cyrilzakka/clinical-trials huggingface dataset:
Hemodialysis-Induced Blood Pressure Change In End-Stage Renal Disease

Cardiovascular events are still the leading cause of mortality and morbidity in patients with ESRD including hemodialysis patients . Although the conventional risk factors of CVD are relatively recognized in general population, an inverse epidemiologic relationship has been reported for many CV risk factors in CKD patients, including hypertension, BMI and lipid profile .Therefore, a comprehensive investigation is necessary to be able to do effective risk management strategies in this population and some surrogate markers are required to be determined for illustrating the net effect of the risk factors.

While several mechanisms have been attributed to hypertension in hemodialysis (HD) patients, the exact pathogenesis, impact, monitoring and control of hypertension in HD patients are still challenging subjects in clinical nephrology. Both low and high BP associate with higher mortality in HD. But a reliable marker for defining an optimal BP in HD is still an important question.

It seems that arterial stiffness play an axial role in the cardiovascular and renal adverse outcomes in CKD and HD, as it is in several other populations , Arterial stiffness has been demonstrated as an independent predictor of mortality in hemodialysis patients . However, hemodialysis patients experience a fluctuating hemodynamic state and there are several limitations for consecutive measurement of arterial stiffness indices such as pulse wave velocity (PWV). Furthermore, the expensive measurement devices and expert operators might not be available in every dialysis center.

From 60 patients who were on a HD program in a HD center in a referral hospital, fifty one individuals were included into the study. Patients on maintenance hemodialysis, for at least 12 hours per weeks were included into the study. But, patients with symptomatic CVD, AV fistula on both arms, acute deteriorating states and any recent major trauma or patients who refused measurements were excluded. No change in their current medication was administered. All patients were on maintenance HD for at least 12 months and were assumed as good volume controlled. Dialysis protocol with a mean sp KT/V = 1.4/ session, using Bicarbonate dialysate, dialysate flow rate = 500cc /min was applied by Fresenius B 4008machine. BP was measured using a validated automated device (Omron-HBP1300). Pulse wave analysis was performed using the SphygmoCor (Sydney, Atcor Medical®,2005) to assess Augmentation Index (AIx) as a surrogate for arterial stiffness, as well as several hemodynamic measures at the recruitment and repeated in alive individuals after 5 years of follow-up. Similarly Echocardiography was employed at the beginnings and repeated at the end of the study by EKO 7 Cardiovascular Ultrasound System (Samsung Medison©). A single observerwas responsible for each series of measurements, double checked.

Eligibility Criteria:
Inclusion Criteria:

* Patients on maintenance hemodialysis for at least 12 hours per weeks

Exclusion Criteria:

* Patients with symptomatic CVD
* Recent major trauma
* Patients who refused measurements
Factors Influencing Cesarean Section Rate: Does the Audit Still Work?

To elucidate the audit's effect on caesarean section rate, and also define the factors influencing the caesarean section rate.

From Jan 2007 , pregnant women who delivered in a medical center will be included retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the indications of cesarean section, began from July 2008. Clinical data, indications of cesarean section, and perinatal outcomes were compared between the cases of before and after the audit. Multivariate logistic regression was performed to identify factors affecting cesarean section rate.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who delivered in a medical center will be included retrospectively in this study

Exclusion Criteria:

* All pregnant women who delivered in a medical center will be included retrospectively in this study , no exclusion criteria
Aerobic Exercise and Neck Exercises in Pediatric Migraine Treatment

This randomized controlled single-blind trial will include 60 pediatric migraine patients. Participants will be divided into two groups: one performing aerobic exercise, and the other conducting neck exercises. Assessments include attack frequency, severity, duration, and neck pain over three months.


Eligibility Criteria:
Inclusion Criteria:

- Pediatric Migraneurs, as per International Classification of Headache Disorders-3 guidelines

Exclusion Criteria:

* individuals with any other concomitant headaches
* those showing findings beyond nonspecific hyperintense areas on cranial Magnetic Resonance Imaging
* patients with systemic diseases other than migraine, such as fibromyalgia
* individuals who had experienced treatment changes or required treatment changes within the last month
* limited mental capacity or psychological illnesses that could hinder their participation in surveys and exercises
* a history of increased attack frequency or severity with previous physical activity program involvement, or a history of trauma to the neck or face
* individuals with a history of a herniated disc in the cervical region or symptoms of cervical radiculopathy
Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

This study aims to survey the drug disposal methods of orthopedic foot and ankle patients with excess pain medication following and operation. The study is a randomized control trial comparing the use of FDA approved at home disposal methods to current clinical methods of recommending disposal at medication drop off locations.


Eligibility Criteria:
Inclusion Criteria:

* This study will include foot and ankle orthopedic patients at Brigham and Women's Hospital undergoing a surgical procedure.

Exclusion Criteria:

* Those under age 18 will be excluded from this study, as their variation in care could affect the data. We will also exclude adults with impaired decision-making capacity and adults who take methadone or have a history of prior opioid dependence.
Exercise Training in Asthma Children

The purpose of this study is to assess the effects of a physical training program with active video game in inflammatory markers, quality of life variables , clinical control and physical and functional respiratory assessment of asthmatic children from 5 to 11 years.

The aim of the present study will be to determine whether an aerobic exercise using an active video game system improves asthma control, lung inflammation and functional capacity in children with moderate or severe asthma.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5 to 11 years;
* Having a diagnosis of asthma, according to the criteria of the National Heart, Lung, and Blood Institute, and
* Not be included in any program of regular physical activity.

Exclusion Criteria:

* Having received aminophylline and theophylline or oral corticosteroids in the last 30 days;
* Respiratory infection have shown over the past two months;
* Have done with inhaled bronchodilator in less than 12 hours before the assessment;
* Inability to perform any of the tests;
* Have heart disease of inflammatory origin, congenital or ischemic;
* Being in the presence of any infectious process with fever and
* Do not agree to the terms of consent
An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.


Eligibility Criteria:
Inclusion criteria:

1. Written ICF signed voluntarily before the first trial related activity.
2. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during the last 6 months
3. Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.
4. ≥3 days per week with heartburn and/or regurgitation symptoms of at least moderate severity and a minimum of 25 liquid containing reflux events over 24h (pH/MII monitoring).

Exclusion criteria:

1. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
2. Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic, cancer or AIDS.
3. Alarm symptoms suggestive of malignancies or organic disease.
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Primary Objective:

To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).

Secondary Objectives:

To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.

To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

* Systemic exposure
* Anti-drug antibodies
* Biomarkers

A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval.

Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.

Eligibility Criteria:
Inclusion criteria:

- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.

Exclusion criteria:

- Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant.

The above information was not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Implementation of a Telehealth Palliative Care Model for Persons With Dementia

Grounded in the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Model, this study will assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention for persons living with dementia (PLWD) and their care-partners newly admitted to nursing homes (NHs) for post-acute care.

This single arm embedded pragmatic pilot clinical trial will provide data to assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention among 30 persons living with dementia (PLWD) and their care-partners newly admitted to one nursing homes (NH) for post-acute care.

Eligibility Criteria:
Inclusion Criteria:

Stakeholders:

* (1) PC provider
* (2) Social Work (SW) NH champions
* (3) post-acute care unit nursing staff and providers (including medical directors)
* (4) NH leadership, information technology staff
* (5) PLWD and their care partner(s).

Person Living with Dementia (PLWD)

* documented dementia diagnosis
* admitted for post-acute care
* age ≥ 60 years
* if unable to participate in a conversation or lacking capacity to make healthcare decisions as determined by the NH staff/providers, a care partner who can act as a surrogate decision maker in the PCC-PAC.

Exclusion Criteria:

Stakeholders:

-PLWD who receives the intervention

PLWD:

* planned discharge within 48 hours of screening
* currently receiving hospice care
Effect of Antioxidant Food Supplement on Sperm Proteomic Structure and Semen Parameters

Infertility is defined as the inability to become pregnant despite 12 months of regular and unprotected intercourse. Male factors include defects in sperm concentration, morphology and motility, among which low sperm motility (asthenozoospermia) is one of the most common types of male infertility and affects approximately 40% of all cases.

It has become clear that protein defects in spermatozoa and semen can cause fertilization failure by affecting sperm motility, and it is necessary to define proteins and related pathways precisely because they have an important role in the treatment phase.

Increasing evidence shows that free oxygen radicals that occur as a result of oxidative stress (OS) play a very important role in the etiology of male infertility.

A systematic review including 29 studies (19 randomized clinical trials and 10 prospective studies) examined the effect of antioxidant food supplementation and reported a positive effect on baseline semen parameters, advanced sperm function, outcomes of assisted reproductive therapy, and live birth rate.

Conversely, few studies have failed to confirm any positive effect of antioxidant therapy and even report a negative effect on male fertility. Therefore, there is no clear consensus on the clinical efficacy of antioxidant therapy yet.

Since the pathogenesis has not yet been clearly demonstrated, treatments are not based on evidence, but based on clinical experience.

Our aim was to randomly divide infertile male patients who applied to our clinic with the complaint of infertility and found asthenozoospermia (restricted sperm motility) in their semen analysis into two arms and examine the effects of antioxidant food supplementation on sperm motility and proteomic structure with a placebo-comparative, prospective, double-blind study (LC-MS/MS). analysis) is to reveal the metabolic pathways that may lead to restriction of movement. The effect of antioxidant food support on sperm parameters and free oxygen radical levels in the control spermiogram after 3 (three) months of treatment to be given to the patients will be measured by ELISA method and compared with pre-treatment values.


Eligibility Criteria:
Inclusion Criteria:

1. Being in the age range of 20-40
2. Be infertile ( 12 months intercourse without any contraception)
3. Due to infertility, you should apply to us and have a spermiogram detection of asthenozoospermia
4. Patients whose spouses have normal gynecological examinations
5. Patients with normal physical examinations
6. Patients with normal hormonal values (FSH, LH,PRL,Testosterone,Estrogen) -

Exclusion Criteria:

1. previous treatment for infertility
2. Previously due to infertility or for any reason take antioxidant food supplements
3. Surgery or physical examination due to varicocele detection of varicocele
4. Detection of endocrine disorder (Defect in serum blends)
5. Smokers and alcohol addiction
6. Detection of infection in the genital tract
7. Having a chronic illness -
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine.

To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.

To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points.

To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.

An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.

Eligibility Criteria:
Inclusion Criteria:

* 15 to 70 years old
* Migraine attacks according to the criteria proposed by the IHS
* 3-12 Migraine attacks per month
* adequate contraception
* Willing and able to give written informed consent
* Willing and able to complete the entire course of the study \& comply with instructions
* Stable dose of preventive medication for at least 4 weeks

Exclusion Criteria:

* Disorders listen in groups 5-11 of the IHS Classification
* Subject is pregnant or lactating.
* Significant medical or psychiatric disease
* Subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including Prinzmetal angina, claudication, Wolff-Parkinson-White syndrome, or other cardiac accessory conduction pathway arrhythmia
* Subject has uncontrolled hypertension.
* Subject has history of basilar, ophthalmoplegic, or hemiplegic migraine or serious neurologic condition associated with headache
* Subject has used monoamine oxidase A inhibitors (MAOI-As) within 2 weeks of randomization
* Subject has had serious adverse event while using another 5-HT agonist, or previous serious adverse event while using zolmitriptan or hypersensitivity to zolmitriptan or eletriptan
* Using CYP3A4 inhibitors listed by the FDA as contraindicated with eletriptan
* Moderate/severe hepatic/renal impairment
* Subject currently using cimetidine
* Concomitant medication treatment with a triptan, ergotamine or methysergide.
The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.

- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in primary anterior teeth pulpotomy and follow up after 3 , 6 , 12 months ( Clinically and Radiographically) : Group A ( Control group ) : primary anterior teeth pulpotomized by White MTA . Group B : primary anterior teeth pulpotomized by White Portland Cement .

- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in pulpotomy primary canines for serial extraction and extract them after 3 months for Histopathlogic study : Group A ( Control group ) : primary canines pulpotomized by White MTA . Group B : primary canines pulpotomized by White Portland Cement .

* Endodontic therapy for primary teeth faces several difficulties including morphology of root canals , physiological root absorption and failure to find ideal root-filling paste absorbs the same degree of root absorption .
* Pulpotomy therapy is considered easy , fast and does not include the length of canal or periapical region .
* The split mouth design will be adopted for the treated samples .
* Clinical success criteria :

  1. Absence of spontaneous or stimulant pain
  2. Absence gingival redness , swelling or fistula
  3. Physiological tooth mobility and absence sensitivity to percussion
* Radiographically success criteria :

  1. Absence periapical translucence
  2. Absence external or internal abnormal absorption

Eligibility Criteria:
Inclusion Criteria:

1. Age between 4 and 9 years.
2. Definitely positive or positive ratings of Frank scale.
3. Caries include maximum two surfaces
4. Pulp exposure during caries removal
5. Pulpal hemorrhage light red acceptable to hemostasis
6. Physiological root resorption no more than the apical third
7. Absence clinical and radiographic signs which indicate pulp necrosis

Exclusion Criteria:

1. Systematic or mental disorders.
2. Definitely negative or negative ratings of Frankel scale
3. Existence periapical translucence
4. Existence external or internal abnormal absorption
5. Existence swelling or fistula
6. Sensitivity to percussion
7. Existence of spontaneous or stimulant pain
8. Excessive movement
A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer

The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.

The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and sign an informed consent form
* Male or female ≥ 18 years of age
* Histologically or cytologically confirmed SCLC
* R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression
* At least 1 measurable lesion as defined by RECIST 1.1
* Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1
* Life expectancy of at least 3 months
* Adequate organ function as described in the protocol
* For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.

Exclusion Criteria:

* Known active leptomeningeal disease (carcinomatous meningitis)
* Known active and uncontrolled central nervous system (CNS) metastases
* Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent \< 14 days prior to initiation of study treatment
* Treatment with radiation therapy \< 14 days prior to initiation of study treatment
* Major surgery \< 21 days prior to initiation of study treatment
* Received live vaccine \< 30 days prior to initiation of study treatment, including intranasal influenza vaccine
* History of another primary malignancy with protocol-defined exceptions
* Active or history of autoimmune disease requiring systemic treatment
* Receiving high doses of steroids or other immunosuppressive medications
* Active hepatitis B or C infection
* Active or history of non-infectious pneumonitis requiring treatment with steroids
* Active uncontrolled viral, fungal, or bacterial infection including tuberculosis
* Pregnant or breastfeeding female patients
* History of severe hypersensitivity reaction to a monoclonal antibody treatment
* History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment
* History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening
* QT Corrected for Fridericia's method (QTcF) \> 470 ms at screening
* Lack of resolution of any toxicity to max Grade 1 (except alopecia)
* Active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study
* Known psychiatric or substance use disorder
* Positive Coronavirus disease 2019 (COVID-19) test at screening