cyrilzakka/clinical-trials huggingface dataset:
Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping

The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental acidosis.

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable transition from fetal to extrauterine life, with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during' natural', 'two-step delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values (placental transfusion). The most effective way to manage umbilical cord in in 'natural', two-step delivery remains to be established. Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management ECC vs. DCC) on the placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.

Material and methods: This is a randomized clinical trial on the effect of different cord management in newborns by 'natural', two-step delivery. After obtaining parental consent, all mothers \> 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio, according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).

Eligibility Criteria:
Inclusion Criteria:

Vaginal delivery

Exclusion Criteria:

Cesarean delivery
The Physical Exercise and Prostate Cancer Study

The purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed locally advanced prostate cancer (clinical stage T2 and T3)
* Referred to RH and UUS for radiotherapy
* \< 75 years
* Capable of reading and writing Norwegian
* Treating oncologist must approve of the subjects' participation
* Living within approximately 1 hour from Oslo by car or public transportation

Exclusion Criteria:

* Routinely resistance training with manuals
* Medication for osteoporosis (i.e. bisphosphonates)
* Conditions of a severity that contraindicate exercise without adjusted actions
* Mentally incompetent conditions
* Conditions of a severity that complicates the ability to participate in a supervised training program
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors

This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.

The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced GI tumors that have relapsed or are refractory to or not considered medically suitable to receive standard of care treatment.

Once the dose is identified in the Dose Escalation Phase, the Dose Expansion Phase will start. The purpose of the Dose Expansion Phase is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 when administered to subjects with advanced GI tumors who meet the entry criteria.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-diagnosed advanced Gl tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment
* Eastern Cooperative Oncology Group (ECOG) score of 0 - 1
* Minimum estimated life expectancy of 3 months
* Adequate organ function
* Recovery from prior treatment-related toxicities
* Ability to swallow capsules
* Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment

Exclusion Criteria:

* Prior exposure to a WNT inhibitor
* Received previous therapy for malignancy within 21 days
* Major surgery within 4 weeks of first dose of study drug
* Radiotherapy within 2 weeks of first dose of study drug
* Significant GI or variceal bleeding or subdural hematoma within 3 months of treatment start
* Uncontrolled central nervous system metastases or leptomeningeal metastases
* Requirement for immunosuppressive agents (must be off for at least 7 days)
* Currently receiving medications that are known CYP3A4/5 inhibitors. Patients currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded.
* Bone abnormalities
* Hypercalcemia
* Cardiac abnormalities
* Known human immunodeficiency virus positive, or active hepatitis A, B or C
* History of additional prior malignancy with the exception of surgically cured carcinomas such as skin, prostate, bladder, thyroid, cervix or other carcinomas in situ
* Active systemic infection requiring intravenous antibiotics within 2 weeks of treatment start
* Pregnancy or lactation
Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card

The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.

This study aims to investigate whether the proposed changes to the INITIATE 2.0 program card lead to an improvement in comfort during pumping as well as increased milk removal during a pumping session. The results of this study will provide important information that a) validates the proposed changes as well as b) builds clear recommendations for which vacuum level should be used for Symphony program cards in this population.

Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 18 years old
* Infant was born maximum 4 (96 hours) days ago
* Subject aims to provide breastmilk for the baby through breastfeeding.
* At least 50% of the milk removal sessions in the last 24hrs were breastfeeds.
* Subject has an indication to pump for reasons
* The subject signs the informed consent documentation

Exclusion Criteria:

* Woman is exclusively pumping
* Woman is experiencing a mastitis event
* Woman is still breastfeeding with the previous child
* Woman has been breastfeeding in the last 6 months
* Woman received morphine pain medication in the last 8 hours
Effects of Multidomain Training of Health With Aging (Train-Old)

The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written and dated informed consent to participate in the study.
2. Subject is a male or female between 55 and 90 years of age, inclusive.
3. Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician.
4. Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week).
5. Ability to walk independently without any gait aid

Exclusion Criteria:

1. Perform high-intensity aerobic exercise on a consistent basis (\>180 min-week).
2. Be performing some other regular and systematic strength training program during the intervention in the first half of 2022.
3. Have a body mass index greater than 35.
4. Have a diagnosis of ischemic heart disease.
5. Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis.
6. Possess uncontrolled blood pressure (TAS \>180 and TAD \>110).
7. Stroke.
8. Severe peripheral arterial disease.
9. Other illnesses such as recent thromboembolic disease, aortic aneurysm, clinically significant renal or hepatic insufficiency, severe COPD, clinically significant acute infections, severe psychiatric illness, uncontrolled metabolic disease, limiting locomotor pathology or musculoskeletal disease worsened by exercise, hormone therapy at the time or one year prior, being a woman with surgical menopause.
10. Other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.
Informativeness to Digital Rectal Examination

Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.

However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.


Eligibility Criteria:
Inclusion Criteria:

* colon or upper rectum cancer operated or not
* recurrent of colon or upper rectum cancer
* rectal bleeding
* hernia

Exclusion Criteria:

* woman
* paraplegic man
* bedridden patient
* current or previous pelvic radiotherapy
* History of prostatectomy
* emergency
Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

To determine the effects of upper limb forearm cooling on Essential Tremor upper limb tremor using a more practical method of limb cooling through a forearm cold pack.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of E.T. for at least a year by a movement disorder neurologist
* A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand
* Ages 18 to 95 years old

Exclusion Criteria:

* (+) sensory loss in the upper extremities
* dermatologic lesions in upper extremities (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash)
* known history of sensitivity to cold (i.e., cold urticaria)
* known peripheral vascular disease
* Raynaud's phenomenon
* scleroderma
Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions

This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects administered under fasting conditions.


Eligibility Criteria:
Inclusion Criteria

* Subjects who have completed the screening process within 28 days prior to Period 1 dosing
* Subjects who are healthy adult men and women 18 years of age or older at the time of dosing.
* Subjects who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weigh at least 110 lbs.
* Subjects who are healthy as documented by the medical history, physical examination (including bur may not be limited to and evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files and agreed upon by both the study physician and investigator prior to enrolling the subject in this study and for continued enrollment.
* Female subjects of postmenopausal (no menses) status for at least 1 year and has a serum FSH level greater than or equal to 30 mIU/mL or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).

Exclusion Criteria

* Subjects who report receiving any investigational drug within 30 days prior to Period 1 dosing.
* Subjects who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
* Subjects whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
* Subjects who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
* Subjects who report a history or allergic response(s) to divalproex or related drugs.
* Subjects who report the use of any systemic prescription medication in the 14 days prior to Period 1 dosing.
* Subjects who report the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period 1 dosing.
* Subjects who report a history of clinically significant allergies including drug allergies.
* Subjects who report a clinically significant illness during the 4 weeks prior to Period 1 dosing (as determined by the clinical investigators).
* Subjects who report a history of drug or alcohol addiction or abuse within the past year.
* Subjects who demonstrate a positive drug abuse screen for this study prior to Period 1 administration.
Long Term Outcome in ICU Treated COVID-19: Risk Factors for 1-year Mortality

Mortality within one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed. Risk and risk factors for one year mortality in ICU patients will be compared to patients admitted to hospital with COVID-19 and general population controls.

The ICU population comprises all Swedish ICU patients with COVID-19 with at lease one year of follow up. The hospital admitted cohort comprises four hospital admitted patients with COVID-19 per ICU patient, matched on age, legal gender and region. The general population controls are matched to the ICU patients in a one to four fashion on age, legal gender and region.

ICU patients are identified in the Swedish intensive care registry. The hospital admitted patients are identified in the national patient registry and the population controls are identified in the population registry. Data on socioeconomics and income are provided by the Statistics Sweden. Data on comorbidity, medications and death are provided from the National board of health and welfare.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to a Swedish ICU and registered in the Swedish intensive care registry with the ICD 10 diagnosis U07.1 before 1 July 2020. ICU-cohort.

or randomly selected from all patients admitted to hospital but not ICU with the ICD 10 diagnosis U07.1 in the national patient registry, matched on age, legal gender and region (four per ICU patient) before 1 July 2020. Hospital cohort.

or randomly selected from the general population (and not included in the ICU or hospital admitted cohorts), matched on age, legal gender and region (four per ICU patient)

Exclusion Criteria:

* Missing a Swedish personal identification number
Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy

Acute appendicitis is the most common abdominal emergency with more than 15 million cases reported worldwide. Although appendectomy is considered a safe surgical procedure, the incidence of complications is up to 10%. The Enhanced Recovery After Surgery (ERAS) has developed guidelines to improve postoperative patient outcomes. The protocol, which consists of more than 20 interventions in the preoperative, intraoperative and postoperative periods, shows that early discharge can be possible with multidisciplinary care given to surgical patients without risking patient safety.

Appendicitis is a common clinical condition and often requires emergency treatment. Although appendectomy is a safe surgical procedure, there is a risk of complications. Pain is common, especially in the postoperative period, and the lack of care management leads to delayed mobilization and oral intake, delayed recovery and prolonged length of hospital stay. However, pain, nausea-vomiting, thirst, fear and stress could be managed with perioperative care. In addition, it is reported that the care provided based on the ERAS protocol shortens the length of hospital stay. In this respect, the aim of this study was to investigate the effect of ERAS protocol-based care on the length of hospital stay of children who were planned to undergo appendectomy. Postoperative pain level, stress and fear level, time to first mobilization, flatulence, defecation and oral intake, nausea, thirst were the secondary outcomes of this study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥6 years and ≤18 years, girls or boys
* Underwent appendectomy
* Written informed consent or requirements of local/national ethical committee

Exclusion Criteria:

* ASA (American Society of Anesthesiologists, ASA) score of ≥ 3
* Any comorbidity/contraindication that may prevent mobilization and oral feeding
Periconceptional Iron Supplementation in Rural Bangladesh

The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.

In 2007, the National Strategy for Anemia Prevention and Control in Bangladesh included adolescents and newly married women as target groups for future iron and folic acid (IFA) supplementation programs. This double-blinded RCT examined the effect of daily periconceptional IFA vs. folic acid (FA) on anemia and iron indictors before and during pregnancy among married, nulliparous women in rural Bangladesh. Biochemical indices were collected at baseline and either at 15 weeks gestation or after 9 months among non-pregnant women (NPW).

Eligibility Criteria:
Inclusion Criteria:

Women were eligible if they were:

* Married
* Nulliparous
* \< 40 years old
* Living in the same household as their husband

Exclusion Criteria:

Women were excluded if they were:

* Pregnant at enrollment
* Planning to move out of the region
* Using iron supplements within the previous 3 months
* Using an implant form of birth control, or had surgery to prevent pregnancy
* Women with a Hb concentration of \< 70 g/L, defined as severely anemic according to WHO definition (5), were excluded from the study and appropriately treated
Head-to-head Comparison of Empagliflozin and Dapagliflozin

This open-labeled, prospective, observational, 3-year, clinical study was conducted to compare the effectiveness and safety between empagliflozin (25 mg once daily) and dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes despite preexisting triple OAD combination.

All participants included in this study were initially requested to initiate therapy with insulin, but they insisted on another form of OAD. When participants declined insulin injection and requested another OAD, they were not randomly assigned to each groups. It is fairly common among participants with T2D to decline insulin therapy, despite being aware of its importance and the benefits in controlling blood glucose. Their lack of willingness to use insulin is explained by their avoidance of painful injections, the potential for body weight gain and their fear of hypoglycemia. The investigators conducted a regimen consisting of four OADs, including empagliflozin or dapagliflozin, to confirm which regimen would be effective and safe.

Eligibility Criteria:
Inclusion Criteria:

* Inadequately controlled under triple OADs (metformin, glimepiride, dipeptidyl peptidase inhibitor) as evidenced by HbA1c 7.5-12%

Exclusion Criteria:

* Type 1 diabetes
* Gestational diabetes
* Diabetes due to secondary causes
* Receiving anticancer treatment
* Receiving glucocorticoids or immune-suppressants
* have been treated with sodium-glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering this study
Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus

The purpose of this study is to learn if conversion from immediate release tacrolimus to Envarsus improves cerebral blood flow, brain blood flow response to exercise, and cognition.

Each patient will have two study assessments: one at baseline and another one at 12 weeks after the baseline assessment. Each assessment may be divided into 2 visits to accommodate the MRI and TCD (Transcranial Doppler ultrasound). Detailed medical history will be extracted from the patients' medical records, interviews and questionnaires. We will obtain brain MRI (without gadolinium contrast) in enrolled patients. Neuropsychological test (NP) tests will include a standard battery to detect subclinical changes in cognition which can be missed by screening tests like the mini mental state exam.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 85 years
* English speaking (NP tests will be in English);
* able to sign informed consent
* able to arrange transportation to and from study sites
* without acute stroke, concussion or traumatic brain injury
* received a kidney transplant at least 12 weeks before recruitment
* stable kidney function with serum creatinine \<3mg/dl

Exclusion Criteria:

* are claustrophobic or have other contra-indication for MRI
* have hearing or visual impairment
* are unable to read, write, speak or understand English
* have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
* dual organ transplant
* oxygen-dependent chronic obstructive pulmonary disease
* diagnosis of dementia
* unable to perform exercise on the Nustep (muscle weakness or cardiac safety concern)
* uncontrolled blood pressure
Fabry Disease Screening in ESRD Patients in West of France

Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.

Detection of Fabry disease is done by dried blood spot test, in dialyzed and transplanted men, who reached ESRD for vascular or unknown disease and were not previously screened.

Eligibility Criteria:
Inclusion Criteria:

* Men less than 70 years old
* ESRD treated by dialysis or kidney graft in one of the 4 following regions : Bretagne, Centre, Pays de la Loire and Poitou-Charentes
* For unknown nephropathy OR vascular nephropathy and/or diabetic nephropathy unproved by biopsy
* Agreeing freely to participate in the study

Exclusion Criteria:

* Men less than 18 years old
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.