cyrilzakka/clinical-trials huggingface dataset:
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS

Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%

The purpose of this randomized, double-blind study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

Eligibility Criteria:
Inclusion Criteria:

* history of pain/soreness after exercise
* BMI between 18-30
* negative drug, alcohol, pregnancy screens
* other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* upper extremity workout in last 3 months
* job or hobby requiring heavy lifting
* history of muscle disorders
* allergy or intolerance to NSAID or study drug
* history of recent pain medication use
* other protocol-defined exclusion criteria may apply
Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia

This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without an inhibitor.

This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without an inhibitor. The study will enroll at least 8 adult male subjects with moderate or severe Hemophilia A or B with or without an inhibitor, in each dosing stage. Each subject will receive escalating doses of MarzAA for each stage of the study (except for Stage 5, where subjects receive the same dose as in Stage 4 split between two anatomical sites).

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe congenital Hemophilia A or B, with or without an inhibitor
* Male, age 18 or older
* Affirmation of informed consent with signature confirmation before any trial related activities

Exclusion Criteria:

* Inability to discontinue and washout prophylaxis treatment 72 hours prior to dosing.
* Previous participation in a trial involving SC Administration of rFVIIa or any trial using a modified amino-acid sequence FVIIa
* Known positive antibody to FVII or FVIIa detected by central laboratory at screening
* Have a coagulation disorder other than hemophilia A or B, with or without an inhibitor
* Significant contraindication to participate
Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease

The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease treated with an acetylcholinesterase inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of probable early Alzheimer's disease
* stable dose of acetylcholinesterase inhibitor
* community dwelling
* stable medical condition

Exclusion Criteria:

* unstable and significant medical conditions
* recurrent major psychiatric disorder
* treatment with memantine
Augmented Reality for Subdural Drain Placement

This study involves using a augmented reality (AR) system to assist in the placement of a subdural evacuating portal system (SEPS). In the first part of the study, all participants will have skin marking of an AR-guided and non-AR-guided site to determine feasibility and method accuracy. In the second part, subjects will be randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.

Chronic/subacute subdural hematoma (SDH) is one of the most common diseases encountered in neurosurgical practice. However, there is little consensus on first-line treatment. The SEPS was developed to implement a minimally invasive approach to drainage. New imaging technologies, such as augmented reality (AR) interfaces, can provide anatomical models and can help visualize hidden structures. The hope is that this study can give insight on whether AR-guidance can be used to improve SEPS placement, which can lead to higher volume drainage, greater symptomatic improvement, and decreased hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or Bilateral subdural hematoma that is planned to be treated by SEPS

Exclusion Criteria

* Unable to have CT scan
* Pregnancy
Binge Drinking And Addiction : Case-Control Study in Hospital

Case Control Study :

Objective:

Frequent Binge drinking during 18-25 years is a risk factor of alcohol addiction in adulthood (25-40 years) Hypothesis: 25% of frequent binge drinking, OR = 2, power 80%, alpha risk : 5% 126 Cases aged 25 to 40 years: alcohol addict patients recruited in Addiction Unit in Rouen University Hospital 126 controls aged 25 to 40 years: non alcohol addict recruited by the Clinical investigation center in Rouen University Hospital An anonymous self-questionnaire was completed Binge Drinking during 18-25 years was retrospectively evaluated Confusion biais was also recorded


Eligibility Criteria:
Inclusion Criteria

* 25 to 40 years:
* alcohol addiction for the cases

Exclusion criteria

* age \<20 and \>40
* alcohol addiction for the controls
Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

The incidence of postoperative atrial fibrillation (POAF) after on-pump cardiac surgery remains high, at around 30%. POAF increases the risk of cardiac decompensation, stroke, acute myocardial infarction, and death, resulting in increased morbidity and mortality, hospital length of stay, and cost of patient management. Episodes of POAF are usually paroxysmal and asymptomatic, increasing the risk of developing permanent AF at five years by 4 to 5 times. POAF occurs between 3 and 4 days after cardiac surgery, mainly when the patient is hospitalized in a surgical ward without heart rate monitoring as opposed to critical care, where the patient benefits from continuous rhythmic monitoring. The diagnosis of POAF is therefore made with the help of a 12-lead electrocardiogram (ECG) when the patient presents clinical symptoms and when the medical staff notes a significant variation in heart rate. However, many patients with episodes of asymptomatic POAF have a higher risk of stroke and mortality than those with symptomatic POAF.

Faced with this public health problem, the development of tools for diagnosing AF is in full swing, mainly the marketing of smartwatches (SWs) that allow for the performance of 1-lead ECG. SW is also equipped with algorithms to analyze heart rate variability and diagnose asymptomatic atrial fibrillation (AF) episodes. The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) recommend the use of smartwatches to detect AF, in particular, to reduce the economic impact of AF.

The aim of the study is to diagnose POAF within the first five days after patient discharge from the critical care unit for the cardiac surgery department.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\>18 years old)
* The patient was hospitalized at Amiens University Hospital for on-pump cardiac surgery.
* The patient has had a recent on-pump cardiac surgery (\< 96h)
* Patient with the motor and cognitive abilities to perform a 1-lead ECG with the smartwatch
* The patient was transferred to the cardiac surgery department of Amiens University Hospital.
* The beneficiary of a social security plan
* Signature of the consent to participate in the study

Exclusion Criteria:

* History of AF
* Need for rhythmic monitoring by telemetry in cardiac intensive care for atrioventricular block and rapid supra and ventricular rhythm disorder (\>140 bpm).
* An external pacemaker connected to epicardial electrodes depends on ventricular and atrial pacing.
* Patients already included in an interventional clinical research protocol may alter the incidence of POAF.
* Pregnant woman
A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors

This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.

This study is a study of Max-40279-01 in combination with toripalimab in patients with advanced solid tumors. This study includes two Parts, the Part 1 will assess the safety and efficacy of the preset several dose levels of Max-40279-01 and toripalimab, and recommend a dose level of Max-40279-01 combined toripalimab for stage 2. The part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic solid tumor.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0) at the time of randomization.
3. Inadequate organ or bone marrow function.
4. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
5. Pregnant or breast-feeding woman.
6. Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments.
A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol

Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by monitoring vital signs, ECG and adverse events.

16 healthy volunteers of both sexes, age 18 to 45 years, will be enrolled. The mean dose necessary to suppress the Dobutamine induced heart rate increase of at least 30 bpm above baseline rate (maximum heart rate app. 110 bpm) by at least 20 bpm will be calculated for AOP200704 and Esmolol and the dose/efficacy relation of both agents to each other will be calculated for the steady state condition. For both drugs the time to reach a decrease of 10 bpm, 20 bpm and the maximum effect will be calculated. In addition the mean time to increase in 10 and 20 bpm and the time to reach maximum heart rate (increase of 30 bpm above baseline or more) after termination of infusion will also be assessed for both drugs. Blood pressure values will be compared for all above mentioned time points where heart rate is assessed for pharmacodynamics.The study will consist of a screening, cross-over 1, cross-over 2 and end-of-study visit.

Eligibility Criteria:
Inclusion Criteria:

* Male and female human subjects, age 18-45 years
* Body weight of at least 50 kg, maximum of 90 kg. Body-mass index 18.5 to 30.0 kg/m2
* Caucasians
* Subjects without clinically relevant abnormalities
* Subjects agreeing to not using any prescription and over the counter medications including vitamins and minerals for 7 days prior to study and during the course of the study
* No drug or alcohol abuse
* Non-smokers, ex smokers and mild smokers

Exclusion Criteria:

* Subjects with history or presence of clinically relevant cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or skin diseases.
* Subjects with bradycardia (heart rate below 50 bpm), tachycardia (heart rate above 100 bpm), hypotension (systolic blood pressure below 100 mmHg, and/or diastolic blood pressure below 70 mm Hg) at screening, clinically relevant or history of clinically relevant arrhythmias
* Subjects with clinically relevant cardiac supraventricular or ventricular arrhythmias.
* Subjects with atrioventricular block of grade II and III, sick sinus syndrome, sinoatrial block or congestive heart failure
* Participation in a clinical drug study or bioequivalence study 60 days prior to present study.
* History of malignancy or other serious diseases.
* Any contraindication to blood sampling.
* History of i.v. drug abuse.
* Subjects with positive HIV tests, HBsAg or Hepatitis C tests or other acute, subacute or chronic infectious disease.
Lypo-hypertrofia Characterization in Diabetes

Aim/hypothesis: Subcutaneous insulin absorption is one of the factors which strongly influence blood sugar control in patients with diabetes mellitus on insulin therapy. In response, a regular absorption is influenced by lipo-hypertrophy in subcutaneous tissue on injection sites. So far lipo-hypertrophy diagnosis has only been clinical since there are no imaging studies that have characterized precisely morphometry of lipo-hypertrophic tissue. Methods: In two groups of 20 type 1 diabetes patients on insulin therapy, lipo-hypertrophy is characterized and defined by clinical tapping or by ultrasound with multi frequency linear probe (6-18 Mhz). Patients are therefore advised to avoid insulin injections on those areas so defined. Patients are reevaluated 3 and 12 months later

An observational study has been carried out, checked with parallel arms in which type 1 diabetes patients are recruited with clinical evidence of lypo-hypertrophy in insulin injected areas. Patients attend to the Diabetes Unit of Niguarda Ca' Granda Hospital. Obese patients with a thickening fat subcutaneous tissue that could have interfered with the interpreting and analyzing of the data are left out of this first study. In the control group the investigators manage to define the lypo-hypertrophic area by tapping and body inspection. In the study group the investigators can define and mark out the area/areas with lipo-hypertrophy by ultrasound scan test. All the tested patients both the control group and the study group, are discouraged from use insulin in areas where lypo-hypertrophy is present. Patients are reassessed after 3 months with a clinical assessment of glucose control by HbA1c. After 12 months subcutaneous tissue scan is repeated in 10 patients within the experimental group and a new assessment of HbA1c is performed. Ultrasound assessment. The scan used is Esaote My Lab70 linear probe multi-frequency \[6-18 Mhz)

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* age between 18 and 75 years old
* lack of extended cutaneous diseases
* BMI \<30

Exclusion Criteria:

* BMI\> 30
* active allergies
* cancer
* liver failure
* kidney failure
The Effect of Hippotherapy Simulator in Children with Spastic Cerebral Palsy

The horseback riding simulator (HRS) is a dynamic robotic device that mimics the movement of a horse for hippotherapy purposes. HRS aims to improve the patient's balance, adaptation and provide postural adjustment by mimicking the rhythmic movements of the horse.

This study aims to research the potential benefits of the horseback riding simulator on the lower extremity selective motor control, balance and trunk control in children with Cerebral palsy.

Between the dates of the study, children with Cerebral palsy (CP) who meet the inclusion criteria will be allocated into two groups (intervention group, control group) by randomiZation method.

Intervention group: horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. This group will receive 20 minutes of routine physiotherapy training and 20 minutes of HRS application in addition to 2 sessions per week for 8 weeks.

Control group: Routine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks.

All the assessments will be performed before and after the training in the 8-week groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Spastic Cerebral Palsy
* Voluntary participation
* Age between 5-17 years,
* GMFCS Level I-II-III
* MACS Level I-II-III
* Modified Asworth Scale (MAS) Level 1-2-3
* Have the ability to sit with support

Exclusion Criteria:

* Having severe visual and hearing problems
* Severe distractibility problems and inability to follow task instructions,
* Not voluntary to participate in the research,
* Individuals with CP who have had hip or spine surgery in the last 6 months
* Individuals with CP who have undergone Botox in the last 6 months
Impact of Clear Aligners and Metal Brackets on Nutritional Status

This study aims to investigate the effect of clear aligners and traditional brackets on the nutritional status of orthodontic patients. With the increasing demand for more aesthetic and comfortable orthodontic appliances among adults, clear aligner treatment has gained popularity as an alternative to traditional fixed appliances. However, limited research has been conducted to evaluate the impact of clear aligners on dietary habits and nutrition. The study will include adult participants undergoing orthodontic treatment with either clear aligners or traditional brackets. Anthropometric measurements, dietary assessments, and oral health impact evaluations will be conducted to assess the nutritional status of the participants. The findings of this study will contribute to a better understanding of the influence of orthodontic appliances on nutrition and guide clinicians in providing comprehensive care to orthodontic patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult individuals (18 - 45 years old)
* Undergoing orthodontic treatment, without missing teeth in the mouth (excluding wisdom teeth)
* Having received orthodontic treatment for more than 6 months
* Citizens of the Republic of Turkey
* Proficient in reading and writing in the Turkish language
* Not under the influence of alcohol or drugs
* Able to understand and follow instructions for filling out the questionnaire
* Willing to participate in the study

Exclusion Criteria:

* Adult individuals (18 - 45 years old)
* Undergoing orthodontic treatment, without missing teeth in the mouth (excluding wisdom teeth)
* Having received orthodontic treatment for more than 6 months
* Citizens of the Republic of Turkey
* Proficient in reading and writing in the Turkish language
* Not under the influence of alcohol or drugs
* Able to understand and follow instructions for filling out the questionnaire
* Willing to participate in the study
Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease experiencing abdominal pain.


Eligibility Criteria:
Key Inclusion Criteria:

* A clinical diagnosis of Crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with Crohn's disease.
* Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple endoscopy score for Crohn's disease (SES-CD) score of \< 10 or fecal calprotectin \< 500 mcg/g within 4 weeks before Screening.
* Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of \>/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).

Key Exclusion Criteria:

* Female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
* Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial infarction, unstable angina.
* Other significant chronic pain conditions that in the opinion of the Investigator may influence the abdominal pain score.
* History of extensive colonic resection, subtotal or total colectomy.
* History of \>3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization.
* Chronic active hepatitis B within the last year (unless shown at the time of study entry to be hepatitis B antigen negative) or any history of hepatitis C.
* Evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening.

Note: other protocol defined Inclusion/Exclusion criteria may apply.
Self-contamination Following Removal of Two Personal Protective Equipment Suits: a Crossover Trial

Anesthesiologists and other professionals are at high risk of viral infection during aerosol-generating procedures. Knowledge of the protective quality of PPE suits and the risk of self-contamination after removal is paramount. This trial used an ultraviolet-fluorescent solution to explore differences in self-contamination after removal of gown PPE (PPE-G) and coverall PPE (PPE-C). A two-period/two-intervention (AB/BA) design was chosen; each intervention consisted of audio-guided placement of PPE, full-body spraying of fluorescent solution, audio-guided removal of PPE, and assessment of self-contamination through ultraviolet light scanning. The primary outcome was the mean within-participant difference (traces of any size) between PPE suits. Statistical significance was tested using t test for paired data.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology Department member (Hospital Italiano de Buenos Aires, Buenos Aires, Argentina), participation in the PPE training workshop.

Exclusion Criteria:

* Refusal to participate in the study
* Known allergy to any of the components of the fluorescent lotion
Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland

The purpose of this study is to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at the investigators' clinic. The further purposes are to identify the population at risk for vitamin D deficiency and to analyse whether vitamin D deficiency is associated with pregnancy complications.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending prenatal care at our clinic who had a vitamin D blood-testing at admission

Exclusion Criteria:

* Pregnant women lost to follow-up, Birth outside our clinic