cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effectiveness of Structured Education According to Premenstrual Syndrome Symptom Map

In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test.


Eligibility Criteria:
Inclusion Criteria:

Meeting ACOG's PMS diagnostic criteria Being over 18 years of age, Not using psychotherapeutic medications, Not having a mental illness, Not being pregnant, Agreeing to participate in the study

Exclusion Criteria:

Not having regular menstruation in the last 3 months, Using analgesics during menstruation while participating in the study.
Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?

It is well documented in the literature that myocardial revascularization during valve surgery increases the risk of early mortality and morbidity.

According to the most recent version of the European Guidelines, the possibility of myocardial revascularization via coronary artery bypass should be evaluated in patients with an indication for surgical treatment of heart valve disease but with coronary artery stenosis ≥ 50-70%.

In this study, patients hospitalized for surgical heart valve disease, with occasional pre-operative finding of ≥ 50-70% coronary artery stenosis, without angina, are examined. After interdisciplinary discussion in the Heart Team, it was decided not to treat coronary artery disease during valve surgery. The aim is to evaluate the short and medium-term results of this "conscious omission".


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* Presence of valve disease of surgical interest.
* Occasional pre-operative finding of coronary stenosis \>= 50-70%.

Exclusion Criteria:

* angina
Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With r/r Cluster Of Differentiation 7（CD7）+ T-Acute Lymphoblastic Leukemia(ALL)/T-Lymphoblastic Lymphoma(LBL) /Acute Myelogenous Leukemia(AML)

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 3-70
2. Diagnosis of r/r T-ALL/LBL/AML.
3. CD7 positive expression
4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
6. Left ventricular ejection fraction ≥ 50% .
7. Baseline oxygen saturation ≥ 92% on room air.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
9. The estimated survival time is more than 3 months.
10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC).
2. Subjects with concomitant genetic syndromes associated with bone marrow failure states.
3. Subjects with some cardiac conditions will be excluded.
4. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
5. History of malignancy other than non-melanoma skin cancer or carcinoma.
6. Primary immune deficiency.
7. Presence of uncontrolled infections.
8. Subjects with some anticancer therapy before CAR-T infusion will be excluded.
9. Active uncontrolled acute infections.
10. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
11. Subjects who are receiving systemic steroid therapy prior to screening.
12. Subjects with acute graft-versus-host disease (GvHD)
13. Having received live/attenuated vaccine within 4 weeks prior to screening.
14. History of allergy to any component of the cell therapy product.
15. Pregnant or breastfeeding women
16. Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.
Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Local Esophagus Cancer

The purpose of this study is to investigate the effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer.

This is a prospective observational study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test).Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed primary esophageal cancer, aged more than 20 years, and communicate without difficulty

Exclusion Criteria:

* inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy
In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement

In this work the importance of the potentiation and recovery of the balance with a physiotherapeutic intervention that begins in the early preoperative phase is compared with the conventional postoperative rehabilitation. The objective is to evaluate the influence of a muscle enhancement protocol in which a specific work of balance is included, with the physical benefits that this entails for the evolution of the patient. It also seeks to verify if the teaching and recommendation of exercises at home as preparation and conditioning for the intervention of ATR is effective, and to what extent, compared to a guided training in the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with severe knee osteoarthritis that have not been operated before of total knee replacement.
* The score in Berg scale must be greater than 21.
* The score of the Mini-Mental State Examination must be equal or greater than 20.
* Once the informed consent is read and explained, patients must accept and agree to participate in the study.

Exclusion Criteria:

* Post-surgical infection of the operated knee.
* Pathology of central origin (i.e. cerebellar) that could interfere with balance or strength
* Vestibular pathology that could interfere with balance
Effect of Cash Benefits on Health Care Utilization

Using data from the Chelsea Eats program, we propose to study a randomized controlled trial in which the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months during the first two years of the COVID-19 pandemic. We will analyze the impact of the cash benefit on health care utilization and health.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Chelsea, Massachusetts
* Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income

Exclusion Criteria:

* See inclusion criteria
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not below 140/90 mmHg) with the use of adequate doses of at least three different anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible mechanism of resistance is the aldosterone-escape phenomenon.

During aldosterone escape, aldosterone plasma levels are normal or even elevated despite therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH), local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood pressure independent effects on cardiac, vascular and renal damage.

Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients with resistant hypertension.

see above

Eligibility Criteria:
Inclusion Criteria:

* Casual blood pressure \>=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic

Exclusion Criteria:

* Contraindication for eplerenone
* Creatinine-Clearance \< 60 ml/min
* Diabetes mellitus
Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV

About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving and have reduced quality of life. There are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials. Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases venous return to the heart and raises blood pressure. There is considerable lower level evidence that it might prevent vasovagal syncope.

The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible if they have:

  * ≥2 syncopal spells in the year preceding enrolment, and
  * ≥ -2 points on the Syncope Symptom Score for Structurally Normal hearts, and
  * Age ≥ 18 years with informed consent.

Exclusion Criteria:

* Patients will be excluded if they have:

  * other causes of syncope, such as ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome,
  * an inability to give informed consent,
  * important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia,
  * hypertrophic cardiomyopathy,
  * a permanent pacemaker,
  * a seizure disorder,
  * urinary retention,
  * hypertension defined as \>140/90 mm Hg,
  * hepatic disease,
  * glaucoma or
  * a 5-minute stand test resulting in diagnoses of Postural Orthostatic Tachycardia Syndrome or Orthostatic Hypotension.
Safety Study of GRNOPC1 in Spinal Cord Injury

The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).


Eligibility Criteria:
Major Inclusion Criteria:

* Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation \< 5 levels
* Last fully preserved neurological level from T-3 through T-11
* From 18 through 65 years of age at time of injury
* Single spinal cord lesion
* Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 11 days following injury
* Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI

Major Exclusion Criteria:

* SCI due to penetrating trauma
* Traumatic anatomical transection or laceration of the spinal cord
* Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
* Inability to communicate effectively with neurological examiner
* Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
* History of any malignancy
* Pregnant or nursing women
* Body mass index (BMI) \> 35 or weight \> 300 lbs.
* Active participation in another experimental procedure/intervention
Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
* An informed consent is signed by the patient.

Exclusion Criteria:

* The qualifying episode of AF has never been documented in ECG or Holter ECG monitoring.
* Patients with atrial fibrillation, atrial flutter or atrial tachycardia at inclusion time.
* Patients with permanent atrial fibrillation or permanent atrial flutter.
* Age \<18 years.
* Patients with a pacemaker or an implanted cardiovert-defibrillator.
* Patients suffering from dementia or other severe neurological disorders and thus incapable to participate.
* Patients who present with antisocial behavior and/or do not want to participate in the study.
Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients

Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Background

Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.

Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

Purpose

The primary objective of this study is to compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Angiographically-proven coronary artery disease
* Recent (\< 12 months) percutaneous coronary intervention
* Class I indication to receive statin treatment
* Previous (\< 12 months) withdrawn of a statin due to side effects
* Unwilling to receive treatment with an alternative statin
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
Restoration Repairs Using Composite Resin Versus Glass Ionomer in Primary Molars: a Randomized Clinical Trial

The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).

Failed restorations in primary teeth will be repaired using GIC or composite resin.

Eligibility Criteria:
Inclusion Criteria:

* Children who have sought treatment in the School of Dentistry, University of Sao Paulo
* Children between 3 and 10 years old
* Children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth

Exclusion Criteria:

* Children whose parents did not agree to participate in the study
* Children with behavioural issues at the initial exam or who did not assent to participate in the study
Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.


Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* KPS \>=70
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness

The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.


Eligibility Criteria:
Inclusion Criteria:

* Are 8-14 years of age;
* Are able to read (or be read to), understand and sign the assent document;
* Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
* Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
* Are willing and able to follow instructions.

Exclusion Criteria:

* Are participating in any concurrent interventional clinical or research study;
* Have a history of myopia control treatment in the past year;
* Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
* Have any known active ocular disease and/or infection;
* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
* Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
* Are a child of a member of the study team.
Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)

The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed advanced solid tumor
* Radiographic progression on prior systemic therapy; prior localized therapy (i.e., radiation, ablation, embolization) is allowed provided radiographic progression out-of-field or in the treatment, field is shown
* Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene fusion/rearrangement potentially leading to a functional FGFR aberrant protein, identified through local and/or central molecular assay

Exclusion Criteria:

* History of hypersensitivity to any of the excipients in the Debio 1347 formulation
* History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon calcifications
* Administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors)
Transperineal Ultrasound to Assess the Progress of Labour

This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.

This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.

AIMS:

This study aims to firstly assess the effectiveness and acceptability of transperineal ultrasound in women presenting between 24 and 42 weeks gestation in comparison with digital vaginal examination (VE). Secondly, in all term (37-42 weeks) labouring women, investigators aim to create an ultrasound based labour record, "a sonopartogram" and from this develop a predictive model for the outcome of labour.

Eligibility Criteria:
Inclusion Criteria:

* Gestation 24-42 completed weeks at study entry
* Aged 18-44
* Cephalic
* Singleton pregnancies
* Nulliparous
* Multiparous (excluded for the term predictive model group)
* Multiple pregnancies (excluded for the term predictive model group)
* Established (Active) phase of labour (included for the term predictive model group) o Clinician opinion that patient is in the established phase of labour according to the current NICE guidelines

Exclusion Criteria:

* Younger than 18 years.
* Imminent iatrogenic intention to deliver
* Life threatening maternal or fetal compromise needing immediate medical attention and/or delivery
* Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study.
* Miscarriage
* Intra-uterine death
* Previous cervical surgery eg. cone biopsy, cervical cerclage. Note- Single LLETZ is not excluded.
* Non-cephalic presentations
* Multiple pregnancies (for the term predictive model group)
* Multiparous patients (for the term predictive model group)
* Not in established labour (for the term predictive model group)