cyrilzakka/clinical-trials huggingface dataset:
Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy

Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.

Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.

Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.

Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.


Eligibility Criteria:
Inclusión Criteria:

patients aged between 20 to 48 years old. BMI less than 35 kg/m2 symptomatic uterine myomas. Intramyometrial myoma staging from (3 to 6) according to FIGO staging through trans vaginal ultrasonography (TVUSG) or magnetic resonance imaging (MRI) according to FIGO classification.

maximum diameter of the largest myoma is 15 cm. Uterine size between 14 to 28 weeks of pregnancy.

Exclusion Criteria:

1. History of previous myomectomy
2. Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine.
3. Hypertension.
4. Cardiac and Pulmonary diseases.
5. Patients who have bleeding disorders.
6. Patients on antiplatelets or anticoagulant before surgery.
7. Anemia (Hb \< 10g %).
8. Chronic endocrine or metabolic diseases such as Diabetes.
9. Renal and hepatic impairment.
10. Moderate and morbid Obesity (body mass index \> 35 kg/m2).
11. Cases that will require intraoperative conversion of myomectomy to hysterectomy.
12. Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,8.
13. history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.

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Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 and 75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
3. Life expectancy ≥12 weeks.
4. Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive.
5. Has progressive disease during or after crizotinib treatment.
6. Has a measurable disease.
7. Adequate organ system function.
8. Understood and signed an informed consent form.

Exclusion Criteria:

1. Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
2. Hypersensitivity to TQ-B3139 capsule.
3. Has received ALK TKIs other than crizotinib.
4. Has received any cancer therapy within 4 weeks or 5 times of t1/2.
5. Has received major surgery within 4 weeks.
6. Has received any radiotherapy or minor surgery within 2 weeks.
7. Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
8. Has active viral, bacterial and fungal infections within 2 weeks.
9. Has serious cardiovascular diseases.
10. Has currently uncontrollable congestive heart failure.
11. Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval \> 480ms.
12. Has interstitial fibrosis or interstitial lung disease.
13. Brain metastases with symptom or carcinomatous meningitis.
14. Has active hepatitis B or hepatitis C.
15. Has multiple factors affecting oral medication.
16. Breastfeeding or pregnant women.
17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Multiple Myeloma Turkish Prospective Patient Registry

This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey

In this study, approximately from 40 centers 1000 patients will be recruited. All patients will be followed-up till the study end.

All the laboratory results, treatment protocols and responses will be recorded and assessed with EORTC Multiple Myeloma Specific Quality of Life Multiple Myeloma Specific (MY-20) and EORTC Quality of Life-C30 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as multiple myeloma
* Patients signed informed consent form
* Patients received no more then 2 lines of therapy

Exclusion Criteria:

* Patients below 18 years old
Clinical Performance of Different Resin Cements

The clinical performance of different resin cements in adhesion of hybrid ceramic inlay and onlay restorations produced with CAD/CAM will be evaluated and compared. After obtaining a signed informed consent form from all the patients, all restorations will be placed by a single clinician. All hyrid ceramic restorations (Cerasmart, GC, Tokyo, Japan) will be produced using the same CAD/CAM CEREC Omnicam (Sirona Dental, Bensheim, Germany) system. 70 restorations will be divided into 2 groups: a self adhesive resin cement (RelyX U200 Automix, 3M ESPE, Seefeld, Germany), and an adhesive cement (G-Cem LinkForce, GC, Tokyo, Japan) which is applied after surface treatment (etch\&rinse). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12, 18, 24, 36 and 48 months. Descriptive statistics will be performed using Friedman test and Chi-square test.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with or without systemic disease
* Patiens older than 18 years old
* Good oral health
* Patients who at least have1 large and deep carious lesion or broken restoration in a vital tooth
* Patients who agreed to participate in the study after being informed about this study

Exclusion Criteria:

* Patient with periodontal disease
* Patients with partial dentures
* Patients with bruxism
* Patients with malooclusion
* Non vital or endodontically treated teeth
* Preparetions under the cemento-enamel junction
Short Term Cardiovascular Effects and Oxidative Status of Calcium and Vitamin D Supplementation of Postmenopausal Hypertensive Blacks Women

This study aims to determine the effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.

This study is a double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital

Aim: to determine and compare the short term effect of calcium and vitamin D supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in Yaoundé, Cameroon.

Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital. Postmenopausal hypertensive blacks women who are taking taking antihypertensives drugs since 12 months,without diabetes mellitus or any inflammatory disease or hypercalcemia, are randomize into 2 groups. Depending on the group, the intervention consisted of the administration of Calcium 1000 mg daily or Vitamin D/Calcium 1000 mg/800 UI daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant).

Progress: Recruitment for this study was completed in May 2019 with 22 patients.

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal hypertensive women since 12 months
* On a stable antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

* Diabetes mellitus or inflammatory diseases
* Hypercalcemia,
* Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
* Withdrawal of consent
The Use of Capnography and Integrated Pulmonary Index in the Electrophysiology Laboratory

The study sets out to assess whether in the context of nurse administered procedural sedation in the electrophysiology suite, the routine use of capnography and Integrated Pulmonary Index results in lower incidence of severe adverse respiratory events.

In the electrophysiology lab, the use of procedural sedation, often by nurses is considered routine and safe.Standard monitoring during these procedures includes continuous Oxygen Saturation (SpO2), Heart Rate and rhythm and interval Respiratory rate and blood pressure.

Capnography allows for continuous monitoring of exhaled carbon dioxide, it is an important tool during anesthesia, providing valuable information on the patient's respiratory status and is standard equipment in most operating rooms. Its use in procedural sedation has increased over the past years as the body of evidence supporting this practice has been growing.

It has been previously shown, use of capnography may allow for earlier detection of respiratory adverse events in various types of procedural sedation. The fall of oxygen saturation can occur very late during an adverse respiratory event, especially if supplemental oxygen is given. Today's procedural sedation in the electrophysiology catheterization lab are more complex, patients are of increasingly older age, have more comorbidities, procedures are lengthier and often require deeper sedation (i.e. during complex ablation procedures).

The use of capnography in the electrophysiology lab has not been addressed thoroughly in the literature. A recent multidisciplinary review of anesthesia in the electrophysiology lab states: "In the obstructive sleep apnea or non-obstructive sleep apnea patient, capnography should ideally be employed throughout the sedation period."..."Capnography appears to be underutilized in the electrophysiology lab, given its omission from electrophysiology literature documenting safety of sedation by non-anesthesiologists" We hypothesize that the routine use of capnography during nurse administered procedural sedations in the electrophysiology lab could aid in detection of early signs of adverse respiratory events, thus allowing early intervention and reduction of these events.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years of age or older
2. Patient is scheduled to undergo nurse administered procedural sedation in the electrophysiology laboratory.

Exclusion Criteria:

1. Patient is scheduled for anesthesiology based anesthesia.
2. Patient requires ventilator support at baseline (i.e. intubated patient, Bilevel Positive Airway Pressure or continuous positive airway pressure devices are in use)
3. Patient presents to electrophysiology laboratory with capnography monitoring in place.
Implantable Cardioverter Defibrillators - Improving Risk Stratification

Worldwide three million people a year die from sudden cardiac death (SCD). In most cases there is no warning and the heart is stopped by a sudden arrhythmia. We know that some people are at high risk of sudden cardiac death and can prevent their deaths with an implantable cardioverter defibrillator (ICD) that is implanted in a minor operation.

However, most people who die from sudden cardiac death are not found to be at high risk by our current risk markers and 40% of the people who have ICDs do not have therapy within the first 4 years after implant. We need new and better ways of identifying people who are at high risk of sudden cardiac death so that we can prevent their deaths with ICDs. Our understanding of the electrical signals in the heart has increased considerably in recent years; in no small part this is due to our Principal Investigator Professor Andre Ng's basic science work. This study aims to take the understanding of action potential duration (APD) restitution gained through our work and other studies in humans and in computer simulations and translate it into a fresh way of assessing risk of sudden cardiac death.

This study will carefully examine electrical activity, using APD restitution, in the hearts of patients who are having ICDs fitted because of their high risk of sudden cardiac death and combine this with a detailed heart scan, assessment of autonomic nervous system and gene expression data. We will then follow these patients up to see who benefits from their ICD. This wide ranging information will give us as complete a picture as possible of the factors that cause sudden cardiac death. We hope to use this to identify better predictors of sudden cardiac death.

The study hypotheses are as follows:

Primary

1. Regional Restitution Instability Index (R2I2) will be significantly higher in patients reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.
2. An R2I2 cut-off of 1.03 will partition patients into high and low risk groups.

   Secondary
3. Peri-infarct zone mass in grams will be significantly higher in patients reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.


Eligibility Criteria:
Inclusion Criteria:

* Attending for ICD implantation under NICE criteria or attending for an ICD box-change procedure or attending for an Electrophysiological test as part of NICE assessment for ICD implantation
* Age \>18
* History of ischaemic heart disease or non-ischaemic cardiomyopathy or inherited sudden cardiac death syndrome.

Exclusion Criteria:

* \<28 days since acute coronary syndrome / cardiac surgery
* Unable to give informed consent
* Women who are pregnant / planning pregnancy
* Contraindication for defibrillator safety margin test

  * Haemodynamic instability
  * Severe valvular heart disease
  * Symptomatic, severe, coronary artery disease
  * Recent stroke
The Effect of Magnesium Oxide on Plasma Phosphate in Hemodialysis Patients

Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

hemodialysis with duration\>3 months serum P level \>5.5 mg/dl serum Ca\>8 mg/dl.

Exclusion Criteria:

Mg level \>3 mg/dl
Effect of Fixed and Removable Space Maintainer on Some Salivary Parameters: An In-Vivo Study

The aim of this study is to evaluate and compare the effect of lower lingual holding arch space maintainer versus removable partial denture space maintainer on some salivary parameters (salivary flow rate, pH, viscosity and buffering capacity).

This study is a randomized clinical trial, it will be conducted on forty children, aged from (7-10) years, who are in need for space maintainer.

* Children will be randomly and equally divided into two groups according to type of space maintainer used; group (1): twenty children with lower lingual holding arch, group (2): twenty children with removable partial denture.
* Un-stimulated and stimulated saliva will be collected at specific duration of time from children before the delivery of the appliance and after 1, 3 and 6 months of wearing the space maintainer to measure salivary flow rate, pH, viscosity and buffering capacity.

Eligibility Criteria:
Inclusion Criteria:

Apparently healthy with no systemic disease. Age between 7-10 years old. Both boys and girls will be included.

Children with the following dental criteria:

Clinical criteria:

* Children should have a good oral hygiene.
* Children in mixed dentition stage.
* Fully erupted permanent lower first molar.
* Children with multiple loss of deciduous molar teeth.
* Seek for space maintainer appliance.

Radiographic criteria :

* Presence of at least 1mm bone overlaying successor.
* Tooth germ with less than one third of the root formed.

Exclusion Criteria:

* Allergy to any used material
Food Pantry Client and Staff Preferences for Nutritious no Prep Ready-to-eat Meals

The specific aims of this pilot study are: Aim 1) To identify whether no prep ready to eat meals (intervention) or ingredient bundles (control) have higher client acceptability, liking, satisfaction, and perceived diet quality ratings. Aim 2) To identify whether no prep ready to eat meals (intervention) or ingredient bundles (control) have higher feasibility ratings with food pantry staff. Exploratory Aim) To identify whether no prep ready to meals (intervention) or ingredient bundles (control) lead to greater improvements in food security, perceived diet quality, and fruit and vegetable consumption.

To test the first hypothesis, we will use a randomized repeated measures between-subjects design with half of the participants randomized to receive 14-days of no prep ready-to-eat meals (intervention, n=35) and half of the participants randomized to receive 14-days of ingredient bundles (control, n=35). To test the second hypothesis, we will use a mixed-methods approach with food pantry staff (N=15), including questionnaires with fixed and open-ended items on feasibility and satisfaction of each distribution strategy followed by 30-minute semi-structured 1-1 interviews conducted by UT Southwestern study staff.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* ability to read, write, and speak English or Spanish;
* ability to provide informed consent;
* current or new pantry user at our community partner;
* willing to participate;
* no dietary restrictions, allergies, or sensitivities that would put the participant at-risk of harm from consuming study foods.

Exclusion Criteria:

* Under 18 years of age;
* inability to read, write, and speak English or Spanish;
* unable to provide informed consent;
* not a pantry user at our community partner or uninterested in becoming a pantry user;
* not wanting to participate;
* dietary restrictions, allergies, or sensitivities that would put the participant at-risk of harm from consuming study foods.
A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer

The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 years, female.
2. With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.
3. With a life expectancy of ≥ 12 weeks.
4. Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).
5. With at least one measurable lesion as per RECIST v1.1.
6. With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.
7. Persistent, recurrent, or metastatic cervical cancer.
8. Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).
9. Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.
10. Patients must agree and have signed the informed consent form.

Exclusion Criteria:

1. With known contraindications to paclitaxel, cisplatin, or carboplatin.
2. With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies.
3. With inadequately treated CNS metastasis.
4. With uncontrolled hypertension.
5. With uncontrolled cardiac diseases or symptoms.
6. With major vascular disease.
7. With arterial/venous thrombotic events within 6 months prior to randomization.
8. Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization.
9. With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization.
10. With severe, unhealed, or open wounds as well as active ulcers or untreated fractures.
11. With any active autoimmune disease or a history of autoimmune disease that is expected to recur.
12. Had other active malignant tumors within 5 years prior to study enrolment.
13. With congenital or acquired immunodeficiency (such as HIV-infected patients).
Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.

Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.

* Increased HBeAg seroconversion rate
* Increased HBsAg loss rate
* To define the best treatment condition for chronic HBV hepatitis patients


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA \> 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.

Exclusion Criteria:

* Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.
Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study

The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.

Bone diseases have been recognized recently as complications of genetic hemochromatosis. Further studies are needed to describe the role of iron in bone injuries. The purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 80 years
* C282 homozygosity

Exclusion Criteria:

* corticosteroids during the last 3 months
* following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.
* following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate.
* cancer or evolutionary hemopathy (including monoclonal gammopathy)
* pregnancy at inclusion time
* treated osteoporosis
* patient in wich follow up seems hard
* inclusion in another study incompatible with this one