cyrilzakka/clinical-trials huggingface dataset:
Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure \>140/90 mmhg) in pregnancy is classified into one of four conditions

1. chronic hypertension that precedes pregnancy
2. pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings
3. pre eclampsia superimposed upon chronic hypertension
4. gestational hypertension or nonproteinuric hypertension of pregnancy

Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure \>140/90 mmhg) in pregnancy is classified into one of four conditions

1. chronic hypertension that precedes pregnancy
2. pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings
3. pre eclampsia superimposed upon chronic hypertension
4. gestational hypertension or nonproteinuric hypertension of pregnancy evaluate the effectiveness, safety and acceptability of Oral nifedipine versus oral labetalol in treatment of persistent postpartum hypertension

Eligibility Criteria:
Inclusion Criteria:

* Women who have hypertension during pregnancy and persist after delivery till discharge of hospital about 2 days of monitoring the blood pressure

Exclusion Criteria:

Women with history of secondary hypertension Women with eclampsia who need intensive care unit admission and indicated other drugs rather than oral nifedipine and oral labetalol Women who have any contraindication to Nifedipine or labetalol
A Twelve Week Study of Supervised Mouth Rinse and Flossing

The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.


Eligibility Criteria:
Inclusion criteria:

* Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products according to instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
* Able to attend once daily session during weekdays for flossing and rinsing occurring on site
* Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
* Able to read and understand the local language (participants capable of reading the documents)
* Adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect)
* A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
* A minimum of 10 bleeding sites based on the BI
* Absence of advanced periodontitis based on a clinical examination at Baseline and discretion of the dental examiner

Exclusion criteria:

* History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
* Dental prophylaxis within four weeks prior to Screening/Baseline visit
* History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
* Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses within the two weeks prior to Baseline
Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury

The goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is:

* Which RNA, protein and metabolites are differently expressed in lesion tissues?
* What molecular mechanism is participated in TBI? Participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 and \<65
2. Within 12 hours after brain injury
3. Control group is hydrocephalus
4. GCS ≥3 and ≤8
5. Closed brain injury with frontotemporal contusion
6. Need emergency intracranial hematoma evacuating or cerebrospinal fluid shunting operation
7. Patient's agents are informed and consent the research

Exclusion Criteria:

1. With TBI, stroke, ICH or intracranial tumor history
2. Death within 24 hours
3. Immunosuppression state
4. Severe organ dysfunction
5. Complicated infective disease
6. Pregnant
Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients

The purpose of this randomized, controlled pilot study is to evaluate the performance of this novel Anemia Controller (vis-à-vis standard of care) for anemia management in hemodialysis patients. Since the Anemia Controller is designed to bring patients to a pre-defined Hgb target level and keep them there, the target population for this study are patients whose Hgb levels are currently not well-controlled (rather than patients who are already relatively stable within the Hgb target range under a standard anemia management algorithm). Specifically, therefore, the target population for this clinical study are chronic hemodialysis patients who are exhibiting Hgb cycling.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Ability to give written informed consent to the study
* End-stage renal disease treated with thrice-weekly hemodialysis for at least 180 days preceding enrollment
* Receiving intradialytic Crit-Line® monitoring, with available Crit-Line® data going back at least 180 days from the date of enrollment
* Laboratory Hgb data going back at least 180 days from the date of enrollment
* On average, Hgb values available from at least 2 treatments per week (from either source, Crit-Line® or laboratory) during the past 180 days preceding enrollment
* Renal anemia treated with intravenous Mircera®, with at least 2 Mircera® dose administrations during the 150 days preceding enrollment
* On an active Mircera® anemia management algorithm order during the 180 days preceding enrollment
* Exclusively on Mircera® (no other ESAs) during the 180 days preceding enrollment
* Pattern of Hgb cycling as defined above during the 180 days preceding enrollment

Exclusion Criteria:

* Having received the maximum Mircera® dose (225 µg every other week) consistently throughout the 90 days preceding enrollment
* Hospitalization for more than 10 days during the 30 days preceding enrollment
* Severe iron deficiency (TSAT \<20%, ferritin \<100 ng/mL) in the most recent routine blood work prior to enrollment
* Any known cause of ESA resistance other than iron deficiency and inflammatory states (e.g. hematologic malignancies, hypersplenism, antibody mediated pure red cell aplasia)
* Simultaneous participation in another clinical study that may impact anemia management or the outcomes of this trial
* Inability to communicate in English or Spanish
An Expanded Access Protocol for Sebelipase Alfa for Patients With Lysosomal Acid Lipase Deficiency

This is an open-label, multicenter expanded access protocol to allow patients with a confirmed diagnosis of Lysosomal Acid Lipase (LAL) Deficiency in the United States (US), access to sebelipase alfa (recombinant lysosomal acid lipase \[rhLAL\]) until commercial product is available.

Patients enrolled in the expanded access protocol will receive 1 mg/kg intravenous infusions of sebelipase alfa every other week.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 8 months of age at commencement of treatment with sebelipase alfa.
2. Patient has a confirmed diagnosis of LAL Deficiency.
3. Patient or patient's parent or legal guardian (if applicable) consents to participation in the study. If the patient is of minor age, he/she is willing to provide assent where required per local regulations, and if deemed able to do so.
4. Male and female patients of childbearing potential must use a highly reliable method of birth control (expected failure rate less than 5% per year) from the time they commence treatment through 4 weeks after the last dose of sebelipase alfa.
5. Women of childbearing potential must have a negative serum pregnancy test at commencement of treatment with sebelipase alfa.

Exclusion Criteria:

1. Women who are nursing or pregnant.
2. Patients who received an investigational product within 30 days (for a small molecule) or 60 days (for a biologic) of commencing treatment, and which in the opinion of the investigator or Sponsor, may negatively impact patient safety.
3. Patients who have received sebelipase alfa as part of a clinical trial that is currently active.
4. Patients with known hypersensitivity to eggs.
The Effect of Magnesium Sulfate on Motor and Somatosensory Evoked Potentials in Children Undergoing Scoliosis Surgery

The primary objective of this study is to determine whether magnesium sulfate has a clinically important effect on the amplitude and latency of somatosensory and motor evoked potentials in patients undergoing surgical correction of idiopathic scoliosis.

Motor and somatosensory evoked potentials are continuously monitored in the setting of scoliosis surgery to evaluate the integrity of spinal cord pathways. Detection of neural irritation or injury using motor or somatosensory evoked potentials allows the surgeon to modify technique to reverse the insult and proceed without spinal cord compromise. To facilitate evoked potential monitoring, anesthetic agents that attenuate the evoked responses must be avoided.Several different agents have been studied to try to diminish the acute opioid tolerance and/or hyperalgesia seen with remifentanil.

Two studies investigated the effect of magnesium sulfate on intraoperative remifentanil-induced hyperalgesia. In both studies, post-operative pain scores and opioid consumption were decreased in those patients who received magnesium.

Our aim is to establish that magnesium sulfate does not adversely affect somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) in patients undergoing correction of idiopathic scoliosis. Future clinical trials can then be performed investigating the effect of magnesium sulfate on remifentanil-induced hyperalgesia in the same population.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) status I or II
* Adolescent children aged 12 to 18 years undergoing surgery for idiopathic scoliosis

Exclusion Criteria:

* Magnesium use within the last two weeks, either intravenous or oral supplements
* Patients with known electrolyte imbalances or conduction disorders. (Sodium \<135 or \>143 mmol/L OR Potassium \< 3.7 or \> 5.0 mmol/L if 12 to 15 yrs; Potassium \<3.7 or \>4.8 mmol/L if 16 to 18 yrs)
* Renal, cardiac or neuromuscular disorders.(Urea \< 2.9 or \> 7.1 mmol/L OR Creatinine \>79 µmol/L if \< 13 yrs; Creatinine \> 98 µmol/L if \>= 14 yrs)
Relationship Between Analgesia Techniques and Post-cesarean Recovery Quality

The question remains whether the patients in whom USG-guided regional anesthesia and analgesia techniques are applied have a better recovery score than subarachnoid morphine administration, which is considered the gold standard. The primary aim of this study is to evaluate the quality of recovery score using the Obstetric Recovery Quality Score-ObsQoR-10 questionnaire experienced by the patients who underwent elective cesarean section and compare the results of different regional anesthesia techniques with subarachnoid morphine.

National and international guidelines, hospital protocols, the anesthesiologist's experience, and the patient's decision play a role in selecting the technique used for postoperative analgesia after cesarean section. The quality of recovery score experienced following elective cesarean section in a total of 180 patients over one year (December 31, 2021-2022) who applied subarachnoid morphine, lateral TAP block, posterior-TAP block, QL block, ESP block, and TFD block (30 patients for each technique) will be evaluated with the ObsQoR-10 questionnaire 24 hours after delivery. The regional anesthesia techniques information applied to the patients will be obtained from the patient file. Researchers will not perform any interventional procedure, and any randomization will not be applied. After the data collection process for the study is completed, ObsQoR-10 will be compared statistically. The secondary aims of this study are to compare the cases in terms of postoperative analgesia and antiemetic requirements, first food intake and standing up without support, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Term obstetric patients aged 18-47 years who underwent elective cesarean section under spinal anesthesia and applied regional anesthesia techniques such as lateral TAP, posterior-TAP, QL, ESP, and TFD blocks or subarachnoid morphine.

Exclusion Criteria:

* Patients with psychiatric disorders
* Patients requiring emergency cesarean section.
* Patients with additional obstetric pathology (such as placenta previa, preeclampsia, DM)
* The need for intensive care in the mother or newborn at the end of the birth.
* Patients who have undergone general anesthesia.
* Preterm pregnants
Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer

This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.


Eligibility Criteria:
Other specific eligibility criteria may apply. Examination by the investigator is necessary to fully determine eligibility.

Inclusion Criteria:

* Ability and willingness to provide written informed consent
* Histologically or cytologically confirmed solid tumors or lymphoma
* Locally advanced or metastatic disease
* Life expectancy of at least 16 weeks
* ECOG performance status of 0 or 1
* Acceptable physical exam and laboratory tests at study entry
* Willingness to use medically acceptable contraception
* A negative serum pregnancy test for women with reproductive potential

Exclusion Criteria:

* Anticancer therapy within 2 weeks
* Treatment with an investigational agent within 4 weeks
* Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy
* Known brain metastases unless stable for at least 28 days
* Active autoimmune disease
* Insulin-dependent diabetes mellitus
* Clinically significant cardiac disease within 6 months
* Significant infection or fever within 1 week
* Pregnant or breast-feeding females
* Other conditions or circumstances that could interfere with the study
Influence of Sonic Activation of Root Sealers on Post-Operative Pain

Aim: This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation.

Materials and Methods: The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis. They were randomly divided into 4 groups according to the root canal sealer (AH Plus or Endosequence BC) and activation protocol (sonic activation or non-activation) (n=18). Participants were ask to rate their post-operative pain intensity on a NRS scale as none, minimal, moderate, or severe after 24 h, 48 h, 72 h and 7 days following treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. The collected data were statistically analyzed at 0.05 significance level.

Root Canal Treatment After inferior alveolar nervus block anesthesia with 4% Articaine with 1:100,000 adrenaline, the tooth was isolated with a rubber dam. The access cavity was opened using high-speed diamond round burs under water cooling. The working length (WL) was set at 0.5 mm shorter than the 0.0 reading using a 15 K-type file and apex locator (Morita Root ZX, Japan) and checked with radiographs. The root canals were prepared with Resiproc (Resiproc, VDW, Munich, Germany) R25 and R40 files, respectively, at the WL using the crown down technique. A total of 20 mL of 2.5% sodium hypochlorite (NaOCl) was used with a 30-gauge needle (Max-i-Probe; Dentsply Sirona) during preparation. 5 mL of distilled water was left in the canal for 1 min to neutralize the effect of NaOCl, and then the root canals were irrigated with 3 ml of 17% ethylene diamine tetra acetic acid (EDTA). EDTA was activated for 3 × 20s with the EA 25/04 tip 2 mm shorter than the WL. The EA tip was used with 2-4 mm vertical strokes. The root canals were irrigated with 5 mL distilled water and dried with paper points.

The subjects were divided into four groups for root filling. Randomization was performed using online software (www.randomizer.org) with a four-block-sized block randomization technique to ensure even distribution between the groups (allocation ratio 1:1:1:1). A co-investigator managed the allocation and reported the allocated treatment procedure to the operator. The operator could not be blinded due to the different stages of the treatment protocols. The patients were blinded to the chosen root canal sealer and activation protocol.

Eligibility Criteria:
Inclusion Criteria:

* Mandibular first and second premolar teeth diagnosed with asymptomatic apical periodontitis
* Single rooted teeth with a single canal.

Exclusion Criteria:

* Previous root canal treatment
* Use of any analgesic or antibiotics in the last 7 days
* Symptomatic teeth
* Sinus tract
* Presence of advanced periodontal problem (probing depth \>4 mm)
* Complications during treatment such as broken file, ledging
* Teeth with extensive coronal destruction.
A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.

This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo


Eligibility Criteria:
Inclusion Criteria:

Men and women with idiopathic Parkinson's disease (PD) who have met inclusion criteria for PRESTO, and have completed the 26-week PRESTO study. The subject should be available to participate in the sub-study immediately following the last PRESTO visit (same day). Subjects must continue PRESTO study drug until the morning of the Tyramine Sub-Study.

Subjects must provide separate informed consent to participate in the Tyramine Sub-Study.

Exclusion Criteria:

Subjects must not have a history of intracranial aneurysm or stroke.

Subjects should not have uncontrolled hypertension, defined as systolic pressure \> 160 mmHg, or diastolic pressure \> 90 mmHg.
TDCS for Laryngeal Dystonia

This project will apply transcranial direct current stimulation (tDCS) to multiple brain areas to evaluate the effects as a potential treatment for laryngeal dystonia (formerly spasmodic dysphonia).

Baseline neuroimaging data will be acquired from all participants via MRI, EEG. Each participant will be seen for multiple testing sessions over a five day period. LD participants will undergo the neuromodulation (HD-tDCS Stimulation) for twenty minutes while engaged in watching videos/movies or performing a word production task.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be clinically evaluated for the diagnosis of LD or have the proof of LD diagnosis. (Not applicable for control participants)
* No other known or history of speech, voice disorder other than LD.
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Must not be pregnant.

Exclusion Criteria:

* All individuals who do not meet the above mentioned criteria are excluded from the study.
* Subjects with a history of epilepsy or depression or is claustrophobic.
Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

This study is to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-\[18F\]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard.

This is a phase II study (with targeted recruitment of 30 participants) designed to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-\[18F\]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard. Subjects consenting to study participation will receive the \[18-F\] CETO followed by the PET/CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with hypertension
* Individuals with an elevated screening adrenal renin ratio (ARR)
* Individuals with or without spontaneous or diuretic-induced hypokalemia, and/ or plus a discrete adrenal nodule or nodules (1 cm or greater) with concordant lateralization on AVS.

Exclusion Criteria:

* Individuals with chronic kidney disease (estimated glomerular filtration rate \<40 mL/min/1.73m2),
* Individuals with a history of uncontrolled severe hypertension (\>180/110 mmHg), severe uncontrolled diabetes, suspected or proven hypercortisolism (e.g., cortisol-secreting adrenal adenoma), or individuals with an anatomical disease of the liver (e.g., hepatic adenoma or focal nodular hyperplasia)
* Allergy to intravenous contrast, coagulopathy, use of chronic corticosteroids.
* Pregnancy, lactation, and pheochromocytoma.