* Dutch-speaking
* Signed and approved informed consent
* Follow-up by nephrology at the University Hospitals Leuven or General Hospital Groeninge

Exclusion Criteria:

* No Dutch-speaking
* Impaired cognitive condition or medically unstable
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 and older, inclusive, at the time of providing informed consent.
* Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) added onto their blinded study medication

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
* Hemoglobin A1c (HbA1c) \> = 7.0% and \< = 10.5%
* Body mass index \< = 45kg/m2
* Fasting C-peptide \> = 1 ng/mL

Exclusion Criteria:

* Symptomatic poorly controlled diabetes
* Recent cardiac or cerebrovascular event
* Serum creatinine \> = 2.0 mg/dL
Study of the Quality of Life of Patients Treated by Heavy Surgery as Part of an Enhanced Recovery at Beau Soleil Clinic- QUALICHIR

Heavy and oncological surgery is undergoing a major evolution. Some surgical dogmas are falling and care is better rationalized. The interactions between the patient and the caregivers on the other hand, and from the caregiver to the caregiver are favored. Thus was born, about 10 years ago, the principle of enhanced recovery after surgery (ERAS).

But recovery has improved in the patient in the best possible shape in the operating room, and, during the gesture, minimize the negative effects of surgery and anesthesia. Finally, postoperatively, to re-empower the patient as quickly as possible.

The interest of this study is the benefit of the quality of life of the patient being treated for cystectomy as part of an enhanced recovery program. This is to argue the diffusion of this program and the care teams for its realization.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication of cystectomy validated by the surgical team and if there is an oncological indication by the multidisciplinary meeting of onco-urology.
* Patient affiliated to a social security scheme
* Patient classified ASA from 1 to 3
* Patient informed and having accepted the principle of enhanced recovery after surgery

Exclusion Criteria:

* Patients classified ASA ≥4
* Patients with severe or poorly balanced associated conditions (diabetes, long-term corticosteroid therapy, severe undernutrition, cirrhosis, immunosuppression, cardiac disease), contraindications to enhanced recovery after surgery (ERAS) may be temporary if they are corrected.
* Patients who can not comply with the ERAS protocol because they do not understand the language or cognitive disorder.
* Vulnerable people (Article L 1121-6 of the CSP)
* Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)