cyrilzakka/clinical-trials huggingface dataset:
Effect of Ultrasound Cavitation on Static and Dynamic Balance in Obese Postnatal Women With Diastasis Recti

the aim of this study is to investigate the efficacy of ultrasound cavitation on static and dynamic balance in obese postnatal women with diastasis recti

Rectus diastasis defined as the widening of the linea alba by more than 2 cm at the midline. A great proportion of pregnant women are complaining from rectus diastasis during pregnancy reaching 100% of all women that may continue for years after delivery in 66% of women, and do not return to the first state automatically. This occurs due to a combination of physiologic, hormonal and mechanical factors, leading to reduction of abdominal muscle functional strength, increased low back pain out of increased lumbar hyperlordosis and postural instability, which may seriously disable woman from taking care of her baby, perform her daily activities. Weight gain is one of the predisposing factors that increases the possibility of developing rectus diastasis postpartum. Being obese increases liability to have rectus diastasis as carrying excess abdominal fats puts greater pressure against linea alba and can develop or aggravate symptoms for both men and women. This massively displaces the center of gravity anteriorly, disturbs body balance, increases joint loads and influences negatively pelvis posture leading to increased anterior pelvic tilt with subsequent exaggerated lumbar hyperlordosis. Ultrasound cavitation is the most revolutionary method that destroys excess body fat through creating microbubbles and releasing energy that breaks down fat cells. This trial has two groups: one will be treated by low caloric diet regimen only and the second one will be treated by ultrasound cavitation in addition to low caloric diet regimen for eight weeks

Eligibility Criteria:
Inclusion Criteria:

1. All women had a diastasis recti more than 2.5 cm and less than 4 cm in supra umbilical region.
2. Their ages were ranged from 25: 35 years.
3. Their BMI was more than 30 Kg/ m2.
4. All women were with lumbar hyperlordosis.
5. All women were multipara.
6. Their mode of delivery was normal vaginal delivery.
7. They were selected from 2: 5 months postnatal.

Exclusion Criteria:

1. Previous cesarean section.
2. Previous abdominal and/ or back operation.
3. Spinal disorders.
4. Abdominal skin diseases.
5. Serious diseases such as heart disease, pace maker, uncontrolled diabetes or hypertension, autoimmune disease, malignancy, gastric ulcer, liver or renal failure and any other contraindication for body sculpting-weight loss.
Ritanserin in Treatment of Cocaine Dependence - 1

The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence.


Eligibility Criteria:
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Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit

Immediate skin-to-skin contact (SSC) is already standard care for healthy term newborns, but its use for term or preterm newborns requiring admission to neonatal unit (NICU) with or without respiratory support is challenging. This study aimed to assess the safety and feasibility of SSC during the transfer of newborn infants, using a new purpose-built mobile shuttle care-station, called "Tandem".

A monocentric prospective observational study was conducted at the tertiary referral center of the Université libre de Bruxelles in Brussels, Belgium Infants born with a birth weight above 1500g were eligible. Following initial stabilization, infants were placed in SSC with one of their parents and transferred to the NICU using the Tandem.

Prior to delivery, the trained neonatal team prepares both the Tandem and a transport incubator as a backup. Delayed umbilical cord clamping will be performed for at least one minute unless prompt resuscitation required. Then, infants will be stabilized on a resuscitation table following European Resuscitation Council guidelines, with applying electrodes for continous monitoring of heart rate, saturation and temperature. After initial stabilization respiratory support will be continued if needed using the Tandem's gas supply. In cases when, antibiotics or continuous IV glucose infusion are necessary, peripheral venous catheters will be placed before departure. In case of respiratory support, nasogastric tube will be insterted. Infants will be then transferred to the NICU under the supervision of a pediatric nurse and/or pediatrician with the Tandem in skin-to-skin position with either the mother or the father. Whenever possible, SSC will be continued for at least 120 minutes before placing the infant in an incubator. Blood glucose measurement will take place at least once during the procedure.

Eligibility Criteria:
Inclusion Criterias:

* neonates with an estimated foetal weight above1500 grams
* neonates requiring admission to the neonatal intensive care unit
* neonates requiring or not non-invasive respiratory support
* neonates with at least one parent who has a good understanding of the method of transfer

Exclusion Criteria:

* neonates presenting a malformation incompatible with this type of transfer
* neonates with invasive ventilation
Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer

This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of locally advanced or metastatic colorectal cancer (CRC) that is not curable. The histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. Patients with neuroendocrine carcinomas will be excluded.
* Received 6 cycles (3 months \[12 weeks\]) of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for metastatic CRC. Patients have received at least 5 cycles with bevacizumab. Patients who received 6 cycles of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for recurrent CRC that has relapsed at least 12 months after completion of adjuvant therapy will also be included. All standard FOLFOX (FOLFIRI) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed.
* No more than 4 weeks may pass between the end of first-line therapy (that is, Day 14 of Cycle 6) and randomization.
* Documented evidence of tumor response of complete response (CR), partial response (PR), or stable disease (SD) by computed tomography (CT) scan or magnetic resonance imaging (MRI). Confirmation of response is not required.

Exclusion Criteria:

* Are unable to swallow tablets.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have known central nervous system metastases.
* Are receiving concurrent administration of any other antitumor therapy.
* Patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

The study will test:

1. whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function
2. whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function
3. whether estrogen therapy leads to enhanced immune response in older transwormen

All subjects will participate in a 2-hour oral glucose tolerance test (OGTT) and DXA scan for estimation of lean body mass. Only the transgender subjects will have a repeat OGTT two weeks after discontinuation of Gender Affirming Hormone Therapy (GAHT).

Beta cell function will be correlated with the Estrogen/Testosterone ratio to evaluate the relationship between sex hormones and beta cell function. Plasma Glucagon-like peptide 1 (GLP-1) response during the OGTT will be measured to evaluate if estrogen treatment modulates insulin secretion by increasing GLP-1 secretion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: healthy male or female
* MTF transgender
* FTM transgender
* Non-diabetic (A1c\<6.5%), fasting glucose \<126mg/dl and OGTT after 2 hr \<200mg/dl)
* Stable hormone treatment (estrogen or testosterone) for at least 6 months

Exclusion Criteria:

* History of or newly diagnosed diabetes mellitus
* For healthy volunteers, not current treatment with estrogen or testosterone
* For FTM transgender, no recent cardiovascular event: acute coronary syndrome (ACS), stroke (CVA)
* For MTF and FTM transgender, less than 6 months of stable hormone treatment
* Anemia with hemoglobin (Hb) \<11.0 hematocrit (Hto) \< 34 and Glomerular Filtration rate (GFR) \<30
Blood Pressure Variability in Acute Ischemic Stroke

The purpose of this study is the evaluation and comparison of blood pressure variability indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.

All consecutive patients admitted with acute (within 24 hours after stroke onset) ischemic stroke in three University Hospital of Northern and Central Greece will be included.

Blood pressure measurements are being obtained with ambulatory 24-hour BP monitoring (ABPM) every 20 minutes within 24 hours of admission using automated oscillometric device (TM2430, A\&D Company Ltd) during day-time (7:00-22:59) and night-time (23:00-6:59).

Several clinical, laboratory and imaging parameters are prospectively registered. Also, patients' medical history, previous medical treatment and cardiovascular risk factors are registered.

Functional outcome is assessed by the modified Rankin Scale score at 3 months. Also, stroke recurrence and cardiovascular and all-cause mortality will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke
* Admission within 24 after the onset of symptoms

Exclusion Criteria:

* Transient ischemic attack
* Intracerebral hemorrhage
* Subarachnoid hemorrhage
* Cerebral sinus venous thrombosis
* Stroke mimics
* Late admission (\>24 hours after stroke onset)
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease

The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium oligo-mannurarate capsule.

Alzheimer's disease is known for placing a great burden on caregivers which includes social, psychological, physical or economic aspects. Research indicates that the disease is associated with plaques and tangles in the brain. Currently used treatments offer a small symptomatic benefit. No treatments to delay or halt the progression of the disease are, as of yet, available. The investigators suppose sodium oligo-mannurarate capsule to be effective to halt the progression of the disease.

Eligibility Criteria:
Inclusion Criteria:

* At least primarily educated.
* Accord with Probable Alzheimer disease of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA)'s Criteria.
* 10 points ≤ Minimum Mean-Square Error(MMSE) ≤ 24 points.
* Hachinski ischemia scale \<4 points.
* Hamilton depression scale ≤10 points.
* Should have stable accompanying person, or at least contact 2 hours per day, 4 days per week with accompanying person. The accompanying person should help the patient throughout the trial.
* Signed the information consent form.

Exclusion Criteria:

* Have been in other clinical trials within 30 days before this trial' start.
* women during pregnancy or lactation.
* Dementia caused by other diseases.
* previous nervous system diseases.
* Abnormal laboratory results.
* Uncontrolled hypertension.
* Unstable or serious diseases of heart, lung, liver, kidney and blood.
* Visual or auditory handicap.
* Significant focal lesions revealed by electronic computer X-ray tomography(CT) or magnetic resonance imaging(MRI) in one year before enrollment.
* Alcohol abuse or drug abuse.
* psychotic, including patients with serious depression.
* Patients being in drug therapy of Alzheimer disease which cannot be stopped.
* In treatment of heparin, Polysaccharide sulfate, mannose ester 3 weeks before the recruitment.
* Investigator consider the patient cannot finish this trial for any reason.
* Relatives or employees of the investigators, staff of the investigate centers, contract research organization and sponsor.
A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm

The purpose of this study is to determine whether a single treatment with administration of NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the arm (Unilateral Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.

The following treatment cycle will investigate the safety and tolerability of two-sided treatment with NT 201 (botulinum toxin) (Open Label Bliaterial Period). All participants will receive NT 201 treatment.


Eligibility Criteria:
Inclusion Criteria:

- Score of ≥ 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) confirmed by an independent TETRAS expert by means of video assessment.

Exclusion Criteria:

* History or presence of day-to-day fluctuations in ET which would jeopardize meaningful tremor assessment over time, e.g. severe tremor on one day and minimal or no tremor on another day.
* Other neurological signs, such as dystonia, ataxia, or parkinsonism, which in the judgment of the investigator could interfere with the ET diagnosis and/or assessment of ET in ULs.
* Tremor types other than ET
Neurophenotype Predicts CD Disease Progression

The goal of this observational study is aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of Crohn's Disease patients and assess its ability for predicting disease progression, using multiomics data to interpret the model.

Participants will be followed-up of at least six months for patients without disease progression to assess the relationship between neurophenotype and intestinal outcomes.

Brain-gut axis plays a crucial role in the pathogenesis of Crohn's disease (CD); however, CD neurophenotype and its impact on intestinal disease progression remain unclear. We aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of CD patients and assess its ability for predicting disease progression, using multiomics data to interpret the model. This study enrolled CD patients who underwent baseline testing (including neuroimaging, psychological scales, MR enterography, and ileocolonoscopy) and faecal/blood samples collection. The neurophenotypes of patients were characterized using a neuroimaging-based model. The predictive ability of neurophenotype model for disease progression was evaluated using Cox regression analysis. Multiomics data (including faecal microbiome, faecal/blood metabolomics, intestinal permeability, blood-brain-barrier permeability, and blood neurotransmitter levels) were used to elucidate how neurophenotypes reflect brain-gut interactions.

Eligibility Criteria:
Inclusion Criteria:

* (a) CD patients aged 18-45 years; (b) the completion of multimodal brain MRI and administration of psychological questionnaires; (c) MR enterography (MRE), ileocolonoscopy, and blood or faecal samples, collection within one week of brain MRI; (d) a follow-up of at least six months for patients without disease progression; and (e) right-handedness.

Exclusion Criteria:

* (a) recent use of antibiotics, probiotics, or prebiotics within three months prior to inclusion; (b) history of neurosurgery, cerebrovascular disease, or brain trauma; (c) use of central nervous system drugs or antidepressants within three months prior to inclusion; (d) identification of brain lesions on MR scan; (e) claustrophobia; or (f) presence of metal implants.
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty

The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following abdominoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18-70 years old, inclusive. Female subjects must meet additional criteria according to childbearing potential.
* Planning to undergo abdominoplasty
* Ability to provide written informed consent
* Ability to understand study procedures and communicate clearly with the investigator and staff
* American Society of Anesthesiologists (ASA) risk class of I to II.

Exclusion Criteria:

* Emergency or unplanned surgery
* Previous abdominoplasty
* Pre-existing condition causing preoperative pain around the site of surgery
* Women who are pregnant or breastfeeding
* Chronic pain diagnosis and ongoing or frequent use of pain medications
A Phase ll Study of Neoadjuvant Short-course Radiotherapy Followed by Ivonescimab and Chemotherapy in pMMR/MSS Locally Advanced Rectal Cancer

The purpose of this study is to evaluate the efficacy and safety of short-course radiotherapy followed by ivonescimab and chemotherapy in participants with pMMR/MSS locally advanced rectal cancer. Patients were randomly assigned to experimental group A or control group B according to a 1:1 ratio. In group A, patients will receive neoadjuvant short-course radiotherapy followed by ivonescimab and chemotherapy. In group B, patients will receive neoadjuvant short-course radiotherapy followed by chemotherapy. After neoadjuvant treatment, the patients and investigator could choose one of the following treatments:(1) Surgery. The patients will receive surgery within 4-8 weeks after the last dose of capecitabine, and the surgical method is selected by the investigator, (2) Watch and Wait (only for patients with clinical complete response after neoadjuvant therapy).


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years;
2. ECOG perfommance status of 0 or 1;
3. Life expectancy: more than 2 years;
4. Histologically proven rectal adenocarcinoma;
5. Tumor biopsy immunohistochemistry proven pMMR, positive for four proteins, MLH1, MSH2, MSH6 and PMS2, or MSS determined by gene testing;
6. According to the 8th Edition of the AJCC Staging Manual, clinical stage cT3-4NanyM0 or cTxN+M0 of II-III rectal cancer was determined by Magnetic resonance imaging (MRI)±transrectal ultrasonography/ ultrasound endoscopy. Lower edge of the tumor was ≤ 12 cm from the anal verge;
7. Eligible for R0 surgery;
8. No prior anti-tumor treatment for rectal cancer,including radiotherapy,chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc;
9. Adequate organ function;
10. Males or females with reproductive ability who are willing to use contraception in the trial;

Exclusion Criteria:

1. Any distant metastasis or inoperable disease, regardless clinical stage;
2. Previous (within 5 years) or concurrent other malignant tumors, excluding those that have been cured;
3. Current presence of gastric intestine obstruction, bleeding or perforation which need emergency surgery;
4. Multiple primary rectal cancers;
5. Previous pelvic or abdominal radiotherapy;
6. Difficulty swallowing;
7. Current presence of uncontrolled combined disease;
8. Active clinical infections;
9. History of severe bleeding tendency or coagulation dysfunction;
10. Presence or history of immunodeficiency; positive for HIV antibodies, current long-term use of systemic corticosteroids or other immunosuppressants;
11. Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection;
12. Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study;
13. Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival;
A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects

This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55 years healthy subjects
* Hemoglobin values of 13.5-17.0 g/dL for males or 12.0-15.5 g/dL for females.
* Females cannot be pregnant.

Exclusion Criteria:

* Cannot have exposure to greater than 4 new chemical entities within 12 months.
* Cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule.
* Cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months.
* Must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry.
* Cannot use be taking prescription, non-prescription or illicit drugs.
Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement

Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality and quantity with orthodontic tooth movement.


Eligibility Criteria:
Inclusion Criteria:

* Malocclusion that requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site, such as Class I bimaxillary protrusion, and Class II division 1 cases.
* Normal shape and structure of the maxillary canines, with no history of root canal treatment

Exclusion Criteria:

* Patients who underwent previous orthodontic treatment.
* Patients currently receiving drug therapy, e.g. hormonal therapy and corticosteroids, as well as patients with chronic diseases.
* Pregnancy and lactation.