cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis

The goal of this clinical trial is to learn if the investigational drug CAL101 can help prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis.

Researchers will compare CAL101 with placebo to compare change from baseline in forced vital capacity (FVC).

Participants will be randomly assigned to a study group that will receive an IV infusion of either the study medication or placebo about once a month for 6 months.

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CAL101 in participants with IPF, taking and not taking background therapy (i.e. nintedanib or pirfenidone).

The study will consist of a 28-days Screening Period, intravenous (IV) infusions of CAL101 once every 4 weeks over 24 weeks, and a 16 week Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 40 years of age
* Diagnosis of IPF supported by centrally read chest high-resolution computed tomography
* Definite or probable usual interstitial pneumonia (UIP) pattern on chest high-resolution computed tomography (HRCT) performed within 12 months of screening, confirmed by central review (if an evaluable HRCT \< 12 months is not available, the baseline HRCT will be used to determine eligibility).
* FVC ≥ 45% of predicted.
* Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 25% predicted.
* Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.7
* Either stable dose with antifibrotics (either nintedanib or pirfenidone) for at least 8 weeks prior to screening or not treated with antifibrotics for at least 8 weeks prior to screening.

Exclusion Criteria:

* In the opinion of the Investigator, other clinically significant lung disease (e.g. asthma, emphysema, chronic obstructive pulmonary disease, cavitary or pleural diseases) at screening.
* Interstitial lung disease (ILD) other than IPF (including, but not limited to, connective tissue diseases, vasculitis).
* Acute IPF exacerbation within 16 weeks prior to screening and/or during the screening period (investigator-determined).
* Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
* Evidence of impaired kidney function, unstable cardiovascular disease, moderate or severe hepatic impairment or any significant disease or condition other than IPF which may interfere with trial procedures or interpretation of trial results, or cause concern regarding the patient's ability to participate in the trial or any medical condition which could lead to a life expectancy \< 12months
Availability of Poor Quality Embryos

The purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos

Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are further cultured to different developmental stage and then cryopreserved. The viability of these embryos are tested in frozen-thawed transfer.

Eligibility Criteria:
Inclusion Criteria:

* unfertile women

Exclusion Criteria:

* women older than 40 years
A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain

This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men

The study consists of the following parts:

* a Screening Visit
* an MRI scanning visit
* an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day \[11C\]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period
* a Follow-up Visit 7 days after dosing

Eligibility Criteria:
Inclusion Criteria:

* The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
* The subject has a normal MRI performed during the screening period, as judged by the investigator
* The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
* The subject can tolerate confined spaces for prolonged periods of time
* The subject is suitable for radial artery blood sampling and cannulation

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)

Other in- or exclusion criteria may apply
Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care

The overall purpose is to study quality in patient education by means of the patients' self-rated enablement. Specific aims are:

To assess the validity of the patient enablement instrument in relation to self-efficacy and empowerment; To investigate if patient enablement can be effective in identifying which patients would benefit the most from patient education; To study if patient enablement has any relation to self-efficacy, function or self-rated health; To analyze if patient enablement has a causal effect on health care consumption; To evaluate whether patient education is a cost-effective intervention. The project is a longitudinal study, including patients from a patient education programme for osteoarthritis in primary health care. Data consist of patient reported outcome measures and health care consumption. Cost-effectiveness and cost-utility analysis will be used. Inclusion of patients will start August 2016. Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included are from primary health care settings and researchers in the field of OA, patient education and health economy. Our increasingly older and more inactive population will raise huge demands on the health care. The importance of optimizing treatments that are available in primary health care cannot be underestimated. The project will contribute with important knowledge about the patient's own process of getting well.

The project is a longitudinal study, including patients who are referred to patient education for osteoarthritis in primary health care and is planned to follow the patients one year before baseline measures as well as one year after baseline measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are referred to patient education for OA in primary health care
* Speaks and write Swedish

Exclusion Criteria:

* Not having OA
* Not able to speak or write Swedish
Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)

Giant cell arteritis (GCA), also known as Horton's disease, is an inflammatory arteritis of the large and medium-sized arteries, with an estimated incidence of 17.8/100,000 in people over 50.

The disease presents potential ophthalmological, neurological, cardiac and aortic vascular complications, making diagnosis an emergency in cases of suspected Horton's disease.

only corticosteroid therapy started as early as possible can prevent these complications.

Diagnosis has historically relied on temporal artery biopsy, but the recent ACR/EULAR 2022 classification criteria propose alternatives to this invasive examination, in particular imaging tests such as temporal artery ultrasound and PET scans. Although not included in these latest recommendations, high-definition wall MRI can also provide arguments in favor of this diagnosis, and avoid the need for a temporal artery biopsy, the sensitivity of which is only 75%. The investigators recently demonstrated in a prospective cohort that wall MRI, possibly coupled with temporal artery ultrasound or retinal angiography, was far superior to temporal artery biopsy in diagnostic performance.

The main limitation of these imaging tests is the lack of data in the literature on the evolution of abnormalities over time, and in particular after initiation of oral corticosteroid therapy. This uncertainty makes it difficult to use these examinations to monitor disease activity, particularly in cases of suspected relapse, a frequent situation in which the clinician is regularly put at fault due to an often frustrating symptomatology and the possible absence of a frank biological inflammatory syndrome.

The investigators propose to conduct a study aimed at describing the evolution of cranial vessel wall abnormalities on wall MRI and ultrasound by systematically repeating these examinations at 1 month, 3 months from the initial MRI performed at diagnosis, in addition to the follow-up performed as part of care at 6 and 12 months from diagnosis. In the event of a relapse in the intervening period, a new MRI scan can be performed and compared with the most recent MRI scan, to look for evidence of disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 50 and over
* Having received informed consent to participate in the study
* Affiliated or beneficiary of a social insurance scheme
* Patients with giant cell arteritis according to ACR/EULAR 2022 criteria
* Diagnosed with MRI and ultrasound.

Exclusion Criteria:

* Absolute or relative contraindication to MRI (incompatible implantable device, claustrophobia, etc.)
* Hypersensitivity to gadobutrol
* Patient under legal protection
* Pregnant or breast-feeding women
Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets

The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of periodontal pockets in people with gum disease.

This research consists of clinical and radiographic studies. Participants should have symmetric periodontal pockets in the upper or lower jaw.

Participants will be treated surgically using hyaluronic acid on one side of the jaw.

Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken for each participant before surgical treatment and 12 months after surgical treatment.

The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of infra-bony pockets in chronic periodontitis patients.

This research consists of clinical and radiographic studies.

1- The clinical study: is a randomized controlled trial with a split mouth technique.

Chronic periodontitis patients with Infra-bony pockets will be collected from the Department of Periodontics in faculty of dentistry - Damascus university.

Participants should have symmetric infra-bony pockets in the upper or lower premolar area with pocket probing depth more than 6 mm.

Participants will be treated surgically using open flap curettage.

Open flap curettage will be done for each patient in both sides of the jaw, but hyaluronic acid will be used in one of the two sides with random allocation of the site that in going to be treated with hyaluronic acid.

Plaque index, gingival index, bleeding on probing, tooth mobility index, pocket probing depth and clinical attachment loss will be taken for each participant four times; before surgical treatment, 3 months, six months and 12 months after surgical treatment.

Radiographic study: will be done using CBCT radiography technique. CBCT will be taken for each participant before and after 12 months of surgical treatment. Different distances, vertical bone fill and depth of infra-bony defect will be measured on CBCT images.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic periodontitis
* Symmetric Infra-bony defects with periodontal pocket depth more than 6 mm.
* in upper or lower premolar area.
* All participants will be collected from patients attending department of Periodontology - faculty of dentistry for periodontal disease treatment.
* Males and females.
* 35-65 years old.
* Systematically healthy.
* Accepting to participate in the study. Informed written consent will be required.

Exclusion Criteria:

* A history of previous scaling and root planning in the last 6 months
* Smokers
* Pregnant women
* Diabetes mellitus
Genomic Study of Relapse Esophageal Cancer After Radiotherapy

Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. However, about half patients received radiotherapy occurred relapse. Once relapse occurred, there is no better treatment strategy. Genomic study of relapsed esophageal cancer is seldom. So the investigators attempt to collect relapsed tissue to conduct with whole exome sequencing in order to investigate the genome landscape of recurrence esophageal cancer.

Tumor tissue of patients received radiotherapy with diagnosis of recurrence between Jan 1, 2010 and Dec 1, 2020 were collected retrospectively. Recurrence tumor tissue is collected between Dec 31, 2020 and Dec 31, 2022 prospectively. Blood and preradiotherapy tumor tissue were also collected to be as contrast. A total of 100 paired blood, preradiotherapy tumor tissue and relapse tumor tissue were collected. What is more, a total of 100 paired blood and preradiotherapy tumor tissue with diagnosis of no recurrence were collected. All samples were conducted with whole exome sequencing.

Here the investigators define recurrence period as within 2 years and no recurrence period as more than 3 years after radiotherapy.

Criteria of relapse: (1) pathologic diagnosis is squamous carcinoma before radiotherapy;(2) received radiotherapy; (3)pathologic diagnosis is also squamous carcinoma after radiotherapy; (4) clinical symptoms including feeding obstruction etc; (5) imaging evidence showed disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. pathologic diagnosis is squamous cell carcinoma before radiotherapy;
2. pathologic diagnosis is squamous cell carcinoma after radiotherapy;
3. received radiotherapy
4. clinical symptoms including dysphagia, feeding obstruction, etc
5. image evidence showed disease progression
6. the period of recurrence was within 2 years after radiotherapy

Exclusion Criteria:

1. pathologic diagnosis is not squamous cell carcinoma before radiotherapy;
2. pathologic diagnosis is not squamous cell carcinoma after radiotherapy
3. not received radiotherapy
4. the period of recurrence was more than 2 years after radiotherapy
5. the period of no recurrence was within 3 years after radiotherapy
Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)

The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.


Eligibility Criteria:
Inclusion Criteria:

* Participants are in general good health.
* All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control

Exclusion Criteria:

* Participant is pregnant or breastfeeding.
A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients

This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
* Specific cognitive impairment
* Smokers and non-smokers

Exclusion Criteria:

* Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing.
* Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
* History of neuroleptic malignant syndrome.
* Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
* Score 4 or 5 on the Suicidal Ideation item or any "yes" on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years

Other protocol-defined inclusion/exclusion criteria may apply
Inuline Supplement in Patients With Irritable Bowel Syndrome

The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study.

In this study patients diagnosed using Rome IV criteria with irritable bowel syndrome with constipation are included. The study was approved by the Ethic Committee of the University of Medicine and Pharmacy "Gr. T Popa" Iasi to be conducted at the Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi. The patients are assigned after a randomized scheme to one of the groups: diet restriction scheme or diet restriction scheme plus a product with inuline, choline and silymarin. After 28 days the patients are crossed between the groups and followed for additional 28 days diet scheme with or without inuline, choline and silymarin supplementation. All the patients are evaluated initially, in the day 28 and in the day 57 for the stool habits, stool characteristics using Brystol Scale and symptoms severity (abdominal pain, frequency of abdominal pain, bloating severity, patients satisfaction in relation with stool frequency and the impact of IBS on daily activity) as appreciated by the patients for the last 10 days.

The acquired data will be analyzed and published.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years, diagnosed with Irritable Bowel Syndrome using Roma IV criteria

Exclusion Criteria:

* Patients with IBS with predominant diarrhea or mixt symptoms
* Patients with known hypersensitivity to any of the ingredients of the dietary supplement
* Patients who used prebiotic, probiotic or laxative products in the last 10 days
* Pregnancy and lactation
Drug-free Without Toothache. A Study of Free Dental Treatment as a Part of Substance Abuse Treatment

Objectives: The main objective of the study is to investigate

1. How many patients will attend and complete dental care if they are offered it for free during the stay at "The department of substance abuse treatment, University Hospital North Norway (UNN) in Narvik".
2. Explore whether a parallel dental treatment in addition to the other treatment at the department has a beneficial effect on the abuse treatment, or whether it can be disruptive to offer dental treatment in combination with admission for drug rehabilitation?

This is a non-randomized clinical study without a control group. Approximately 50 persons admitted to "The department of substance abuse treatment (Russeksjon UNN Narvik)" will be offered free dental service during treatment for drug addiction.

Eligibility Criteria:
Inclusion Criteria:

People who are hospitalized for drug abuse at Russeksjon UNN Narvik.

Exclusion Criteria:

Non
Splinting Versus Casting for Type I Supracondylar Fractures

Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3-12
* Type 1 supracondylar fracture

Exclusion Criteria:

* A type 2 or 3 supracondylar fracture
* Neurovascular compromise associated with the fracture
* Previous diagnosis with a metabolic or structural bone disease
* Other fractures to ipsilateral upper extremity
* History of injury to affected elbow
Drug-Drug Interaction Study of Glucokinase Activator HMS5552 and Metformin in T2DM

This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).

This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM). The study is to assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM. The study is also to evaluate the safety and tolerability of HMS5552 with simultaneous administration of metformin in subjects with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects between the ages of 18 and 70 years
* Body Mass Index (BMI) of approximately 22 to 38kg/m2
* HbA1c ≥7% and ≤12%
* Are capable of giving informed consent and complying with study procedures

Exclusion Criteria:

* fasting blood glucose ≤110 or ≥270mg/dL
* Type 1 diabetes mellitus, or latent autoimmune diabetes in adults
* History or symptoms of clinically significant cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart disease within one year of screening
* History of liver disease and clinically significant renal disease
* Known hypersensitivity to metformin hydrochloride;
* Positive pregnancy test result;