cyrilzakka/clinical-trials huggingface dataset:
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.

The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines.

There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females, 18 - 75 years old.
2. Diagnosis of chronic spontaneous urticaria (CSU) despite the use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists, as defined by:

   1. Diagnosis of CSU for \>/= 6 months.
   2. The presence of itch and hives for \>/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines.
   3. UAS7 of \>/= 16 and HSS7 of \>/= 8 during the 7 days before treatment
   4. In-clinic UAS \>/= 4 on one of the screening visit days
   5. Use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists for at least 3 days immediately prior to study entry and throughout the study.
3. Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
6. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.

Key Exclusion Criteria:

1. Women who are pregnant or nursing.
2. Cleary defined cause for chronic urticaria.
3. Known HIV, hepatitis B or hepatitis C infection.
4. Vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza for injection.
5. History of anaphylaxis.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study

The aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. The investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. Participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. If they so wish, participants will be able to take part in a transcranial magnetic stimulation (TMS) study to assess the facilitation of cortical excitability due to the haptic effect.

Firstly, the investigators would like to carry out a study into the validity of measuring haptic deficits using vibro-tactile sensors positioned on the hands of chronic stroke patients and young and elderly healthy subjects. They believe that identifying the haptic deficit using a simple and rapid method, in combination with motor training, could make it possible to improve the prediction of recovery and personalise the rehabilitation of manual dexterity deficits after stroke. They will also compare the effect of tactile feedback with that of auditory feedback in order to study the specificity of the effect of this feedback on manual dexterity. In the second part, to better understand this and to study the cortical mechanisms involved in sensory-motor integration, the investigators propose to measure the haptic effect on cortical excitability in stroke patients and healthy subjects using Transcranial Magnetic Stimulation (TMS).

Eligibility Criteria:
Inclusion Criteria for healthy controls:

* between 18 and 40 years old
* or age and sex match with chronic stroke patients
* Ability to perform motor, cognitive (MOCA score ≥26/30) and sensory assessment

Inclusion Criteria for chronic stroke patients:

* More than 18 years old
* Ability to perform motor, cognitive (MOCA score ≥26/30) and sensory assessment
* First symptomatic stroke more than 6 months ago
* Upper limb paresis (≤4/5 on the MRC scale)
* Feel ≥3/6 touch on the index and thumb fingers
* Box and Blocks test score between 1 and 54 blocks / min

Exclusion Criteria:

* Contraindication to TMS (epilepsy, metal implants)
Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.

Offspring from overweight or obese mothers appear to be at up to 38% increased risk of being admitted to the neonatal intensive care unit than the offspring of mothers with a normal BMI. In terms of Apgar scores at birth, babies of obese mothers have been reported to have a 31% excess risk of having a low Apgar score (defined at \<7 at 1 minute) . Infants born to obese mothers demonstrate a spectrum of outcomes, suggesting that there is a complex interplay of factors that defines the precise altered metabolic environment to which the fetus is exposed and that determines the risk of complications

The investigators need to improve understanding of the specific molecular factors that contribute either individually or synergistically to detrimental fetal outcomes. Moreover, The investigators need to identify the essential maternal markers that need to be tightly regulated during pregnancy to improve outcomes. Here in, The investigators discuss the influence of maternal obesity and factors associated with the obesogenic intrauterine environment on fetal lung development and respiratory outcomes in offspring at birth importantly, The investigators identify a series of molecular changes encountered during pregnancy that may program the observed respiratory outcomes in clinical practice. The effects of maternal obesity on severe neonatal asphyxia may be partly explained by traumatic labor, which often results from macrosomia. Another consequence of maternal obesity is fetal hyperinsulinemia, which may be related to chronic hypoxia even without diabetes . Other mechanisms that explain the effect of maternal obesity on neonatal asphyxia include lipotoxicity, placental inflammation and vasculopathy, and cord coiling. Evidence has demonstrated altered gene expression in full-term newborns of mothers with obesity, involving dysregulation of brain development, inflammatory and immune signaling, glucose and lipid homeostasis, and oxidative stress

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 - 40 years.
2. Term pregnancy (37 weeks gestation or more)
3. Singleton pregnancy
4. Cephalic presentation at time of delivery
5. In labour

Exclusion Criteria:

1. Any medical disorders that affect neonatal outcomes (diabetes mellitus, hypertension, mixed connective tissue disorders)
2. Scarred uterus (myomectomy, previous cesarean section)
3. Macrosomic baby\>4 kgs
4. Condition jeopardizing the maternal or fetal life (for example: antepartum hemorrhage, pathological CTG, cord prolapse)
5. Liquor abnormalities (oligohydramnios or polyhydramnios).
6. Other indications for cesarean sections for example: placenta accreta spectrum
7. Smokers.
8. Any abnormalities in follow up of delivery regarding partogram.
Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both

The aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP injections alone and collagen injections alone.

BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%). Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes and their incidence increases significantly with age (up to 30% over 60). One of the factors contributing to the injury is a negative collagen balance and slowed tendon metabolism in proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative origin is the first choice management, but there are no clear guidelines. External supply of collagen and PRP could potentially counteract these processes.

AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP alone, collagen alone in the treatment of PTRCI.

DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Three groups of patients (each group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each group treated by three ultrasound guided injections into the shoulder bursa every consecutive week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B - collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary control tools: percentage of patients where the RC continuity were preserved and percentage of patients who had ultrasonographic signs of RC regeneration (crossection width increase, improvement of echogenicity) during the observation period between W0 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* clinical signs and symptoms of rotator cuff pathology
* an adult person consenting to injections
* partial thickness rotator cuff injury confirmed by ultrasound examination without coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage OA)
* no traumatic event
* no injections or any other local treatment in previous 1 month

Exclusion Criteria:

* full thickness rotator cuff injury
* acute, traumatic injuries requiring surgical treatment
* coexisting injuries of the shoulder joint requiring other intervention
* severe pathologies of the shoulder of another origin (systemic inflammatory disease, malignancy, severe stage OA)
* no consent
Optimal Tube Feeding Method in Head and Neck Cancer Patients

The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.

It is a great challenge to maintain the nutritional status of the head and neck cancer (HNC) patients through treatment advances such as combined chemoradiation therapy or CRT. For all these reasons, HNC patients undergoing treatment, frequently require alternate methods of nutrition support such as as enteral tube feeding via a gastrostomy tube.Upon gastric tube feeding initiation, the registered dietitian (RD) must consider the three different methods: bolus (using a syringe), gravity (using gravity feeding bags), and pump (using a tube feeding pump).

Typically, patients are started on bolus (OPTION A), changed to gravity (OPTION B) if bolus feeds are not tolerated, and ultimately changed to pump (OPTION C) if gravity feeds are not tolerated. The concern is that in this process of starting with OPTION A, and moving to OPTION B or further to OPTION C, the patient may experience unintentional weight loss and dehydration related to tube feeding intolerance and/or tube feeding inadequacy. Consequently, this places the patient at risk of, but not limited to, hospital admission for dehydration and/or malnutrition, and treatment interruption. Therefore, exploring the idea of an optimal feeding method and starting patients on it from the beginning, may improve patient outcomes in terms of nutritional status.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 18 years or older
* Diagnosis of SCCHN undergoing concurrent chemoradiation therapy (including patients who received induction therapy upfront

Exclusion Criteria:

* Patients who have a small bowel feeding tube (only tube feeding via pump is allowed in this case)
* Patients with history of gastric surgery which may have resulted in altered gastrointestinal function
* Patients with history of uncontrolled diabetes and/or gastroparesis which may interfere with gastric emptying and inability to tolerate bolus feeds
* Patients at high risk of aspiration in which case slower feeds by using gravity or pump are indicated
ClearSight System CHN Study

The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The results of this study may be used for registration and regulatory submissions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age
* Subjects provide written informed consent prior to trial procedures
* Subjects' height and weight must be accurately obtained prior to study start.

Exclusion Criteria:

* Aortic or tricuspid valve regurgitation
* Aortic stenosis or aneurysms
* Cardiac rhythm disorder
* Patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud's or Buerger's disease or with extremely cold hands
* Inability to place the finger cuff appropriately due to subject anatomy or condition
* Known pregnancy
* Patients being treated with an intra-aortic balloon pump
* Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
* Intracardiac shunt
Understanding Mechanisms of Health Behavior Change

This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically fruit and vegetable consumption. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards. The study will also examine how cognitive and anthropomorphic factors may contribute to intervention response and the effects on psychological constructs.


Eligibility Criteria:
Inclusion Criteria:

* Consume fewer than 3 servings/day of fruits and vegetables
* Daily access to internet for 3 weeks following baseline session
* Have or are willing to create an account on PayPal
* BMI greater than or equal to 25, from self-reported height and weight

Exclusion Criteria:

-
Single Ascending Dose Study of WAL0921 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing
2. Healthy individuals without known current or chronic medical conditions in the opinion of the Investigator
3. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2

Exclusion Criteria:

1. Clinically significant findings in physical examination, vital signs (blood pressure, heart rate, and body temperature), ECG, and safety laboratory parameters at screening in the opinion of the Investigator
2. Renal function calculated by the CKD-EPI (2021) equation with eGFR \<90 mL/min/1.73 m2 at the time of screening
3. Abnormal levels of proteinuria detected on Urine Protein-Creatinine Ratio (UPCR) test \>0.30 g/g
4. Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems
A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany

This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Samples derived from men and women of age greater than or equal to (\>/=) 18 years
* Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or
* (Histo-)Pathological work-up of the tumor sample as at or after start of this study
* Available information on the year of birth of the participant
* No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up.

Exclusion Criteria:

* Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up.
* Samples derived prior to the start of this study.
Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, active controlled study.

Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. Study design: phase 2, double blinded, randomized, active controlled.Ninety patients with malignant pleural effusion, who meet the study inclusion criteria and none of exclusion criteria, will be randomized into 3 treatment groups: rAd-p53, cisplatin, and rAd-p53 combined with cisplatin. The study endpoints are objective response rate, Karnofsky score, effusion-free survival, and safety.

Eligibility Criteria:
Inclusion Criteria:

1. histopathologically diagnosed original cancer with malignant pleural effusion;
2. 18 years or older;
3. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
4. signed the informed consent form

Exclusion Criteria:

1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.
Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.

Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.

The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena, Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered vaginally will be invited to participate in the study. Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded. The patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops containing computer-generated codes. The primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of \< 300 mL of blood during the first hour after enrollment. The secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL), changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication.

Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.

Eligibility Criteria:
Inclusion Criteria:

* primary atonic postpartum hemorrhage after vaginal delivery

Exclusion Criteria:

* Patients who delivered by caesarean section
* Retained placenta
* Traumatic postpartum hemorrhage
* Associated coagulopathy
* Chronic medical illness (hepatic , renal diseases)
* Refusal to participate in the study.
Atrioventricular Node Ablation in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure

The purpose of this study is to determine whether cardiac resynchronization therapy (CRT) is superior to interventricular right ventricle (RV) septal pacing in respect of reverse remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)


Eligibility Criteria:
Inclusion Criteria:

* Age of 18-75 years
* CHF II-III NYHA
* Persistent/permanent AF requiring AV node ablation
* LVEF \< 45%
* Signed informed consent
* Able to complete all testing required by the clinical protocol

Exclusion Criteria:

* Myocardial infarction or stroke less than 3 months prior to randomization
* Patients who require revascularization, radiofrequency ablation of pulmonary veins and substrate of AF
* The congenital and acquired heart diseases, LV aneurysm, which requires a surgical correction
* Active inflammatory and autoimmune diseases of a myocardium
* The thyrotoxicosis
* The diseases that limit life expectancy (cancer, tuberculosis, etc.)
* Contraindications to anticoagulants administration at CHADS2\> 2
* Uncompliant patients