cyrilzakka/clinical-trials huggingface dataset:
Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant

The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.

The study is carried out to evaluate primarily the difference in the activity of the renal transporter ENaC (through dosage of sodium) through its inhibition with a single dose of Amiloride in hypertensive patients characterized by the polymorphism of alpha Adducin rs496. It's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration

Eligibility Criteria:
Inclusion Criteria:

* male patients aged 18-60 years;
* naïve hypertensive patients: newly diagnosed, never previously treated for hypertension;
* BMI\<30 Kg/m2,
* documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg or diastolic BP \>=90 mmHg;
* signature of the informed consent for participation in the study
* patient who has already undergone genomic DNA sampling (accompanied by relative consent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT).

Exclusion Criteria:

known causes of secondary hypertension;

* severe or malignant hypertension; history of renal artery disease;
* significant renal disease (creatinine clearance less than 60 ml/min);
* hyperkalemia (Kpl \> 6mEq/l) at enrollment visit;
* hypercalcaemia (Ca pl \> 2.6 mmol/l) at enrollment visit;
* symptomatic hyperuricemia (\> 7.5 mg/dl);
* liver disease (transaminases greater than 3 times the normal value);
* cardiac pathologies (myocardial infarction, atrial fibrillation, etc.);
* diabetes (fasting blood sugar \>125mg/dl);
* in therapy with statins, NSAIDs, systemic steroids;
* known hypersensitivity to Amiloride or to any of the excipients;
* patients unable to express a valid consent -
Drug Sensitivity and Mutation Profiling

This study is a prospective, non-randomized observational study. Freshly isolated tumor cells will be tested for chemosensitivity to the standard of care drugs as single agents and in combinations using state-of-the-art viability assay designed for ex-vivo high-throughput drug sensitivity testing (DST). In addition, the genetic profile of the tumor will be obtained from the medical records and correlated with drug response.

The excised tumors or a biopsy will be interrogated for sensitivity or resistance to FDA-approved and/or available investigational agents. In addition, normal samples (blood or buccal swab) will be collected for genetic analysis of germline mutations and cancer predisposition markers. The timeframe between the sample acquisition and ex vivo DST results return will be approximately 5-10 working days. All drugs tested in the DST assay will be assigned a hybrid score reflecting the tumor's sensitivity and drug toxicity.

This is an observational study and not a treatment protocol. It will assess how ex vivo drug testing and mutation profiling may predict clinical outcomes (response, survival, or relapse). The treating physician will decide which of the standard treatment options is appropriate independent of the DST results. The results of DST will not be available to the treating physician at the time of decision on the treatment regimen. DST will include all drugs from the standard treatment regimens available for all types of sarcomas

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years or younger at the time of enrollment on this study of any gender, race, or ethnicity.
* Subjects with suspected or confirmed diagnosis of all types of sarcomas.
* Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers).
* Subjects are willing to have a blood draw or buccal swab done for the purposes of genetic testing.
* Subjects or their parents or legal guardians willing to sign informed consent.
* Subjects aged 7 to 17 willing to sign assent.

Exclusion Criteria:

* Subjects who do not have malignant tissue available and accessible.
* The amount of excised malignant tissue is not sufficient for ex vivo drug testing and/or genetic profiling.
* Patients with other types of tumors and tumors that have a high (\>90%) cure rate with safe standard therapy.
Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography

The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molars

The patients will be selected according to the following criteria:

1. Patient with full permanent dentition.
2. Good oral hygiene.
3. None of the patients had received any orthodontic treatment.
4. Class II molar relationship.
5. Minimal or no crowding in the mandibular arch.
6. Non-extraction treatment plan with molar distalization.
7. Low angle cases.
8. No medical problems or active periodontal disease.

Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization.

The patients will be divided into two groups:

Group 1: Consisted of 10 patients, their upper molar will be distalized with bone suppored Fast Back (Fast Back Rapid Distalizer, leone, s.p.a, Italy).

Group 2: Consisted of 10 patients, their upper molar will be distalized with bone supported modified Leaf Spring Self-Activated Expander. (Leaf Self Expander, leone, s.p.a, Italy).

* Assessment of the 3D dentoskeletal treatment effects of the palatally bone supported Fast Back and palatally bone supported modified Leaf Spring Self-Activated Expander will be performed by using the CBCT scans.
* Pretreatment CBCT (T1) and post-distalization until study completion with an average of 1 year (T2) for each subject

All data will be collected, tabulated and statistically analyzed using the SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Patient with full permanent dentition.
* Good oral hygiene.
* Class II molar relationship.
* Non-extraction treatment plan with molar distalization.
* Low angle cases.
* medical problems or active periodontal disease.

Exclusion Criteria:

* The patients had received any orthodontic treatment.
* Crowding in the mandibular arch.
* Medical problems or active periodontal disease.
Auricular Acupuncture to Facilitate Outpatient Opioid Weaning

This study is to compare two groups undergoing opioid weaning as ordered by their referring physicians. One group will undergo the standard opioid weaning process and the other group will have the addition of the NADA Protocol to the weaning process.

The NADA (National Acupuncture Detoxification Association) Protocol is a standardized acupuncture technique in which five designated points in the ear are needled (+/-beads/seeds at points for home acupressure therapy in between treatments). The NADA Protocol is indicated for treatment of the following conditions: detoxification, withdrawal, emotional trauma, craving, stress syndromes, relapse prevention, rehabilitation \& recovery maintenance. It is also commonly used for PTSD and addiction; however it has not been studied as an adjunct to outpatient opioid weaning protocols for pain.

It is cited in the literature as yielding improvements in engagement, retention, decreased cravings, anxiety, and physical symptoms. Given these documented results, it seems feasible the outpatient opioid weaning patient would likely benefit from this procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older
* Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.

Exclusion Criteria:

* None
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture

a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.

this study aimed to compare the adhesion of microorganisms to the non metallic denture base of PEEK and metallic denture base of cobalt chromium alloy in patients with class III modification 1

Eligibility Criteria:
Inclusion Criteria:

* patients are medically free

Exclusion Criteria:

* patients with badly broken abutments
Post-operative Imaging in High Grade Glioma: is Management Influenced?

Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. The aim of this study is to determine whether neuroimaging performed at each component of the patient pathway after initial high grade glioma treatment, actually results in a real change in management (as opposed to a perceived change in management). The main emphasis is on all imaging used at the time of a MDM, however, we will also study specifically dynamic susceptibility contrast-enhanced (DSC) MRI and dynamic contrast enhanced (DCE) MRI.

The study is in the format of Mock MDMs to be compatible with real life decision making. Using retrospective identical information available at the MDM i.e. compiled recent correspondence, histopathological and molecular information, the MDM members (oncology nurse, oncologist, neurosurgeon, neuroradiologist, pathologist/molecular scientist) will prospectively determine the patient management with and without the imaging.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven HGG patients (Grade III and IV WHO criteria)
* Underwent surgery, radiotherapy and chemotherapy regimen according to 2018 NICE guidelines (1)
* \>=18 years old
* Has follow-up MRI imaging (T1, T2, FLAIR and T1 with contrast enhancement) and also DSC and DCE imaging
* Evaluated at MDT meetings between March 2018 and March 2020.

Exclusion Criteria:

* Patients who have insufficient clinical and radiological follow-up
A Pilot Research Project on Outcome of Trauma Informed Stabilization Treatment (TIST) for Adults with Complex Trauma Symptoms After Childhood Trauma, At the Department of Trauma Treatment, Modum Bad, Norway

The purpose of the study is to examine the effects of residential group and individual Trauma Informed Stabilization Treatment (TIST) for complex symptoms in adult survivors of childhood trauma in a naturalistic observational study.

Adult survivors of childhood trauma have complex and diverse symptom profiles. The aim of the study is to examine the effects of theTrauma Informed Stabilization Treatment (TIST) model, developed by dr Janina Fisher, in adult survivors of childhood trauma.

32 patients will be recruited from referrals to an residential open door trauma clinic in Norway, Modum Bad. Patients will be admitted for in-patient pre-planned treatment over 11 weeks - consisting of individual therapy and group therapy using different modalities, all within the TIST approach and framework. Patients will be summoned for 6 day follow-up 8 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years
* Complex symptom presentations connected to childhood trauma
* All patients will have undergone outpatient therapy with insufficient effect
* Most included patients will have a diagnosis of complex PTSD (diagnosed by M.I.N.I. and clinical evaluation)
* Patients may have diagnosis of unspecified dissociative disorder, personality disorders, depression and other comorbidity.

Exclusion criteria:

* Dissociative identitiy disorder
* Ongoing psychosis
* Ongoing drug addiction
* Very disturbed group function
* Ongoing life crisis
* Mental disability
* Acute suicidality
* Ongoing severe self harm
* Patients with complex dissociative disorders and patients eligible for exposure therapy will be referred to/prioritized for other treatment programmes.
Anthocyanin Dose-escalation Study in Healthy Young Adults

Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently, study of anthocyanin pigments has drawn more and more interest since several epidemiological studies have demonstrated their health-promoting properties, such as reducing lipid accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear need for advancing understanding with regard to effective amounts of intake for these phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of anthocyanin in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Blood test, liver function test, renal function test are normal;
* Blood lipids, cardiac function are normal;
* 18.5\<BMI\<23.9;
* Regular dietary, seldomly eating outside;
* Stable condition of body weight in recent 3 months

Exclusion Criteria:

* \> 140 grams of alcohol/week for male and \>70 grams of alcohol/week for female, smoking regularly;
* Known diagnosis of acute diseases or chronic diseases in recent 1 month;
* Be planning to be pregnant in a year, or being pregnant and lactation.
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.

This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.


Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
* MMSE score of ≥10 and ≤ 26;

Exclusion Criteria:

* Bradycardia (beats per minute less than 50)
* Body weight less than 40 kg;
* Hypersensitivity to cholinesterase inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply
Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.

Eligibility Criteria:
Inclusion Criteria:

* admitted for unilateral primary total knee arthroplasty.

Exclusion Criteria:

* ASA score \> 3
* BMI \> 40
* refusal of loco-regional technique.
* psychiatric disease.
* inability to understand/ use the Local anesthetic delivery pump.
* local anesthetic allergy,
* porphyry,
* uncontrolled epilepsy,
* severe cardiac arrhythmia.
Frailty Prevention in Elders From Reunion Island

In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty.

The study evaluates tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.

The 5P research program is a 6-years program that started in 2016.

Its objective is to set up tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.

The diversity and transversal nature of the research disciplines in this program make it original. This allows it, through common protocols, to explore the concept of frailty and the care pathway of the elderly through different prisms of complementary observations.

This program is deployed in three stages: proof of principle, proof of concept (called 5P-PILOT) and "the Scaling up" (called 5P-ECHELLE). It combines an evaluation of the acceptability of technological detection tools, a measurement of the impact of prevention workshops on the loss of autonomy among independent frail elderly people and an evaluation of tools to help detect frailty.

The ageing of the population poses a real societal challenge. The loss of autonomy, which is the result of multiple individual or environmental factors for the ageing person, has a costly impact in terms of recourse to care and on the people around them. It is therefore urgent to act on the levers of frailty by acting as early as possible to prevent its irreversibility.

The "5P ECHELLE" project aims to develop a semi-automatic and non-medical method for detecting weak signals of frailty in older people, by combining standardized clinical indicators for assessing their state of robustness with large-scale intelligent detection devices that allow for longitudinal monitoring, while integrating the necessary participatory dimension of the subject.

Eligibility Criteria:
Inclusion Criteria:

* Persons over 65 years of age
* Retired persons
* Person affiliated to or benefiting from a social security scheme.
* Free and informed consent given

Exclusion Criteria:

* Persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons), pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure
* Difficulty in understanding the French language
Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer

To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR.

The study is aimed to assess the postoperative acute complication and the short-term acute efficacy on the patients with middle and low rectal cancer by treated with intraoperative radiotherapy,especially those with peritoneal inversion rectal cancer.

Abstract objective: To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR）.

Methods: Patients, who were diagnosed with ultra-low rectal cancer and had strong desire of preserving anal function, will take part in the research,whose tumor invading the levator ani muscle or above, the diameter less than 6cm, the lower tumor margin away from the anal verge by less than 5cm and away from the dentate line by less than 3cm.They will undergo total mesorectal excision(TME) and ISR combined with IORT and prophylactic ileostomy.

Outcomes Measures:The evaluation of short term effects includes complications such as anastomotic leakage, acute radiation injury ,urinary dysfunction ,dysfunction of anal sphincter ,sexual dysfunction ,local recurrence , total life expectancy and expectancy without metastasis. The postoperative pathological examination reported to be moderately differentiated adenocarcinoma .We wili assess their postoperative acute complications and short-term efficacy .Their time of follow up visit wil be 1 year or more.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Aged 40 to 80 years old, gender not limited.
* Be diagnosed as colorectal cancer by coloscopy.
* Patients with middle and low rectal cancer,whose preoperative staging evaluation is T3 ,T4 or N+.
* Accept surgery and intraoperative radiotherapy.
* Signed informed consent

Exclusion Criteria:

* the patients whose preoperative evaluation is below T3 stage with middle and rectal cancer.
* Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
* Severe liver and kidney dysfunction
* Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
* Thrombolysis treatment in one week
* Allergies of thrombolysis drug or contrast
* Participated in any clinical trials within three months
Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey

to report our patients' outcomes of SNM in tertiary health centres in Turkey

We retrospectively analyzed 18 patients who underwent SNM for urinary or bowel dysfunction between 2017 and 2022 in our clinic. We excluded 2 patients due to non-effective responses after the test period. After local ethics committee approval was obtained from our institute (Number and date: 21-12.1T/14). Patient characteristics and demographic data including age, gender, indications to the SNM, age at diagnosis, and comorbidities were collected from our Hospital patients' record system. Urinary functions were evaluated by the ICIQ-SF questionnaire form. Patients' diagnosis, implantation duration, complications, and improvement of symptoms were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with urinary incontinence
* Patients diagnosed with faecal incontinence
* Patients diagnosed with interstitial cystitis

Exclusion Criteria:

* Presence of urinary infection
* Presence of previous incontinence surgery
* Presence of 2nd motor neurone disease
* Inability of detrusor muscle contraction activity
* Previous radical cystoprostatectomy history
* Presence of bladder outlet obstruction
A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\])

This is a Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with atumelnant (also known as CRN04894) (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) over a 10-day or 14-day treatment period in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\]). Participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female, aged 18 years or more
2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome
3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1
4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria

Exclusion Criteria:

1. Women who are pregnant or lactating
2. History of bilateral adrenalectomy
3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm
4. Presence of any known malignancy
5. Use of mitotane
6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks