cyrilzakka/clinical-trials huggingface dataset:
Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia

Engage-Ataxia will implement a physical activity coaching program for people with cerebellar ataxia at Teachers College, Columbia University. This program expands upon the current Engage program for people with Parkinson's disease (Engage-PD), an exercise coaching program for people with early stage Parkinson's disease to target individuals with early stage cerebellar ataxia. Engage-Ataxia will utilize a physical or occupational therapist to provide up to five one-on-one coaching sessions for individuals newly diagnosed with cerebellar ataxia. Therapists will work with participants to provide individualized structured support to facilitate and optimize exercise uptake as one part of comprehensive disease management. Participants will undertake two assessments three months apart, and will receive coaching interventions via Zoom healthcare platform. The primary objective of this program is to increase physical activity and exercise engagement in individuals with early stage cerebellar ataxia. This feasibility study will provide preliminary data and insight into the benefits of a remote coaching intervention for people with cerebellar ataxia.


Eligibility Criteria:
Inclusion Criteria:

* Neurologist confirmed diagnosis of cerebellar ataxia
* Scale for Ataxia Rating and Assessment (SARA) score between 8-25 (total score of 40), which will capture mild to moderate stage of the disease
* Ambulatory for indoor and outdoor mobility without assistance or assistive device
* Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) or medical clearance from primary doctor
* Medical clearance to exercise

Exclusion Criteria:

* Musculoskeletal injury that would prevent participation in an exercise program
* Other neurological disease or disorder such as stroke
* Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
* Metabolic conditions that would affect participants during an exercise program
* Currently do moderate-vigorous exercise 5 days a week or more
Bioavailability of Omega-3 Food Supplements in Healthy Subjects

The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods. The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period. On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing. Twenty-four subjects will be enrolled to complete dosing of 20 subjects.


Eligibility Criteria:
Inclusion Criteria:

* males or females
* any ethnic origin
* age 40 - 65 years
* BMI 18.5 - 30.0 kg/m2
* generally in good health
* signed informed consent

Exclusion Criteria:

* males or females not willing to use appropriate contraception
* prescribed systemic or topical medication taken within 14 days
* taken supplements containing omega-3 faty acids or fish oil last 14 days or any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
* taken any medication including St. John's Worth known to alter drug absorption within 30 days
* subjects participating in a clinical study past 3 months
* recent blood donation
* significant history of drug allergy or any allergic disease
* allergy or hypersensitivity to omega-3 fatty acids, fish, soya, oleic acid, sesame oil or other constituents of pharmaceutical preparation.
* high consumption of tobacco
* high consumption of alcohol
* other significant medical history or physical findings (including HIV,hepatitis)
* vegetarians
* not willing to follow dietary restrictions
* frequent migraine attacks
* previously taken part in or withdrawn from study or according to investigator should not participate.
Study of Erythropoietin (EPO) Administration Schedule

The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 80.
* Dialysis for at least 3 months.
* Epoetin treatment for the last 3 months.
* Baseline hemoglobin (Hb) value of \>= 9.0 g/dL and \< 13.0 g/dL.
* Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU
* Patients who agree to participate in this study in writing.

Exclusion Criteria:

* Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types.
* Hemolysis as defined
* Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months.
* Patients with uncontrolled hypertension.
* Acute infection of unstable systemic inflammatory disease.
* Current malignant disease.
* High likelihood of early withdrawal or interruption of the study (e.g. severe diseases within the last 3 months, such as myocardial infarction, unstable angina, stroke, deep venous thrombosis).
* Life expectancy below 12 months.
* Planned elective surgery during the study period.
* Blood transfusions within the last 3 months.
* Pregnancy and lactation.
* Other conditions regarded as unsuitability by investigator.
Staged Bilateral Percutaneous Nephrolithotomy

To determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared.

The aim of the study is to determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. In our study, patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared. With the guidance of preoperative and postoperative data, it is aimed to determine the optimal time with the lowest complication and highest operational success.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stones of 2 cm or more in each kidney

Exclusion Criteria:

* Renal Failure
* Coagulopathy
* Pregnancy
Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon

The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.

Fedovapagon is a vasopressin V2 receptor agonist in development for the treatment of nocturia. Agonism of the V2 receptor, located in the collecting ducts of the kidney, leads to translocation of aquaporin channels and increased re absorption of water and anti-diuresis.

A number of drugs that are commonly co-prescribed in the population who may present for treatment of nocturia are inhibitors of CYP3A4, including diltiazem, verapamil, erythromycin and clarithromycin and may therefore impact the plasma levels of fedovapagon if co administered.

Conversely, concomitant intake of drugs that are potent CYP3A4 inducers may lead to lower than anticipated plasma concentrations of fedovapagon thus reducing the efficacy of fedovapagon. It is therefore important to assess the effect of CYP3A4 induction on the pharmacokinetic (PK) parameters of fedovapagon.

The study design uses itraconazole as a potent inhibitor of CYP3A4 and, in a separate cohort of subjects, rifampicin as a potent CYP3A4 inducer at doses intended to maximize the potential to demonstrate an interaction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 18 to 45
* Have a body mass index between 18 and 29.9 kg/m2 (weight: ≥50 kg and ≤100 kg)
* No clinically significant medical history
* Ability to comply with the requirements of the study
* Provide written informed consent
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be below or equal to upper level of normal (ULN). Otherwise liver enzymes should show no clinical significant abnormalities. Total bilirubin should not exceed 1.5 x ULN. Liver enzymes will be re-tested only once before randomization if required.
* Be judged by the Investigator to be in good health based on medical history (in particular, no congestive heart failure, ischemic heart disease, valvular heart disease, significant pulmonary disease, renal failure, edematous disorder, liver disease, gastric disorders, porphyria, diabetes mellitus or hereditary disorders of carbohydrate metabolism), physical examination, vital sign measurements and laboratory safety tests
* Agree to refrain from the consumption of grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) and charbroiled meats containing products beginning 1 week prior to administration of the initial administration of trial drug, throughout the trial
* Use of any prescribed medication or St John's Wort within 14 days (or 5 half-lives if this is longer) or over-the-counter medication (except paracetamol) within 1 week of dosing. Specific medication not to be taken within 2 weeks of (before or after) administration of itraconazole is described in the Summary of Product Characteristic for Sempera®
Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy

The purpose of this study is to assess the feasibility of performing prophylactic McCall culdoplasty at the time of total laparoscopic hysterectomy. The investigators will also be measuring pelvic support (using POP-Q) and sexual function before and at different time points (up to 12 months) postoperatively.

The investigators hypothesize that women undergoing the McCall culdoplasty will not have different immediate surgical outcomes (operative time, etc) and may have better pelvic support and sexual function in the future.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-99 undergoing elective laparoscopic hysterectomy for benign indications with surgeons in the division of Advanced Laparoscopy and Pelvic Pain at UNC-Chapel Hill.

Exclusion Criteria:

* Current symptomatic or asymptomatic pelvic organ prolapse as measured by the Pelvic Organ Prolapse Quantification (POPQ) system.
* Pregnancy
* Non-English speaking
* Unable to provide informed consent
* Pathology causing an obliterated cul-de-sac
Evaluation of Medicines Use Review in Slovenia

Medicines Use Review service (PUZ) has been officially introduced in Slovenian pharmacy practice in 2015 and has been offered to pharmacy customers by pharmacist, certified to provide the service. Patients can to talk to a pharmacist and discuss their medicines, how they use it and any issues or question they might have. We designed a study to evaluate how Medicines Use Review (PUZ) work and how it is reaching the set objectives. The objectives of the PUZ service are to address actual patient medicines use and consequently improve medication adherence, identify and solve drug related problems and enhance medication knowledge. Pharmacists, who are certified to provide the service, recognized the patients, who might need the service and invited them to participate in the study. The study consisted of two visits in 12 weeks' time period. Patients, who decided to participate, were randomly allocated in two groups - intervention and control. Both groups were interviewed and fulfilled questionnaires at visit 1 (V1). Afterwards the test group patients received PUZ. After 12 weeks both groups attended the visit 2 (V2), where they were re-interviewed and fulfilled questionnaires again. After the study completion also the patients from control group received PUZ due to ethical reasons.


Eligibility Criteria:
Inclusion Criteria:

* at least one prescription medicine for a chronic condition for at least six months
* deemed to be suitable for MUR by a pharmacist, certified to provide the MUR service;
* ability to communicate in Slovenian; The inclusion of patients was performed in accordance with the SOP MUR, to reflect how patients are generally offered MUR service in Slovenia.

Exclusion Criteria:

* urgent need of MUR (the service delay due to randomization would risk their health);
* referred for MUR by a healthcare professional (general practitioner, nurse, etc.);
* the patient's carer, rather than the patient themselves, was able to attend the interviews and receive MUR;
* previously received MUR or an advanced medication review;
* difficulties understanding, communicating or other issues (vision, hearing) that might affect study outcomes.
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

This phase I trial investigates the safety of testosterone replacement therapy around the time of major urologic surgery (perioperative) in order to improve quality of life and post-operative outcomes such as decreased length of hospital stay, complications, and mortality in patients with low testosterone levels. Studies have demonstrated that patients undergoing testosterone replacement therapy have increased lean body mass, decreased fat mass and have improved physical function. Testosterone replacement therapy can also stimulate bone formation and may decrease the risk of fracture. Information from this trial may be used to support the incorporation of testosterone level testing and testosterone replacement into the perioperative treatment decision-making process.

PRIMARY OBJECTIVE:

I. To examine the safety and feasibility of perioperative testosterone replacement (TR) therapy in hypogonadal male patients undergoing major operations.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients with low testosterone levels receive testosterone cypionate intramuscularly (IM) once a week (QW) for 3 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients with normal testosterone levels receive standard peri-operative care.

Eligibility Criteria:
Inclusion Criteria:

* Patients already scheduled for major surgery requiring an overnight hospital stay
* Patients must be able to give informed consent
* Patients must be willing to do study's preoperative and post-operative assessment tools

Exclusion Criteria:

* Patient with history of prostatectomy with detectable prostate specific antigen (PSA)
* Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA
* Patients with history of/undergoing orchiectomy
* Patients undergoing hormone replacement therapy currently or history of testosterone use within last year
* Patients who use anabolic steroids
* Patients with history of solitary or undescended testis
* Patients with history of pituitary disorders
* Patients with history of thromboembolic events in last year
* Patients with hematocrit \> 55%
* Patients with uncontrolled congestive heart failure
* Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners
Ketamine Assisted Psychotherapy for Opioid Use Disorder

This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.

The purpose of this study is to conduct a Stage 1 randomized controlled trial to test a potential optimization of the evidence-based Mindfulness-Oriented Recovery Enhancement (MORE) intervention for opioid use disorder (OUD). Here we will add Ketamine to MORE (MORE+KAP) and test the MORE+KAP intervention versus the standard MORE intervention in a sample of patients receiving medications for OUD (MOUD; e.g, buprenorphine). The primary aim to is evaluate the extent to which MORE+KAP improves OUD treatment relative to MORE. The secondary aim is to identify the psychobiological mediators of MORE+KAP.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Opioid Use Disorder
2. Receiving OUD treatment with a buprenorphine formulation

Exclusion Criteria:

1. Previous experience with a mindfulness-based intervention program
2. Pregnancy
3. Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
4. Prior use of ketamine other than as prescribed by a physician
5. Any of the following medical conditions

Blood Vessel Disease Heart Valve Disease Heart Failure Class 2 or Above Heart Disease Pregnancy/Breastfeeding Arteriovenous Malformation History of Intracranial Bleeding or Stroke History of Seizures Hypoxia defined by current need for supplemental oxygen Liver Disease History of allergic reaction to Ketamine Dementia (moderate-severe) History of Psychotic Disorder, Bipolar Disorder, or Personality Disorder Dissociative Identity Disorder
Once-Daily Oral Dose of BeneFlax to Healthy Older Adults

The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. Flax lignan is separated from the whole flax seed as this compound is believed to have health effects. Decreasing oxidative stress and inflammation should improve a number of the problems associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an equivalent amount of whey protein.

The investigators are comparing lignan to a placebo (whey powder) to examine whether a dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult 60 to 80 years residing in Saskatoon.
* Able to comply with study protocol.
* Able to follow simple instructions.

Exclusion Criteria:

* Age below 60 or above 80 years at initiation of the study.
* Individuals living in long term care homes.
* Individuals at risk of hypotension or with symptomatic hypotension.
* Fasting hypoglycemia.
* Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study).
* Current cancer or diagnosed with cancer in the past 2 years.
* Women with an immediate family history or personal history of breast cancer or ovarian cancer.
* Significant liver or other gastrointestinal disorder including inflammatory bowel disease. (While constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication)
* Significant kidney disorder.
* Unstable or severe cardiac disease, recent myocardial infarction or stroke (either in past 6 months or significantly affecting physical mobility).
* Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
* Migraine with aura within the last year (as this is a risk factor for stroke).
* Current diagnosis of a bleeding condition, or at risk of bleeding.
* Significant immunocompromise.
* Other unstable conditions.
* Current use of hormone replacement therapy (except thyroid medication is allowed).
* Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
* Intolerances or allergies to flax or vitamin D.
* Allergy to whey
* Surgery within the last six months.
* Participation in any other clinical trial with an investigational agent within one month prior to randomization.
Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases

In the literature, temporomandibular joint diseases on the diagnostic value of the use of ultrasonography in diagnosis studies are lacking. In this study in the diagnosis of temporomandibular joint diseases revealing the reliability of the use of ultrasonography. It is aimed to contribute to the literature in terms of.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who apply with TMJ problems
* Patients with pain in the joint and chewing muscle area

Exclusion Criteria:

* Syndromic patients
* Patients under the age of 18
* Patients with a history of orthognathic surgery
* Pregnants
* Antidepressant Users
* Patients Using Removable Dentures
* Patients who have had joint treatment in the past six months
Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response

In the literature, the risk of moderate to severe OHSS is 3 to 6% and reaches 31% in high risk populations 9 days after oocyte triggering with hCG. Many studies report no or a markedly decreased risk of OHSS after triggering ovulation with a GnRH agonist. However, criteria to define OHSS are rarely explained and OHSS itself is not thoroughly asserted. It is well known that OHSS is associated with hypercoagulability. However, no study after triggering with a GnRH agonist assessed haemostasis in these high-risk patients with high circulating estradiol levels.

Study design, size, duration: In a French academic reproductive medicine centre, a systematic prospective observational follow-up of all patients triggered by GnRH agonist for excessive follicular response will be conducted. Participants/materials, setting, methods: All patients undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering) will be triggered by GnRH agonist. No luteal phase support and a "freeze-all" strategy will be performed. On the day of oocyte retrieval (T0), at 48h (T1) and at day 7 (T2), OHSS and hypercoagulability will be systematically assessed. Haemostasis data will be compared to the initial status of each patient.

Seventy-five patients will be required for this study.

Eligibility Criteria:
Inclusion Criteria:

* estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol

Exclusion Criteria:

* agonist protocol no health assurance estradiol level \< 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering
Finding the Latent Treponema Pallidum

Some syphilitic patients remain in a serologically positive state after the recommended therapy. Whether a serofast state could represent a persistent low-level infection by Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies after treatment represent persistence of Treponema pallidum was raised by some investigators. The investigators use the Next-Generation Sequencing to test blood plasma, srum, cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast patient and other positive and negative controls.

Some syphilitic patients remain in a serologically positive state after the recommended therapy. Whether a serofast state could represent a persistent low-level infection by Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies after treatment represent persistence of Treponema pallidum was raised by some investigators. The investigators use the Next-Generation Sequencing to test blood plasma, serum, cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast patient and other positive and negative controls.

Eligibility Criteria:
Inclusion Criteria:

* All clinical diagnosis of syphilis cases

Exclusion Criteria:

* Auto-immune disease (such as SLE)
* Lyme disease