cyrilzakka/clinical-trials huggingface dataset:
Asymmetric Movement of the Diaphragm

The aim of this study is to investigate the movement of the right hemidiaphragm when lifting a load with the left and right hand.

Hemidiaphragm movement will be assessed by m-mode ultrasonography in a standing position. The study will include 30-40 healthy adult volunteers. The examination will consist of two tidal inspirations and expirations, two inspirations and expirations during lifting the kettlebell with the left hand and two inspirations and expirations during lifting the kettlebell with the right hand. The weight of the kettlebell will correspond to about 10% of the participant's body weight.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Able to comply with the study protocol, in the investigator's judgment
* Aged 18-40 years, inclusive
* Healthy as determined by the Investigator based on medical history, physical examination, vital signs and neurological examination
* Waist-to-height ratio \< 0,59

Exclusion Criteria:

* Low back pain (acute or chronic)
* Previous abdominal or spine surgery
* Acute or chronic respiratory or musculoskeletal disorder
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks before initiation of the study
* Pregnancy
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes

The purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with HbA1c of 7.5 - 11%
* Willing to make behavior and lifestyle modifications
* No previous bariatric surgery (gastric bypass, gastric banding)
* Meet additional study criteria

Exclusion Criteria:

* History of substance abuse or chemical dependency with in the last 3 years
* Prior GI surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes
* Severe congestive heart failure
* Any underlying illness other than diabetes or obesity that affects gastrointestinal motility
* Currently taking medications for weight loss
Efficacity and Safety of Metformin XR in CKD Stage 1 to 3

There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)

Exclusion Criteria:

* Pregnancy and lactation
* Hyperlactatemia (\> 2.5 mmol/L)
* No creatinine levels available since 3 months
* Severe hepatic insufficiency
* No liver function parameters available
* Need of investigation with iodized contrast media
* Hypersensitivity to metformin
Effects of WBV in Children With Hemiparetic CP

The aim of this study was to investigate short and long-term effects of Whole Body Vibration therapy on spasticity and motor performance in children with hemiparetic cerebral palsy in addition to conventional physiotherapy.

Twenty-six patients undergoing conventional physiotherapy in a private rehabilitation center were included in the study. Patients were randomized to treatment and control groups. Study was completed with a total of 22 cases (11 for each group). At the beginning of the study, cases were evaluated with Gross Motor Function Measure-88, LEGSys Spatio-Temporal Gait Analyzer, SportKAT550tm Portable Computerized Kinesthetic Balance Device and Modified Ashworth Scale. Cases in the treatment group were treated with Compex-Winplate for 8 weeks, 3 times a week, 15 minutes a day in one session. All cases were reevaluated immediately after the treatment and 12 weeks after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients with hemiparetic CP
* patients were followed-up and treated by a special rehabilitation center
* aged between 6-18 years
* patients could walk independently without using assistive devices

Exclusion Criteria:

* any other neurological diseases
* cooperation problems
* visual or auditory disability
Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5%

It is thought that alopecia areata occurs as the result of an inappropriate response of the body's own immune system to certain substances in or around the hair follicle. We will be examining the efficacy of Aldara Cream 5% in treating extensive alopecia areata and observe its affect on the hair follicle.

We will examine how the application of Aldara Cream 5% daily for 6 months will affect the hair follicle and the inflammation present in the skin of patients with alopecia areata. In the study we will obtain additional scalp biopsies to examine how the drug affects the quality and state of activity of the immune cells in the biopsy specimens. This type of information will provide data about the behavior of these inflammatory cells in mediating the hair loss associated with alopecia areata and how this behavior may be effected by Aldara Cream 5% treatment. Such information may be valuable to the successful management of alopecia areata.

Eligibility Criteria:
Inclusion Criteria:

* Must be in good health.
* No topical or systemic treatment for alopecia areata for at least 2 weeks prior to study initiation.
* Must be at least 18 years of age and older
* Will have to have extensive scalp alopecia areata (\>95% involvement) of less than 2 years duration.
* Willing to refrain from other alopecia areata treatments during the course of the study.
* Will have to agree to shampoo their scalp daily with Free and Clear shampoo. Participant in "Aldara for the Treatment of Extensive Alopecia Areata" study.

Exclusion Criteria:

* History of any illness or condition that in the opinion of the investigator might confound the results of the study or pose additional risk to the patient
* Significant abnormalities on screening clinical evaluation.
* Previous use of Aldara Cream 5%.
* A history of drug or alcohol abuse.
* Use of UV radiation including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation.
* Use of systemic or topical glucocorticoids, corticosteroids, estrogenic, progestogenic, androgenic or antiandrogen drugs, cyclosporine, FK506 or immunotherapy with DNCB,SADBE or DCP within 6 months of study initiation.
* Alterations in thyroid medication within 6 weeks of study initiation. Pregnant or nursing females. Not participating in the "Aldara for the Treatment of Extensive Alopecia Areata" study.
Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions \[ADRs\]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to as Vyndaqel) in all patients who received this drug under actual use conditions after its marketing.

Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered

Eligibility Criteria:
Inclusion Criteria:

The subjects of this surveillance are all patients who received Vyndaqel.

Exclusion Criteria:

Patients not receive Vyndaqel.
A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma

The primary objectives are

* to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled allergen
* to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days in patients with asthma

The secondary objectives are:

* to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following allergen exposure, and
* to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced airway hyperresponsiveness (AHR) as measured by methacholine challenge

The study will examine if ONO-6950 could alleviate EAR and LAR caused by an allergen challenge in subjects with asthma. Patients will be required to have EAR and LAR after standardized allergen challenges during the screening. Eligible patients will complete a randomized, double-blind, three-way crossover study. During each of three evaluation periods, patients will be administered either 200 mg ONO-6950, 10 mg Montelukast, or placebo for 8 days. Each evaluation period will occur over 8 days and will include various assessments following allergen challenge and methacholine challenge. The study does not require an overnight stay at the clinical research center.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, between 18 to 60 years of age, with bronchial asthma symptoms for at least 6 months
* Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing
* Screening allergen challenge demonstrates that the patient experiences both an early and late asthmatic response
* Sensitivity to methacholine resulting in a ≥ 20% fall in FEV1 (PC20 methacholine)
* Non-smokers with free from the usage of nicotine-containing products at least for a year prior to screening

Exclusion Criteria:

* Previous history of life-threatening asthma, respiratory tract infection and/or exacerbation of asthma within 6 weeks prior to the first screening visit
* Past or present disorders and diseases including, but are not limited to, cardiovascular, malignancy, hepatic, renal, hematological, neurological, psychiatric, endocrine, or pulmonary other than asthma
* Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue disk during the study procedures
* History of clinically significant multiple drug or food allergy
Treatment Intensity/Factors Predicting Short and Long Term Outcomes in Elderly Critically Ill Patients

1. Patients greater than 90 years of age will have poorer outcomes in terms of mortality than younger patients controlling for disease and acuity
2. Patients greater than 90 years old will consume more resources than younger patients controlling for disease and acuity
3. Patients greater than 90 years old will show lower levels of function than younger patients controlling for disease and acuity
4. Patients greater than 90 years old will show lower levels of HRQOL at 90-120 days post ICU discharge than younger patients controlling for disease and acuity

Elderly patients make up between 26% and 51% of patients who are admitted to ICUs. The proportion of individuals in North America aged \> 65 is projected to increase to 20% of the population by 2026. As population demographics change, and as new technologies, pharmaceuticals, and interventions prolong lives, the proportion of elderly patients admitted to ICUs and surviving ICU stay will continue to increase. Studies that have examined only ICU or hospital survival as an outcome have had variable results. Few studies have demonstrated that elderly ICU patients experience higher mortality rates, while others have demonstrated that age alone, when adjusted for other factors, is not an important prognostic indicator among elderly patients admitted to the intensive care units (ICU). However, age is still used as an important criteria for admission to ICUs. Most studies reviewed have looked at patients sixty-five to ninety years old. To our knowledge only two studies to date have addressed this issue among patients older than 90 to an ICU, both were retrospective.

With increasing age there is a parallel increase in health care costs. The use of expensive technology and procedures in the very elderly is fast becoming a major concern. Data on resource allocation and treatment intensity in the (90+) subgroup is sparse.

Beyond mortality and cost, health-related quality of life (HRQOL) is a fundamentally important end point of medical care. Few studies have addressed outcomes in terms of HRQOL and functional status of elderly following discharge the from critical care unit. These studies were limited by small number of subjects enrolled, retrospective design, and lack of validated tool to assess HRQOL.

We plan to prospectively collect data to look at determinants of treatment intensity, outcome, and resource allocation in elderly patients ages 65 and above admitted to the ICU with care taken to including as many patients in the age interval above 90 years of age. We will also assess HRQOL and functional status in very elderly patients who survive admission and are discharged from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients 65 year an older Admitted to MICU, SICU, and CCU

Exclusion Criteria:

* Patients who refuse to complete HRQL questionaire while hospitalized
* Subjects refuse to participate
The Effect of ACT and Tranexamic Acid on Bleeding in Cardiac Surgery

The goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery.

The main questions it aims to answer are:

1. Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion?
2. Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion?

Participants will divided into four groups which have different tranexamic acid dose and ACT level during cardiac surgery to see if there is any different in the amount of bleeding and blood transfusion.

This study is going to analyze the medical records of patients who underwent cardiac surgery between December 1, 2023, and December 31, 2026.

The investigators will categorize patients into four groups based on anticoagulation indices (ACT 400-600 seconds; ACT \> 600 seconds) and tranexamic acid dosages (low dose; high dose) within the range considered safe for CPB.

The primary outcome will be the volume of postoperative bleeding within 24 hours for each group.

The findings of this study will contribute to the existing clinical evidence and provide insights for the monitoring and pharmacological management in cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* adult, cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* pregnant
* emergency procedure
* immune compromised
* aortic surgery
* end-stage renal disease
* liver disease
* critical status
* incomplete clinical data
Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
* Healthy male volunteers in the age between 20 to 45 years old
* Weight: over 50kg, within ±20% of ideal body weight
* Subjects who were determined to be appropriate through screening

Exclusion Criteria:

* Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
* Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
* A history of hypersensitivity to drugs or clinically significant allergic disease
* Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
* Subjects who had a history of drug abuse or who had a positive results on urine drug screening
* Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
* Subjects who participated in another clinical trial within 2 months before enrolling in this study
* Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
* Subjects who drank Over 21 units/week of alcohol or subjects who were unable to stop drinking alcohol during the hospitalization
* Subjects who stopped smoking within 3 months before the treatment
* Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
* Subjects who had a beverage containing caffeine during the hospitalization
* Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
Ceprotin Treatment Registry

The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.


Eligibility Criteria:
Inclusion Criteria:

Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study:

* Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable
* Males and females of any age, including neonates, children, adolescents and adults
* Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment

Exclusion Criteria:

* None
Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation

Distal radius fracture is a common injury with a high percentage of surgical treatment. In the last decades, volar plate fixation has been the treatment of choice. However, complication rates range between 6% and 50% according to the different study groups. One of the main complications is due to errors in screw measurement given the particular anatomy of the distal radius.

Numerous views in addition to the standard ones have been described in order to increase the specificity and sensitivity in the detection of poorly implanted screws. In the absence of a radiological projection superior to another, we believe that the use of intraoperative ultrasound can provide a non-invasive and quick revision element that avoids scope time for both: the patient and the surgical team.

Patients will be recruited in a sequential mode after signing the usual informed consent (IC) as well as the consent to accept participation in the study.

The intervention will be carried out as usual and, once the radiological checks have been carried out, an ultrasound of the wrist extensor compartments will be performed. Compartments will be studied individually in order to detect invasion of the dorsal cortex by the screws.

All surgeries will be performed only by members of the upper limb trauma team or hand surgery unit.

Postoperative follow-up will be the standard one prior to the present study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Both sexes
* Surgical criteria distal radius fracture.
* Patients with sufficient understanding capacity to read and understand an informed consent.

Exclusion Criteria:

* Patients with a history of any type of surgical intervention on the same limb distal to the elbow.
Morbidity After Surgical Treatment of Perforated Ulcer

The main objective of our study is to identify the risk factors for postoperative morbidity after surgical treatment of Perforated peptic ulcer

the investigators conducted a retrospective study of 116 patients, operated on for a perforated peptic ulcer, carried out in the General Surgery Department of Taher Sfar University Hospital in Mahdia over a period of 11 years 6 months.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent surgery for a perforated peptic ulcer in the General Surgery Department of Taher Sfar University Hospital in Mahdia, between January 1, 2010, and June 1, 2021, were included in this study.

Exclusion Criteria:

* patients who have medical treatment
Investigating Participation Patterns Among Recurrent Ovarian Cancer Patients

Clinical trials, with a particular focus on recurrent ovarian cancer, play a crucial role in assessing the safety and efficacy of novel treatments for this condition. These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to support their widespread adoption.

By actively participating in recurrent ovarian cancer observational study serves pivotal role in expanding the boundaries of medical knowledge and advancing the quality of care provided to those enduring the same condition.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Able to comprehend the investigational nature of the protocol and provide informed consent
* Diagnosis of recurrent ovarian cancer

Exclusion Criteria:

* No diagnosis of recurrent ovarian cancer confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.

Participants who had a good or moderate European League Against Rheumatism (EULAR) response but not achieve remission at the end of Part 1 were invited to participate in Part 2 and were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.

Eligibility Criteria:
Inclusion Criteria:

For Part 1:

* Age \>=18 years, either sex, any race.
* Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
* Active disease despite DMARD treatment
* Subject must be taking at least one of the allowed DMARDs, and must be able to continue with it during the trial.
* Eligibility for anti tumor necrosis factor (TNF) use according to the following criteria:

  * Participant must have failed conventional treatment according to the investigator's opinion OR local guidelines.
  * Local guidelines regarding safety screening of anti TNF candidates (ie, tuberculosis \[TB\] screening and other safety screening such as vaccination, if applicable) must be met. Chest X-ray and either a PPD skin test or QuantiFERON®-TB Gold test are also required.
  * Anamnesis and physical examination must make the participant eligible for anti TNF use and trial participation according to the investigator's judgment.

For Part 2:

* Participant must have completed Part 1 of this trial.
* Participant must have:

  * good or moderate response to SC golimumab at the end of Month 6 compared to Baseline, AND.
  * no DAS28 ESR remission.
* Both the investigator and the subject must agree to switch the participant's treatment to IV administration as may be required in Part 2 of this trial.
* The investigator must judge that no safety events (eg, serious adverse events \[SAEs\], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.

Exclusion Criteria:

* History of biologic drug use for RA.
* Evidence of active TB. or latent TB that is untreated.
* Moderate to severe heart failure
* Certain inflammatory rheumatic disease other than RA or certain systemic inflammatory condition
* Allergy to latex