cyrilzakka/clinical-trials huggingface dataset:
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women, aged 55-75 years;
* diagnosed osteopenia.

Exclusion Criteria:

* history of osteoporotic vertebral fracture;
* contraindication to ibandronate.
Collection of Electrophysiological Data During Colon Resection

The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery.
3. Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out.

Exclusion Criteria:

1. Subject has gastroparesis.
2. Subject has significant multisystem (autonomic) diseases.
3. Subject has a body mass Index greater than 35 kg/m2
4. Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
5. Subject has significant cardiac arrhythmia or ectopy.
6. Obstructing lesion and pre obstruction bowel dilatation
7. Subject has an existing implanted electrical stimulator (e.g., pacemaker.
8. Subject requires chronic anticoagulant therapy
9. Subject is currently enrolled in other potentially confounding research.
10. Pregnancy
11. Current alcohol abuse
12. Subject poses a significant general anesthesia risk
13. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of this study is that shifting cardiac metabolism from free fatty acids to glucose will improve myocardial ischemia

The present study will evaluate the effect of free fatty acid inhibition with Trimetazidine on silent myocardial ischemia and total ischemic burden in coronary artery disease patients with type II diabetes.

Patients will undergo ambulatory ECG monitoring at baseline and will be randomized to receive on top of thei standard anti-anginal therapy trimetazidine or placebo for 6 months. Patients will repeat the ambulatory ECG monitoring at the end of the study

Eligibility Criteria:
Inclusion Criteria:

coronary artery disease type II diabetes mellitus -

Exclusion Criteria:

unstable coronary artery syndromes impaired liver and kidney function

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Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma

This trial studies how well a mind-body intervention works in improving overall quality of life in adolescents and young adults with lymphoma. A meditation based mind-body intervention may help lower distress, depressive symptoms, and anxiety in adolescents and young adults coping with lymphoma.

PRIMARY OBJECTIVE:

I. Examine the feasibility of the mind-body intervention in adolescents and young adults (AYAs) with lymphoma.

SECONDARY OBJECTIVE:

I. Establish the initial intervention efficacy regarding psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group.

EXPLORATORY OBJECTIVE:

I. Explore mediation (e.g., mindfulness, compassion, social connection, inflammatory processes) and moderation (e.g., demographic and medical factors) of the intervention effects.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.

GROUP II: Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.

After completion of study intervention, patients are followed at 6 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 18-39 diagnosed within 6 months with stage I-IV Lymphoma (all types)
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below
* Having access to the internet
* Able to read, write and speak English

Exclusion Criteria:

* Major psychiatric or cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
* Regular (self-defined) participation in psychotherapy or a formal cancer support group
InTone for Urinary Incontinence

The rationale for the conduct of this study is that the Intone device (along with pelvic physiotherapy) can be used to help females suffering from urinary stress incontinence by using electrical stimulation and biofeedback during pelvic floor muscle training. This investigation is important because it can aid in the greater acceptance and development of non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The study results will address if the Intone device is beneficial and promotes long-term improvement in women that suffer from urinary incontinence.

Urinary incontinence is very common in women and is linked to a reduced quality of life (Corcos et al., 2002). The three main types of urinary incontinence are Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and Mixed Urinary Incontinence (MUI). SUI and UUI involve losing urine involuntarily. In SUI this is during either effortful motion such as coughing or sneezing, or in UUI is associated with a feeling of urgency. Urinary incontinence has various treatment options including: surgery, medication, pelvic floor muscle exercises and electrical stimulation (Norton \& Brubaker, 2006).

The most common physiotherapy treatment used for women with urinary incontinence is pelvic floor muscle training (Dumoulin \& Hay-Smith, 2010). Several studies have investigated the effects of PFMT in comparison to other treatments such as no treatment and vaginal cones. They found that women in the PFMT group reported more improvement and better quality of life than women in other treatment groups. The PFMT group also had fewer daily incontinence episodes and less leakage (Bø, Talseth, \& Holme, 1999; Dumoulin \& Hay-Smith, 2010).

Electrical stimulation of the pelvic floor muscles is another treatment for urinary incontinence, and may often be combined with PFMT. Success rates of electrical stimulation in treating urinary incontinence range from 50-90% (Bent et al., 1993; Erikson, Bergmann, \& Mjølnerød, 1987; Fall, 1984; Pelvnik et al., 1986).

A new product has been developed called InTone which combines PFMT, electrical stimulation and biofeedback. This device is inserted into the vagina and facilitates PFMT while providing electrical stimulation and biofeedback to the patient. This study will examine the effectiveness of the InTone device in treating urinary incontinence in women.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Between ages 18-70
* Diagnosed with Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI), or Mixed Urinary Incontinence (MUI)

Exclusion Criteria:

* Incontinence of less than 6 months
* pregnancy or delivery within 6 weeks
* vaginal or pelvic surgery within previous 6 months
* pelvic organ prolapse greater than stage 2 (based on POP-Q)
* active UTI or history of recurrent UTIs (more than 3 in a year)
* recurrent vaginitis (bacterial/fungal)
* pelvic pain/painful bladder syndrome
* implanted cardiac device or untreated cardiac arrhythmi
* Underlying neurologic/neuromuscular disorder, or inadequate vaginal caliber (can't accommodate device).
Novel Dose Adjustment Schedule for Late Injection in SCIT in AR

Allergen specific immunotherapy is currently the only curative intervention for allergic rhinitis (AR). Subcutaneous immunotherapy (SCIT) need to be reinstituted with an interruption of more than 16 weeks in maintenance period, leading to increased time and economic cost burden and difficulties for continuing further treatment for patients. The aim of present study was to develop a novel dose adjustment schedule for such situation and to compare the clinical efficacy and adverse reactions between novel and conventional schedules for dust mite (DM) SCIT of AR subjects.


Eligibility Criteria:
Inclusion Criteria:

* (1) aged 18 to 60 years;
* (2) only had a positive response to Der p and Der f but no other inhalant allergens based on EUROline Allergy Diagnostics (Beijing Oumeng Biotechnology Co., Ltd., Beijing, China). Meanwhile at least Der p -specific IgE (sIgE) in serum of was ≥ 0.7 kU/l (CAP Pharmacia, Uppsala, Sweden) using ImmunoCAP system (Pharmacia, Uppsala, Sweden) regardless of the result of Der p -specific IgE in serum;
* (3) had reached cluster SCIT maintenance period and the overall treatment time was more than 1 year but less than 2 years;
* (4) hope to continue to complete the entire treatment and have good compliance.

Exclusion Criteria:

* (1) diagnosed as asthma based on the guidelines of the Global Initiative for Asthma(13);
* (2) had Grade II or above systemic adverse reactions occurred in the past SCIT period.
Outcomes of Geriatric Hip Fractures in Assiut University Hospital

hip fractures are common problem specially in elderly population the incidence is increasing nowadays because of increased incidence of motor vehicle accidents

hip fractures are a common problem specially in elderly population the incidence is increasing nowadays because of increased incidence of motor vehicle accidents the incidence of morbidity and mortality is increasing today and the mortality rate is about 30% the aim of the study is follow up of the patients aged 65 years and older who experienced hip fractures for one year to evaluate the outcome of different ways of intervention in elderly population.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 65 years and older
* with fractures acetabulum , neck of femur , trochanteric , subtrochanteric and reverse trochanteric fractures

Exclusion Criteria:

* no patient will be excluded
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy

Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.

Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Clinical findings of actinic cheilitis.
* Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).
* Age above 18.
* Willingness to take post-treatment biopsy.

Exclusion Criteria:

* Disorders predisposing to photosensitivity (porphyria, SLE).
* Pregnancy or nursing.
* Known allergy to any excipients in the study creams.
* prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.
Breath Analysis in Lung Fibrosis

The aim of the study is to answer the question whether a disease specific profile of breath in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical symptoms consistent with IPF
2. Age 40 through 80 years
3. Diagnosis of UIP or IPF by HRCT and surgical lung biopsy as outlined in table 1. Only patients fulfilling the category "YES" will be included in the study.
4. Extent of fibrotic changes (honeycombing, reticular changes) greater than extent of emphysema on HRCT scan
5. No features supporting an alternative diagnosis

Exclusion Criteria:

1. Acute exacerbation within the last 6 weeks.
2. Any relevant lung disease other than pulmonary fibrosis.
3. Acute inflammatory disease (e.g. common cold) within the last 6 weeks.
4. Acute or chronic hepatic disease.
5. Renal failure or renal replacement therapy.
Lipid Profile of Tenon's Capsule

The purpose of this study is to provide data on the lipid profile of the Tenon's capsule in Human glaucomatous eyes and to establish possible relationships with the short term outcome of filtration surgery.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma
* Eligibility for surgery

Exclusion Criteria:

* Patients without Glaucoma
Method for Improved Intraoperative Blood Loss Estimates

The purpose of this study is to develop a mathematical algorithm which the investigators plan to use to more accurately estimate intraoperative blood loss.


Eligibility Criteria:
Inclusion Criteria:

All elective surgical patients

Exclusion Criteria:

1. Age \< 18
2. Pregnant women
3. Prisoners
4. Lack of informed consent
5. Attending Physician feels enrollment could interfere with optimal patient care
6. Patients who did not have a preoperative hemoglobin measured as part of their preoperative work-up
7. Patients whose preoperative hemoglobin fraction is abnormal.
8. Patients who will likely require an intraoperative blood transfusion.
9. Patients for whom the intraoperative use of the Cell Saver is anticipated.
Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.


Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, ECG, and physical exam
* Body mass index ranging between 18.0-32.5 kg/m2, inclusive
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
* History of addiction, abuse, or misuse of any drug
* Use of nicotine-containing products within 30 days
Local Injection for the Treatment of Chronic Wounds and Pain Caused by Chronic Wounds

Chronic wounds are wounds or ulcers that do not heal properly and are generally classified as venous, arterial, diabetic, traumatic and pressure chronic wounds and is often associated with inflammatory and neuropathic pain. Preliminary clinical studies have confirmed that injection of freshly prepared HA35 promoted the healing of chronic wounds and relieved the pain associated with chronic wounds. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.

Our previous study, together with other studies, showed that topical use of the tissue-permeable HA fragment HA35 relieves swelling of the skin and mucosal wounds. In this study, the tissue-permeable 35 kDa HA fragment HA35 was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089). The therapeutic effect of the tissue-permeable HA fragment HA35 for the treatment of pain-associated chronic wounds was studied in a single-arm off-label study before and after treatment comparison.

Eligibility Criteria:
Inclusion Criteria:

* The chronic wounds of painful diabetic wounds, venous wounds, arterial wounds, traumatic and pressure wounds whichvhad not been closed more than 3 months.
* All the chronic wounds were clinically presented by surface darkeness and purulent secretions on the wounds, and darkness or redness, swelling, dryness and broken surface of the skin immediately surrounding the wounds.
* Subject agrees to be compliant with study related visit and treatment schedule.
* Written informed consent.
* Adults aged 18-60 years.

Exclusion Criteria:

* Have a persistent pain resulted from other medical conditions or unknown causes.
* History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing.
* Subjects with any known coagulation disorder.
* Pregnant females.
* Be concomitantly participating in another clinical study.
Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.

In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Healthy urogenital microbiome improves implantation rate and pregnancy outcomes, whereas 40% of dysbiosis prevalence is observed in women under assisted reproductive treatment (ART).

Infertility causes are associated with male, female, or combined failure. It has been shown that oral probiotic treatment, mainly with Lactobacillus, recovers a healthy vaginal microbiota without safety concerns.

An interventional, randomized, double-blind, placebo-controlled study will be conducted to confirm the positive effect of the commercial probiotic product Fertibiome® on the vaginal dysbiosis of couples or women with fertility disorders.

The duration of the study will be of 6 months approximately, including 6 months of product intake. In case of pregnancy during intervention, women will continue their participation until week 12 of gestation.

Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. Women will take 1 capsule every 12 hours and men 1 per day. In case of women participating alone they will take 1 capsule every 12 hours. In case of pregnancy, only women will continue taking 1 capsule per day for the first 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Couples or women with ages between 18 and 40 for woman and between 18 and 55 for man (in case of couple participation).
* Couples or women with fertility disorders.
* Couples or women undergoing IVF treatment or willing to start it.
* Signature of the Informed Consent.

Exclusion Criteria:

* Women, not participating in the study with a couple, who have not undergone at least 4 cycles of artificial insemination with donor's sperm (AID) or 1 cycle of IVF without achieving evolutionary pregnancy.
* Women with Body Mass Index (BMI) ≥ 30.
* Couples where the woman has not infertility diagnosis while the man has any of the following characteristics:

  * Azoospermia
  * Sperm motility (A + B) \< 25%.
  * Sperm morphology ≤ 2%.
  * Vas deferens obstruction.
* Couples or women with any of the following characteristics:

  * Chronic diseases that cause intestinal malabsortion.
  * Congenital or acquired immunodeficiency.
  * Current history or diagnosis of alcohol, tobacco, or drug abuse.
  * Uncertainty about the willingness or ability of participants to comply with the requirements of the protocol.
  * Under treatment with probiotics during the last week.
Cholecalciferol Supplementation in Hemodialysis Patients

This is prospective single-blind randomized study, in Ain Shams University hospital) in Egypt, to assess the impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients

This Srudy is to assess the Impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients in terms of increase of Hgb \>11 g/dl, transferrin saturation (TSAT) of ≥ 30%, and ferritin levels to achieve a range of (300 to \< 800 ng/ml), and effect on Epoetin Dose needed. This study is also to adress the factors affecting the correcetion of Anemia by Cholecalciferol supplementation, such as oxidative stress and Inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* : Male or female patients who are willing to participate in the trial should have been on maintenance hemodialysis sessions for not less than 3 months, aged between 18-70 years old, clinically stable (no prior hospitalization on the past three months), with serum 25(OH)D levels of less than 30 ng/ml and their iPTH levels of 150-800 pg/ml, and hemoglobin levels of less than 11 mg/dl.

Exclusion Criteria:

* Patients with previous or known hypersensitivity to cholecalciferol,
* Patients who are already on cholecalciferol therapy, or patients on immunosuppressants.
* Blood transfusion in the past 4 month, and patients who had anemia for other than renal causes,
* Those who were participating in another clinical trial within the past 4 weeks or pregnant/breastfeeding female patients were excluded as well.
Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, no gender restrictions.
2. Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC).
3. Early stage PTC (stage T1N0M0).
4. Preoperative ultrasonography showed unilateral glandular lobe malignant tumor and the largest diameter was not more than 2cm, without cervical lymph node metastasis and extensive metastasis.
5. Patients undergoing thyroid lobectomy and central lymph node dissection.
6. Patients who have signed an approved Informed Consent.

Exclusion Criteria:

1. Patients who do not accept case data collection for various reasons.
2. The clinical data unfit this study (at the discretion of the investigator).
3. Patients who have undergone neck surgery or radiotherapy before this trail.
4. Patients who have uncontrolled hyperthyroidism.