cyrilzakka/clinical-trials huggingface dataset:
Valuation of the Evolution of Passive Mobility in the Spastic Upper Limb After Injection of Abobotulinumtoxin(Dysport®)

Assessing the objective measurement of passive joint mobility (ROM) in the spastic upper limb with Jost's pattern III in patients with post-stroke spasticity after infiltration with BoNT-A allows to objectify the increase in passive joint balance (ROM).

Changes in joint mobility in patients with post-stroke upper limb spasticity after infiltration of botulinum toxin type A.

The spasticity pattern that will be evaluated will be pattern number III based on the classification of Jost et al. Joint mobility will be measured with the Lynx instrument (DyCare)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years.
* Hemiplegic patients with post-stroke upper limb spasticity affected by pattern III1 who have undergone at least 2 cycles of previous treatment with BoNT-A
* Patients with a MAS scale (Modified Ashworth Scale) between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
* Patients with Hackett ultrasound qualitative scale between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.

Exclusion Criteria:

* Patients who do not wish to sign the informed consent.
* Prior lack of primary or secondary response to any BoNT-A for any specific condition or known sensitivity to BoNT-A or any excipient.
* Routine or prescribed treatment with any medication that directly or indirectly interferes with neuromuscular function in the last 3 months prior to study botulinum toxin treatment.
* Having undergone surgery on the muscles, ligaments, tendons, nerves or bones of the limb to be treated.
* Any medical condition or analytical finding that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of the study protocol or exclude the administration of BoNT-A.
* Treatment with an investigational new drug in the 4 weeks or 5 half-lives prior to screening to enter the study.
* Pregnancy.
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive Bladder caused by neurological condition
* Patient has predominance of stress incontinence
* Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening
* Previous use of solifenacin
* History or evidence of pelvic or urological abnormality
* Previous use of any botulinum toxin of any serotype for any urological condition
* Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Comparison of Coenzyme A and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia

The purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in Chinese patients with moderate dyslipidemia.

Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule by comparing with fenofibrate.

Eligibility Criteria:
Inclusion Criteria:

* TG 2.3～6.5mmol/l
* 18-75 years of age

Exclusion Criteria:

* TC \>7.0 mmol/l;
* Body Mass Index \> 30 kg/m2
* drug induced secondary hypercholesterolemia (such as dibenzothiazine, contraceptive agent or adrenal cortex hormone)
* pregnancy
* acute coronary syndrome, acute myocardial infarction or undergone a revascularization procedure within 6 months
* acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 3-fold the upper normal limit
* nephrotic syndrome or serum creatinine (Cr) (≥179 µmol/L) and creatine •phosphokinase (CK) more than 3-fold the upper normal limit
* primary hypothyroidism
* psychiatric patients
* poorly controlled hypertension, as indicated by a Systolic Blood Pressure \>180 mmHg or Diastolic Blood Pressure \>110 mmHg
* Type I diabetes mellitus（DM）, poorly controlled Type II DM (BS\>11.0 mmol/L ) or Type II DM with LDL-C \>2.6 mmol/L.
* using immunosuppressive drugs, prohibited medication or other lipid-lowing drugs
Women's Perception of Respectful Maternity Care, Birth Experiences and Perception of Traumatic Birth

The effect of the ıntrapartum care model given in line with the world health organization (WHO) recommendations on women's perception of respectful maternity care, birth experiences and perception of traumatic birth

The research is a randomized controlled trial. The research will conducted with 124 primiparous pregnant women (intervention group n=62, control group n=62) who were hospitalized in the delivery unit of Aksaray Training and Research Hospital between September 2023 and January 2024. The pregnant women in the intervention group will given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group will received only the standard intrapartum care in the hospital. Data will be collected using the personal information form, birth follow-up form, respectful maternal care scale, birth experience scale, and traumatic birth perception scale.

Eligibility Criteria:
Inclusion Criteria:

* Those who are 18 years of age or older,
* Those who are in term pregnancy (38-41 weeks),
* Those who are primiparous,
* Those who have a single, healthy, vertex positioned fetus,
* Those who have cervical dilatation of 5 cm or more,
* Those who can speak and understand Turkish,
* Those who voluntarily agree to participate in the research.

Exclusion Criteria:

* Those with chronic diseases (hypertension, diabetes, etc.),
* Those with a diagnosed mental illness (depression, anxiety or other psychotic disorder, etc.),
* Those with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, intrauterine growth retardation, fetal anomalies, intrauterine death, macrosomic baby, cord prolapse, etc.),
* Those with any complications that prevent vaginal birth (cephalopelvic disproportion, etc.),
* Elective cesarean section,
* Those who became pregnant with assisted reproductive techniques,
* Those who received childbirth preparation training.
Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.

The optimal timing for clamping the umbilical cord after birth in preterm infants has been a subject of controversy and debate for many years. It has been until recently the standard practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for immediate transition resuscitation of the neonate, especially in preterm infants. Due to the fact that optimal timing for cord clamping has yet to be definitively established in the preterm population, more information is needed. Immediate cord clamping, however, could preclude the infant from an extra boost in blood volume that may prove beneficial later in the newborn life. Directly comparing the recently recommended practice of delayed umbilical cord clamping to milking the umbilical cord prior to clamping has the potential to prove beneficial for the neonates in question, as well as change daily obstetrical practices. In this study all infants below 34 weeks will be randomized into one of two groups: delayed cord clamping and milking the umbilical cord prior to clamping. The decision was made not to include immediate cord clamping due to a recent American Congress of Obstetricians and Gynecologists (ACOG) recommendation that all preterm infants have their cord clamping be delayed. Their outcomes will be measured by serial hemoglobin and hematocrit levels while in the NICU, the incidence of necrotizing enterocolitis, incidence of intraventricular hemorrhage, and the need for neonatal blood transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Labor \& Delivery at Good Samaritan TriHealth Hospital in Cincinnati, Ohio with expected/possible preterm delivery between 23-34 weeks gestation
* Care provided by Good Samaritan TriHealth Hospital's Faculty Medical Center or Tri-State Maternal Fetal Medicine

Exclusion Criteria:

* Declined to participate
* Known congenital anomalies
* Precipitous delivery preventing completion of the protocol
* Placental abruption around the time of or as indication for delivery
* Mother has uterine rupture
* Non reassuring fetal heart tracing (FHT) immediately prior/leading to delivery
* Multiple gestation
* Parvo B19
* Infants known to be at risk of anemia due to isoimmunization (mother has red blood cell antibodies
PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, aged ≥ 18 years at time of consent.
* Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.
* Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) PsA at time of screening.
* Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
* May not have axial involvement alone
* Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine
* Have ≥ 3 swollen AND ≥ 3 tender joints.
* Males \& Females must use contraception
* Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.

Exclusion Criteria:

* Pregnant or breast feeding.
* History of allergy to any component of the investigational product.
* Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.
* Therapeutic failure on \> 3 agents for PsA or \> 1 biologic tumor necrosis factor (TNF) blocker
Management of Retained Placenta With the "Windmill" Technique of Umbilical Cord Traction

The incidence of leftover placenta after vaginal delivery is between 0.1% and 3.3%, with a maternal mortality of up to 10% reported. The traditional management is ultimately the manual removal of the retained placenta (MROP) in the operating room. However, MROP itself increases the risk of further bleeding, postpartum infection, uterine perforation and inversion of the uterus. In a preliminary study with a small cohort, the "Windmill Technique" has already been successfully tested.

The Windmill technique of placenta development for the management of the retained placenta involves the application of a continuous 360-degree umbilical traction force with centripetal rotation in such a way that it runs at the level of the introitus perpendicular to the direction of the birth canal.

The aim of this prospective randomized study is to compare the Windmill placental development technique with traditional placental development strategies. It also analyzes the need to carry out MROP in both groups.

The primary objective of the study is to compare the success rate of removing the placenta in retained placenta pregnancies between the Windmill technique and the control group. Based on this objective, we expected the difference of success rate between groups of 30% (from the previous study, the success rate of the Windmill technique was 86%\]. The sample size of 35 participants per group will be required to provide 90% power at a 0.05 two-sided significance level.

Eligibility Criteria:
Inclusion Criteria:

* Presence of the written consent of the patient
* The patients must be over 18 years old
* Patients are not limited in their ability to consent

Exclusion Criteria:

* Age under 18
* Limited ability to work
* Known coagulation disorder
* Blood loss\> 500ml
* Known placenta accreta
* No extension of the umbilical cord on traction.
Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality

A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution

Of the annual four million neonatal deaths, 99% occur in developing countries, and more than one-third globally can be attributed to infections. In areas with high-mortality rates, the proportion attributable to infections is as high as 50%. Many infections in infants can be prevented or treated with already existing measures, yet finding the best way to provide these measures in communities that are limited in resources need to be identified. Applying chlorhexidine to the umbilical cord of newborns may be a simple way to help reduce neonatal mortality and morbidity in the community at low cost.

A study by our group was recently completed in Nepal. It was a large community-based, factorial-designed trial in southern Nepal to: (1) assess the impact of newborn total body skin cleansing with 0.25% chlorhexidine on neonatal mortality and morbidity and (2) assess the impact of cleansing of the umbilical stump with 4% chlorhexidine on omphalitis and neonatal mortality.

The results of these studies have suggested that chlorhexidine antisepsis interventions may significantly reduce neonatal mortality and omphalitis. A single full body cleansing of the neonate with chlorhexidine as soon as possible after birth reduced mortality among low birth weight (LBW) infants by 28%. Repeated cleansing of the umbilical stump with chlorhexidine reduced the rate of severe cord infection by 75% and, if this treatment was begun within the first 24 hours following birth, reduced neonatal mortality by 34%.

In rural Bangladesh, over 90% of women deliver at home with only untrained local women or family members in attendance, and low birth weight babies are delivered approximately 30% of the time. The overall neonatal mortality rate exceeds 36 per 1000 live births and in order to reduce this burden, simple, cost-effective interventions that can be delivered at the community level are urgently needed. Given the potential impact of repeated chlorhexidine cleansing of the cord demonstrated in the Nepal trial, a replication study of this regimen and further investigations of more simple regimens are necessary. The number of treatments necessary to reduce neonatal mortality has important programmatic implications for who can deliver the intervention, and how it is packaged.

Eligibility Criteria:
Inclusion Criteria:

* live-born infants delivered in one of three upazillas of Sylhet District (Zakiganj, Khanaighat, Beanibazar)
* married women of reproductive age within their individual target areas listed above

Exclusion Criteria:

* individuals outside of the target area in Sylhet(Zakiganj, Khanaighat, Beanibazar)
* infants not met at home by a project worker during the first seven days of life
Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation

Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.

Prospective double dummy triple blind study of 159 patients undergoing CPB; randomised in 3 groups treated with iron intravenously (iv) (group I), with iron orally (group II) controlled with placebo (group III). Patients from group I were treated with iv Iron sucrose , three doses of 100 mg of iv iron every 24 hours during postoperative hospitalization and 1 pill/24 h of oral placebo during the first month after discharge. Group II was programmed to receive 1 iron pill orally every 24 hours pre and postoperatively and up to one month after discharge and a placebo while hospitalized. Group III was programmed to receive an oral and iv placebo pre and postoperatively.

Variables were collected preoperatively, at operation room and at Intensive Care Unit admission and discharge, at postoperative floor discharge and at one month after surgical discharge.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* Patients subject to elective cardiac surgery under extracorporeal circulation
* Patients without previous anaemia, susceptible of treatment
* Patients without need of blood transfusion preoperative
* Patients providing written informed consent
* Patients who are able to complete all study visits per protocol

Exclusion Criteria:

* Patients subject to elective cardiac surgery, but without extracorporeal circulation
* Patients who were treated with fibrinolytic therapy 48 hours before the surgery
* Patients with history of impaired renal function, (e.g., calculated creatinine clearance \<50 mL/min/1.73 m2)
* Patients operated of active endocarditis
* Redo-surgery patients
* Women who are pregnant or lactating
* Patients with clinical of digestive bleeding
* Patients with vitamin B12 deficit
* Patients with ferropenic anaemia
* Patients with clinical history of asthma or allergy
* Patients with active infection
* Patients who are included in another clinical study
* Patients with hepatic disease
* Patients with history of allergy to iron
* Patients unlikely to adhere to protocol follow-up
Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA

Nucleix EpiCheck® tests analyzes the methylation pattern in a panel of DNA methylation biomarkers and determines whether this pattern is consistent with cancer under test or with non-cancer tissue.

This study is being performed as part of the development process of the Pan Cancer EpiCheck test which includes the identification of different methylation profiles in various cancer types and healthy controls.

The aim of this study is to characterize methylation patterns that will distinguish cancer from normal samples and will be able to recognize the origin of the cancer by collecting cfDNA (circulating free DNA) from blood samples collected from patients with a new diagnosis of cancer and from healthy volunteers who do not have diagnosis or history of cancer. Identifying those methylation patterns may assist in the development of blood test that will be able to detect the presence and the origin of wide range of human cancers

Eligibility Criteria:
Inclusion Criteria - Cases:

1. Age ≥ 22 years
2. Subjects who are willing and able to provide written informed consent.
3. Subjects with confirmed diagnosis of cancer (primary or recurrent) at all stages, however did not yet undergo any surgery, chemotherapy, radiation or any other treatment for this cancerous lesion (including, but not limited to systemic therapies). Recent cancer staging should be within 60 days prior to baseline visit.

Exclusion Criteria - Cases:

1. Known prior diagnosis of cancer except of:

   1. Fully resected non-melanoma skin cancer
   2. History of the original cancer in cases of recurrent disease.
2. Current co-diagnosis of another type of cancer.
3. Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of the cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy
4. Pregnancy (by self-report)
5. Current febrile illness
6. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant

Inclusion Criteria - Controls:

1. Age 45 to 80 years
2. Subjects who are willing and able to provide written informed consent

Exclusion Criteria - Controls:

1. Known current or prior diagnosis of cancer except of fully resected non-melanoma skin cancer
2. Currently in work-up due to suspicion of cancer of any kind
3. Oral or IV corticosteroid use in past 14 days prior to blood draw
4. Pregnancy (by self-report)
5. Current febrile illness
6. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
8. Life expectancy \< 24 months
Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial

This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.

Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral area in right lateral decubiti. All solutions will have the same volume and total of calories.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy at term
* Fasted with an emptying stomach (assessed by ultrasound)
* During Labor
* No diabetes, esophageal disease, obesity
* Not emergency
* High risk of need of general anesthesia

Exclusion Criteria:

* Vomiting before the end of the protocol
* Did not drink the whole solutions
* Ultrasound not performed for any reason