cyrilzakka/clinical-trials huggingface dataset:
Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle

This research project's objective is to investigate substrate metabolism behavior in response to the RT during different phases of the menstrual cycle.

Based on the literature the investigators hypothesize an increase in fat oxidation in early follicular phase(EFP) and late follicular phase (LFP) when compared to early luteal phase (ELP) and late luteal phase (LLP). Given the lack of research in exercise and menstrual cycle - especially in resistance training - results are uncertain unless the investigators base their hypotheses only on the general physiological effects of sex hormones (without exercise). In this case, the investigators expect to see a reduced carbohydrate utilization and an increased utilization of fats in EFP and LFP. In addition, the intervention is focused on muscular endurance and, therefore, it is expected to see a higher reliance on aerobic pathways. It is expected that the effects of the intervention will be added to the effects of estrogens, with increasing fat oxidation when estrogen levels are higher. Lastly, a comparison of fat oxidation levels obtained on each sub-phase would reveal if there are differences in the magnitude of the effect of distinct concentrations of estrogen and progesterone.

Eligibility Criteria:
Inclusion Criteria:

* Females with BMI-18.5-34.99 and between 18-45 years, with normal menstrual cycle defined as 28-30 days cycles +-3 days.
* Including higher BMI participants might alter the results as increased body fat has been linked to changes in different hormonal levels (not only sex hormones) and that might influence substrate utilization.
* Sedentary .or physically active for 2 days a week or less.

Exclusion Criteria:

* • Musculoskeletal injuries,

  * cardio-respiratory conditions,
  * metabolic conditions,
  * irregular menstrual cycle,
  * menstrual dysfunction or unusual sex hormone levels,
  * on contraceptives,
  * on medication that alter hormonal or cardio-respiratory responses,
  * pre-menopausal symptoms,
  * on moderate to high-intensity exercise regime more than 2d/week.
  * All these exclusion criteria are chosen because any one of the listed criteria above can alter the responses and/or affect the safety of the subject during their participation in the study.
Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

For chronic hemodialysis patients, the creation of a well-functioning arteriovenous (AV) fistula is critical for ensuring that patient receive adequate hemodialysis. Unfortunately, the primary failure rate for AV fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of pharmaceutical agents and biologic agents. A key to success in the development of a useable AV fistula is an adequate arterial and venous diameter in the access forearm. Although exercise is commonly used to increase vessel diameter after AV fistula placement, Investigators are unaware of published studies that report on the effect of exercise prior to AV fistula placement to assist with the maturation of a newly created AV fistula. In this pilot trial, the Principal Investigator will evaluate the feasibility and possible benefits of pre-surgical exercise on forearm AV fistulas.

The trial is designed to determine if a pre-surgical exercise program will improve the likelihood of a useable forearm AV fistula. In this pilot study, the feasibility of the proposed intervention will be assessed in terms of both patient acceptability and patient outcomes. In addition, results from this feasibility study will be used to help determine power calculations for a full-scale trial.

Patients will be eligible for this pilot clinical trial if scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access. Patients will be randomized using a random number generator to either the intervention or the control group. The intervention group will be instructed in the use of hand grip with built in digital counter. These instructions will include the use of the hand grip on a daily basis with an increasing number of hand grip squeezes to be performed each week up until the time of fistula placement.

Patients in the control group will not receive any pre-surgical instructions for exercise in the access arm. In both groups, patients will be provided with post-surgical instructions on the use of a squeeze ball on a daily basis once the steri-strips from the surgical site have fallen off.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access.

Exclusion Criteria:

* The presence of joint or musculoskeletal impairments that prevent the patient from using a handgrip device on a daily basis
Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults

The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week supplementation study during winter months.

The UK (McCance \& Widdowson) food composition tables suggests that 25-hydroxyvitamin D (which is present in some foods, albeit at very low concentrations, but which is also commercially available) may possess up to 5-times the activity of native vitamin D3 in food. Thus, in theory, each micogram of 25-hydroxyvitamin D consumed in the diet could boost vitamin D status up to five times most effectively compared to each microgram of native vitamin D in food. It is worth noting, however, that estimates of potency range from 2 to 5, depending on approach used, and that the real potency needs to be confirmed in a human study. This study aims to examine the biological activity of 25-hydroxyvitamin D (i.e., its potency relative to vitamin D3) as well as its effect on selected functional markers in a randomised, double-blind, human intervention trial in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible if they are 45+ years of age
* Body Mass Index (BMI) 19-30

Exclusion Criteria:

* have hypercalcaemia
* chronic illness
* renal or liver disorders
* taking medications that might interact with vitamin D or metabolite
* drank more than \> 21 standards (male)/ 14 standards (female) of alcohol per week
* planning to change smoking habits
Multidisciplinary Teamwork Perceptions When Mobilizing Ventilated Neurosurgery Patients

The purpose of this research study is to decide if using a nurse-led mobility protocol affects teamwork perceptions, when mobilizing ventilated neurosurgery patients. Participants will mobilize ventilated neurosurgery patients according to either facility standard procedures or a piloted nurse-led mobility protocol. Each selected patient will be mobilized once during his/her hospitalization for the purposes of this study. Patient mobility may take up to 1 hour. Following this, participating staff will be asked to complete a survey used to measure teamwork perceptions. Participants will be given up to 30 minutes to complete the survey. Total study duration is 3 months.


Eligibility Criteria:
Inclusion Criteria:

* adult (18 years of age or older)
* male or female registered nurses or licensed vocational nurses, patient care technicians, respiratory therapists, and physical therapists
* currently employed by the medical center
* currently care for neurosurgery patients in a part time or full-time capacity
* may work during day shift and/or night shift hours.

Exclusion Criteria:

* staff members employed by an agency outside of the medical center
* staff not routinely assigned to care for neurosurgery patients on the neurosurgical ICU (float pool staff)
Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera

To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Females ≥18 years of age
* Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following:

  * Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier
  * History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease)
  * History of Cowdens or Li Fraumeni Syndrome
  * A first degree relative with Cowdens or Li Fraumeni Syndrome
  * Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH)
  * Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator

Exclusion Criteria:

* Pregnant or lactating
* History of invasive breast cancer or ductal carcinoma in situ (DCIS)
* Unable to undergo MRI because of:

  * Renal dysfunction with an estimated creatinine clearance of \< 30 ml/min calculated using the Cockcroft-Gault formula
  * Implanted ferrous metal prostheses
  * Claustrophobia
  * Medical or psychological conditions that on assessment, make them unable to complete the procedure
  * Known allergies to Gadolinium-DTPA
* Known allergies to Sestamibi (Miraluma or Cardiolite)
* Prior bilateral mastectomy
* Prior breast biopsy or surgery within 3 months
Emotional and Change-related Attention in Autism

Several studies seem to indicate that emotional attention and change-related attention are impaired in ASD. The goal of this study is to identify the relationships between those two types of automatic attention in visual and auditory modalities in subjects with ASD compared to healthy controls and also, over the course of development (children, adults). In order to achieve this goal, the investigators will use complementary techniques (EEG and MRI-based techniques (fMRI, DTI)).

Autism Spectrum Disorders (ASD) are characterized by major handicap in social interaction and in daily life adaptation. The orienting response towards potentially relevant events involves automatic attentional mechanisms that would be elicited mainly by two classes of biologically important stimulations: novel stimuli and emotional stimuli. The neural basis of emotional and change-related attention in ASD will be explored by investigating brain reactivity in both visual and auditory modalities, during tasks mixing emotional and non emotional stimuli.

Eligibility Criteria:
Inclusion Criteria:

* No past history of central nervous system disorders
* Written consent
* Affiliated to the National Health Insurance
* Do not participate to another biomedical research
* For ASD group: Children with autism spectrum disorder (DSM-V criteria) and adults with high-functioning autism
* For healthy subjects: No past history of difficulties in early childhood for acquisition of walk, language or reading and no psychiatric disorders

Exclusion Criteria:

* Abnormal corrected vision
* Abnormal audition
* Not stabilized psychoactive treatment or treatment that can modify electrogenesis
* Infectious or metabolic diseases
* Epilepsies
* Impossibility to participate to the whole study
* For subjects participating to the MRI recordings: MRI counter-indications (pace-makers ...), claustrophobia or a positive pregnancy test
Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.


Eligibility Criteria:
Inclusion Criteria:

* emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

* none
Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects

This study is intended to compare the efficacy of platelet-rich fibrin as a graft and a membrane versus hyaluronic acid(Gengigel) and amniotic membrane in the treatment of mandibular grade II furcation defects.

Platelet-rich fibrin is a fraction of plasma that provides a rich source of growth factors and may enhance the stabilization and revascularization of the flaps and grafts.

Hyaluronic acid is a naturally occurring non-sulfated high molecular weight glycosaminoglycan that forms a critical component of the extracellular matrix and contributes significantly to tissue hydrodynamics, cell migration and proliferation. Hence its administration to periodontal wound sites could achieve beneficial effects in periodontal tissue regeneration.

Amniotic membrane is being used for various regenerative procedures as it is a rich source of various collagen and non-collagen proteins such as laminin, fibronectin and proteoglycan.

Eligibility Criteria:
Inclusion Criteria:

* Grade II furcation involvement

Exclusion Criteria:

* Smokers,
* Pregnant and lactating women,
* Systemically compromised patients
Effectiveness of Cognitive Behavioral Therapy for Insomnia in Young Adults With Chronic Pain

The aim of the Young Adult Cognitive Behavioral Therapy (YAC) study is to evaluate the effectiveness of the Delivering Online "ZZZ's with Empirical support (DOZE) app, a unique digital cognitive behavioral therapy for insomnia (CBTi) in young adult patients with chronic pain.

Sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. Long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. Degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on Health Related Quality of Life (HRQL).

Cognitive behavioral therapy for insomnia (CBTi) is a behavioral modification approach and is currently a frontline therapy for adults with sleep disorders. However, CBTi is still in early stages of development for adolescent and young adult populations, and less so for youth with comorbid mental and physical health conditions and chronic pain.

Primary aim: Assess the feasibility of implementing the DOZE app.

Secondary aim: 1). To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL). 2). To determine the required sample size for a future definitive trial.

Eligibility Criteria:
Inclusion Criteria:

* Young adult patients aged 18 - 25 years old, who have
* Non-malignant chronic pain lasting more than 3 months, with
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for insomnia,
* English speaking with
* Access to a mobile phone or a computer with internet access.

Exclusion Criteria:

* Patients who require urgent CBT treatment as per their health care provider
* Patients who have received CBT in the past 3 months
* Patients participating in other psychological treatments and/or drug trials during the study
* Patients who have other significant medical conditions- Life threatening (e.g. cancer), neurological conditions (e.g. epilepsy)
* Patients who have other significant psychiatric conditions-Severe depression or active suicide intent
* Situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work \> 2 nights per week in the past 3months, pregnancy or breastfeeding.
* Inability to communicate with health care providers or the research personnel
* Inability to fill out self-report questionnaires, study materials, or follow instructions.
Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients

The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.


Eligibility Criteria:
Inclusion Criteria:

* laboratory confirmed positive test for SARS-CoV-2
* admitted to ICU because of respiratory failure caused by Covid-19

Exclusion Criteria:

* patients with treatment for thromboembolic complications at arrival to the ICU
* short ICU length of stay defined as discharged the same date as ICU admission
* patients without initial thromboprophylaxis
E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience greater benefit.

This open-label, multicenter, randomized study will consist of a Phase 1b: a safety run-in period with 3 ascending doses of E7050 in combination with cetuximab; and a Phase 2 portion: a randomized 2-arm period. Approximately 95 participants with platinum-resistant squamous cell carcinoma of the head and neck will be enrolled in the study (10-15 participants in the Phase 1b portion and 80 participants in the Phase 2 portion). Participants will only participate in either the Phase 1b or the Phase 2 portion of the study.

In the Phase 2 portion, participants will receive study treatment (E7050 plus cetuximab or cetuximab alone) for approximately six 28-day cycles (24 weeks). Beyond 24 weeks, participants who are experiencing clinical benefit may continue E7050 plus cetuximab, cetuximab alone or E7050 alone (Arm 1), or may continue cetuximab alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Platinum-resistant (defined as failure to respond to treatment with a platinum agent or recurrence of disease after initial response to platinum within 12 months of completing therapy), locally advanced, recurrent and/or metastatic SCCHN, which is untreatable by surgical resection or radiation therapy
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
* Blood pressure must be well-controlled. Participants must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function

Exclusion Criteria

* Nasopharyngeal tumors
* Previously received E7050, anti-angiogenic therapy, or anti-epidermal growth factor receptor (EGFR) therapy (prior anti-angiogenic/EGFR therapy is permitted in Phase 1b only. Prior cetuximab is permitted if administered in combination with radiation
* Presence of brain metastases, unless the participant has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization
* Palliative radiotherapy is not permitted throughout the study period
* Clinically significant hemoptysis
* Serious non-healing wound, ulcer, or active bone fracture
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for a major surgical procedure during the course of the study
* Clinically significant gastrointestinal bleeding within 6 months prior to first dose.
The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla

RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections. However, the underlying causes remain undetermined in up to 50% of cases. In this clinical cohort study, we intended to get an epidemiological evidence for patients with recurrent spontaneous abortion associated with thrombophilla.


Eligibility Criteria:
Inclusion Criteria:

* Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form.

Exclusion Criteria:

1. having experienced severe allergies, trauma history and/or operation history within 3 months;
2. with a history of mental illness and/or family history of mental illness
3. limb disabled
4. taking medicine within one month
5. suffering major events or having mood swings
6. with a history of recurrent pregnancy loss
7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
8. chromosome aberrations in anyone of the couple.
Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer

maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine


Eligibility Criteria:
Inclusion Criteria:

1. female patients aged 18 years or older
2. patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
4. measurable tumour deposits by one or more radiological techniques (MRI, CT)
5. life expectancy of at least 6 months
6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
7. patients must have given written informed consent (which must be consistent with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

Exclusion Criteria:

1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
2. known secondary malignancy requiring therapy
3. active infectious disease
4. brain metastases requiring therapy
5. neuropathy grade 2 or above
6. absolute neutrophil count less than 1,500/mm3
7. platelet count less than 100,000/mm3
8. bilirubin greater than 1.5 mg/dl (\> 26 μmol/L, système internationale (SI) unit equivalent)
9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
10. serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L, SI unit equivalent)
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
13. radiotherapy to breast and thorax region within the past four weeks prior to treatment with the trial drug or during the trial
14. women who are sexually active and unwilling to use a medically acceptable method of contraception
15. pregnancy or lactation
16. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
17. patients unable to comply with the protocol
Sofosbuvir in Treatment of COVID 19

Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients

Sofosbuvir containing treatment of COVID 19 Egyptian patients: a randomized-controlled trial

Eligibility Criteria:
Inclusion Criteria:

* Covid positive patients.

Exclusion Criteria:

* Contraindication to sofosbuvir or ribavirin.