cyrilzakka/clinical-trials huggingface dataset:
Vaginal Vault Prolapse Surgical Treatment

Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration.

Hysterectomy is one of the common surgical procedures in current gynecology practice and is a risk factor for vault prolapse. Since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (VVP). The increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. Laparoscopic lateral suspension (LLS) using mesh is an efficient alternative technique for apical support. In addition, vaginal approaches have been used in cuff prolapsus surgery for many years. Uterosacral ligaments are strong native tissues used in cuff surgery and apical support. In recent years, Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration. Lack of incision pain, better cosmetic results, and direct visualization of important structures such as the rectum and ureter that cannot be obtained with the traditional transvaginal approach are important advantages of vNOTES approach.

Eligibility Criteria:
Inclusion Criteria:

* Women with vaginal vault prolapse

Exclusion Criteria:

* Women who have previously undergone surgical treatment for pelvic organ prolapse
* Women who needed additional surgery due to anterior or posterior prolapse or stress incontinence
* Pelvic inflammatory disease
* Suspected gynecological malignancy
* Rectovaginal endometriosis
* obliterated rectovaginal space detected on pelvic examination.
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

The aims of the study are to investigate individual, combined and added effects of acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving medication adherence and quality of life among people living with HIV/AIDS. The study will also explore the mechanism of these therapeutic effects of acupuncture and the relaxation response.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV-positive status or AIDS diagnosis
2. Self report of having at least one of the 6 GI symptoms: diarrhea, loose stools, gas/flatulence or bloating, abdominal pain, nausea, or vomiting that have persisted for at least 8 weeks.
3. Being on a stable antiretroviral regimen containing Nucleoside/nucleotide reverse transcriptase inhibitors and/or protease inhibitors- for at least 8 weeks.

Exclusion Criteria:

1. Incident diagnosis of any of the following conditions within the past month or during study period: Pneumocystis carinii pneumonia, Kaposi's sarcoma, Mycobacterium avian complex, Cytomegalovirus, Non-Hodgkins lymphoma, Lymphoma or other cancer, Pelvic inflammatory disease, AIDS-related dementia, Bacterial or other infection, Diabetes, Acute moderate or severe neutropenia, Cryptococcus, Progressive multifocal leukoencephalopathy, Idiopathic thrombocytopenic purpura. All of these conditions are major opportunistic infections or medical complications that may require hospitalization and additional pharmaceutical intervention.
2. GI diagnoses of irritable bowel syndrome, Crohn's Disease, parasites, any type of gastric ulcer or ulcerative colitis or cancer in any part of the gastrointestinal system. These are conditions not related to HIV diagnosis and could result in digestive problems similar to those we are investigating.
3. Onset of acute opportunistic infection.
4. Hemophilia or other bleeding disorder since that will make acupuncture treatment unsafe.
5. Pregnant women will be excluded since, although none of the acupuncture points or combinations are contraindicated in pregnancy, the presence of morning sickness could serve as a potential confounding factor.
6. Current users of acupuncture for treating GI symptoms.
7. Current practice of relaxation response.
8. Current enrollment in another clinical intervention study.
9. Cognitive impairment as measured by Mini Mental Status Examination (MMSE), a reliable and valid screening instrument for the detection of cognitive impairment, using a commonly used cut-off point of 24.
10. If use of Chinese herbs has been recently discontinued, a potential participant must have at least 2 weeks without herb use to be eligible for the study. Because use of herbs is occasionally accompanied by digestive disorders,a period of stabilizing is required before acupuncture treatment can be initiated. This washout period has been conservatively estimated by ACP staff herbalists to constitute a sufficient time for effects of herbs to cease.
Development of Web Application and Evaluation Its Impact on Healthy Lifestyle

The study is planned for people who would like to reduce or maintain their weight and keep a healthy life style .After signing an informed consent, participants will be divided randomly into two groups :control group and an intervention group that will get the application (eBalance ). Participants will be followed for 12 weeks.

Primary objective: to develop a web application based on energy balance and evaluates its effectiveness in promoting healthy lifestyle habits versus a control group.

Secondary objectives:

1. To evaluate the frequency and convenient of usage of the internet intervention
2. To test the impact of the intervention on nutrition knowledge, diet quality and physical activity
3. To evaluate the effect of the intervention on weight management status

Eligibility Criteria:
Inclusion Criteria:

* People aged more than 18 years
* Web and e-mail experience
* Interested in either reducing weight or maintaining a healthy lifestyle

Exclusion Criteria:

* without any mail experience
* pregnancy
* involvement in other diet programs
Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer

Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.

Phase III multicentre, randomized, open-label study comparing early evaluation of the efficacy of chemotherapy by determination of circulating tumour cells versus conventional clinical and radiological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 years.
* WHO performance status: 0 to 4.
* Metastatic breast cancer.
* Progression after 2 lines of chemotherapy with decision to initiate third-line chemotherapy.
* Disease evaluable by CTC (CTC-positive before starting chemotherapy).
* Histology: lobular or ductal adenocarcinoma.
* Information of the patient and signature of the informed consent form by the patient or her legal representative.

Exclusion Criteria:

* Disease not evaluable by CTC (CTC-negative before starting chemotherapy).
* History of other potentially metastatic cancer (stage III or IV cancer) different from breast cancer.
* Histology other than lobular or ductal adenocarcinoma.
* Pregnant woman, women likely to become pregnant or nursing mothers.
* Persons deprived of their freedom or under guardianship.
* Women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.
Effects of Instrument Assisted Soft Tissue Mobilization on Delayed Onset Muscle Soreness

The aim of our study is to investigate the effect of instrument assisted soft tissue mobilization therapy on delayed onset muscle soreness

Joint range of motion, pressure pain threshold, edema, isometric muscle strength measurement, visual pain scale, two-point discrimination, biochemical measurements (muscle damage in blood (serum creatine kinase (CC), lactate dehydrogenase (LDH), myoglobin, its effects on aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and biomarkers of inflammation (interleukin-1 beta), Carbonic anhydrase III, and C-reactive protein, and at what time interval and after which treatment session in the process after delayed muscle pain formation. It is aimed to determine how it affects the parameters.

Eligibility Criteria:
Inclusion Criteria:

1. The participant must be between the ages of 18-35,
2. No fear of needles,
3. Having read and understood the Informed Voluntary Consent Form and agreeing to participate in the study.

Exclusion Criteria:

1. Having neurological or perception problems,
2. Having any cardiovascular, pulmonary and metabolic disease,
3. Any musculoskeletal injury in the last 6 months,
4. Having a history of pain and surgery in the upper extremity,
5. Participating in upper extremity weight training in the last 6 months,
6. Exercise, caffeine and alcohol consumption, and drug use up to 12 hours before the study were determined as
The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism

The findings of previous experiments suggested that polyunsaturated fatty acids(PUFAs) has been linked to anti-hyperlipidemia, and reducing the risk of cardiovascular disease.This is a randomized double-blind trial, aims to study the effect of PUFAs on blood lipids and human metabolism. Firstly, the investigators will investigate the efficacy of mixed plant oil(echium oil, camelina oil, safflower oil) and pure echium oil on improving the levels of blood lipids. Secondly, next generation sequencing (NGS), ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass spectrometry detection will be conducted to explore the role of PUFAs on gut microbiota as well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by Time-of-flight mass spectrometry to find the gene-environment interaction effect.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 30-60 years of age
* Marginal elevated blood lipids or hyperlipidemia\[Total cholesterol≥5.2 mmol/L(200 mg/dl) or triglyceride≥1.70 mmol/L(150mg/dl) or low density lipoprotein cholesterol≥3.4 mmol/L(130 mg/dl)\]

Exclusion Criteria:

* Pregnancy；
* Known cardiovascular disease, diabetes, hypertension and any other chronic disease；
* Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on；
* Acute or chronic inflammatory conditions;
* Liver or kidney dysfunction;
* An unwillingness to discontinue nutritional supplements；
* Use of lipid-lowering, antiinflammatory, antidepressant, or blood pressure medication;
* Evidence of drug or alcohol abuse；
* Take antibiotics or probiotics in the last three months.
Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\&E) in the clinic setting.


Eligibility Criteria:
Inclusion Criteria:

* clinic-based D\&E at 18 weeks gestational age and above
* speaks English or Spanish

Exclusion Criteria:

* refuses IV
* history of coagulopathy
* anticoagulant use in the preceding five days
* chorioamnionitis or sepsis
* suspected placenta accreta spectrum
* intrauterine fetal demise
* multiple gestation
* use of misoprostol for cervical preparation
Galvus (Vildagliptin) vs Placebo in Combination With Metformin and Insulin

The main objective is to show that the addition of Galvus versus placebo in patients with type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.

The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c less than 7%) after 3 months of treatment with Galvus or placebo

* Visit V1 : screening
* Inclusion visit V2: Be verified inclusion criteria of patient. At the inclusion visit will be collected:

  * Informed consent to participate in the study...
  * The following data: age, duration of diabetes, usual basal insulin dose, other co-morbidities : hypertension, complications of diabetes, dyslipidemia, smoking (and their associated treatments).
  * Data from physical examination and in particular: weight, BMI, waist circumference, systolic blood pressure (SBP) and diastolic (DBP)
  * Therapeutic adjustments can be made. In the case of inefficient combination with a sulphonylurea (HbA1c\> 7%), it will be stopped and basal insulin will be titrated during the run- in period (2 months) in order to obtain a good control of fasting glucose.
* Visit V3 : At the randomization visit, be collected the results of HbA1c and other biological assessment (FPG, fasting lipid profile). Moreover, the insulin will be collected and the patient will receive the treatment for 3 months (for ex Galvus in this case according to randomisation).
* Visit V4a the glycemic holter will be introduced and removed 5 days later (at visit V4B). The interstitial glucose will be calibrated during the Holter by the blood glucose. When collecting the glycemic holter, patients will also have a clinical examination and a new biological assessment (HbA1c, FPG, C peptide, fasting lipids ...) and an assessment of their dietary intake during the port the holter (overall calorie intake: cal + G, L, P)
* Visit V5 : the patient will receive the treatment for 3 months (placebo at this visit according the example cited above ).
* Visit V6A, it will be the same as for the visit V4a, the glycemic holter will be introduced and removed at V6B visit. Similarly, in the collection of glycemic holter, patients will also have a new clinical examination, laboratory evaluation (HbA1c, FPG, fasting lipids ...) and a dietary assessment (overall calorie intake: cal + G, L, P).

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for at least 3 months with metformin (at the maximum tolerated dose (for at least 1 month) + / - sulfamide and basal insulin
* Patient with an HbA1c between 7 and 9% at the inclusion visit
* Patients able to use a continuous glucose monitoring system,

Exclusion Criteria:

* Patients already receiving a specific treatment of postprandial (GLP1, ..)
* Patients with type 1 diabetes, or secondary diabetes
* Patients with eating disorders
* Patients with major complications of diabetes
* Patients participating in another clinical trial
* Pregnant
Exploratory Study Using Nanotechnology to Detect Biomarkers of Parkinson's Disease From Exhaled Breath

Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. Exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinsonism

Exclusion Criteria:

* Severe dementia
Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.

The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.


Eligibility Criteria:
Inclusion Criteria:

* Anterior cruciate ligament rupture

Exclusion Criteria:

* Current malignant disease
* Rheumatoid arthritis
* Other knee ligament instability
* Obesity BMI \>30
* Morbus Bechterew
Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone

A semi-rigid cervical collar is recommended for immobilization of the cervical spine in patients with cervical spine injury. It has been suggested that a reduction in mouth opening is the major contributing factor to the deterioration in the glottic view obtained. Fiberoptic intubation is among the most versatile techniques for managing both the anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic bronchoscope with videolaryngoscope has been suggested to permit visual control of the passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and bronchoscope with pentax airwayscope.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status class I, II

Exclusion Criteria:

* uncontrolled or limited cardiovascular disease
* abnormality of airway
* necessity for rapid sequence induction
* BMI \> 30
Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial

Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type

Exclusion Criteria:

* individuals diagnosed with dementia, cognitive impairment or chronic pain;
* individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention;
* procedure for reoperation for any reason
Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF

In the operating room, as part of the open heart surgery, the surgeon will stimulate the superior right atrium section of the heart with a pacemaker for 30 seconds just prior to starting the heart and lung bypass machine. The stimulation is done to see how sensitive the heart is to developing atrial fibrillation. This test result will be documented. The procedure will only take 60 seconds out of the entire operation. It does not involve taking any samples of tissue or blood. Following this step, if the heart demonstrates atrial fibrillation for at least 30 seconds then the participant will then be randomized to either receive the prophylactic drug treatment using Amiodarone or to no prophylactic drug administration. The participant has a 50% chance of receiving the FDA approved study drug Amiodarone. The study arms consist of prophylactic drug administration with Amiodarone, No prophylactic drug administration, or no atrial fibrillation reaction after stimulation with the pacemaker. The remainder of the surgical procedure will not be affected, and will follow routine surgical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or replacement, combined CABG with valve repair or replacement, or valve sparing aortic root repair
* Normal sinus rhythm
* No documented history of atrial fibrillation

Exclusion Criteria:

* Prior surgical procedures involving heart surgery and cardiopulmonary bypass
* Any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds
* Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias
* Patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or Maze procedure.
The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices

This study aimed to evaluate the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women. The study hypothesized that simulation-based breast health education would have an effect on breast cancer awareness and breast self-examination practices scores among Afghan refugee women.

Purpose: The aim of the research is to examine the effects of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women.

Methods: The study will conduct with 64 (32 in the intervention group, and 32 in the control group) Afghan. The study population consisted of Afghan women. The simulation-based breast health education will applied to the intervention group once a week for 8 weeks.

No intervention will offer to the control group. Data will collected by a socio-demographic questionnaire, Breast Cancer Awareness Measure (BCAM) and breast self-examination practices checklist.

Eligibility Criteria:
Inclusion Criteria:

* 20-65 years,
* must be able to speak Turkish or Dari.

Exclusion Criteria:

* breast cancer