cyrilzakka/clinical-trials huggingface dataset:
Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation

The primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk.

A pilot study will be performed on patients undergoing oocyte retrieval (OPU) for the first time, and correlated to camel milk consumption versus never consumed camel milk, as well as age, BMI (body mass index), number of follicles at the time of OPU, number of previous OPUs in other clinics, previous vaginal delivery, past medical history positive for chemo therapy, alcohol consumption, use of prescribed or illicit drugs, or chronic pain medication.

The main objective is to analyse if the consumption of camel milk, the frequency, or lack thereof correlates with the amount of the sedative drug Midazolam needed to achieve an acceptable level of sedation in order to estimate the dosage needed in both patient groups more adequately, reducing either discomfort felt at a too low an initial dosage, as well as avoiding a deeper level of sedation than needed with subsequent prolonged stay in recovery and unpleasant feelings of dizziness and drowsiness, potentially requiring antagonizing Midazolam by the use of Flumazenil, and reducing overall costs and length of stay in recovery and bed occupancy and enhancing patient experience and satisfaction.

Would this study enable the Investigators to determine further effect of camel milk on other drugs used for various other purposes, and lead to a change in dose regimen?

Eligibility Criteria:
Inclusion Criteria:

* Arab origin
* Female 18 -48 years of age
* BMI \< 37 kg/m2
* All ovarian stimulation protocols

Exclusion Criteria:

* Previous oocyte retrieval at our center
* Post chemo therapy
* Illicit drug use
* Chronic pain medication
* Medication which is known to increase the activity of liver enzymes
* Any alcohol consumption
* Previous vaginal delivery
Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis

To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.

Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.

While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.

After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are 13 years of age or older (parent or guardian consent required if under 18).
* Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study.
* Have AIDS.
* Have CMV retinitis.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of heart or kidney disease.
* Have medical problems which would prevent you from completing the study.
* Are pregnant.
Osteoporosis in Children With ALL

Hypothesis:

Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as a part of the leukemia treatment protocol, will have an increased incidence and severity of osteoporosis.

Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue. Osteoporosis is a devastating disorder with significant physical, psychosocial and financial consequences. Intensive chemotherapy and radiotherapy have led to significant improvements in long term, disease-free survival of children with malignancies. Unfortunately, there are many deleterious side effects associated with this therapy. Little is known about the longitudinal changes in bone mass accumulation and bone metabolism in these patients.

The purpose of this study is to evaluate the timing and severity of changes in bone mineral metabolism for children treated for childhood leukemia. Data will be used to establish treatment protocols with the goal of preventing severe fractures and pain in the acute treatment stage and severe osteoporosis and related pathology in the chronic stage.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients with a new diagnosis of ALL between ages 4-18
* Patients who are expected to receive glucocorticoids as part of the leukemia treatment protocol
* Bone density measurements must be performed at the diagnosis visit or maximally within 48 hours after the first dose of glucocorticoids

Exclusion Criteria:

* Patients under 4 years of age are excluded due to lack of age appropriate standards for bone mineral density
* Glucocorticoid therapy of at least one month or longer within the six months prior to DX
* History of connective tissue or musculoskeletal disorders
* Biphosphonate therapy within the past 6 months
* Acute renal failure
* Serum creatinine equal to or higher than 4.5mg/dl
* Positive serum pregnancy test in adolescent females
Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders

The aim of the present study will be to determine if different forms of active reminders regarding oral hygiene compliance have an influence on the level of compliance within orthodontic patients


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a complete natural dentition.
* Patients who need to undergo orthodontic therapy using fixed appliances.
* Good oral hygiene, with no signs and symptoms of periodontal disease.
* Patients with no medical or mental problems.

Exclusion Criteria:

* Patients with health risks associated with periodontal probing.
* Syndromic patients ex; Down syndrome.
* Previous orthodontic treatment.
* Patients with carious teeth
Study Comparing the Effects of SPM Techniques, Individually vs. Grouped in Children With ASD

Autism is the most prevalent disorder as it affects attention, awareness, cognitive development, social development, and emotional aspects too. It is one of the comprehensive developmental disorders in the early stage, which is characterized by weak social learning and communication, limited activities, interests, learning, insufficient imaginative and stereotypical thinking or non-functional thinking of movements and verbalities. A lack of sensory perception leads to a leading autistic child\&#39;s sensitivity to sensory stimuli or weak sensitivity and the child is not aware of the surrounding environment.

The current study will be randomized control trial; data will be collected from Lahore Garrison Institute of Special Education. This study will be conducted with 32 participants equally divided into two groups. Inclusion criteria will be Children who diagnosed with Autism Spectrum Disorder (mild \&amp; moderate) according to Diagnostic and Statistical Manual of Mental Disorders, (DSM-5), Have an IQ 70 according to Stanford-Binet Intelligence Scales and be able to understand and follow instructions, Children whose age between 4 to 12 and All participants had to be able to sit and walk without support according to GMFCS. Exclusion criteria for the study include Children who will associate with attention deficit hyperactivity disorder signs, Upper limb musculoskeletal injuries, Visual or auditory impairments, Children who had received sensory integration therapy for \&gt; 3 months within the past 6 months and Children with speech delay, hearing impairment, or intellectual disability. SPM training will be given each child individually in the first group. In the second group techniques will be apply in a group therapy. The SPM training programme will apply for 10 months. Outcomes, including the Test of Movement Battery for Children, Quality of life scale will be use. Data analysis will be performed using SPSS version 23.00

Eligibility Criteria:
Inclusion Criteria:

* Children who diagnosed with Autism Spectrum Disorder (mild \& moderate) according to Diagnostic and Statistical Manual of Mental Disorders, (DSM-5)
* Have an IQ 70 according to Stanford-Binet Intelligence Scales
* Children whose age between 4 to 12
* All participants had to be able to sit and walk without support

Exclusion Criteria:

* Children who will associate with attention deficit hyperactivity disorder signs
* Upper limb musculoskeletal injuries
* Visual or auditory impairments
* Children who had received sensory integration therapy for \> 3 months within the past 6 months
* Children with speech delay, hearing impairment, or intellectual disability
To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen

This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with follitropin beta (Puregon) liquid pen.

Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as in-vitro fertilisation (IVF) and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF/intracytoplasmic sperm injection (ICSI) currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotrophin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH in terms of requiring fewer ampules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.

Recently, a new formulation of follitropin alfa has been developed due to a general trend in the field of therapeutic recombinant proteins to move from presentations based on biological activity to presentations based on physico-chemical characteristics. Until now follitropin alfa has been produced as a powder for injection (either as monodose or multidose preparations) in glass ampoules or in glass vials and administered using plastic or glass syringe. Serono developed a multidose solution for injection in a prefilled disposable injection pen. This study involved comparing the administration of follitropin alfa liquid formulation applied by pen with that of follitropin beta liquid formulation also applied by pen.

OBJECTIVES The objectives of this study were to evaluate the convenience, safety and efficacy of Follitropin alfa (Gonal-f) liquid pen compared with Follitropin beta (Puregon) liquid pen.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal woman, between her 18th and 39th birthday, receiving recombinant FSH as stimulation for IVF and/or ICSI
* Subjects who were able to communicate well with the investigator and to comply with the requirements of the entire study
* Subjects who had given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice

Exclusion Criteria:

* Subjects who had known allergic reaction against one of the ingredients
* Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries (PCO)
* Subjects with gynaecological bleeding of unknown origin
* Subjects who had ovarian, uterine, or mammary cancer
* Subjects with tumors of the hypothalamus or the pituitary gland
Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients

According to the inclusion and exclusion criteria, a total of 108 patients were enrolled and randomly divided into control group (n = 56) and intervention group (n = 52). The control group received routine nursing, while the intervention group received upper limb lymphedema prevention program for breast cancer patients after surgery. Before surgery, at the third chemotherapy (about 2.1 months after surgery) and the sixth chemotherapy (about 4.2 months after surgery), the self-designed general information questionnaire was used to investigate the patient's basic situation, and the corresponding tools were used to measure the volume of the patient's upper arm, the grip strength of the affected arm, and the range of motion of the affected shoulder joint.


Eligibility Criteria:
Inclusion Criteria:

* Female patients were≥18 years old
* Pathological puncture confirmed breast cancer with unilateral, no recurrence, and no metastasis
* Patients with clinical TNM stageⅠ\~Ⅲ
* Patients with proposed surgery and 6 or more chemotherapy
* The patient was conscious and aware of his condition, with no cognitive impairment or communication problems

Exclusion Criteria:

* Patients who had cancer other than breast cancer
* Patients who had history of arm or neck trauma, infection or surgery
* Patients who had serious diseases such as cardiovascular, cerebrovascular, liver, kidney, etc
* Patients who had upper limb disability or the affected limb has edema before surgery
* Patients who had thrombus in the blood vessels of the affected limb
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013; 369:1406-15).

Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.

Real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. Documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. In addition, recurrence of symptomatic VTE and death will be captured retrospectively at time point of Last Patient Out per country.

Patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.

Eligibility Criteria:
Inclusion Criteria:

* Established acute initial or recurrent VTE
* Clinical decision for treatment with edoxaban is made at the time of enrollment
* Written informed consent for participation in the study (ICF)
* Not simultaneously participating in any interventional study

Exclusion Criteria:

* None
Pain in Newborn Heel Blood Collection

This study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.Questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and previous heel blood collection were collected with the "Information Form".The Newborn Infant Pain Scale (NIPS) was used to evaluate the pain levels of newborns.


Eligibility Criteria:
Inclusion Criteria:

* gestational week 37 and above,
* fasting time \< 1 hour,
* without comorbidity and congenital anomalies,
* not receiving oxygen or mechanical respiratory support,
* no analgesic sedation before the procedure
* neonates with stable physiological findings before the procedure

Exclusion Criteria:

• newborns whose heel blood cannot be taken at once
Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis

This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM. Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation. This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible.

Each patient will be randomized to receive either standard care and immunosuppression therapy (treatment group) or standard care alone (control group). To prevent bias, randomization will be stratified by recency of symptom onset to ensure that both the treatment and control groups are balanced with respect to it. Within each of these 2 strata, permuted-block randomization will be done to keep the number of treatment and control patients balanced. Due to the necessary monitoring of the patients randomized to receive immunosuppression therapy, treatment cannot be blinded. Approximately 1 year after the last patient has been randomized, the observed times from randomization to the composite endpoint (death, transplantation, or LVD placement) will be compared in the treatment and control groups.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Idiopathic heart failure and/or arrhythmia of less than 3 months duration
* Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis
* Negative pregnancy test

Exclusion criteria:

* Clinical evidence of sepsis or active infection (e.g., meningitis or osteomyelitis)
* Pregnant
* Any contraindication to immunosuppression
* Allergy to cyclosporine or muromonab-CD3
* Creatinine greater than 2.5 mg/dL
* AST or ALT greater than 3 times upper limit of normal
* Other severe concurrent disease that would preclude study
* Unreliable or uncooperative subject
Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer

This study aims to evaluate the rate of patients submitted to pancreatic resection for pancreatic cancer, who fail to access to adjuvant therapy or do not complete adjuvant therapy. The purpose is to give an overview concerning the most frequent conditions and/or reasons associated with failure or omission of adjuvant therapy.

This prospective observational study will evaluate all patients submitted to pancreatic resection for pancreatic cancer.

The rate of omission to adjuvant therapy and rate of failure of completion of adjuvant therapy will be evaluated as primary outcomes. As secondary outcomes, survival analyses will be performed to investigate whether these factors influence prognosis, that will be evaluated through a disease free survival analysis at 18-months. Epidemiological and perioperative data will be analyzed to identify conditions associated with the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of pancreatic cancer

Exclusion Criteria:

* Non exocrine pancreatic tumors
* Periampullary malignancies
Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Investigators conducted a prospective cohort study between June 2021 and October 2023. They screened 1450 patients who presented with AIS and received alteplase and included 616 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset.

The investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase.

The study consisted of two distinct groups. The first group consisted of 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction.

The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Eligibility Criteria:
Inclusion Criteria:

* The investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis.

Exclusion Criteria:

* The investigators excluded patients who had not been followed up on for 90 days after enrollment, Those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded The investigators excluded patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit).

The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings.

The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks.

The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest