cyrilzakka/clinical-trials huggingface dataset:
Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Electronic fetal hear rate monitoring (EFM), or cardiotocography (CTG), records changes in fetal heart rate and their temporal relationship to uterine contraction. It has been developed with the aim of detecting fetal hypoxia during labor and hence to prevent metabolic acidosis. Despite being the standard for intrapartum management, this technique, significantly increase the operative delivery rate, and is associated only with less seizures as neonatal benefit. Another concern is also the variability in the interpretation.

Several techniques have been studied in order to decrease the high false positive rate. Fetal ST waveform analysis (STAN) has been studied combined with CTG. A recent meta-analysis of randomized trials, however, showed that STAN during labor did not improve perinatal outcomes or decrease operative delivery rates, except for a 9% decrease in operative vaginal delivery.Comparisons of visual and computerized interpretation of EFM have also been reported. However, whether or fetal monitoring with computer analysis improve perinatal outcomes is still subject of debate.

Thus, we aim to evaluate whether intrapartum fetal monitoring with computer analysis increase the incidence of obstetric intervention when compared with visual analysis through a single-center randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Women with singleton gestation
* 18 years to 50 years
* High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia

Exclusion Criteria:

- IUGR
Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion

Prospective multicenter study of consecutive patients with acute ischemic stroke and large intracranial vessel occlusion in which a thorough and systematic evaluation of all variables that may be related to the degree of collateral circulation is performed.

Introduction. In patients with an acute ischemic stroke due to a large-vessel intracranial occlusion (LVO), the status of the colateral circulation (CC) is related to clinical outcome and to the success of mechanical thrombectomy. However, CC is highly variable from patient to patient.

Methods. An observational, prospective, multicenter study of 700 consecutive patients with acute ischemic stroke and a LVO. Factors to be evaluated: 1) Modifiable: Vascular risk factors, blood analysis, prior medications, vital constants (with emphasis on continuous blood pressure monitoring), head position, metrics (time to admission, Computed tomography (CT), groin puncture, end of procedure), 2) Non-modifiable: age, sex, completeness of Circle of Willis, etiology, type of mechanical thrombectomy, plasma biomarkers, genetic/epigenetic factors (a discovery phase with GWAs study and a replication phase). CC grade will be assessed by the ASITN/SIR collateral score from CT-angiography (CTA) and the Digital substraction angiography (DSA, when performed). Statistics: bivariate analyses and a logistic regression to predict CC grade (poor versus good) and CC persistence comparing CTA with DSA (4 possibilities: poor-poor, poor-good, good-poor, good-good).

Expected results. Our study may find markers of the CC status, facilitate the design of clinical trials to improve CC grade, may find new therapeutic targets and new treatments to enhance the beneficial effects of mechanical thrombectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke.
* Large vessel occlusion of an intracranial internal artery: M1, M2 or TICA. (terminal intracranial carotid artery), as demonstrated by CTA.
* CTA performed within the first 24 hours after stroke onset. Patients with wake-up stroke are included.
* A previous modified Rankin Scale score of 0 to 3.
* The patient or a legal representative signs a written consent to participate.

Exclusion Criteria:

* More than 24 hours from last been known to be well.
* Occlusion of other arterial segments (vertebrobasilar circulation, A1, P1, M3, M4).
* Age below 18 years.
Ovarian Clear Cell Adenocarcinoma Review

Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40% of the patients with clear cell carcinoma are diagnosed in the advanced stage. The investigators studied the response to chemotherapy and survival for either paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with pure, advanced, clear cell ovarian carcinoma were also evaluated.

1. Several authors have reported frequent admixtures of clear cell ovarian carcinoma with serous, mucinous, and endometrioid tumors. However, few papers addressed the difference in response to chemotherapy and survival between patients with pure and mixed-type advanced clear cell carcinoma.
2. Recent trends in the clinical management of advanced ovarian cancer include increased attention to maximal cytoreduction and general acceptance of paclitaxel-platinum-based adjuvant chemotherapy.
3. The introduction of paclitaxel markedly changed the postoperative management of ovarian cancer patients, but the results and value of these newer efforts and therapies applied to clear cell carcinoma are as yet undetermined.
4. Today, paclitaxel-platinum-based chemotherapy is becoming the standard regimen for ovarian cancer worldwide. Previous research suggests a potential benefit of paclitaxel plus carboplatin regimens for stage I clear cell carcinoma. However, few papers specifically addressed the efficacy of paclitaxel-platinum-based chemotherapy for advanced clear cell carcinoma because clear cell carcinoma occurs only rarely in Western countries.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Ovarian clear cell carcinoma

Exclusion Criteria:

* not undergo operation
Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain

The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 years of age and 60.
* Body Mass Index (BMI) of less than 34.
* Low Back Pain duration of 3 months or greater (chronic).
* Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater.
* Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater.
* Understands English

Exclusion Criteria:

* Positive nerve root tension signs
* Progressive neurological deficit
* Positive Babinski sign.
* Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves.
* History of spinal surgery
* History of inflammatory joint disease
* Contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise.
* Contraindications to NMES including cardiac pacemaker or skin allergy to adhesives
* History of metastatic cancer in previous 5 years or present treatment for cancer
* Women who indicate that they are pregnant or plan to become pregnant
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients

This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes


Eligibility Criteria:
Inclusion Criteria:

* Non-Insulin-Dependent Diabetes Mellitus
* Adults 21 to 79 years, inclusive
* Body mass index between 30 and 40 kg/m2, inclusive

Exclusion Criteria:

* Currently prescribed aspirin or anti-coagulants
* Contraindications to aspirin
* Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus
* Patient requires insulin
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after allogeneic hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients will receive allogeneic hematopoietic stem cell transplantation

Exclusion Criteria:

* Aspartate transaminase or alanine transaminase level \> 5 times UNL
* Bilirubin \> 2. 5 times UNL
* History of allergy, sensitivity, or any serious reaction to an echinocandin
* Invasive fungal disease at the time of enrolment
* Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
* Positive pregnancy test
Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease

The objective of this prospective, multicenter, non-randomized, single-arm observational study is to evaluate the efficacy and the safety of the iCover covered stent for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).


Eligibility Criteria:
Inclusion criteria

1. ≥ 18 years of age
2. Rutherford clinical stage 2 to 5
3. Atheromatous aorto-iliac lesions evidenced by duplex scan, CT angiography or arteriography.
4. De novo atheromatous lesion of the aortoiliac segment
5. Patient informed about the study and collection of the patient's informed consent agreement.

Exclusion criteria

Subjects will not be eligible to participate in the study if any of the following conditions are present in the subject:

1. Protected adult patients, guardianship, curatorship, safeguard of justice
2. Woman with possibility of pregnancy
3. Patient with asymptomatic atheromatous lesions
4. Patient with inflow lesion in the infrarenal aorta
5. Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
6. Acute ischemia or acute thrombosis
7. Non-atherosclerotic disease
8. History of coagulopathy
9. Severe comorbidities with life expectancy \<2 years
10. Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure
11. Patient participating in another clinical study which may interfere with the results
12. Comorbidity or any reason which, according to the investigator, could limit the participation, the patient's adherence with the follow-up or the scientific integrity of the study
13. Lesion near or adjacent to an aneurysm
14. Inability to follow-up during the trial
15. Patient objection to participate in the trial
Diet for Colonoscopy Preparation in Diabetic Patients

This trial will compare the efficacy of to 2 different sets of dietary recommendations to be followed before colon cleansing for colonoscopy in diabetic patients.

Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to follow one of two different sets of dietary recommendations. The experimental group will be asked to start a low-residue diet 4 days before the procedure, during which the therapy for diabetes will be adjusted. The control group will be asked to follow a low-residue diet for 3 days followed by a liquid diet during the day before the procedure, and no adjustments will be made to their usual treatment.

Colon cleansing will be undertaken with polyethylene glycol (4 liters in the usual split administration scheme) in both groups.

Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
* Diabetes mellitus (being treated with insulin or any oral agent).

Exclusion Criteria:

* Unwillingness to participate.
* Hospital admission at the time of colonoscopy.
* Inability to follow instructions
* Active inflammatory bowel disease
* Previous colectomy.
* Incomplete colonoscopies due to technical reasons or contraindication for the procedure as evaluated by the endoscopist
Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%

When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.

The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
2. Ability to sign informed consent.
3. Ability to follow study protocol, and speak, read and write in English.
4. Must have valid phone number for follow-up purpose.
5. Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.

Exclusion Criteria:

1. Patient younger than 18 years old and older than age 70
2. Patient refusal to sign consent
3. Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
4. Allergy to any of the protocol medications
5. Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
6. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Diabetes, Falls, and Fractures

Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements


Eligibility Criteria:
Inclusion Criteria:

1. Men and women with minimum 40 years of age and maximum 70 years of age.
2. Diagnosis of T1D or T2D
3. Diagnosis of diabetes with at least one year prior to inclusion of the study
4. Signed the informed consent.

Exclusion Criteria:

1. Severe decreased liver function (Alanin amino-transaminase (ALAT)\>250u/l, GammaGlutamyltransferase (GGT)\>150u/l)
2. Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) \<15mmol/L/1,73m2
3. Pregnancy or breast feeding
4. Active malignancy or terminal ill.
5. Current or previous alcohol- or drug abuse

8. Not being able to understand Danish written and/or verbally 9. Terms according to investigators judgement that makes subjects unsuitable to participate including lack of understanding or reduced physical ability. 10. Participating in other clinical studies 11. Maximum of 10 hours of weekly exercise.
Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura

This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 2 and 12 years.
* Written informed consent signed by parents/caregivers (signature or thumbprint) and, for children aged 6-12 years, written assent from the child.
* Agree to comply with study procedures, including provision of two stool samples at the baseline and at follow-up assessment 14-21 days after treatment, respectively.
* At least two out of four Kato-Katz thick smears positive for T. trichiura at baseline.
* Willing to be examined by a study physician prior to treatment.

Exclusion Criteria:

* Presence or signs of major systemic illness or abnormal physical findings at screening, e.g. severe anaemia (Hb level \<80 g/L according to WHO) upon initial clinical assessment.
* Known allergy to study medication (i.e. oxantel pamoate, mebendazole or any of the excipients).
* Use of anthelminthic drugs within 4 weeks before or during study period.
* Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.
* Actively participating in other clinical trials during the study.
* Pregnancy (female participants that report to have reached menarche
Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement

The goal of this clinical trial is to evaluate whether digital cognitive behavioral therapy (dCBT) can be used to address clinical anxiety in marginalized and low-income pregnant people in California. The main question it aims to answer is:

What is the efficacy of digital cognitive behavioral therapy (dCBTI) for reducing clinical anxiety among marginalized and low-income pregnant people?

Participants will receive digital cognitive behavioral therapy immediately, or 10 weeks after enrollment (i.e., waitlist control). Participants will complete surveys and interviews until 6-8 weeks postpartum.

Although therapist-delivered cognitive behavioral therapy (CBT) has been shown to be effective for treating clinical anxiety in non-marginalized pregnant populations, barriers to access exist among pregnant people (e.g., long waitlists, childcare issues, limited appointment windows). Recent innovations have focused on addressing barriers to CBT by adapting it for automated, digital delivery. Digital CBT (dCBT) has been shown to be effective for treating clinical anxiety in mostly White, higher socioeconomic status, pregnant, and non-pregnant populations. Person-centered adaptations of dCBT are likely needed to maximize access in marginalized and low-income pregnant people. This study addresses the critical need to evaluate whether dCBT can be used to address clinical anxiety in marginalized and low-income pregnant people in California.

Eligibility Criteria:
Inclusion Criteria:

* California MediCal participant
* Pregnant, 8-27 weeks gestation by ultrasound
* 18-years of age or older
* English speaking
* 9th grade level of education or more
* Daily access to web-enabled computer, smart phone, or tablet
* Current elevated anxiety symptoms (score on the seven item Generalized Anxiety Disorder (GAD-7)questionnaire of 10 or more

Exclusion Criteria:

* Received CBT for anxiety in the last 12-months
* New or changed dose of prescription medication for anxiety, depressive symptoms, or poor sleep in \< 4weeks
* Self-reported diagnosis of schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder, severe cognitive impairment (characterized by experiences like forgetting events, having decreased periods of alertness, decreased social awareness)
* Recent trauma to the head or brain damage
* Serious physical health concerns necessitating surgery or hospitalization in the last 6-months
Emotional and Cognitive Abilites of Schizophrenia Patients at Various Time Points

Longitudinal investigation of cognitive, emotional and illness awareness of schizophrenia outpatients (Shalvata Mental Health Center). The study uses computerized assessment of cognitive functioning and questionnaire to assess performance of patients assessed in the past as part of a routine clinical assessment.


Eligibility Criteria:
Inclusion Criteria:

1. Schizophrenia diagnosis by a senior psychiatrist (according to DSM-4 criteria).
2. Age between 18-65 (male and female).
3. Prior cognitive assessment in the Emotional-Cognitive Research Laboratory (Shalvata Mental Health Center)
4. Signed informed consent by participants.

Exclusion Criteria:

1. Hospitalization at the time of experiment.
2. A history of brain-injury or other neurological condition precluding participation in the study.
3. Guardianship.
4. Current alcohol or drug abuse
Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.


Eligibility Criteria:
Inclusion Criteria:

* History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
* GI symptoms for at least 2 months before entering study

Exclusion Criteria:

* Very high body weight
* Significant diarrhea
* Ulcers

Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.