cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients

Prophylactic treatment will start from surgery until the patients are discharged from the hospital(18). Then each patient will have 2 follow up visit in gyne- oncology clinic. The first visit will be 2 weeks from discharge \& the second visit will be 3 months after surgery. In each visit patient will be evaluated for any evidence of thrombo-embolic events clinically \& radiologically if needed ( spiral CT, V/Q scan \& lower limp Doppler ). Any side effect or adverse reaction will be reported \& it will be evaluated if it is related to the drug used or not.

This study is a phase IIIB, randomized, open label, non-comparative controlled trial, and prospectively enrolling 150 females to assess the efficacy and safety of the Enoxaparin (Group A) and Unfractionated Heparin (Group B) for Gynecologic Oncology Patients In the Kingdom of Saudi Arabia who required surgery or admission for the prevention of VTE.

Patients who meet the Inclusion Criteria and signed an informed consent will be randomly assigned to 1 of the 2 treatment groups (Group A or Group B). Subjects will be assigned consecutive study numbers according to a predetermined random code generated by the Biostatistician. The randomisation will be based on a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients aged 18 years or older were admitted with diagnosis of malignancy or suspension of malignancy and going for major surgery.
2. Patient with the following conditions:

   1. Any patient were admitted with diagnosis of Gynecologic malignancy \& going for major surgery such as laparotomies \& abdominal hysterectomy OR
   2. All staging laparotomies done for suspected ovarian malignancy by either ultrasound finding or tumor markers (raised CA 125) \& found to be either borderline or benign ovarian tumor
3. Signed the Informed Consent Form

Exclusion Criteria:

1 Renal failure assessed by serum creatinine \> 2.0mg/dL (180 mmol/L) 2. Patients on anticoagulant treatment in the previous 6 months 3. Bleeding disorders or platelet count \< 80x109/L 4. Known hypersensitivity to unfractionated heparin or LMWHs 5. Pregnant women 6. Obese patients with body mass index ≥ 47
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy

BACKGROUND: Upper limb nerve root dysfunction with increased active myofascial trigger point in upper trapezius is common problem in patients with cervical radiculopathy.

The purpose of this study was to evaluate the effect of Extracorpeal shock wave on the myo-electric and nerve function responses in patients with cervical radiculopathy.

Randomized controlled clinical trial among Forty eight (48) patients with cervical radiculopathy.

They will be allocated randomly by sealed envelopes into two groups: Group (A): will receive a designed physical therapy program in addition to sham Extracorpeal shock wave on upper trapezius. Group (B): will receive Focused Extracorpeal shock wave on the active myofascial trigger points in upper trapezius in addition to the same physical therapy program as in group A.

Somatosensory evoked potential for upper limb median nerve will be applied using the Electromyography (EMG) device. Hand grip strength will be assessed using the handheld dynamometer (HHD) , Level of radiating pain will be assessed using the numeric rating scale , Pain and tenderness in upper trapezius muscle will be also assessed using Pressure pain threshold (PPT).

Eligibility Criteria:
Inclusion Criteria:

1. All patients suffer from unilateral discogenic cervical radiculopathy of lower cervical spine(C5-C6 and/ or C6-C7) as confirmed with MRI.
2. All patients suffer from pain and tenderness on active trigger points of the upper trapezius .
3. Age ranging from 36 to 46 years old.
4. Duration of symptoms more than 3 months to avoid acute stage of inflammation.
5. Side to side amplitude differences of 50% or more in DSSEPs measurement (Naguszewski et al.,2001)

Exclusion Criteria:

1. Posterior osteophytes
2. Spinal canal stenosis
3. Rheumatoid arthritis
4. Vestibular insufficiency
5. Osteoporosis
6. Any signs or symptoms of myelopathy
7. Any abnormalities of deep sensation
8. Associated pathologies of upper cervical region or the upper limb that may cause overlapping with clinical findings as referred pain from costotransverse joint, rotator cuff tendonitis, cervical rib syndrome and entrapment neuropathy.
Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.

OBJECTIVES:

* Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer.
* Determine the response rate, response duration, and overall survival of these patients treated with this regimen.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage III, IV, or recurrent endometrial carcinoma for which curative radiotherapy or surgery is not an option
* Bidimensionally measurable disease

  * Irradiated field as only site allowed if evidence of progression since radiotherapy

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* GOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN
* Alkaline phosphatase no greater than 3 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Cardiovascular:

* LVEF normal by cardiac echocardiogram or MUGA

Other:

* No concurrent active infection
* No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior chemotherapy as radiosensitizer allowed
* No prior chemotherapy for advanced or metastatic disease
* No other concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* Recovered from prior radiotherapy

Surgery:

* See Disease Characteristics
* Recovered from prior surgery

Other:

* No prior therapy that would preclude study
* No other concurrent antineoplastic agents
* No other concurrent investigational agents
Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.

30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.

Eligibility Criteria:
Inclusion Criteria:

* Necrotic incisors with immature roots
* Pulp space not needed for post and core.
* The patient has to be free from any coagulation disorders, with normal platelets count.
* Good oral hygiene
* Cooperative patient

Exclusion Criteria:

* Internal or external root resorption.
* Root fracture and/or alveolar fracture.
* Previous root canal treatment.
* Medically compromised patients
* Uncooperative patient
The Influence of Music Choice on Pain Tolerance in the Context of Social Background

This study will investigate the effect of different music on the pain tolerance during an increasing electric stimulus in healthy individuals, taking social background into account.

The implementation of music in health care settings has shown promising results in alleviating stress, anxiety, and pain-related outcomes. However, the heterogeneity in music selection and characteristics across clinical trials has made it difficult to draw direct comparisons between different music interventions. Additionally, the influence of social background on music perception remains largely unexplored, despite its potential significance. Therefore, a collaboration of medical and sociological experts propose a randomized controlled trial to investigate the effects of two different music interventions on pain tolerance, taking into account the participants' social backgrounds. The primary objective of this study is to assess the impact of self-chosen and researcher-chosen music compared to a control intervention (podcast) on pain tolerance among healthy female volunteers at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 60 years of age
* Female
* Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
* Provision of written informed consent by subject

Exclusion Criteria:

* Significant hearing impairment
* Current complaints of tinnitus
* Current use of analgesic medication
* Presence of acute or chronic pain
* Current treatment by a medical specialist or general practitioner
* History of cardiac disease of arrhythmias
* (Suspected) pregnancy
* Diagnosed psychiatric or neurological impairments
* Electric implants (e.g. pacemakers)
Phase I Trial From GRID 18F-FDG-PET Biological Imaging-guided Intensitymodulated Radiotherapy (BG-IMRT) With Patients With Recurrent or New Head or Neck Tumor in Previously Radiated Area

This trials examines the feasibility of GRID-therapy combined with biologically imaging based IMRT (BG-IMRT). Within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. The GRID and BG-IMRT technique might be possible to reduce the total radiation dose 2 to 3 times.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or new head or neck tumor
* 18 years or older
A Study to Evaluate Lu AF90103 in Healthy Men

The purpose of this study is to investigate the safety and tolerability of Lu AF90103 and what the body does to Lu AF90103 after single doses of the drug administered directly into a vein.

This study is the first-in-human (FIH) study with Lu AF90103. The study is divided in two parts, Part A and Part B.

Part A is an interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Lu AF90103 in healthy men.

Part B is an interventional, randomized, double-blind, cross-over study to investigate the safety profile after administration of Lu AF90103 as an infusion at two different rates to healthy young men.

The dosage in Part B is guided by the cohorts in Part A and is a repetition of one of the doses from Part A.

The total study duration per participant from baseline to the end of follow-up will be maximum 11 days in Part A and 16 days in Part B.

Eligibility Criteria:
Inclusion Criteria:

* The participant is ≥18 and ≤45 years of age at the Screening Visit for Cohorts A1 to A6 (excluding cohort A2b) or ≥55 to ≤65 for participants in the CSF sampling Cohorts A2b and A7.
* The participant has body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m\^2) and ≤30 kg/m\^2 and body weight ≥60 kilograms (kg) at the Screening Visit and at the Baseline Visit.
* The participant has a normal resting electroencephalogram (EEG) at Screening.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Other inclusion and exclusion criteria may apply.
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.

The specific aim of this study is to determine if early restoration of metabolic control will improve C-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process.

Following completion of the baseline procedures (Mixed Meal Tolerance Test and blood sample collection), participants are randomized to either the Standard Treatment Group or the Intensive Treatment Group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management.

All subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. Subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 6.0 to \<46.0 years
* Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)
* If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
* Willing to accept randomization to either the intensive diabetes management group or the standard care group.
* Willing to complete the planned 2 years of follow-up.
* Able to electronically transmit data monthly.
* Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.

Exclusion Criteria:

* Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
* Currently anemic (hematocrit level will be obtained at the screening visit).
* Chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study.
* Complicating medical issues that might interfere with study conduct.
* Inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver).
* Currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.
Transcriptome Profiling and Endometrial Receptivity

The aim of this study is to correlate and identify the biochemical markers which may reflect WOI. Blood samples will be collected and endometrial biopsy will be performed at particular time points.

Endometrial receptivity in the midluteal phase of the menstrual cycle, known as the window of implantation (WOI), occurs only for a very short period of time. However, so far, there is no reliable clinical and biochemical indicators of WOI. Therefore, this study is to correlate and identify the biochemical markers which may reflect WOI.

participants will be asked to be:

1. performed endometrial biopsy
2. taken blood for a few time points (e.g. pre-conception and being pregnant) and to compare different kinds of biochemical markers.

Eligibility Criteria:
Inclusion Criteria:

Age 20-40 years.

Exclusion Criteria:

* Uncorrected uterine anomalies, such as septate or bicornuate uterus, fibroids (submucous/intramural).
* Intrauterine adhesions.
* Adenomyosis.
Woodcasting Versus Thermoplast Splint in CMC Arthroplasty

This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.

Patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years old.
* Intact Medical Decision Making
* Eligible for Surgical Intervention
* Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks

Exclusion Criteria:

* Pregnant Women
* Deemed Unsuitable by Principal Investigator
Bioequivalence Trial of a New Opioid Combination Compared to Reference

The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference


Eligibility Criteria:
Inclusion Criteria:

* Standard Phase I
* Cyp 2D6 extensive metabolizers

Exclusion Criteria:

* Standard Phase I
* Contraindications of current reference tablet SmPC
Study of Cabozantinib in Combination With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer

This study is designed to evaluate the safety and efficacy of combining abiraterone (with prednisone) with cabozantinib in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Must be surgically or medically castrated (serum testosterone levels less than or equal to 50 ng/dL)
* Must have castration-resistant prostate cancer (CRPC) with disease progression during LHRH therapy or after a surgical bilateral orchiectomy.
* Bone metastasis related to prostate cancer
* Adequate organ and marrow function
* Capable of understanding and complying with the protocol requirements and signed the informed consent document
* Sexually active subjects and their partners must agree to use medically accepted methods of barrier contraception (eg, male condom or female condom) as well as one other medically accepted method of contraception during the course of the study treatment and for 4 months after the last dose of study treatment.

Exclusion Criteria:

* Any prior treatment with abiraterone, enzalutamide, or any investigational agents blocking androgen receptor (AR) or androgen synthesis.
* Any prior treatment with cabozantinib or participation in a prior clinical trial of cabozantinib.
* Any prior cytotoxic therapy (including estramustine) or biologic therapy for the treatment of prostate cancer (a few exceptions will be allowed)
* Any prior radionuclide therapy (eg, samarium 153, strontium 89, alpharadin)
* Use of investigational agent within 28 days
* Any pathological finding consistent with small cell carcinoma of the prostate
* Known brain metastases or cranial epidural disease
* Diagnosis of another malignancy within 2 years, except for superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy
Prevalence of Osteoporosis Among Inflammatory Bowel Disease Patients in Assiut University Hospitals

the prevalence of osteoporosis in patients with inflammatory bowel disease in Assiut University Hospitals.

Inflammatory bowel disease (IBD) includes ulcerative colitis (UC) and Crohn's disease (CD) (1) .There has been a global rise in the incidence of IBD over the last few decades. (2) In the course of this disease, apart from the involvement of the gastrointestinal tract, up to 50% of patients may also have extraintestinal manifestations (EIMs) .One of them may be osteoporosis (OST), which is present in over half of IBD patients; this constitutes a significant problem due to the increased risk of fractures, especially non-traumatic fractures.(3) Known risk factors for OST in IBD include the persistence of chronic inflammation, treatment with glucocorticosteroids, extensive range of the disease, previous resection of the small intestine, arthralgia, and current nutritional deficiencies. Some risk factors are similar to those found in the general population, such as age, smoking, or low physical activity.(3) The pathogenesis of osteoporosis is multifactorial and comprises such elements as steroid therapy, low body mass index (BMI), malnutrition, genetic predispositions, and vitamin D deficiency (4) Given that the gastroenterologist is often regarded as the main provider for IBD patients, gastroenterologists and primary care physicians are equally responsible to recommend preventive measures and screening for osteoporosis, in addition to other healthcare maintenance issues.(5) Dual energy X-ray absorptiometry (DEXA) scans are globally recognised as the screening tool for low BMD (6) The Z and T scores are used to establish the diagnosis of osteoporosis, osteopenia or low BMD according to the 2019 International Society of Clinical Densitometry official position for adults.(7)

Eligibility Criteria:
Inclusion Criteria:

* The study will include Patients aged 18-65 years, diagnosed with either Crohn's disease or ulcerative colitis, The diagnosis of UC and CD based on the clinical, endoscopic, laboratory and histological criteria according to ECCO Guidelines. The activity of IBD will be determined with the use of the Crohn\&#39;s Disease Activity Index (CDAI) for CD, and the Mayo score for UC, data collection will obtained over one year duration

Exclusion Criteria:

1. Patients Known to have osteoporosis and on treatment
2. Female patients on COCs
3. Patients with malignancy
4. Patients with CKD
Renalof in the Treatment of Elderly Patients With Gallstones

The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged \>65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.
* Signed informed consent

Exclusion Criteria:

* Previous surgical intervention for the treatment of cholelithiasis
* Cholelithiasis with acute symptoms requiring emergency surgery
* Cholelithiasis associated with neoplastic condition of any localization or origin
* Usage of other antioxidants within the duration of the clinical trial
* Handicap and/or psychiatric condition preventing treatment accomplishment