cyrilzakka/clinical-trials huggingface dataset:
Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor

Effect of dexamethasone on fetal heart rate variability in case of preterm labour: prospective cohort study

prospective cohort study on Effect of dexamethasone on fetal heart rate variability in case of preterm labour

Eligibility Criteria:
Inclusion Criteria:

* Preterm labor

Exclusion Criteria:

* Twins
Resistance Training in Patients With Diabetic Neuropathy

This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).

Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain, muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural instability increasing the risk of frequent falls and thereby increased morbidity and mortality. Thus, diabetic neuropathy is associated with significant disabilities having major impact on activities of daily living and quality of life.

The effects of resistance training on neuropathy symptoms, muscle strength and muscle structure in patients with and with diabetic neuropathy will be examined.

Perspective: The studies will likely improve the understanding of diabetic neuropathy and the relation between risk of falls in patients with and without motor dysfunction. The results may enable new and more precise recommendations for exercise in diabetic patients with diabetic neuropathy. In addition, the results may lead to a better understanding of the mechanisms underlying the effects of training. The improvement of motor function may lead to improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes patients, resulting in lower morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

* Neuropathy due to any other cause

  * BMI \>40
  * Pacemaker
  * Comorbidity that contraindicates exercise
  * History of stroke with affection of the lower extremities
  * Ischemic heart disease
  * Any other neurological disease
  * Pregnancy
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Documented progression from most recent line of therapy
* 1-3 prior lines of therapy
* Measurable disease
* Life expectancy ≥3 months
* Prior treatment with Lenalidomide permitted if:

  1. Best response achieved was ≥Partial Response (PR)
  2. Patient was not refractory
  3. Patient did not discontinue due to a Grade ≥3 related adverse event
  4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Exclusion Criteria:

* Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
* Active plasma cell leukemia
* Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin

The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to botulinum toxin.

A full description of the patient registry can be found in the paper titled: Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Clin Infect Dis. 2019 Apr 15;70(9):1950-1957.

Eligibility Criteria:
Inclusion Criteria:

* Any patient of any age \[age category: pediatric-newborn infants (0 to 27 days), infants and toddlers (28 days to 23 months), children (2 to 11-years), and adolescents (12 to \<17-years); adult (17-64-years); and geriatric (≥65-years)\] with a confirmed or suspected exposure to botulinum toxin who were treated with BAT® provided by the CDC.

Exclusion Criteria:

* None.
A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer

This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of PEP503(radio-enhancer).

There are 2 portions in this study.

* Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended injection volume of PEP503 for intratumor injection.
* Expansion phase (Part II): Following the confirmation of the recommended volume of intratumor injection, 18 additional patients will be enrolled at the recommended volume level to evaluate for efficacy.

The target population is composed by patients who have confirmed adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable, with tumor distal margin within 10 cm of the anal verge, with no evidence of distant metastatic disease, ECOG performance 0-1, and adequate bone marrow, renal and hepatic function.

Eligibility Criteria:
Inclusion Criteria

* Histologically proven adenocarcinoma of the rectum which is T3-4, N any, or locally unresectable disease , without evidence of distant metastases (M0)
* Distant border of the tumor must be located ≤ 10 cm from the anal verge
* Staging with MRI, transrectal ultrasound or CT-scan to confirm stage and resectability
* ECOG performance 0 - 1
* Age: 20 - 80 years old
* Adequate bone marrow, renal, and hepatic function as:

  * absolute neutrophil count (ANC) ≥ 1,500/mm3
  * platelet count ≥ 100,000/mm3
  * total bilirubin ≤ 1.5x the upper limit of normal (ULN)
  * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN
  * alkaline phosphatase (ALP) ≤ 2.5 x ULN
  * calculated creatinine clearance ≥ 50 mL/min, or creatinine within normal range
* All female patients of childbearing potential must have negative urine pregnancy test within the 7 days prior study treatment with PEP503. Patients must agree to use effective contraception during the study

Exclusion Criteria:

* Prior history of pelvic radiation therapy
* Hypersensitivity to fluoropyrimidine
* Uncontrolled serious medical or psychiatric illness
* Myocardial infarction or uncontrolled angor pectoris (angina) within the prior 6 months
* No more than 4 weeks since prior participation in any investigational drug study
* Major surgery within 28 days
* Other malignancy within the past 3 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
* Cardiovascular disease that would preclude study treatment or follow-up
* Informed consent not duly signed and dated to participate in the study
Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Oocyte donor candidates
* Regularly cycling
* BMI ≥18 and ≤ 29 kg/m2
* Signed informed consent
* Non-smokers.
* AMH \<7,53 and \>1,18 ng/mL (90th and 10th percentile for healthy women aged 25-29 according to the used Elecsys® AMH kit by Roche)
* PRL, T and TSH within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior or at screening

Exclusion Criteria:

* Intra-uterine device
* Previous enrollment
* Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (\< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study
* Acute urogenital disease during the course of the study
* Known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients)
* Intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start.
* Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study.
* Current or recent substance abuse, including alcohol and tobacco (patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
* Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests.
* Known or suspected progestogen dependent neoplasms (e.g. meningioma)
* Serum progesterone level \>1.5 ng/mL at ovulation triggering
Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.


Eligibility Criteria:
Inclusion Criteria:

* If female, subject is either postmenopausal for at least two (2) years or surgically sterile or is practicing at least one (1) method of birth control.
* If female, subject must have negative results for pregnancy tests.
* The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a diagnosis of DNP.
* Subject's DNP must be present for a minimum of six (6) months and should have begun in the feet with relative symmetrical onset.
* Subject has an HgbA1c \<= 9. Subjects who have an HgbA1c \> 9 and \<= 11 may be included in the study.
* If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method (condom) of birth control for the duration of the study and for 7 days following the last dose of study drug.

Exclusion Criteria:

* The subject has failed previous treatment with duloxetine for DNP.
* Subject has a diagnosis of narrow-angle glaucoma.
* Subject has a history of an allergic reaction or intolerance to duloxetine, acetaminophen, or any other NNR agonist.
* Subject has a diagnosis of fibromyalgia that requires treatment.
* Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
* Subject has a history of seizures (febrile may be ok) or major depressive episode within the past two (2) years or major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
* Subject has a history of myocardial infarction (MI) within six (6) months of the Screening Visit.
* Subject has unstable angina.
* Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
* Subject has undergone a cardiac revascularization procedure within 30 days of Screening.
* Subject has uncontrolled hypertension (HTN) defined as a systolic blood pressure (BP) \>= 160 and/or a diastolic blood pressure (BP) \>= 100 at Screening and/or Baseline.
* Subject has a clinically significant abnormal ECG at Screening
* Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years.
* Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
* Subject's screening laboratory results show hepatitis A, B or C.
* Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).
Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital haemophilia and inhibitors to factor VIII or IX
* Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Clinically relevant coagulation disorders other than congenital haemophilia A or B
NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

The purpose of this study is to determine if NT-BNP levels obtained at time of admission for delivery are predictive of intrapartum or postpartum complications in patients with adult congenital heart disease.

Amino-terminal pro-B-type natiuretic peptide (NT-proBNP) is a prohormone released from cardiac ventricular myocytes in direct response to cardiac workload. Secreted in the biologically inactive form, NT-proBNP is cleaved in the circulation into BNP, which subsequently exerts both vasodilatory and diuretic effects. The principal clinical utility of serum NT-proBNP measurement has been as an adjunctive marker in the diagnosis of subclinical heart failure, with higher levels typically reflective of increasing cardiac dysfunction.

The proposed prospective cohort study intends to collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events. Both pregnant patients with previously-diagnosed ACHD and those diagnosed and delivering during the study interval will be candidates for participation, and a gestational age threshold of 37 weeks will be utilized for the control group.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant adult women ages 18 - 50
* Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)

Exclusion Criteria:

* Non-pregnant patients
* Non-English-speaking patients
* Maternal age \<18 years or \>50 years
* Patients with hypertensive complications of pregnancy
* Maternal peripartum cardiomyopathy
* Multiple gestation
Relmacabtagene Autoleucel in Hematologic Malignancies

To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world

The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Patients who have been treated with Relma-cel, including those who have received off-label products;
3. If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.

Exclusion Criteria:

1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache

Introduction:Migraine is a prevalent disabling primary headache disorder which is classified in two major types; migraine without aura and migraine with aura. The aim of this study was to compare the efficiency of mesotherapy with systemic therapy in pain controlin patients with headache related tomigraine without aura.

Methods: We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with headache related to migraine without aura. One group was treated with mesotherapy, and the control group with intravenous dexketoprofen. Changes in pain intensity at 30th minute, 60th minute, 120th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 hours,re-admission with same complaint to emergency department (ED) within 72 hours, and adverse effect rate of the methods were compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older age, and (2)
* Admission to Emergency Department (ED) with headache related to the migraine without aura.

Exclusion Criteria:

* Taking analgesic drugs before admission,
* Having VAS score of lower than 4 on admission,
* Having diabetes mellitus,
* Body mass index\>30 kg/m2,
* Pregnancy,
* Lactation,
* Having active bleeding or bleeding disorder,
* Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions,
* Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).
Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids

This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of multiple-dose PF 06651600 on single-dose oral contraceptive (OC) pharmacokinetics (PK) in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total of 28 healthy female subjects (14 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods.


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Sex:

1. Female participants of non childbearing potential who, at the time of screening, are between the ages of 18 and 60 years, inclusive.
2. Female participants who are healthy as determined by medical evaluation including detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.
3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
4. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
3. Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first-degree relative with a hereditary immunodeficiency.
4. Infection with hepatitis B or hepatitis C viruses -
Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease

This is a proof of concept observational study is to determine if there is correlation between Aβ plaques and vascular findings in the Retina versus brain ARIA.

Based upon studies and histological evidence, investigators and study sponsor suspects that the primary mechanism that causes CAA in the brain (and increased risk of ARIA) may also occur in the retina. Investigators propose use of both amyloid brain PET imaging, MRI, and retinal imaging to determine if patients undergoing Lecanemab treatment allows for in the ability to correlate ARIA from retinal amyloid and vasculature versus MRI criteria, and a measurable reduction in amyloid in the retina when compared with amyloid PET scans of the brain post-treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be eligible for and intend to receive LEQEMBI under standard of care treatment.
2. Male and female subjects ages ≥50 years old.
3. Must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging.
4. Patient or patient's legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.

Exclusion Criteria:

1. History of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils.
2. Self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina.
3. Subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery,
4. Unable or unwilling to comply with the protocol requirements.
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation

Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.

The purpose of the DOUBEL-CHOICE study is to demonstrate non-inferiority of a latest-generation self-expanding valve (SEV) (ACURATE neo2, Boston Scientific, Marlborough, MA, USA) in comparison to another latest-generation SEV (Evolut Pro and Pro+, Medtronic Inc., Minneapolis, MN, USA) and of a minimalist approach vs. standard of care with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
* Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
* Heart team consensus that the patient is anatomically suitable for both device types
* Suitability for transfemoral vascular access
* Written informed consent

Exclusion Criteria:

* Life expectancy \<12 months due to comorbidities
* Native aortic valve annulus \<21 mm and \>27 mm
* Bicuspid aortic valve
* Cardiogenic shock or hemodynamic instability
* Active endocarditis
* Contraindications for transfemoral access
* Active peptic ulcer or upper gastro-intestinal bleeding \<2 weeks
* Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
* Contraindication for minimalist approach
* Clear patient-specific clinical or anatomic reasons to prefer one approach or valve type over the other
* Active infection requiring antibiotic treatment
* Age \<18 years
* Participation in another interventional trial where the primary endpoint has not been reached