cyrilzakka/clinical-trials huggingface dataset:
Platelet-rich Plasma for Stress Urinary Incontinence

Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as "the complaint of any involuntary loss of urine on effort or physical exertion or on sneezing or coughing. The treatment varies from Kegel exercise, bulking agents, vaginal LASER, to surgery. Platelet-rich plasma (PRP) stimulates angiogenesis, promoting vascular in-growth and fibroblast proliferation, enhancing wound-healing in both soft and hard tissue. PRP regulates tissue reconstruction and has been previously used in orthopedics and plastic surgery. The previous study revealed some promising results for PRP use in pelvic floor dysfunction, including SUI. We aim to evaluate the effect of PRP on female SUI.

Women with SUI were enrolled. Pre-treatment evaluation included Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), Female Sexual Function Index (FSFI), Urinary Distress Inventory Short Form (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), pelvic examination, and urodynamic study (UDS) (including pad test).

10 milliliter blood was taken from each participant. The RegenKit-THT (RegenLab SA, Switzerland) was used to separation of plasma and blood cells. 3 milliliter PRP was extracted from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external urethral sphincter, and into endopelvic fascia. The participants received one treatment per month for three times. Follow-up schedule is as below: 1st month (transperineal ultrasound and questionnaires), 3rd month (UDS and questionnaires), 6th month (questionnaires), and 12th month (questionnaires).

Eligibility Criteria:
Inclusion Criteria:

* Women with SUI
* Age between 20 to 85 years

Exclusion Criteria:

* Under anti-platelet agent treatment
* Under NSAIDs
* Platelet dysfunction syndrome
* Critical thrombocytopenia
* Hypofibrionogenaemia
* Sepsis
* Acute and chronic infections
* Chronic liver disease
* Anti-coagulation therapy
* History of malignancy
* Pregnancy
The Impact of CYP2D6 Polymorphism on Tramadol Pharmacodynamics

CYP2D6 is an enzyme involved in the hepatic metabolism of many clinically important drugs: antiarrhythmics, antidepressants, antipsychotics, β-blockers, and analgesics such as tramadol and codeine. CYP2D6 is highly polymorphic and significant interindividual variability has been observed worldwide. This study aims to investigate the distribution of CYP2D6 polymorphisms among post-cesarean female patients in Erbil city, Iraq. The findings of this study may indicate the presence of CYP2D6 gene variants among the Kurdish female population in Erbil, which could contribute to tramadol analgesic failure or exaggerated adverse effects. This study could also serve as a foundation for further pharmacogenetic research, individualizing treatments and targeting a larger sample size in the future.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18-56 years old
* Patients who undergo cesarean section surgery
* Patients receive tramadol drug for postpartum pain management

Exclusion Criteria:

* Patients with any history of severe renal, liver, respiratory diseases and/or seizures
* Patients with history of psychiatric disorders or unable to provide consent
* Patients with complicated surgeries or neonatal distress or unable to perform the clinical assessment of pain
* Patients with history of consumption of chronic alcohol or opioid or drug abuse
* Patients with history of known allergy to tramadol
Evaluating New Formulation of Therapeutic HSV-2 Vaccine

This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.

This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.

Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.

Eligibility Criteria:
Inclusion Criteria

* A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy
* Diagnosis of genital HSV-2 infection for \> 1 year
* Willing and able to provide written informed consent
* Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form
* Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study
* Men and women must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, tubal ligation, hysterectomy, licensed hormonal methods, intrauterine device, or barrier method (e.g., condom, diaphragm) with spermicide for 28 days before and 90 days after receiving the Study Drug

Exclusion Criteria

* On suppressive antiviral therapy within 14 days of starting the study
* Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study
* Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days of starting the study
* History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
* Immunocompromised individuals
* Use of corticosteroids within 30 days of starting the study and during the study or other immunosuppressive agents
* Presence or history of autoimmune disease regardless of current treatment
* Current infection with HIV or hepatitis B or C virus
* History of hypersensitivity to any component of the vaccine
* Prior receipt of GEN-003 or another vaccine containing HSV-2 antigens
* Receipt of any investigational product within 30 days prior to Dose 1
* Receipt of blood products within 90 days prior to Dose 1
* Planned use of any vaccine over the course of the study
* Pregnant or nursing women
* History of drug or alcohol abuse
* Other active, uncontrolled comorbidities
Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Cesarean delivery is one of the most common surgical procedures, performed at an increasingly high rate. It is associated with intense postoperative pain that may hamper the rehabilitation process and interfere with patient satisfaction and care provided to the newborn. Therefore, control of perioperative pain with multimodal regimens using local anesthetic may be important in short- and long-term convalescence after surgery.

Opioid-based regimens are the "gold standard" of cesarean delivery analgesia. However, spinal and epidural opioids have a ceiling effect.

Wound infiltration with local anesthetics has been used widely in the multimodal approach of pain relief. Continuous wound infusion with local anesthetic through a multiorifice catheter increases the duration of action and efficacy of local surgical wound infiltration compared with a one-time wound injection of local anesthetic.

After cesarean delivery, Local anesthetic continuous wound infusion would be associated with better reduction in pain scores when compared to intrathecal morphine . Therefore, an assessor and patient blinded, randomized study that aimed to compare the efficacy and side effects of these analgesia techniques was conducted.


Eligibility Criteria:
Inclusion Criteria:

* women.
* age between 18 and 50 years.
* gestational age 37 to 42 weeks.
* body mass index ranging from 18.0 to 30.0 kg/m2
* American Society of Anesthesiology (ASA) physical status I or II
* elective cesarean delivery with a Pfannenstiel incision
* spinal anesthesia.

Exclusion Criteria:

* history of chronic opioid use.
* Allergy to opioids and or local anesthetics.
* absolute or relative contraindication to neuraxial anesthesia.
* fever or any other sign of infection.
* Diabetes Mellitus under insulin therapy
* physical separation of patients from the neonate during the postoperative period.
Antipsychotics and Metabolic Syndrome

The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Gender male
* Age 18-45
* Debut drug-naive schizophrenics,
* Caucasians
* Consent given to take part in the project

Exclusion Criteria:

* Compliance-problems
* Major lung-/kidney/hart/lever disorders
* Abuse of alcohol/drugs
* Diabetes 1 and 2
* Antihypertensive
* Anticholesterol-reducing medication
* Patients under duress
The Normal Reference Values of Pulse Oximetry Plethymographic Waveform Parameters

The purpose of this study is to determine the normal reference values of pulse oximetry plethymographic waveform parameters in Chinese population.


Eligibility Criteria:
Inclusion Criteria:

Healty adults; Comply with ethical requirements and signed informed consent.

Exclusion Criteria:

Leuconychia; Stained fingernails; Diseases that have an impact on the blood flow of the peripheral tissue (such as Raynaud's phenomenon, vasculitis and so on); Any conditions the study physicians believe not suitable for inclusion.
Evaluation of Dental Anxiety in Second-Stage Implant Surgery With Er,Cr:YSGG Laser

Implants embedded under the oral mucosa were exposed with scalpel (Group 1) or laser surgery (Group 2). Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) and Dental Anxiety Scale (DAS) while resting in the waiting room.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing second-stage implant surgery

Exclusion Criteria:

* Patients without sufficient keratinized gingiva
* Bone overlap on closure screw
* Implants that can not be localized due to gingiva thickness,
Endotracheal Tube Audible Leak Test

The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed assessment to verify appropriate tube size in neonates, infants and children. However, many factors are known to influence the audible leak test. Even though the test is widely performed, the accuracy has not been evaluated.

The endotracheal tube (ETT) leak test (LT), or audible leak when the peak airway pressures reach 15-30 cmH2O, is a commonly performed assessment to confirm that an endotracheal tube size is appropriate for a child in order to minimize the risk of airway injury and adverse events after removal of ETT. Many factors are known to affect the results of the leak test and variation in results among experienced anesthesiologists may be as great as 38%, but the accuracy of the audible leak test by directly observing the presence of a leak around the ETT has not been evaluated. This study will attempt to use direct visualization of the air leak to correlate to and assess the accuracy of the audible air leak test.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.

Exclusion Criteria:

* Known history of subglottic stenosis
* Known history of recurrent croup
* Known history of endolaryngeal or subglottic lesions
* Parents refusal of participation in study
A Study of Olanzapine in Patients With Acute Agitation

The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients between the ages of 18 to 65 years, inclusive.
2. Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder.
3. Patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the PANSS-EC and at least one individual item score≥ 4 immediately before randomization.

Exclusion Criteria:

1. Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse.
2. Patients who have had previous suicidal behavior or currently at serious risk of suicide.
3. Patients with glaucoma or at risk of angle-closure glaucoma.
4. Patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, Parkinson's disease, Parkinson's syndrome, and dementia.
5. Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization.
6. Treatment with psychostimulants or reserpine within one week before randomization.
7. Patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval.
8. Treatment with clozapine within 4 weeks before screening.
9. Patients with serious or unstable medical illnesses.
10. Female patients who have a positive pregnancy test at screening or are breastfeeding.
11. Patients who have participated in other clinical trials within 3 months before randomization.
Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome

To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome.

This prospective, randomized controlled study was conducted in patients with acute coronary syndrome in an cardiology service of tertiary training and research hospital. The clinical pharmacist, within the scope of the discharge education services, provided medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally \[by using Teach back method especially for patients with low health literacy\]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model). The control group received standard care.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the cardiology department due to acute coronary syndrome
* Older than 18 years old

Exclusion Criteria:

* Patients who transferred to another ward
* Patients with active malignancy
* Patients with alzheimer and/or dementia diagnosis
* Patient with \>%80 visual loss or deaf muteness reported at medical record
Linaclotide for Colonoscopy Bowel Prep

The goal of this clinical trial is to learn if drug Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.

The main question it aims to answer is:

Does drug Linaclotide with Gatorade provide adequate bowel preparation for colonoscopy instead of the standard 4 Liters of Polyethylene glycol (PEG)?

Participants will:

Take one 290mg dose of Linaclotide 36 hours before the procedure and One 290mg dose of Linaclotide 8 hours before the procedure + 2 Liters of Gatorade and a clear liquid diet 24 hours before the procedure. As per standard of care, all patients will be made Nil Per Oral (NPO) starting midnight before the procedure.

The colonoscopy report will then be reviewed for Boston Bowel Preparation Score (BBPS) as a marker of bowel preparation quality, insertion time as a marker of procedure difficulty as well as noted pathology and any complications or physician noted comments.

Linaclotide is a novel, FDA approved, intestinal prosecretory agent used to treat chronic constipation and irritable bowel syndrome. Linaclotide reduces colonic transit time and increases luminal fluid secretion. Use of Linaclotide in colonoscopy bowel preparation decreased the volume of oral prep required. We hypothesize that Linaclotide can be used as a single agent regimen to adequately prepare bowel for colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients (age 18 years to 65) admitted, who are scheduled for a colonoscopy during their admission.

Exclusion Criteria:

* Pregnant patients
* Patients with weight less than 116 pounds
* Patients with prior colon resection surgeries
* Presence of colostomy
* Patients undergoing sigmoidoscopy or pouchoscopy
* Patients unable to swallow pills/tablets
* Patients who would use a G or J feeding tubes to administer medications/preparation regimen
* Patients who are unable to consent for themselves
* Patients with a history of renal failure
* Patients already taking Linaclotide
* Patients who experienced hypersensitivity reactions to Linaclotide in the past
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.


Eligibility Criteria:
Inclusion criteria:

* Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
* Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

Exclusion criteria:

* Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
* Impaired hepatic function
* Renal insufficiency with a creatinine clearance \< 50 mL/min
* Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.
Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness

Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.


Eligibility Criteria:
Inclusion Criteria:

* Vegetative State or Minimally Conscious State diagnosis
* \>3 months from acute brain injury

Exclusion Criteria:

* No clinical stability
* Sepsis
* Orthopaedic contraindications for verticalization
* Deep Vein Thrombosis
* weight \>130 Kg
* height \>210 cm
Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.


Eligibility Criteria:
Inclusion Criteria:

* women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
* abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
* pain (dull aching lower abdominal pain or dysmenorrhea)
* pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
* progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
* maximum diameter of the largest fibroid is greater than 4 cm
* maximum number of uterine myomas is not to be more than 5 myomas
* uterine fibroid may be subserous or intramural

Exclusion Criteria:

* obesity (BMI \>30 kg/m2)
* cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
* patients known to be allergic to prostaglandin preparations
* patients who received preoperative hormonal therapy (GnRH analogue)
* patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
* patients with positive pregnancy test
* virgin patients
Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC

To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer

This is a nonrandomized, open-label, phase II study of irinotecan plus capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. Up to 44 qualified patients will be enrolled according to the exact single stage design.

Irinotecan 90 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period). For practical reasons, capecitabine doses are rounded to the nearest dose that could be administered with a combination of 500-mg and 150-mg tablets of drug. Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of breast cancer Stage IV or recurrent.
* Previous chemotherapy with anthracyclines and taxane in adjuvant setting
* Previous hormonal therapy in adjuvant and metastatic setting is allowed
* Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
* No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.
* Performance status of 0, 1, 2 on the ECOG criteria.
* Clinically measurable disease, defined as uni-dimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm, as defined by x-ray, CT scan, MRI, or physical examination.
* Estimated life expectancy of at least 12 weeks.
* Patient compliance that allow adequate follow-up.
* Adequate hematologic (WBC count ³ 3,000/mm3, platelet count ³ 100,000/mm3), hepatic (bilirubin level £ 1.5 mg/dL), and renal (creatinine concentration £ 1.5 mg/dL) function.
* Informed consent from patient or patient's relative.
* Males or females at least 18 years of age.
* If female: childbearing women should use non-hormonal contraceptive method

Exclusion Criteria:

* MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia.
* Serious concomitant infection.
* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).