cyrilzakka/clinical-trials huggingface dataset:
Biomechanical Changes in Women With Chronic Pelvic Pain

Chronic pelvic pain (CPP), a frequent complaint in clinical gynaecology, is defined as cyclic or acyclic pain located in the pelvis, persisting for 6 months or more, and severe enough to cause functional incapacity that requires medical or surgical treatment (or both). Chronic pelvic pain is the reason for approximately 10% of all gynaecologic consultations

Women who showed an imbalance of the pelvis also experienced greater pain. A possible explanation for this is that the change in the position of the uterus, due to the imbalance of the pelvis, prompted an excessive amount of prostaglandin to be secreted. When the spinal alignment of women who had intense menstrual pain was put back to normal, the pain was alleviated. The level of tension in the ligaments and nerves connecting the sacral vertebrae and the uterus is the cause off the menstrual pain. Due to the abnormal restriction of movement of the lumbosacral vertebrae, body fluid increase within the pelvis as wells contraction of the uterus leading to the intensification of the menstrual pain.

Stabilization of anterior and lateral pelvic curves through exercise or osteopathic manipulative techniques that utilizes techniques of muscle energy, balanced ligamentous tension, myofascial release, strain and counterstrain to assist muscles to keep the spine upright and sufficiently flexible to support good posture . Correct posture involves a straight spine, which maintains the natural curve of the spine in the human body. Correct posture minimizes the strain on the human body by maintaining balance of the muscles and skeleton. This balanced musculoskeletal state protects the supporting structures in the body and prevents damage or progressive deformation in all positions, including standing, lying down, and sitting. Additionally, correct posture implies not inclining the body forward, backward, left, or right.

The temporomandibular joint is surrounded by ligaments, muscles, nerves, and blood vessels. The masticatory muscles enable mouth opening and closing, lateral movement, and forward and backward movement of the mouth, and excessive tension or imbalance of muscles can limit the joint movements, possibly resulting in limited ROM. Thus, it can be surmised that the imbalance in the spinal muscles caused the imbalance in the temporomandibular muscles and limited TMJ mobility.

Eligibility Criteria:
Inclusion Criteria:

* The age of the participants will be ranged from 20 to 40 years.
* Their body mass index will be ranged from 20 to 25 kg/m2.
* They will have regular menstrual cycle.
* They will not receive any hormonal therapy or taking any regular drugs.

Exclusion Criteria:

* Bone disease.
* Discogenic state with radiculopathy or not.
* Systemic disease of musculoskeletal system.
* Any sensory problems.
* Previous vertebral fractures.
* Major spinal structural abnormality.
* Major jaw abnormality.
* Any jaw orthotics or prosthesis.
* Missing teeth.
Evaluation of Blastocyst Morphology and Quality in Patients With Embryo Transfer at the Blastocyst Stage

In this prospective study, the investigators aim to investigate the role of trophectoderm cells and inner cell mass cells on pregnancy outcomes in blastocyst transferred in-vitro fertilization pregnancy. The investigators will support findings with bilateral uterine artery Doppler measurements to be made between the 11th and 14th weeks of pregnancy.

Patients scheduled for thawed blastocyst transfer between May 2022 and December 2022 in Akdeniz University Hospital Center for Reproductive Endocrinology and Assisted Reproduction will be included in the study. Embryos that have reached the Blastocyst stage after the ICSI procedure will be examined by a single experienced embryologist using the ALPHA Istanbul consensus evaluation system.

This system includes separating the blastocyst from the zona pellucida - hatching (Grade 1,2,3,4), the size of ICM and arrangement (grade A, B, C), and the number of TE cells and arrangement (grade A, B, C).

Among the embryos whose quality is determined, the best quality embryo belonging to the patient will be transferred single, patients who develop pregnancy after the transfer will be called for follow-ups for uterine artery Doppler measurements to evaluate uteroplacental flow between 11and 14 weeks, and their Doppler measurements will be recorded. By contacting the patients with the phone numbers recorded at the time of the first visit, the weeks of birth, baby weight, gender, and complications that developed during the pregnancy (Abortion, Preeclampsia, Eclampsia, Fetal Growth Restriction, Oligohydramnios, Polyhydramnios, Gestational Diabetes Mellitus and Antenatal Bleeding) will be recorded.

In case the related relationship can be revealed, the risk situations in terms of complications are determined before the transfer, and it is aimed to increase the number of live births together with the risk-based management in the follow-up and screening programs.

Eligibility Criteria:
Inclusion Criteria:

* Exogenous hormone preparation of the endometrial lining
* Single embryo transfer
* Embryo transfer at the blastocyst stage

Exclusion Criteria:

* Double embryo transfer
* Patients who underwent embryo transfer at the cleavage stage
* \>15% loss of embryo viability during embryo thawing
* Patients whose data could not be accessed after follow-up or delivery
Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training

The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve activity and sleep.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 45-60 with hot flashes.
* Participants will be recruited from Rochester, MN and surrounding areas.
* Non-smokers.
* BMI \< 40kg/m\^2.
* No history of cardiovascular disease, except for hypertension.

Exclusion Criteria:

* Detailed medical and social histories will be collected. To allow for ecological validity, participants will not be excluded for use of menopausal hormone therapy or medications affecting cardiovascular function so long as they have been on a consistent regimen for ≥3 months and during the study period. This approach to medications is consistent with recent work in this area.
* Participants will be screened for contraindications to inspiratory muscle strength training including, a history of spontaneous pneumothorax, collapsed lung that has not healed fully, a perforated eardrum that has not healed fully, and/or any other condition of the eardrum.
* Additional exclusion criteria will include the use of sleep aids (i.e., prescription, melatonin, doxylamine, valerian root, etc.).
PANDA-Regional Feasibility Study of a Smartphone Pain Management Application

Despite the numerous benefits of peripheral nerve blocks (PNBs) over general anesthesia (GA) in a variety of surgical procedures, PNBs can be associated with increased post-operative pain if pain medications are not taken correctly (titrated). Unfortunately, this is a common occurrence as patients often have difficulty titrating medications in the absence of direct medical care. PANDA, a smartphone-based postoperative pain management tool, is designed to address this issue by helping patients manage their pain medications. The purpose of this study is to demonstrate the feasibility of this application in patients who are discharged after receiving PNBs. The goal is to identify areas of improvement for the application itself. It is hypothesize that PANDA will be successful in supporting patients' postoperative pain management.

As above

Eligibility Criteria:
Inclusion Criteria:

* Undergoing ambulatory surgical procedures that require peripheral nerve blocks for which there is an anticipated post-surgical pain model
* Planned post-discharge analgesic medications including non-steroidal anti-inflammatory drugs, acetaminophen and/or opioids for at least 2 days
* ASA I-III
* Written informed consent
* Have a smartphone device at their disposal

Exclusion Criteria:

* Inability or refusal to provide informed consent
* Presence of significant cognitive impairment, visual impairments, neurological injury, or psychomotor dysfunction that impairs ability to use the app
* Inability to follow study instructions and complete questionnaires in English
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of subjects with unresectable Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for the treatment of liver tumors.


Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy.
* No extra hepatic disease.
* Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST.
* Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume.
* Intent to treat all lesions within a single session.
* Hypervascular on CBCT, CT, or MRI.
* Evidence that \> 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
* Life expectancy of ≥ 6 months.
* ≥ 18 years old at the time of informed consent

Exclusion Criteria:

* Platelet count \<50,000/microliter or prothrombin (PT) activity \> 50% normal.
* Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
* INR \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
* ALT \> 5x upper limit.
* AST \> 5x upper limit.
* Bilirubin ≥ 2.0 mg/dL.
* eGFR ≤ 50 mL/min/BSA.
* Macrovascular invasion.
* Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
* Estimated lung dose \> 30 Gy as calculated using the lung shunt fraction and partition model.
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.

This is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. Patients on a stable regimen of phosphate binders with plasma phosphorus levels \> 4.9 mg/dL are eligible for enrollment and randomization. The study will span 8 weeks of active medication treatment. The primary end-point will be absolute change in plasma phosphorus levels. Sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dL difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). Placebo will be packaged to resemble the study drug in all physical attributes. The starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. Secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, HDL cholesterol, and percentage change in plasma phosphorus.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Capable of giving informed consent
* Duration of peritoneal dialysis \> 3 months
* Dose of phosphate binder(s) stable over previous 2 week period
* Plasma phosphours \> 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

Exclusion Criteria:

* Pregnancy
* Known liver disease
* Active peptic ulcer disease
* Treatment with carbamazepine
* Intolerance to niacinamide or niacin
* Current medication regimen including niacin or niacinamide \> 100 mg daily
* Planned or expected surgical procedure in the next 4 months
* Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given
Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a waiting list control group that will get no exercise intervention during neoadjuvant CTx (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the tumor size. Further, the effects of resistance and aerobic exercise on the clinical-pathologic stage (CPS-EG) score, the pathological complete response (pCR), tolerability and compliance to CTx, physical fitness, patient reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as cognitive function, and selected biomarkers will be investigated.

A confirmation of the study hypothesis would be a strong argument for patients to engage in exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based guidance for patients regarding type and timing of training.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years of Age
* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
* Scheduled for neoadjuvant CTx (but not yet started)
* Confirmed hormone receptor and Her2 status
* Sufficient German language skills
* Willing to train at the exercise facilities twice per week

Exclusion Criteria:

* Any physical or mental conditions that would hamper the adherence to the training programs or the completion of the study procedures
* Engaging in systematic intense exercise training (at least 1h twice per week)
Short-term Impact of COVID-19 Lockdown on Metabolic Control of Type 2 Diabetes

The strict rules applied in Italy during the recent COVID-19 pandemic, with the prohibition to attend any regular outdoor activity, are likely to influence the degree of metabolic control of patients with type 2 diabetes. The aim of this observational, prospective, single centre study was to evaluate the immediate impact of the lockdown rules on the metabolic profile of a cohort of patients with type 2 diabetes.

All the patients with type 2 diabetes who were previously scheduled for a follow-up visit in our outpatient diabetes clinic during the lockdown for COVID-19 (March 9, 2020-May 04, 2020) were contacted by phone. Patients who accepted to take part of the study received a medical prescription for routine analysis via email. They were asked to perform blood drawing one week after the end of the lockdown period and transmitted us the results.

We then compared the metabolic profile tested one week after the end of the lockdown with the last value and the mean of the last three determinations performed before the pandemic emergency.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* at least two previous clinical records in the last two years

Exclusion Criteria:

* age \>85 years
* first access to the outpatient clinic
* type 1 diabetes
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose

Increased postprandial plasma triglycerides are associated with increased cardiovascular risk. Chronic consumption of carbohydrates is associated with increased levels of triglycerides. Very few studies have assessed the effect of acute consumption of carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present study aims to assess the effects of acute administration of glucose and fructose on hepatic and intestinal lipoprotein production.

Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the study.In study A they will receive intraduodenal intralipid (20% at 60 ml/hour) alongside 60 ml/hour of 20% dextrose or fructose for 15 hours starting at 4am. In study B they will receive 60 ml/hour of intraduodenal intralipid with 60ml/hour of normal saline for 15 hours from 4am. A pancreatic clamp (octreotide with replacement glucose, insulin, glucagon and growth hormone) will be started at 7am. From 9am an iv bolus of deuterated-glycerol (d5-glycerol) along with a regular infusion of deuterated leucine (L-\[5,5,5-2H3\]. Regular blood samples will be drawn to assess lipoprotein kinetics.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 to 60 years
2. Body mass index 20 kg/m2 to 27 kg/m2
3. Hemoglobin above 130g/L.
4. Normal glucose tolerance in response to a 75g, 2-hr OGTT

Exclusion Criteria:

1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP \> 100 or systolic \> 180) or proliferative retinopathy
3. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
4. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
5. Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH \> 6 mU/l
6. Current addiction to alcohol or substances of abuse as determined by the investigator.
7. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
8. Taking any prescription or non-prescription medications at the time of the study
9. Having donated blood three months prior to and three months post study procedures
10. A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. Those who test positive for pregnancy will be excluded.

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Effectiveness of a Postal Intervention to Improve the Use of PPI

It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months.

The intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. Control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses).

The main outcome variable was the number of active prescriptions of each PPI dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients under the care of our organisation who in May 2017 had an active long-term prescription for PPIs at high doses for at least 6 months.

Exclusion Criteria:

* Patients whose GPs declined to participate
Elastography and Treatment of Lymphoma

To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.

Lymphomas are a heterogeneous group of malignancies that arise from the clonal proliferation of lymphocytes. It represents approximately 5% of malignancies. Overall survival is estimated to be 72%. (1)

Lymphomas are broadly classified into Hodgkin lymphoma (HL) (10%) and Non-Hodgkin lymphoma (NHL) (90%).

HL is further classified into classical and non-classical types and NHL into B-cell, T-cell and natural killer (NK) cell types. Diagnosis of lymphoma is confirmed by histopathology (FNAC, True-cut or excisional biopsy).(2) The standard treatment of lymphoma is chemotherapy and radiotherapy.

The modalities used for staging and follow up of lymphoma are:

* Computed Tomography (CT) chest, abdomen and pelvis.
* Positron Emission Tomography (PET/CT).
* Whole body Magnetic Resonance Imaging (MRI).(3)

Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.(4)

Eligibility Criteria:
Inclusion Criteria:

* patients who are histopathologically proven as lymphoma, not receive treatment and have superficial lymphadenopathy.

Exclusion Criteria:

* 1-Lymphoma without superficial lymph nodes. 2-patients under treatment.