cyrilzakka/clinical-trials huggingface dataset:
Automated Chest Physiotherapy to Improve Outcomes in Neuro

Following current standard-of-care, subjects data (brain pressure) will be recorded for 1 hour and include 10-minutes of data during which the subject recieves chest physiotherapy (CPT). The hypothesis is that CPT is not harmful to brain pressure.

The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.

1. The purpose of this study is to examine the effect of chest physiotherapy (CPT) on intracranial pressure (ICP). Because CPT is a normal part of the routine care provided to patients in the neurocritical care unit (NCU) this is an observational study of current practice.
2. The study will include only patients who currently have intracranial pressure monitoring devices in place (intraventricular and intraparenchymal). The study will last 1-hour and all subjects in the study will receive 10-minutes of CPT. The 10-minute CPT episode will be randomly assigned to occur 10, 20, 30 or 40-minutes into the study.
3. ANCOVA using SAS will be used to explore for within and between group differences in ICP. This study observes current standard practice, there are no additional risks to the subject.

Eligibility Criteria:
Inclusion Criteria:

* documented episode of elevated ICP ICP monitoring in situ neurological/neurosurgical diagnosis currently on a specialy bed

Exclusion Criteria:

* spinal cord injury such that CPT is not desired
Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy

Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy

Exclusion Criteria:

* the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum C-reactive protein;
* a history of previous ocular surgery;
* a history of prior treatment of any type for NAION;
* systemic condition such as diabetes mellitus and poorly controlled hypertension
Impact of a Probiotic-based Formula on Digestive Symptoms and Mood in Ultra Marathon Runners

Randomized, prospective, double-blind, placebo-controlled study in ultramarathon runners to evaluate the effects of suplementation with i3.1 probiotic formulation on the relief of common digestive symptoms associated to intense physical exercise. Secondary study outcomes aim to evaluate the effect of the probiotic formulation on fatigue, discomfort and muscle pain, as well as anxiety and mood.

Gastrointestinal symptoms (GIS) are a common feature of intense exercise, especially in ultra-endurance events. The main objective of this study is to evaluate the impact of a 3-strain probiotic formulation comprising Lactiplantibacillus plantarum and Pediococcus acidilactici on digestive symptoms in a maximum of 300 runners registered in an organized ultra-marathon event. A randomized, prospective, double-blind, placebo-controlled study will be conducted. Once recruited, participants will be allocated to recieve either the probiotic or placebo (at a ratio 2:1) for 4 weeks prior to race day. During follow-up, study participants will fulfill several questionnaires at specific time points (baseline, week -3, -2, -1, -24 h previous to the race, as well as 24 h and 7 days after the race). This will be documented through a specifically designed, web-based platform. Digestive symptoms will be evaluated through validated questionnaires: modified from Pfeiffer et al (2012; main outcome) and the Gastrointestinal Symptoms Rating Scale (GSRS). Secondary objectives will comprise anxiety, mood, other symptoms (muscle pain, fatigue, respiratory symptoms), and performance in the ultra-marathon.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Correctly registered in the Salomon Ultra Pirineu 100K® 2023 race
* Stable medication planned during the study period
* Willing to provide informed consent and follow study procedures
* Have signed the consent provided by the organization of the Salomon Ultra Pirineu 100K® 2023 race

Exclusion Criteria:

* Respiratory, gastrointestinal or systemic infection that has caused fever or fatigue in the 15 days prior to the study entry
* Having taken probiotic-based supplements or dairy products with probiotics (including "Actimel" or yogurts with "bifidus") daily in the 15 days prior to the study start
* Taking oral or parenteral antibiotics in the 15 days prior to the study start
* History of gastrointestinal surgery within 6 months prior to the study start
* History of cardiovascular event: angina, heart failure, myocardial infarction
* Diabetes mellitus type 1 or 2
* Pregnancy or lactation, or women planning to conceive during the study period
* Chronic gastrointestinal disease: inflammatory bowel disease (Crohn's disease, ulcerative colitis), pancreatitis, short bowel syndrome
* Gastrointestinal disease or disorders: inflammatory bowel disease (ulcerative colitis, Crohn's disease), irritable bowel syndrome, chronic diarrhea or constipation
* Diagnosis of severe kidney disease (chronic kidney failure) or liver disease (hepatitis, cholestasis, liver failure)
Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients

Lung cancer is the leading cause of death worldwide, with non-small-cell lung cancer (NSCLC) being the most common histotype according to the global cancer observatory 2022. A variety of therapeutic options for advanced/metastatic non-oncogene-addicted NSCLC have recently been approved based on their impact on patient outcomes in terms of survival and safety profile. Current guidelines advocate for personalized treatment options based on molecular and immunologic characteristics, which drives the physician's decision toward tailored oncology.

In the last two to three decades, hundreds of cancer biological prognostic markers for non-small cell lung cancer have been proposed. Although they have shown a potential in this ﬁeld, validation studies are still required and, to date, there is in suﬃcient evidence to recommend the routine clinical use of any of these putative biomarkers. Therefore, the discovery of robust prognostic and/or predictive biomarkers in patients with non-small cell lung cancer is imperative for advancing treatment strategies for the disease and improving patient care.


Eligibility Criteria:
Inclusion Criteria:

* NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
* Measurable disease.
* Age of 18 years to 80 years.

Exclusion Criteria:

* Non-small cell lung cancer patients who had undergone radiotherapy or chemotherapy.
* Pregnant and lactating females.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin.
* Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
Post-COVID-19 Chronic Fatigue Syndrome

Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2.

It has become increasingly clear that infected patients have symptoms not only in the acute phase, but also after recovery from the initial infection.

A recent meta-analysis including 4828 patients with post-COVID-19 showed that symptoms and post-acute sequelae of SARS-CoV-2 can persist weeks to months after the infection.

These patients who reported persistent symptoms have been termed "long haulers" or described as having long COVID, post-acute COVID-19, persistent COVID-19 symptoms, post COVID-19 manifestations, long-term COVID-19 effects, post-acute sequelae of COVID-19 (PASC), or post-COVID-19 syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age . 18
* Male or female
* Post-Covid-19 Fatigue

Exclusion Criteria:

* refusal
Study to Determine if Tetrix Cream is Removed From the Hands by Gentle Washing With Soap and Water

To determine if Tetrix Cream remains on the hands after gentle washing with soap and water


Eligibility Criteria:
Inclusion Criteria:

* Normal subjects
* Male and Female

Exclusion Criteria:

* Under the age of 18 years
ADX10059 Migraine Prevention Study

Evaluation of ADX10059 to prevent migraine attacks


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 to 65 years
* History of migraine
* Aged ≤ 50 years at onset of migraine history

Exclusion Criteria:

* Cluster headache or chronic migraine headaches
* Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors
* Unable to distinguish migraine headache from tension and other types of headache
* Current history of psychiatric disorder requiring regular medication
* Known history of alcohol abuse
* Known clinically significant allergy or known hypersensitivity to drugs
* History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
* Pregnant or breast-feeding
Breakfast for Young Women

Investigators will in a crossover study test the health effects of eating a dairy-based protein-rich breakfast, isocaloric carbohydrate-rich breakfast or no breakfast in young overweight women. Determination of satiety and hunger using visual analog scores (VAS), collection of blood samples and 2x 24 hours food logs will be collected.

This study is a single-blind randomized Cross-Over trial with 30 women aged 18-30 years, each completing three trials. Participants will consume either dairy-based protein-rich breakfast, isocaloric, fiber matched, fat matched, carbohydrate-rich breakfast or no breakfast in randomized order. Three hours later a standardized ad libitum lunch will be served.

Blood samples will be collected (pre, 10 min, 30 min, 60 min, 120 min, 175 min after breakfast) and VAS rating hunger, satiety and desire to eat will be determined (pre, during breakfast, 10, 30, 60, 90, 120, 180 min, during lunch, after lunch). Twenty-four hour food logs on the day before the test day and on the test day will be collected.

Participants will be characterized by determining height (cm), weight (kg), and body composition by a dual-energy X-ray (DXA) scan before the first test day.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 25
* Age 18-25 years
* Regular exercise \< 5 hour per week

Exclusion Criteria:

* illness and use of medication affecting the study outcomes
* allergy towards lactose or gluten
* weightloss/gain \>5kg the last 6 months
* dieting
* eating disorder
* pregnancy
* breast feeding
* unable to speak and understand danish
Does Myomectomy for Intramural Fibroid Improve ART Outcome?

Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results.

This study will include women who have intramural myoma ranging from 3-5 cm

The participants will be randomly allocated into two groups.

In group (1): myomectomy will be performed before ART

In group (2):women will have their trial of ART without myomectomy

In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:
* Women with intramural fibroid without any cavity involvement
* Age ˂ 35 years
* I onCSI or IVF cycles
* normal uterine cavity

Exclusion Criteria:

* Exclusion criteria:
* low ovarian reserve (AFC \< 7 and or AMH \< 1.1 ng/ml)
* Endometrioma
* Untreated hydrosalpinx
* Non obstructive azoospermia
* Any other cavitary lesions (Asherman syndrome, Mullerian anomalies)
* recurrent implantation failure
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps.

Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age 18 years or older)
* Polyp size of at least 20 mm
* - Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)

Exclusion Criteria:

* Polyps with previous failed resection attempts or polyp recurrence
* Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)
* Polyps with nodules too large (\>1-1.5cm) for the use of a cold snare
* Inflammatory bowel disease
DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder

Although borderline personality disorder (BPD) tend to the clinical remission in long-term follow-up studies, a significant subgroup of patients continues to present long lasting symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment. The prevalence of this subsample of individuals is considerably increasing last years. New interventions addressed to these individuals are need, the aim of this study is to evaluate the efficacy of a novel intervention combining dialectical behavioral therapy skills training with self-compassion and contextual-based skills for patients with long-lasting BPD.

Sixty individuals with BPD and long lasting symptoms that have been received previously dialectical-behavioral therapy skills training (DBT-ST) will be included in a randomized clinical trial. They will be randomly assigned to receive an add-on skills training intervention involving the combination of DBT-ST, self-compassion, and contextual-based skills for long lasting symptoms versus treatment as usual during 12-weeks. Patients will be evaluated pre and post intervention and 3-month follow-up. The outcome measures are well-being indicators and clinical variables.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 65 years of age
* Primary diagnosis of BPD according to Diagnostic Statistical Manual IV criteria and by the structured interviews: Diagnosis Structured clinical interview for axis II personality disorders (SCID II; First et al. 1997) and Diagnostic Interview for Borderlines Revised (DIB-R)
* Previous participation in DBT-ST intervention
* Signed informed consent.

Exclusion Criteria:

* Presence of life-threatening behaviors in the last 12 months
* PTSD or related symptoms
* Diagnosis of drug-induced psychosis, organic brain syndrome, bipolar or psychotic disorder
* Intellectual disability
* Participation in any other psychotherapy treatment during the study.
A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence

The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. Since aripiprazole has established effects against schizophrenia, the study focuses on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm of the study will give fewer cocaine positive urine specimens as compared to the perphenazine control arm.


Eligibility Criteria:
Inclusion Criteria:

1. Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder
2. Have a DSM-IV diagnosis of current cocaine dependence.
3. Are capable of reading, comprehending, and signing informed consent.
4. Agree to take Aripiprazole or Perphenazine as treatment for SCHZ and CD.
5. Agree to stop taking any other antipsychotic medication
6. If female and of child bearing potential (WOCBP) agree to use an acceptable form of birth control and have a negative pregnancy test within 2 days prior to starting study medication

Exclusion Criteria:

1. Under 18 years old or over 65 years old.
2. Refusal or inability to give informed consent,
3. Have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension (dehydration, hypovolemia),
4. A history of seizures or conditions that lower the seizure threshold
5. Have current suicidal ideation (history of suicide attempt in past 60 days)
6. Are actively psychotic which in the opinion of the investigator would preclude proper informed consenting or protocol adherence
7. Are receiving or plan to receive an agent metabolized by the Cytochrome P450-3A4 or -2D6 systems, including carbamazepine, ketoconazole, quinidine, fluoxetine, and paroxetine
8. WOCBP not on, or do not agree to use an acceptable form of contraception
9. Known sensitivity to aripiprazole or perphenazine
10. A diagnosis of current or past tardive dyskinesia
11. Pending legal charges or a court mandate for drug treatment
12. Currently taking concomitant medications that have been shown to reduce cocaine use, such as disulfiram
13. Clinically significant liver function abnormalities
14. Currently receiving depot neuroleptics
This is a Single Ascending Dose Tolerance Study

This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)

The Part A of this study is a parallel design followed in a second part by a cross-over design

Eligibility Criteria:
Inclusion Criteria

* BMI 18.0 to 28.0 kg/m2,
* systolic blood pressure 90-140 mmHg,
* diastolic blood pressure 50-90 mmHg,
* heart rate 50 100 beats/min (all inclusive),
* clinically normal safety ECG and laboratory results

Exclusion Criteria

* relevant disease,
* treated with SLV354 before
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis

Sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease), and cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line insomnia treatment for adults in the general population. Although cognitive behavioral interventions have historically been delivered in-person, a growing body of literature supports telephone- and internet-delivered approaches. However, more work is needed to understand the effects of internet-delivered CBT-I on patient-reported and objective outcomes.

This study is a pilot randomized controlled trial to test the preliminary effects of iSLEEPms, a CBT-I-based online intervention with telephone support for individuals with MS. After completing a baseline assessment (Week 1), 90 participants with MS will be randomized (1:1) to four weeks (Weeks 2-5) of iSLEEPms (intervention group) or treatment as usual (TAU; control group), and complete post-treatment (Week 6) and follow-up (Week 12) assessments. iSLEEPms participants will complete daily sleep diary forms and weekly online educational modules. TAU participants will continue usual care without access to the iSLEEPms materials.

The primary outcomes will be patient-reported and actigraphic measures of sleep quality and quantity. Secondary outcomes will be treatment satisfaction, adherence, and integrity (iSLEEPms group only). Exploratory outcomes will be fatigue symptoms, depression symptoms, and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older
* MS diagnosis56 of at least 1 year duration
* Able to speak and read English
* Sleep disturbance as indicated by an ISI score of at least 11
* Willingness to commit to a 4-week intervention and 12-week follow-up assessment

Exclusion Criteria:

* Neurological disorder other than MS
* Hazardous alcohol use, as indicated by the Alcohol Use Disorders Identification Test (AUDIT-C)
* Hazardous substance use, as indicated by the Drug Abuse Screening Test (DAST-10)