cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Lubrication on Appetite, Food Intake and Salivary Biomarkers in Protein Beverages

The main aim of this study is to elucidate the influence of protein beverages differing in their lubrication properties (low/medium/high lubricating) and control (water) on satiety and satiation.

The researchers propose an acute, randomized cross-over study that compares three types of protein beverages differing in their lubricating properties, i.e. one with low lubricating properties made using sodium caseinate, one with medium lubricating properties made by whey protein, and the third one with high lubricating properties made by heated whey protein. All three beverages contain added banana flavour and non-nutritive sweetener. Water acts as a control and has the same flavour and sweetness to match those of the protein beverages.

Participants are asked to come to the laboratory on four occasions. Before participating, each participant is screened for eligibility criteria using an online health screening questionnaire and Three Factors Eating Questionnaire. Participants are offered one of the four treatments (water or either of the three protein beverages), the order of which is randomized and counterbalanced.

Participants are instructed to fast for 11 hours and to restrict from drinking alcohol for 24 hours before each session. Each session lasts 1.5 hours (8.40 am until 10.10 pm). In the first session, weight and height are measured. Participants then provide baseline (- 5 min) appetite ratings on a 100 mm visual analogue scale (VAS). After that they are given the preload - either protein beverages differing in their lubricating properties or water. Then, participants are asked to rate their appetite on a 100-mm VAS every 10 minutes for the next 30 minutes. Ad libitum food is offered as breakfast after 30 min after ingesting the preload and the last VAS is taken. Saliva is taken three times during each session before preload, after preload consumption and before ad libitum breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55 years old
* With a BMI between 18.5 - 27.99 kg/m²)
* Generally healthy

Exclusion Criteria:

* have any blood borne disease;
* have type-1 or type-2 diabetes;
* have liver and kidney disease;
* have past history of gastrointestinal surgery;
* are a smoker;
* have oral infections/ diseases;
* have chronic or acute health condition that may affect ability to sense, eat, digest, absorb or excrete food;
* have a sensitive stomach (Irritable Bowel Stomach);
* are currently using prescribed or non-prescribed medication;
* are pregnant or lactating;
* are suffering from an illness, feeling unwell, having fever, or cold or cough;
* history of food allergy or intolerance;
* are on any special diet or are taking protein and/or fibre supplements;
* cannot tolerate protein beverages;
* present any COVID related symptoms (high temperature, a new continuous cough, a loss or change to your smell or taste);
* if you are self-isolating or if you leave with someone self-isolating or presenting COVID related symptoms.
Angiogenesis in Early Breast Cancer for Prognosis Prediction

This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a breast mass highly suspicious for malignancy from clinical, mammographic or sonographic examination.
* The study has been explained to the patient when she is scheduled for surgery.
* Healthy normal volunteers for imaging protocol optimization.

Exclusion Criteria:

* Pregnancy
* Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
* Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
* Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
* Patients with implanted prosthetic heart valves,
* Patients with pacemakers, neuro-stimulation devices,
* A breast mass with features of benign tumor
* The patients unwilling to participate in the study or fail to sign the consent form
Mulligan Mobilization With Movement Versus Macquarie Injury Management Group in Function and Pain of Knee Osteoarthritis

Knee pain is one of the most usual pain that commonly affects people especially in the late age. It can be caused by osteoarthritis, poor posture or sitting position, bad bending or improper lifting. It is usually not caused by a serious illness. It is the most common cause of disability. To compare the long term effects of Mulligan Mobilization with Movement versus Macquarie Injury Management Group on pain and function of knee osteoarthritis.

It was a randomized clinical trial conducted in Revival Physiotherapy Center, Lahore. A convenient sample of 26 diagnosed patients with osteoarthritis was included in the study. Subjects were randomly distributed in to two groups with use of flip coin method Group of randomization. Group 1 patients got MIMG with routine physical therapy and Group 2 got MWM with routine physical therapy. Visual analogue Scale (VAS),Non modified WOMAC were used to assess all patients before and after 4 weeks of intervention. Statistical analysis was computed by SPSS 20.0.

Eligibility Criteria:
Inclusion Criteria:

* ACR criteria for knee will be over age 50
* less than 30 minutes of morning stiffness,
* Crepitus on active motion,
* Tenderness
* Enlargement
* No palpable warmth of synovium.
* Osteoarthritis grade 1 and 2 by Kelly-green and Lawrence method.

Exclusion Criteria:

* Any surgical procedure done in past 6 months and metal implants in lower extremity.
* Any infection and neoplastic disorder.
* Post traumatic knee stiffness.
* Secondary knee O A peripheral vascular disease
The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

Psoriatic arthritis (PsA) is a type of joint disease that can lead to severe joint damage and disability within the first few years of the disease. This is why early detection and treatment of the disease is essential to prevent serious joint damage and improve long-term outcomes in these patients. However, there is currently no reliable way to tell the difference between PsA and other types of joint disease. This makes it difficult to detect PsA early. Enthesitis is an inflammation of the area where muscle tendons and ligaments attach to bones. Enthesitis is a key feature in PsA and can be easily detected using ultrasonography. The aim of this research study is to develop a system to evaluate enthesitis using ultrasonography, which can be used as an effective tool in the early detection of PsA. This will help in providing patients with early treatment to prevent further joint damage.


Eligibility Criteria:
General Inclusion Criteria:

* Age ≥18
* Able to provide an informed consent

Specific Inclusion Criteria for PsA:

* Meets the CASPAR criteria for PsA
* Early PsA - Less than 5 years from a rheumatologist diagnosis of PsA

Specific Inclusion Criteria for Psoriasis:

* Dermatologist confirmed diagnosis of psoriasis
* No prior diagnosis of PsA or signs of PsA on physical examination
* Psoriasis Epidemiology Screening Tool (PEST) score \< 3

Specific Inclusion Criteria for non-inflammatory rheumatic disease:

* Referred to rheumatology for musculoskeletal symptoms such as joint pain, stiffness, back pain
* No evidence of inflammatory rheumatic condition including rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, scleroderma, gout, septic arthritis or recent joint trauma/surgery
* No psoriasis
* No inflammatory bowel disease

Exclusion Criteria:

* Using any biologic medications including Tumor Necrosis Factor (TNF) inhibitors, Interleukin (IL)-17 inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, Janus Kinase (JAK) inhibitors
* Prednisone ≥ 7.5 mg/day
Postoperative Pain Control in Septum and Sinus Surgery

This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.

Pain control in the postoperative period following septum and/or sinus surgery is controversial, as there is no consensus statement regarding current guidelines to direct clinical practice. Recent legislation limits opioid prescription length to 5 days only, which brings into question whether legislation will affect prescribing practices of physicians and whether or not giving patients an alternative to opiates will be a more efficacious route.

Current prescribing practices for septum and sinus surgery of the Otolaryngology private practice group includes as-needed acetaminophen 325 mg and as-needed acetaminophen/hydrocodone 7.5 mg/325 mg. If it can be demonstrated that use of 650 mg acetaminophen in scheduled doses of every 6 hours can decrease postoperative opiate use in the first week without significantly increase in patient pain, this may be deployed as an effective strategy of pain control as the use of opiates has come under scrutiny and attempts are being made to decrease or limit the use of these medications in the medical setting.

This study would look to demonstrate that scheduled doses of acetaminophen as opposed to reactionary as-needed acetaminophen can control post-operative pain to the point where narcotics would not be necessary.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery
* 18 years of age or older
* Male or female
* No known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone
* Patients discharged to home after surgery

Exclusion Criteria:

* Undergoing revision sinus, septum, or sinus/septum surgery
* Younger than 18 years old
* Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone
* Patients admitted to the hospital postoperatively for airway monitoring
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse

Pelvic organ prolapse is a condition with impaired anatomic structure, which may result in defecatory disorders and usually considered as an indication for surgery. However, operation is not always possible. Existing data suggest that functional component may also be possible, despite on the anatomic impairment. The aim of the study is to evaluate the effect of complex conservative treatment of functional defecatory disorders in patients with mild to moderate grade of pelvic organ prolapse

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate (signed informed consent form)
* Females with rectocele I-II grade or rectocele I-II grade and internal rectal invagination and functional defecatory disorders (per Rome IV guidelines) confirmed on the basis of complex examination including high-resolution anorectal manometry

Exclusion Criteria:

* rectocele III grade;
* internal genitals prolapse;
* history of abdominal or pelvic surgery that may impact bowel motility (excluding non-complicated appendectomy or laparoscopic cholecystectomy);
* gynecological surgery that may influence sensory or reservoir function of rectum;
* history of major cardiovascular events, or presence of current conditions that in case of participation of the patient in the study may put her at risk of exacerbation or complication;
* start of any new concomitant medication with mechanisms of action that influence rectal motility, sensory function, muscle tone and/or contractility
* inability to understand and/or follow the instructions to perform all the procedures required per protocol
* general condition of the patient that make her ineligible by the discretion of the investigator
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.

The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.

Eligibility Criteria:
Inclusion Criteria:

* Chronic genotype 1-3 HCV infection
* Treatment Naive

Exclusion Criteria:

* Child B and C
* HCC patients
* Pregnancy
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.

All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have undergone specified complete surgical staging.
* Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
* Patients must have adequate bone marrow, renal and hepatic function.

Exclusion Criteria:

* Patients with recurrent disease.
* Patients with GOG performance status of 3 or 4.
Effects of Improvement of the Ankle Joint Range on Balance in the Elderly.

The effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. This study seeks to investigate the effects that a mobilization on the ankle will produce in order to improve its joint range and if the balance of the older adult improves after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* 60 years or more

Exclusion Criteria:

* Do not sign the consent
* No acute pathology (3 months)
* Vestibular pathology
* CNS disease
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.

OBJECTIVES:

Primary

* Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.

Secondary

* Determine the clinical benefit and tolerability of this regimen in these patients.
* Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed cancer

  * Metastatic disease
* Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm
* Not a candidate for anthracycline or taxane chemotherapy
* No brain metastases

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* Neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Alkaline phosphatase \< 5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Creatinine \< 1.5 times ULN OR creatinine clearance \> 30 mL/min
* SGOT and SGPT \< 3 times ULN (5 times ULN if liver metastases present)
* No pre-existing neuropathy
* Not pregnant or nursing
* No uncontrolled hypercalcemia
* No familial, social, geographical, or psychological condition that would preclude study treatment
* No other malignancy that is not considered cured

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for metastatic disease, including anthracyclines or taxanes
* Prior hormonal therapy allowed
Efficacy and Immunomodulator Impact of Herbal Combination on COVID-19 Patients Recovery

This study aims to evaluate the efficacy and safety of Herbamuno+, a combination of several herbal ingredients, as an adjunct therapy for moderate COVID-19 patients at Wisma Atlet. The study involves 66 patients who were divided into two groups: one receiving Herbamuno+ and the other a placebo, both for 14 days. Researchers monitored clinical improvements, chest X-rays, and blood tests to assess inflammation and immune response. The goal is to determine whether Herbamuno+ can be safely and effectively added to standard COVID-19 treatment.


Eligibility Criteria:
Inclusion Criteria:

* The RCT included patients who met the following criteria: \&amp;amp;gt;18 years old, had recently tested positive for COVID-19 through RT-PCR within the past five days, and were categorized as moderate cases. The main clinical symptoms required for inclusion were acute fever (greater than 38 °C) and cough, or more than three of the following acute symptoms or signs: fever, cough, fatigue, headache, muscle pain, sore throat, nasal congestion, runny nose, shortness of breath, anorexia, nausea, vomiting, diarrhea, anosmia, or ageusia. The moderate case criteria are based on WHO criteria including the radiology imaging that indicating pneumonia (new infiltrates to consolidation) and clinical signs of pneumonia (fever, cough, shortness of breath, and respiratory frequency between 20 to 30 times per minute).

Exclusion Criteria:

* Patients were excluded if they had any of the following conditions: an oxygen saturation of less than 93%, participating in other clinical trials, pregnant or lactating, receiving other immunomodulatory drugs, had a history of allergies to the test product, or the history of tuberculosis, HIV/AIDS, psychosis, or autoimmune disorders. Subjects may also be dropped from the clinical trial if they withdraw, fail to comply with the protocol (including using less than 80% of the test product), disappear, or no longer meet the inclusion criteria. Adverse events, worsening conditions, or new diagnoses during the trial also warrant exclusion.
Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis

The purpose of this study is to assess patient satisfaction with the Titan one touch release penis prosthesis and to register complications with this prosthesis. This will regard the first prostheses inserted at Herlev Hospital/Frederikssund Hospital.

Patient satisfaction will be assessed by mailing out the "Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire" and recording the patient answers. The most important question will be "Overall how satisfied are you with penile prosthesis?".

Complications (including infection, bleeding, and mechanical failure) will be assessed by a patient chart review and confirmed by a brief phone interview.


Eligibility Criteria:
Inclusion Criteria:

* Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital.

Exclusion Criteria:

* Inability to read Danish
Psychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children

This study designed and evaluated a psychoeducation program for parents of ADHD children in terms of improving medication adherence and clinical benefits.

ADHD is the most common behavioral disorder with poor outcomes. Medication is the most important treatment for ADHD. The adherence to the medication is extremely low. This study aims to investigate the the effect of a psychoeducation program for parents of ADHD children. The investigators intent to recruit 80 ADHD families. They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in a psychoeducation program, which includes a presentation from a specialist in ADHD at the baseline, with parent manual provided, posters, and two group sessions at the end of the 2nd and the 4th weeks. The control group only receives general consultation. The knowledge towards ADHD and its treatment, parents' behavior intent, medication adherence, clinical symptoms, and parents' satisfaction will be assessed and compared at the end of the 1st and 3rd months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* parents of ADHD children diagnosed with ADHD
* 6 - 16 years old;
* first referral to the hospital;
* candidate for medication according to both the doctor and the family

Exclusion Criteria:

* inappropriate for medication;
* being illiterate of the parent or the primary caregiver;
* unable to be followed-up.
Pharmacokinetic Interaction Between AZD3480 and Donepezil

The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood concentrations of each other and 2) assess the safety and tolerability of the combined administration of AZD3480 with donepezil.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Genotyped as an EM, defined in this study as having ≥ 1.5 functional CYP2D6 alleles, or a PM, defined as having zero functional CYP2D6 alleles

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding