cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

This study will be randomized (treatment group assigned by chance, like flipping a coin), double-blind (study investigators and participants will not know what treatment is being administered), and placebo-controlled (a placebo is identical to the study agent, but contains no active ingredients). A total of 160 participants will receive either placebo or JNJ-38518168 once daily. The study duration will be approximately 32 weeks and will include a screening phase of approximately 4 weeks, a 24-week placebo-controlled treatment phase, and a 4-week follow-up phase. Participant safety will be monitored throughout the entire study period..

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1
* Have been receiving inhaled corticosteroid (ICS) (≤1000 µg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1
* At Screening Visit 1, be receiving the same dose of ICS ≤1000 µg/day fluticasone (or equivalent) alone or in conjunction with long-acting β2-agonist (LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening
* Have an Asthma Control Questionnaire (ACQ) score ≥1.5 at Screening Visit 1
* Have a prebronchodilator forced expiratory volume in 1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1
* Have a ≥12% relative change and ≥200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2

Exclusion Criteria:

* Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma
* Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease
* Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1; cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks of Screening Visit 1; theophylline within 4 weeks of Screening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1
* Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1
* Has smoked within 3 years of Screening Visit 1 or has a history of smoking ≥ 10 pack years
* Body-Mass Index (BMI) greater than or equal to 40 kg/m2
The Impact of Moderate Resistance Training on IMAT in Elderly Diabetes Patients Without Obesity

Data shows that high intensity resistance training reduces Intermuscular Adipose Tissue (IMAT) in obesity adults. Whether moderate resistance training reduces IMAT for non-obese elderly patients with diabetes is not clear. Therefore, this study aimed to evaluate the impact of moderate resistance training on IMAT in elderly patients with type 2 diabetes, and the independent effect of IMAT reduction on metabolic outcomes.

In this randomized control trial (RCT), 85 type 2 diabetes patients were randomized into the resistance training group (42 participants) and control group (43 participants) for 6-month intervention. The control group was not asked to participate in any regular exercise. However, the group attended online group educational sessions about diabetes self management once a month, and were asked to record their daily physical activities. Online mini program Wechat was used for communication. The intervention group attended online group education sessions on diabetes self management as the control group, as well as resistance exercise training sessions three times weekly; the sessions were approximately 40 minutes long and included 5 minutes of warm up, followed by 30 minutes of resistance exercises and 5 minutes of cool down. The resistance training consisted of ten upper-body and lower-body exercises using elastic band. The initial sessions were 1 to 2 sets of 6 to 8 repetitions at 45% of the one-repetition maximum (1 RM). It was increased progressively to 2 to 3 sets of 8 to 12 repetitions at approximately 50% -55% of 1 RM. The primary outcome were the changes of IMAT measured by computed tomography（CT）scan and magnetic resonance imaging (MRI) interactive decomposition of water and fat with echo asymmetry and least squares qualification sequence (IDEAL-IQ). The secondary outcomes were the changes in metabolic parameters.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* ≥60 and \<75 years of age
* Normal muscle strength
* Body-mass index (BMI) ≤35
* Glycosylated hemoglobin A1c (HbA1c) \< 9%

Exclusion Criteria:

* Patients who had severe chronic diabetes complications（e.g., stroke, myocardial infarction, end stage renal disease, proliferative retinopathy)
* Cognitive impairments
Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair

Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .. Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications.

Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications There are many studies in the literature on suprascapular, axillary, and interscalene nerve blocks in early pain management after shoulder arthroplasty. All of these focus on pain in the perioperative or early postoperative period. There is a study on USG-guided suprascapular nerve block. In this study, unlike the studies in the literature, it was aimed to show the effectiveness of USG-guided suprascapular nerve block in the subacute rehabilitation process of patients.

Eligibility Criteria:
Inclusion Criteria:

-Having undergone arthroscopic rotator cuff repair surgery within the last week

Exclusion Criteria:

* History of previous surgery on the same shoulder
* History of systemic inflammatory rheumatological disease
* Neurological diseases with muscle weakness in the upper extremity (MS, ALS, Muscular -Dystrophy)
* History of malignancy, pregnancy, breastfeeding
* Use of steroids or immunosuppressive drugs
* History of allergic reactions to local analgesics
* Fibromyalgia syndrome
* Chronic painful conditions that require opioid use
* Presence of known psychiatric disease
* Cognitive impairment (Mini Mental Test Score \<23)
Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients

Diabetes is one of the most common fatal metabolic diseases in the world. Diabetes-induced ocular surface alterations are poorly understood. Indeed, it was once thought that the cornea, avascular, was immune to the effects of diabetes. A growing number of publications now demonstrate the opposite. These alterations affect up to 70% of diabetic patients at some point in the progression of their diabetes.

Another common complication of diabetes is the early development of a cataract, requiring surgery. Diabetic patients are therefore more likely to require surgery at an early age than the general population.

Diabetes and cataract surgery both induce corneal changes. Cataract surgery in diabetic patients is therefore at greater risk of corneal complications. Diabetes induces dysfunction of the main lacrimal gland, corneal neuropathy, meibomian dysfunction and a decrease in conjunctival mucus cells. Diabetic patients are therefore particularly at risk of exacerbation or appearance of alterations of the corneal epithelium and the ocular surface in postoperative cataract surgery.

Therefore, it seems necessary to evaluate the impact of cataract surgery on the ocular surface and corneal epithelium of diabetic patients, in order to improve their management.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years);
* Patient operated on for cataract at HUS between January 2022 and January 2024;
* Patient who did not express his opposition to the reuse of his data for scientific research purposes;
* Patient who benefited from the measurement of the above-mentioned judgment criteria during his pre- and post-operative consultations.

Exclusion Criteria:

* Presence in the medical file of the subject's opposition to the reuse of his data for scientific research purposes.
* Prolonged use of stored eye drops;
* Documented etiology of chronic alteration of the ocular surface (shingles, herpes, Gougerot-Sjogren syndrome, graft-versus-host disease);
* Minor patient or under guardianship or curatorship.
A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed with type 2 diabetes
* Subject has a HbA1c value between 6.8 and 9.5%
* Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
* Subject is on a stable diet and exercise program
* Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study

Exclusion Criteria:

* Subject has type 1 diabetes mellitus
* Subject is using insulin therapy
* Subject has a serum creatinine higher than upper limit of normal
* Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
* Subject has persistent, uncontrolled severe hypertension as indicated by a

systolic blood pressure \>180 mmHg or a diastolic blood pressure of

\>110mmHg

* Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
* Subject is known to have hepatitis or be a carrier of hepatitis B surface

antigen, hepatitis C virus antibody or is known positive for HIV1 and/or

HIV2

* Subject has a history of lactic acidosis
* Subject has a history of drug and alcohol abuse/dependency within last 12

months

* Subject has had a malignancy in the last 5 years, except for successfully

treated basal or squamous cell carcinoma of the skin or of the cervix

* Subject has a symptomatic urinary tract infection or genital infection
* Female subject is lactating
* Subject has an unstable medical or psychiatric illness
Dynamic Preload Dependence Indices in Laparoscopic Surgery

A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance.

The aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.


Eligibility Criteria:
Inclusion Criteria:

* Need to laparoscopic colectomy or hepatic resection
* Written informed consent

Exclusion Criteria:

* Cardiac arrhythmia
* Esophageal and cervical pathologies
* Radial artery Allen test negative
* Allergy to anesthesic treatment, to egg or soja
* Severe kidney failure (estimated glomerular filtration rate \< 30 ml/min)
* Age \< 18 years old
* Pregnancy
Knee Dislocation - Clinical Evaluation of the Use of Hinged External Fixator After Ligament Reconstruction

Knee dislocation is a serious injury, usually caused by high-energy trauma. It is classically defined as complete loss of articular congruence between the femur and the tibia, confirmed by radiography. However it is common that the reduction happens spontaneously. For this reason, today the investigators also consider a patient suffered knee dislocation in the presence of multi-ligament injury involving the posterior cruciate ligament, often in association with anterior cruciate ligament, lateral and/or medial ligamentous complex.

It is considered a serious injury, because both the strong association with vascular and nerve damage, which can lead to the need for limb amputation, such as the difficulty in obtaining a good functional outcome even after treatment of all ligament injuries.

The treatment of these injuries aims to achieve knee stability. Joint mobility is often sacrificed in the postoperative period, with the use of immobilizations such as casts, splints or bracing. Unfavorable clinical outcomes with high rates of stiffness and joint pain are very common in these patients. In attempts to improve these results, rehabilitation protocols with early range of motion can be employed. However, results may remain unsatisfactory, predominantly because of knee instability recurrence.

Stannard and Zaffagnini proposed a new model for treatment of acute knee dislocations. In this model, after multi-ligament reconstruction or repair, a knee articulated external fixator is used. Such external fixator allows early and aggressive joint mobility in the sagittal plane only. Flexion and extension are permitted, but rotational movements, translations in the anterior-posterior plane, lateral (varus) and medial (valgus) openings are not allowed. Thus protective stability is ensured for ligament reconstruction procedures. Simultaneously the investigators allow immediate joint mobilization, reducing the risk of arthrofibrosis, joint stiffness and postoperative ligament laxity.

There is no consensus regarding the use of hinged external fixator postoperatively in multiple ligament reconstruction procedures for treatment of knee dislocations.

The objective of this study is comparing functional outcomes after ligament reconstruction in patients with knee dislocation, with or without the use of hinged external fixator.


Eligibility Criteria:
Inclusion Criteria:

* adults aged between 18 and 50 years old, diagnosed with knee dislocation, classified as KD-III and KD-IV
* absence of knee arthritis in initial radiographs
* absence of systemic diseases or disorders of collagen altering bone quality
* absence of previous surgical interventions in the knee
* possibility of using medications
* maximum of three months of injury to treatment
* understanding and acceptance by the patient to participate

Exclusion Criteria:

* abandoning medical care
* inability to follow the treatment plan
Risk Factors Related to Thirst After Surgery

To investigate the risk factors related to xerostomia (dry mouth) after surgery

Dry mouth of postoperative makes the patient feel thirst, and the pain of the lips is cracked. It will also make the sputum thick and sticky, making it difficult for the patient to cough by himself. Especially the elderly may have sputum accumulation and pneumonia. The incidence of dry mouth was 88%, 6-8 hours after abdominal surgery. Initiating the motivation of this study, it is hoped that through research to understand the relevant factors causing dry mouth after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients
2. Elective surgery patients
3. \>19 years old patients

Exclusion Criteria:

1. cognitive impairment patients
2. ICU patients
Colostrum Supplements Effect on the Physical Performance and Cognitive Function

The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are:

1. What are the effects of the tested regimens on the level of IL-1 and IL-15.
2. What are the effects of the tested regimens on the Fasting Blood glucose?
3. What are the effects of the tested regimens on the HbA1C?
4. What are the effects of the tested regimens on the Body Mass Index?
5. What are the effects of the tested regimens on the Lipid profile?
6. What are the effects of the tested regimens on C-reactive protein?
7. What are the effects of the tested regimens on Hematological indices?
8. What are the effects of the tested regimens on Rate pressure product?

Participants will be separated into four groups:

1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days
2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days.
3. Group 3 (Diabetes Type 2): 23 Patieints, will be receiving Placebo Capsule per oral once daily for 60 days.
4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days.

Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on IL-1, IL-6 ,Fasting Blood Glucose, HbA1c, Body Mass Index, Lipid profile, Rate pressure product, C-reactive protein, and Hematological indices. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Apparently Healthy patients for control
* Patients diagnosed with T2DM
* Age between 18-70

Exclusion Criteria:

* Patients with T1DM
* Patients with a drug history of anabolic substances for more than 14 days duration.
* Patients with co-morbidities (e.g. CVS, renal, hepatic, and endocrine disorders)
* Pregnancy, lactation, or female patient willing for conception.
Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes

Determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of SAS or Caucasian ethnicity.

The prevalence and accompanying morbidity and mortality of obesity and type 2 diabetes (T2D) is increasing on a global scale. Unfortunately the underlying (patho)physiological mechanisms are only partially understood. A key step in the development of negative health effects of metabolic disease might be via dietary fructose metabolism and its accompanying aberrant metabolite production, in which our gut microbiota plays a crucial role.

By bypassing the normal glucose metabolism pathway, fructose plays a role in the development of metabolic disease such as diabetes en fatty liver disease. The mechanism of this effect is unclear and possibly plays in the observation of ethnic specific metabolic risk factors. That is, subjects of different ethnicties (for instance South-Asian Surinamese (SAS)) have a higher risk and worse trajectory of metabolic diseases than Caucasians. Since gut microbiota is altered between these two ethnicities, we hypothesize that aberreant fructose catabolism in patients of SAS descent results in production of specific (gut microbiota derived) metabolites such as ethanol. In this study, fructose metabolism will thus be studied in patients of SAS and Caucasian Dutch descent. To this end the investigators will examine (13C stable isotope based) fructose fluxes before and after randomizing subjects into a four-week high- or low fructose diet. This study aims to elucidate the physiological and microbial catabolism of fructose and possible differences between these two ethnicities.

Eligibility Criteria:
Inclusion Criteria:

* 40 T2D patients (20 Caucasian and 20 SAS)
* 40-70 years old
* Male-female
* BMI 25-35 kg/m2
* Stable anti diabetic drugs for 3 months (metformin is obligatory)
* Stable medication use past 3 months
* Able to give informed consent

Exclusion Criteria:

* - Proton-pump inhibitor usage (known to effect gut microbiota)
* GLP1, SGLT2i or insulin use (known to effect gut microbiota)
* Antibiotic for the past 3 months (known to effect gut microbiota)
* Probiotic or symbiotic usage (known to effect gut microbiota)
* Pregnant women
* Chronic illness (including a known history of heart failure, renal failure (eGFR \<30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
* Active infection
* Previous intestinal (e.g., bowel resection/reconstruction) surgery
* Smoking (due to its influence on gut microbiome)
* Vegetarian diet (since they have different microbiota)
* \>6 alcohol units per day or \>14 alcohol units per week
* Active malignancy
* HbA1c \>9% (75mmol/mol)
Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer

16a-18F-fluoro-17b-estradiol (\[18F\]FES) is radioactive labeled estradiol, developed for in vivo visualization of the estrogen receptor (ER) using positron emission tomography (PET). To date, \[18F\]FES PET has been mainly explored as a diagnostic imaging tool to assess ER expression, thereby identifying locations of disease and their potential sensitivity to endocrine therapy, respectively. The primary aim of this project is to extend the application of \[18F\]FES PET as a baseline diagnostic imaging biomarker for ER expression to use it as an (early) treatment response marker. However, for such an application, visual assessment alone may not be sufficient and a more rigorous quantitative image analysis is needed. Therefore, in this project we shall first derive the optimal pharmacokinetic model for full quantitative analysis of \[18F\]FES uptake and, subsequently, we shall assess the validity of simplified, clinically feasible, quantitative parameters of \[18F\]FES uptake in 5 patients with metastatic estrogen receptor positive (ER+) breast cancer (part A). In addition, the repeatability of these simplified parameters will then be investigated in another 10 patients (part B).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven metastatic ER+ (\>10% positive stained cells using immunohistochemistry) breast cancer on the latest biopsy
* Postmenopausal females aged 18 years or older at screening. Postmenopausal status is defined as one of the following:

  1. age ≥60 years
  2. age \<60 years and amenorrhea for \>12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
  3. patient age \<60 years using LH-RH agonists should continue LH- RH-agonists until after the PET procedures
  4. previous bilateral oophorectomy or medically confirmed ovarian failure
* \[18F\]FDG PET, CT and/or a bone scan should be performed as part of routine clinical staging (≤4 weeks prior to screening)
* Patients should have metastases in the scanning field of view, all located outside of the liver
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
* Estimated glomerular filtration rate (eGFR) ≥30 ml/min
* Written and signed informed consent

Exclusion Criteria:

* History with another cancer within the last 5 years, except cancer treated with curative intent and no evidence of disease as judged by the treating physician
* Use of selective estrogen receptor modulators (SERMs) or downregulators (SERDs) for current breast cancer such as Tamoxifen/Fulvestrant (≤5 weeks prior to screening) or investigational drug therapy
* Pregnancy or lactating women
* Any medical, psychological or social condition that may interfere with the subject's safety and participation in the study, will lead to exclusion from this study