cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients


Eligibility Criteria:
Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

* History or evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Urinary tract infection at time of enrollment
Pain Neuroscience Education for Depression

This study will look at the effects of Pain Neuroscience Education on a Depression outcome tool in patients with chronic low back pain.

Pain and depression have been shown to be interrelated, especially chronic pain: people in chronic pain develop depression and people with depression develop chronic pain. In light of this coexistence it is not surprising that current best-evidence for depression and chronic pain shows significant overlap which includes primarily some type of cognitive intervention, aerobic exercise, and skilled delivery of medication including selective-serotonin-reuptake-inhibitors and/or membrane stabilizers. Current best-evidence regarding musculoskeletal pain provides strong support for Pain Neuroscience Education (PNE) to positively influence pain ratings, dysfunction, and limitations in movement, pain knowledge and healthcare utilization. Additionally, PNE has shown to powerfully influence psychosocial issues that powerfully influence pain and depression: fear-avoidance and pain catastrophization. Evidence is lacking in whether PNE could also influence depression ratings. The purpose of this study is to examine the immediate effect of PNE on pain, function, and depressive symptoms (using the Patient Health Questionnaire - PHQ-9) in patients attending PT for chronic low back pain (LBP).

This will be a pre- and post-intervention convenience sample of consecutive patients with chronic LBP (pain \> 6 months) meeting the inclusion criteria, attending outpatient PT. On initial examination, intake data and information will be collected prior to PNE and immediately following PNE.

Eligibility Criteria:
Inclusion Criteria:

* adults over the age of 18
* presenting at PT with a primary complaint of LBP
* LBP being present for 6 months or more
* fluent in English
* willing to participate in the study.

Exclusion Criteria:

* are under age 18 (minor)
* had undergone lumbar surgery
* cannot read or understand the English language
* presents with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.)
* decline to participate
* present with a medical etiology (red flag) associated with their LBP.
Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. The investigators therefore investigate the effect of Escitalopram as a perioperative analgesic.

Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. Patients with high pain catastrophizing are mentally vulnerable and may be sensitive to the effects of Escitalopram.

We therefore investigate the effect of Escitalopram as a perioperative analgesic in this group of patients where the pain problem is pronounced.

Eligibility Criteria:
Inclusion Criteria:

* Primary, unilateral total knee arthroplasty (TKA)
* Age \> 18 \> 81
* Ethnic Danes
* Score \> 20 on Pain Catastrophising Scale

Exclusion Criteria:

* Medication that causes risk in combination with SSRI (6 month)
* Treatment for anxiety or depression
* History of depression or mania
* Treatment with systemic glucocorticoids (6 month)
* Treatment with opioids (4 weeks)
* Alcohol or drug abuse
* History of malignancy
* Fertile woman
* History of epilepsia
* Treatment with anticoagulants
* BMI \> 40
* Disease affecting central or peripheral nerve function
* Dementia
* History of gastrointestinal bleeding
* History of hepato- or renal insufficiency
* Allergy to Escitalopram
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases

The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent from the patient's guardian
* Patients aged ≥ 1 year to 14 years old
* Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.

Exclusion Criteria:

* Patients less than 10 kg in weight.
* Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the randomisation/registration.
* Significant clinical illness within 4 weeks prior to the registration
* Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
* Positive for pregnancy test by urinary or lactation for post-menarchal females.
* Previous total gastrectomy
Obesity and Brain: Genes and Environment

The aim of this study is to investigate the effects of genetic and environmental risk factors on central nervous system (CNS) reward and satiety circuits in the etiology of obesity. The investigators will also investigate to what extent the alterations in CNS reward and satiety circuits are a cause or a consequence of the development of obesity.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Male or female
* Stable bodyweight (\<5% reported weight change during previous 3 months)
* Women: regular menstruation cycle (to exclude possible menstruation cycle effects)
* Normal fasting blood glucose

Exclusion Criteria:

* Left handedness
* Known diabetes or abnormal fasting blood glucose
* Serious heart, pulmonary, hepatic or renal disease, malignant or hematological disease
* Metabolic disorders (uncontrolled adrenal/thyroid disease)
* Women: irregular menstruation cycle
* Neurological or psychiatric illness
* Pregnancy or breast feeding
* Alcohol abuse
* Nicotine abuse
* Claustrophobia or metal implants
* Visual disability
* Participation in another study
* Inability to understand the protocol or to give informed consent
* Current/chronic use of following medication: antihyperglycemic agents, glucocorticoids, centrally acting drugs, cytostatics, immune suppressants, potentially addictive medications.
Management and Short Term Outcome of Traumatic Wounds in the Emergency Department

Identify the risk factors for complications as well as study the evolution of wounds sutured in the emergency room towards complications such as superinfections, necrosis, disunity of the stitches linked to inadequate initial care.

All traumatic injuries should be considered contaminated upon presentation to the emergency room. This is why the main objective of this study was to describe the attitude of patients towards their wounds, to identify the risk factors for complications as well as to study the evolution of sutured wounds in the emergency room towards complications such as superinfections, necrosis, disunity of stitches linked to inadequate initial treatment.

This is a prospective, observational, monocentric study carried out in the emergency services of the Fattouma Bourguiba hospital in Monastir.

Eligibility Criteria:
Inclusion Criteria:

* Patients who presented to the ambulatory emergency circuit of the EPS Fattouma Bourguiba Monastir having as main reason for consultation an acute suturable wound.

Exclusion Criteria:

* Wounds requiring surgical treatment
* Septic wounds
* Chronic lesions
* Vascular wounds
* Patients who did not consent to the protocol.
Hemoglobin Easy Measurement With Optical Artificial Intelligence

Blood hemoglobin levels are an extremely important measure for a large swath of medical procedures as they reflect the oxygen-carrying capacity of human blood. The gold standard measure for blood hemoglobin levels involve a venous blood draw followed by a laboratory-based complete blood count (CBC), a process which is both painful and time consuming. To date, various methodologies have been tested to either expediate the process or provide a non-invasive alternative. There remains a need to provide a quick, pain-free/non-invasive and accurate modality to measure blood hemoglobin levels. The objective of this study is to determine whether computer vision technologies can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.


Eligibility Criteria:
Inclusion Criteria:

1. A patient aged 6 months to 18 years.
2. A patient who has undergone a venous blood draw for a CBC since being admitted to the PED no more than 6 hours prior to study enrollment.
3. Parents or legal guardian provide informed written consent.

Exclusion Criteria:

1. Patient has subungual hematoma, nail bed lacerations or avulsion injuries on both hands.
2. Patient has total leukonychia.
3. Patient has nail polish applied on fingernails.
4. Patient has nailbed darkening or discoloration due to medication.
5. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety.
Assessment of Dietary Protein Needs of Older Women

The purpose of this study is to evaluate dietary protein requirements in elderly women aged 80 years and older using the indicator amino acid oxidation technique.

Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated average requirement of 0.66 g∙kg-1∙d-1 protein. The recommended protein intake for elderly women is higher than the recommended dietary allowance of 0.80 g∙kg-1∙d-1 protein.

There is currently considerable debate regarding the accuracy of the estimated average requirement (EAR) and the recommended dietary allowance (RDA) for older people. Very limited data obtained from older individuals are available to support the assumption that age does not affect protein requirement. Existing method like nitrogen balance has inherent limitations that diminish it from being considered a reference method. Indicator amino acid oxidation technique is emerging as an alternative method to measure dietary protein requirement. It is more accurate and less demanding. The current study will be the first time this technique is used with elderly adults and will provide an important foundation for geriatric nutrition research.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age range: 80 yrs and older
* Body mass index between 22-30
* Weight stable 4.5 kg weight gain or loss within the last 6 month
* Non-smoking within the last 6 month
* Ambulatory
* Clinically normal blood profiles within 10% of clinical normalc.
* No diseases or not taking medications known to influence protein or energy metabolism,
* Willingness and ability to consume food provided and not allergic to phenylalanine
* Continent, strong bladder control

Exclusion Criteria:

* Male,
* Gained or lost more than 4.5 kg of body weight within the last 6 months,
* Non-ambulatory (i.e. bedridden, wheel-chair bound),
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA

As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites. This study will assess genotyping accuracy as compared to bidirectional sequencing and genotyping reproducibility across variables such as user, day, and site.


Eligibility Criteria:
Inclusion Criteria:

* Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.

Exclusion Criteria:

* There are no applicable exclusion criteria for this test, since the genomic sequence will not vary by ethnicity, gender, age or disease. Inappropriately stored blood samples will be excluded.
Cardio-visual Stimulation in Augmented Reality for Pain Reduction

The objective of this study is to evaluate the feasibility and efficacy of an Augmented Reality (AR) biofeedback intervention to alleviate pain symptoms in individuals suffering from chronic pain of the hand and/or the forearm.

Chronic pain is a major public health problem with implications for high health care costs, lost productivity and an estimated financial burden of $500 billion. Individuals with chronic pain are also at an increased risk of developing an opioid use disorder.

Chronic pain has previously been associated with a distorted body representation, in particular of the affected body parts. Virtual Reality (VR) studies using embodiment-, respiration-, and heart-beat related feedback have demonstrated positive effects for induced pain in healthy participants (e.g., increased pain thresholds) and chronic pain in patient populations (e.g., decreased subjective pain, improved functionality, improved physiological markers of pain). Based on these studies, the AR intervention evaluated here aims to alleviate subjective pain symptoms and improve physiological pain markers in chronic pain patients using heartbeat-related feedback.

This within-subject study will compare subjective pain ratings before, during, and after an AR intervention that provides visual feedback of participants' on-going heartbeat in relation to their affected limb. Primary outcomes include subjective reports from participants (perceived efficacy, acceptability, and demand) and the intervention's clinical feasibility, including reports from therapists. Secondary outcomes include changes in heart rate and variability.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years of age
* Present permanent chronic pain (for more than 3 months), secondary to a peripheral pathology (traumatic, orthopedic or neurological), located in the hand or forearm.

Exclusion Criteria:

* Pregnant women
* People in emergency situations
* Persons unable to give informed consent
* Persons who are mentally or linguistically unable to understand the research test instructions
* Individuals who are not available to complete the entire study protocol
* Cognitive impairments that prevent the use of the equipment
* Psychiatric disorders
* Patients with seizure disorders
* Patients with central hemineglect
* Pain secondary to central nervous system pathology
* Patients with arrhythmia
* Patients with head tremors or head shaking.
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects

The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).


Eligibility Criteria:
Inclusion Criteria:

Part A - Healthy Subjects:

* Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
* Additional inclusion criteria apply

Part B - Crohn's Subjects:

* Male or female subjects with CD between 18 to 55 years-of-age
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of mild to severe CD
* Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months
* Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to or greater than 180 and equal to or less than 450
* Elevated fecal calprotectin and CRP
* Additional inclusion criteria apply

Exclusion Criteria:

Parts A - Healthy Subjects:

* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* Recent or on-going infection(s)
* Underlying condition(s) that predisposes the subject to infections
* History of malignancy of any type
* Additional exclusion criteria apply

Part B only - Crohn's Subjects:

* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* Recent or on-going infection(s)
* Underlying condition(s) that predisposes the subject to infections
* History of malignancy of any type
* Additional exclusion criteria apply
Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. If the target results can be reached, it will be concluded that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with clarithromycin as the primary treatment.

The primary end point in this study is appointed to be "Helicobacter pylori infection eradication with TRIOL treatment" and the secondary end point as "safety". The study involves the investigation of the efficacy and safety of the triple treatment consisting of 500 mg levofloxacin, 1000 mg amoxicillin and 30 mg lansoprazole on Helicobacter pylori eradication in 60 patients with Helicobacter pylori infection.

Eligibility Criteria:
Inclusion Criteria:

* Consenting to an endoscopy
* Signing the informed consent form
* Not receiving Helicobacter pylori eradication treatment before
* Showing Helicobacter pylori infection by rapid urease test and/or Giemsa staining
* Being older than 18 years of age

Exclusion Criteria:

* Being younger than 18 years of age
* Receiving H. pylori eradication treatment previously
* Having gastrectomy or vagotomy in medical history
* Having gastric malignancy, including adenocarcinoma and lymphoma
* Having other severe malignant disease
* Previously having allergic reaction to antibiotics (amoxicillin, levofloxacin) and proton pump inhibitors (lansoprazole)
* Using prompt pump inhibitors (lansoprazole) and antibiotics (amoxicillin, clarithromycin, levofloxacin) in the last 4 weeks
* Having active upper GI bleeding in the last week
* Being pregnant or lactating
* Taking long term high dosages of aspirin, corticosteroid and other NSAIDs in the last 4 weeks
* Taking any antibiotics or proton pump inhibitors other than the study medication during the study period
* Taking antacids and/or H2-blockers during the study period
* Taking bismuth compounds within four weeks prior to and during the study period
* Having dysphasia or vomiting as major symptoms
* Having psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study
* Having severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system.
* Having known uncontrolled hypertension
* Being immunocompromised
* Showing clinically significant abnormal vital signs
* Having clinically significant abnormal ECG findings
* Presenting clinically significant abnormal laboratory data at screening, or any abnormal laboratory value that could interfere with the assessment of safety
* Being exposed to any investigational drug within 30 days prior to screening
* Having known hypersensitivity to or contraindication against fluoroquinolones.
* Having current diagnosis or known history of substance abuse.
Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease

Blood samples and Tumor tissue will be collected at certain timepoints and will be tested.

Blood samples will be tested by Natera to identify residual tumor DNA for genetic changes in the tumor to potentially improve prediction of long term prognosis and guide treatment options.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of epithelial ovarian cancer stage II-IV

Exclusion Criteria:

Insufficient tumor to perform Signatera testing; Inability to provide consent for the trial
Aerobic Exercise for Women With Fibromyalgia

This is randomized controlled trial that investigated the effect of aerobic exercises in women with fibromyalgia. The study was performed in Abu-kabir central hospital - Al Sharquia, Egypt. The sample was recruited from the rheumatology department in Abu-kabir central hospital- Al Sharquia. Sixty women were included in the study based on the inclusion criteria. The first group (study group) included 30 participants who received aerobic exercise in addition to the prescribed medications. The second group (control group) included 30 participants who received the prescribed medications only. The outcome measures included visual analogue scale, Fibromyalgia Impact Questionnaire and cholesterol level. Assessment of outcomes were performed at baseline and after the end of treatment program.


Eligibility Criteria:
Inclusion Criteria:

* (1)Their ages ranged from 30 to 40 years old (2)Their body mass index (BMI) was from 20:26 kg/m2 (3)All patients assured diagnosis fibromyalgia for more than three months (4)Participants were on a stable regimen of pharmacological and/or non pharmacological treatment for FM the previous three months leading up to study period and agree to maintain their present medication unchanged for the duration of their participation in the study

Exclusion Criteria:

Patients with pregnancy, another accompanying central sensitization syndrome Patients with psychiatric illness Patients whose pharmacological treatment for FMS changed within the last three months Patients who do not have a cognitive level to answer the questions in the scale