cyrilzakka/clinical-trials huggingface dataset:
Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse

To find out the effectiveness of physical therapy associated with the surgical treatment over the simptoms and quality of life in III and IV grades of pelvic organ prolapse, patients will be randomly assigned to one of these groups: experimental group: pre-surgical and post-surgical physical therapy + behavioral education + surgical therapy. Control group: surgical treatment + behavioral education.

In both groups several physical therapy assessments will be undertaken: 1st before surgery; 2nd immediately after surgery; and after 6 weeks, 3th, 6th, 12th and 24th months post-surgery.

Intervention in the experimental group, patients assigned to this group will receive:

* Pre-surgical physical therapy: 9 sessions of physical therapy aimed at correcting posture, to the awareness and the strengthening of the pelvic floor muscles. They will be also informed and instructed on hygienic and behavioral education to prevent pelvic organ prolapse and urinary incontinence. Each session will be about 45 minutes and 3 sessions will be held a week for 3 weeks.
* Post-surgical Physical Therapy:

  2. Hospital discharge patients will receive the same fact sheet on sanitary and behavioral measures recommended for the prevention of pelvic organ prolapse and urinary incontinence.

  3. 6th weeks after surgery: 8 physical therapy sessions (2 per week for 4 weeks) about 30 minutes to review hypopressive exercises and contractions of the pelvic floor.

Intervention in the control group, patients assigned to this group will receive:

After surgical correction of pelvic organ prolapse, at hospital discharge, patients will receive a fact sheet on the sanitary and behavioral measures recommended for the prevention of pelvic organ prolapse and urinary incontinence (proper weight, prevent constipation, avoid weight bearing and cough and high impact exercise). No physical therapy intervention will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive women diagnosed with grade III and IV pelvic organ prolapse, which would be operated for this reason at the Asturias Prince Hospital (Madrid-Spain).

Exclusion Criteria:

* Women diagnosed with different III / IV grade of POP or a history of conservative treatment not from the subproject "Physiotherapy in the POP grades I and II", or a history of POP surgery, or concurrent conditions that would be affect the treatment (neurological, gynecological or urological), or recurrent urinary infection or hematuria, or those III / IV grades in POP which is contraindicated or not possible to perform surgery.
* Pregnant women or women with a vaginal birth in the last six months.
* Women with cognitive limitations to understand the information, answer questionnaires, consent and / or participate in the study.
Effect of Oral Rufinamide and Oxcarbazepine on Nerve Excitability, Hyperalgesia, Allodynia and Flare Reaction Compared to Placebo. A Monocenter, Randomized, Double-blind, Cross-over Study

Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder diabetischer Polyneuropathie).

In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal® (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt. Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon® die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der Haut vermindert werden.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria: Male

* Age: 18-65 years
* Weight: 50 - 100 kg
* Height: 155 - 195 cm
* Signed and dated informed consent

Exclusion criteria:

* Contraindications to the class of drugs under study
* Intellectually or mental impaired subjects
* Known hypersensitivity to class of drugs or the investigational product
* Drug abuse
* Known peripheral neuropathies
* Diabetes mellitus
* Chronic alcohol consumption
* Congestive heart disease
* Participants of other studies during study period and 30 days prior to study begin
* Smoker
* Abnormal electrocardiogram
* Any regular concomitant medication
Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.


Eligibility Criteria:
Inclusion Criteria:

* Have a previous 18F-AV-1451 brain scan
* Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
* Ability to provide informed consent

Exclusion Criteria:

* Current clinically significant psychiatric disease
* Are claustrophobic
* Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions

Bone tumors are categorized according to their tissue of origin into cartilagenous, osteogenic, fibrogenic, fibrohistiocytic, haematopoietic, vascular, and lipogenic tumors.

Magnetic resonance imaging (MRI) is now indispensable for the preoperative workup and therapeutic follow-up of patients with musculoskeletal tumors.

The application of DW-MRI in bone marrow is today an established examination technique that provides a unique contrast and that can help in the detection of bone-marrow pathologies and the differentiation of benign and malignant bone-marrow lesions.

Diffusion MRI provides quantitative and qualitative assessments of tissue cellularity and cell-membrane integrity. It is widely used for tumour detection, characterisation, and monitoring during treatment. Diffusion MRI supplies functional information that complements the structural evaluation.

In combination with standard structural MRI parameters, the ADC value improves tumour characterization. Diffusion MRI can also be used to monitor tumours during chemotherapy. Tumour necrosis results in loss of cell membrane integrity and in expansion of the extracellular compartment, leading to greater water-molecule diffusion with an increase in the ADC value.


Eligibility Criteria:
Inclusion Criteria:

* All patients with bony lesions will be included in the study.

Exclusion Criteria:

* Patient with cardiac pacemaker.
* Patients with metallic prosthesis in the region of examination.
* Patients with claustrophobia.
* Patient with recent history of surgical or imagining guided biopsy from the bony lesion.
Mindfulness-Based Stress Reduction for Hot Flashes

This is a study to determine if participation in a mindfulness-based stress reduction program is feasible for women experiencing five or more hot flashes/day, and whether it affects either the frequency and/or intensity of their hot flashes, or the degree of bother they experience from them


Eligibility Criteria:
Inclusion Criteria:

* Women experiencing 5 or more hot flashes/day
GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.

The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.

The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated.

This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16-60
* Diagnosed with previously untreated T-ALL and B-ALL

Exclusion Criteria:

* previously treated ALL patients
* L3 B-ALL
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects ≥18 to ≤75 years of age
* Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening
* Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD
* Control group of matched healthy subjects
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
* History of any major surgery within 6 months
* History of hepatic disease, or significantly abnormal liver function test
* Women who are breastfeeding or are planning to become pregnant during the study
"Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms

The aim of this project is to identify a variable that discerns patients who are interested in their disease (atrial fibrillation/atrial flutter) from patients who show no interest and furthermore test this theory in a questionnaire survey.

This should help distinguish between patients who are interested in shared decision making and patients who are not (further projects planned).


Eligibility Criteria:
Inclusion Criteria:

* Current atrial fibrillation/flutter
* \>18 years of age
* sufficient knowledge of the german language to fill out the questionnaire

Exclusion Criteria:

* \< 18 years of age
* insufficient knowledge of the german language to fill out the questionnaire
* Hemodynamic instability
The Effect of Gluten-free Diet in Type 1 Diabetics With Dyspepsia Symptoms

Patients with type-1 diabetes are more susceptible to motility-related upper gastrointestinal symptoms. Dietary interventions are one of the treatment pillars for these symptoms. Many gastrointestinal conditions other than celiac disease, are being increasingly treated with gluten-free diet (GFD). The role of GFD in non-celiac type-1 diabetic patients with dyspepsia-like symptoms has not been assessed before. In this study, type 1 diabetes patients with concomitant upper gastrointestinal symptoms will be asked to follow a 1-month GFD to assess changes in upper gastrointestinal symptoms and gastroduodenal motility before and after the dietary intervention.

Diabetes mellitus (DM) is a complex and heterogeneous disease that is associated with poor outcomes. In studies from referral centers, 50-65% of diabetics reported dyspeptic symptoms. In addition, approximately 50% of type 1 DM (T1DM) patients, especially those with longstanding disease, have evidence of delayed gastric emptying.

Dietary modification is one of the treatment pillars for patients with dyspeptic symptoms. Further, many individuals in which both symptoms and motility abnormalities improve after a GFD have positive anti-gliadin antibodies (AGA), which reinforces the role of gluten-induced inflammation/immune activation as a possible cause of motility abnormalities and related symptoms.

Ameliorating UGI symptoms is not only pivotal for improving the quality of life of diabetic GP patients, but the improvement in gastroduodenal motility is also needed for a more predictable glycemic response. In non-celiac T1DM patients, the role of the GFD in symptom improvement, gastroduodenal motility and glycemic control has never been assessed.

The overall aim of the present study is to improve the knowledge about the role of dietary interventions as non-pharmacological treatments for upper-gastrointestinal symptoms and underlying motility abnormalities in patients with type 1 diabetes. This will be a non-randomized, open label, before and after trial of a 1-month GFD in non-celiac type 1 diabetics to assess symptomatic, motility and glycemic response changes.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women (18-75 years) with type 1 diabetes diagnosis and no history of celiac disease, that complain of upper gastrointestinal symptoms (early satiety, postprandial fullness, bloating, abdominal swelling, nausea, vomiting, and retching) will be invited to participate.

Exclusion Criteria:

* Patients with very severe symptoms of gastroparesis that require specialized nutritional therapy or surgical treatment;
* Pregnant women;
* Patients with concomitant diseases/treatments that can alter gastrointestinal motility and concomitant severe systemic diseases.
Genetic Predictors to Acupuncture Response for Arthralgia Induced by Aromatase Inhibitors in Patients With Breast Cancer

Purpose:Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of SNPs.

Aromatase inhibitor-induced arthralgia (AIA) is the most common side effect of aromatase inhibitors (AIs) used in breast cancer , may cause poor adherence to AIs. Studies have shown that acupuncture has a certain therapeutic effect on AIA in breast cancer. In this study, acupuncture was used to relieve the symptoms of arthralgia in patients, and the efficacy of acupuncture was observed by using relevant scales. Currently, studies have shown that AIA in breast cancer patients is related to some biological factors.

At the same time, we collected peripheral blood samples of patients, combined with the reported relevant literature, screened out the single nucleotide polymorphisms(SNP) related to AIA and to guide acupuncture treatment of aromatase Inhibitors induced arthralgia, balance the toxicity of endocrine therapy, and improve compliance and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

1. History of stage I-III breast cancer and free of disease by clinical examination;Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment;
2. AI-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ;
3. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
4. Eastern Cooperative Oncology Group (ECOG) score of physical condition (0-1);
5. Patients with previous local recurrence were eligible, but not patients with distant metastasis;
6. The basic indexes were consistent, and the blood routine and ECG were normal.

Exclusion Criteria:

1. Patients with needle phobia;
2. Low platelet count (\<50000); comorbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels \<10 g/dl and haematocrit \<30; anaemia on active pharmacological treatment orreceiving blood transfusion or steroids;
3. Lymphoedematous of limbs;
4. Patients have a history of acupuncture treatment for 6 months;
5. Patients were reluctant to participate in the study;
6. A prior history of inflammation, metabolic disease, or neurotic joints, except for previous treatment with bisphosphonates, steroids, or opioid analgesics.
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma or ocular hypertension.

This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 3 study drug groups: Brinz/Brim, Brinz, or Brim.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open angle glaucoma or ocular hypertension, and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
* Meet qualifying IOP entry criteria.
* Able to understand and sign an informed consent form.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, test positive for pregnancy at Screening Visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Severe central visual field loss.
* Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
* Chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or ocular inflammation within the preceding 3 months.
* Clinically significant or progressive retinal disease.
* Other ocular pathology.
* Intraocular surgery within the 6 months prior to entry.
* Ocular laser surgery within the 3 months prior to entry.
* Any abnormality preventing reliable applanation tonometry.
* Any other conditions, including severe illness, which would make the subject, in the opinion of the Investigator, unsuitable for the study.
* Recent use of high-dose (\>1 gram daily) salicylate therapy.
* Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
* Concurrent use of glucocorticoid medications administered by any route.
* Other protocol-specified exclusion crtieria may apply.
Investigation of Blood Glucose and Insulin Response After Intake of Vitalose

The aim of this study is to assess the postprandial glucose and insulin response of Vitalose.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* Age 18-50 years
* BMI ≥18.5 and ≤30.0 kg/m²

Exclusion Criteria:

* acute or chronic disease
* food allergy or intolerance
* intake of medications which affect glucose tolerance
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM

A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2204

A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* The subject not meet the specified HbA1c and FPG
Chlorhexidine Gluconate Oral Care for Adults Experiencing Trauma

Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of Ventilator Associated Pneumonia and oral bacterial load.

To see a significant decrease in the bacterial load in the oral mucosa and subsequently, a decrease in the pathogenesis of Ventilator Associated Pneumonia through the use of an oral rinse containing 0.12% Chlorhexidine Gluconate as part of an oral care protocol. Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted to ICUs located in Tower Two Critical Care Units: Medical, Surgical, Medical #2, and Trauma Intensive Care Units.
* Patients will be randomized to either treatment or standard group based on day of admission to Intensive Care Units. No limitation regarding gender, race, and ethnicity so that the sample will reflect "typical" Trauma population.

Exclusion Criteria:

* All patients admitted under "Doe" Status
* All patients with acute cervical spine injuries or facial fractures that oral care will create further harm to the patient (physician order stating "no oral care to be given" will be in chart)
* All patients with Oral Trauma or Oral Surgery
* All minors (Study will be completed in Adult Critical Care Units)
* Patients with allergy to chlorhexidine
* Patients without Teeth, or with fewer than 6 teeth
Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab

The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated humoral responses and adaptive T-cell mediated cellular responses were measured in patients treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after completion of vaccination.

The purpose of this study is to see if patients on ocrelizumab (Ocrevus) produce a humoral and T-cell response to the coronavirus vaccine. Ocrelizumab depletes B-lymphocytes and has the potential to reduce the effectiveness of vaccines. The impact of ocrelizumab treatment on coronavirus vaccines is unknown.

Natalizumab (Tysabri) likely has a minimal impact the efficacy of vaccines. In this study the investigators will take blood samples in patients being treated with either ocrelizumab or natalizumab before and after vaccination with an FDA-authorized coronavirus (COVID-19) vaccine and compare the antibody response in both groups.

Eligibility Criteria:
Inclusion Criteria

* Age 18-55
* Diagnosis of multiple sclerosis (as per the revised 2017 criteria)
* EDSS score of 0-5.5 inclusive
* Has initiated ocrelizumab or natalizumab at least 6 months prior to study enrollment
* For women of childbearing potential: agreement to remain abstinent or to use a highly effective (99% efficacy or greater) contraceptive method
* Individual must be able to provide consent, read/write/comprehend English language or must be able to provide a consistent translator

Exclusion Criteria

* Previous infection with COVID-19, confirmed by FDA approved testing
* Cognitive impairment limiting the ability to consent or complete study procedures
* Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
* Any prior use of immunosuppressive or chemotherapy treatment (including, but not limited to, cladribine, alemtuzumab, mycophenolate mofetil, cyclophosphamide, methotrexate, azathioprine)
* Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion excluding standard ocrelizumab pre-treatment therapy
* Use of systemic corticosteroid therapy within 12 weeks of screening (excluding corticosteroid treatment given concurrently with ocrelizumab)
* History of allergic reactions to vaccines