cyrilzakka/clinical-trials huggingface dataset:
Proof of Concept to Assess the Feasibility of a Decentralised Pathway Coordinated by the Advanced Practice Nurse for Patients Receiving Oral Treatment for Cancer or Malignant Haemopathy (ACCELER PLATFORM)

This is an open-label, single-centre, category 2 "Jardé Law" proof-of-concept study designed to demonstrate the feasibility of a decentralised care pathway for patients with cancer or haematological malignancies receiving oral treatment.

The study will be conducted on a population of 33 patients.

In current practice, patients with certain solid cancers or haematological malignancies may be prescribed oral chemotherapy on a retroceded basis. In these cases, the oncologist (coordinating investigator) sees the patient for a consultation every 3 cycles to prescribe/renew the treatment for approximately 3 months. Every month, the patient returns to the centre to have the treatment dispensed by the hospital pharmacy. No medical consultation is associated with this visit.

In this study, it is proposed to decentralise the delivery of treatment to these patients by introducing two visits to the patient's home by a service-providing nurse.

The decentralised patient pathway will be organised and monitored by the Advanced Practice Nurse (APN) at the investigating centre, who will be responsible in particular for coordination with the service-providing nurse and the hospital pharmacy.


Eligibility Criteria:
Inclusion Criteria:

1. Patient over 18.
2. A patient with solid cancer or haematological malignancy receiving oral retroceded therapy as part of standard management.
3. Patient with a performance index (ECOG): 0-2.
4. Patient contactable by telephone for follow-up by the Advanced Practice Nurse.
5. Patient willing to make two home visits within 6 months of inclusion.

Exclusion Criteria:

1. Pregnant or breast-feeding patient.
2. Any psychological, family, geographical or social condition which, in the judgement of the oncologist, could potentially prevent the collection of informed consent or hinder compliance with the study protocol.
3. Patients deprived of their liberty by administrative or legal decision, or patients under guardianship.
WHISH-2-Prevent Heart Failure

The WHISH-2-Prevent Heart Failure (HF) study is an ancillary study to the Women's Health Initiative Strong and Healthy (WHISH) exercise pragmatic trial. The WHISH-2-Prevent HF trial examines the intervention effect of physical activity (PA) on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF. The focus of the parent WHISH trial is on atherosclerotic cardiovascular disease and not heart failure.

A recently funded large pragmatic PA trial, Women's Health Initiative Strong and Healthy (WHISH) trial based upon two decades of PA intervention experience using enhanced communication and behavioral techniques, has randomized 49,936 elderly women (average age 79) and will evaluate its intervention effect on the risk of atherosclerotic CVD. This translational intervention is aimed at reducing sedentary time and achieving or maintaining aerobic and strength enhancing PA levels currently recommended for cardiovascular benefit. The WHISH-2-Prevent HF, represents the first and largest primary prevention exercise trial ever performed focusing on HF and will examine the intervention effect of PA , on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF.

Aim 1: Test whether older women who are initially free of HF and randomized to a translational PA intervention will reduce the rate of incident HF compared to those not randomized to the translational PA intervention.

H1: Women free of HF randomized to the PA intervention will have reduced rates of incident HF compared to those not randomized.

Aim 2: Test whether older women with and without HF at baseline randomized to a translational PA intervention will reduce the HF burden (number of acute HF hospitalizations and CVD death in those with antecedent HF) compared to those not randomized to the translational PA intervention. H2: Women randomized to the PA intervention will have reduced HF Burden compared to those not randomized

Exploratory Aim 3: Analyze the type, intensity and frequency of physical activity including skeletal muscle strengthening associated with a reduced risk of HF and HF burden in elderly women. H3: Women who have low levels of sedentary behavior by either increasing or maintaining light intensity or moderate intensity physical activity will have reduced rates of HF compared to women who remain sedentary. Those that add skeletal muscle strengthening will have additional benefits.

Eligibility Criteria:
Inclusion Criteria:

* alive, community dwelling,

Exclusion Criteria:

* Dementia, need walking aide, reside in nursing home
Multivitamin Intervention and Cognitive Function

The purpose of this trial is to learn how a multivitamin combined blueberry polyphenol supplement (Vitals+) influences cognitive function in healthy adults. A secondary aim is to see how the biochemical level of nutritional factors change with the supplement.

This study will be completed fully remote (from the participants home without in-person visits). Participants will be asked to compete three steps over the course of 3 months:

Step 1:

Participants will be asked to complete an online cognitive function game (45 minutes)

Step 2:

Participants will receive a fingertip blood sample kit in the post to measure nutritional markers in the body (requiring 8 drops of blood). They will then be asked to complete the same online cognitive function game and answer some questions about their general health (50 minutes). After this, participants will be requested to start their multivitamin (Vitals+) subscription, once a day for 3 months.

Step 3:

This final step is the same as step 2. After 3 months participants will receive another fingertip blood sample kit in the post (requiring 8 drops of blood) and asked to complete the cognitive function games again (50 minutes). This will mark the end of the study.

How these measurements responded to the multivitamin supplement will then be measured.

This study will investigate the influence of a 3 month multivitamin combined blueberry polyphenol supplement (Vitals+) on cognitive function, as measured by a validated online cognitive function test. The secondary outcome of this study is to evaluate nutritional biomarker response to the intervention. Specifically, elevated homocysteine concentrations have been reported as a risk factor for cognitive impairment and Dementia. Significant improvements in biomarker status of B-vitamins involved in homocysteine metabolism were found following intervention with this supplement (Vitals+). Therefore, it is hypothesised that the intervention will lead to reductions in homocysteine levels.

Furthermore, Vitamin D is a nutrient of concern, with deficient or suboptimal biomarker status reported across many European populations (particularly in winter months). Whilst vitamin D intervention has been shown to improve cognitive function in healthy adults. Therefore, a secondary hypothesis is that the supplement will lead to increased Vitamin D biomarker status.

It is hypothesised that any observed changes in cognitive function will be associated with changes in the biomarker response of homocysteine and Vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Men and Women age \>18 years
* Newly subscribed to the nutritional supplement
* Access to a PC or laptop with internet connection

Exclusion Criteria:

* Unable to give informed consent
* Consumed a nutritional supplement in past 3 months
* Consuming \> 4 portions of B-vitamin fortified foods a week
* Pregnant or breastfeeding
* Diagnosis of a neurological condition, such as Dementia, depression or anxiety
* Prescribed vitamin B12 injections
Comparing Diabetes Prevention Programs

The purpose of this study is to compare the effectiveness and costs of two programs,the Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in an primary care practice.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* diagnosed with pre-diabetes

Exclusion Criteria:

* diagnosed with diabetes
* pregnant or nursing
* unable to walk 2-3 blocks in 10 minutes
* unable to read and speak English
Fat Perception in Humans (09-0873)

There are many substances naturally present in the mouth that may help us taste fat in food. Two of these substances (lipases and CD36) will be examined in this study.

The presence of fat in food increases food tastiness, therefore people often over-eat high-fat foods and gain weight. The purpose of this study is to determine if blocking lipases and some genetic variations in the CD36 gene will make fatty food less tasty so that people eat less. Our hypothesis is that Orlistat and a particular gene will increase one's ability to detect fat.

1. Determine the effect of lipolysis inhibition in oral cavity on orosensory detection of fat in humans.

   Hypothesis: Orally applied Orlistat will increase detection thresholds of TAGs but not FFA in humans.

   To test this hypothesis we will measure triolein (a TAG) and oleic acid (a FFA) taste detection thresholds with a three-alternative forced-choice (3-AFC) ascending concentration method under two conditions (Orlistat day vs. Control day). To control for olfactory input, subjects will be assessed wearing noseclips.
2. Determine the effect of CD36 variants on fat taste perception in humans. Hypothesis: SNPs that associate with reduced CD36 expression will be associated with higher FFA and TAG detection thresholds

To test this hypothesis we will measure triolein and oleic acid taste detection thresholds in subjects who carry of the common CD36 e-SNP rs1761667 (i.e. a SNP that significantly reduces CD36 level and has a minor allele frequency of 38-48%). We expect subjects who are at least heterozygous for the expression reducing allele to have higher triolein and oleic acid taste detection thresholds compared to non-carrier subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index greater than 30 kg/m²

Exclusion Criteria:

* smokers or who quit smoking less than six months ago
* pregnancy
* breastfeeding
* diabetes
* taking medications that might affect taste perception
* previous malabsorptive or restrictive intestinal surgery
Prostate Stimulation for Sexual Dysfunction

The purpose of this study is to use a device to stimulate the prostate with a goal of helping improve symptoms in men with sexual dysfunction.

The purpose of the study is to use a device to stimulate the prostate. The goal of this is to help men with sexual dysfunction. Sexual dysfunction can include conditions like delayed ejaculation (e.g.takes more than 21 minutes to climax) and can hopefully assist them in achieving faster time to ejaculation (e.g. closer to the median of 5.4 minutes in a "normal" individual) along with erectile dysfunction (e.g. the inability to achieve and sustain an erection).

Eligibility Criteria:
Inclusion Criteria:

* Males \>18 years of age suffering from sexual dysfunction

Exclusion Criteria:

* Individuals who have had a prostatectomy - removal of prostate
* Inability to operate the device for any reason
* Females
* Males \<18 years of age
Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique

The purpose of this study is to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine only in anterior QLblock(transincisional) , where the local anesthetic will be applied before wound closure at the end of surgery through the wound . in combination with general anesthesia in elective open renal surgery with regard to Postoperative pain control,hemodynamic stability, and adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* physical status American Society of Anesthesiologist (ASA) I or II

Exclusion Criteria:

* Patients refusal
* A body mass index (BMI) \>30 kg/m2
* ASA physical status \>II
* major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
* Coagulation abnormalities
* Infection at the injection site
* Allergy or contraindications to the drugs used in the study
* History of drug addiction or alcohol abuse
* A psychiatric illness, or mental retardation interfering with the evaluation of pain scores or PCA programs .
Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture

Patients diagnosed traumatic rib fracture and need admission will be included. Patients will be divided two groups.The experimental group will be given parecoxib after visiting emergency department. The control group will be given Narcotic agent such as morphine for pain control. The outcome such as numerical rating scale (NRS) and hospital length of stay will be recorded.

3.1 Inclusion/exclusion criteria Patients who are diagnosed ribs fracture and need admission. Exclusion criteria included heart failure, Coronary artery disease (CAD) history. Traumatic cardiac injury and cardiac tamponade will be excluded, too.

3.2 Group design Patients will be divided two groups, and the experimental group will be given parecoxib after visiting emergency department. And they will be kept given after admission by intravenous method every 12 hours for 4 days. The control group will be given Narcotic agent such as morphine for pain control. The daily dose will be recorded. Finally the end outcome will be recorded.

3.3 Data collection The data of patient's medical history and laboratory results will be recorded on pre-designed case report forms (CRFs) by study nurses. In all patients, age, gender, diagnosis, co-morbidities, length of hospital and intensive care unit (ICU) stay, Injury Severity Score (ISS) score, numerical rating scale (NRS) and outcomes, will be recorded. In addition, all microorganisms isolated and antibiotic substances applied will be documented.

Eligibility Criteria:
Inclusion Criteria:

1. Investigators will prospective enroll patients who are diagnosed chest trauma with rib fractures
2. Age ≧18 y/o

Exclusion Criteria:

1. Patients who have history of heart failure, CAD history.
2. Traumatic cardiac injury and cardiac tamponade
3. History of allergy effect for Cyclooxygenase 2 (COX2) inhibitor or NSAID
Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®)

This is a multicentre ambispective cohort study involving French patients who have started or are receiving for less than 6 months a treatment with ponatinib. This study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with CML patients' therapeutic history.


Eligibility Criteria:
Inclusion Criteria:

* Presenting a CML in any phase.
* Having initiated for less than six months a treatment with ponatinib.
* The ability to understand the requirements of the study and to comply with the study data collection procedures.

Exclusion Criteria:

* Patients previously treated with investigational ponatinib (within a clinical trial).
* Patients receiving an investigational agent.
* Patients who are pregnant and/or breastfeeding.
* Patients with contraindications for Ponatinib according to Summary of Products Characteristics.
Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD

The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) during exercise may be a useful physiological measure of alveolar-capillary reserve in patients with Chronic obstructive pulmonary disease (COPD). The present study investigated the test-retest reliability of DLCO/NO-based metrics.

The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. These changes are thought to involve acute changes in pulmonary perfusion and are notably relevant for patients with chronic obstructive pulmonary disease (COPD), in which they may be related to exertional dyspnoea. The aim of the present study is to investigate the effects of acute exercise on pulmonary diffusing capacity, and to determine the day-to-day repeatability of such assessments.

Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease (GOLD II + III)

Exclusion Criteria:

* Known heart disease
* Pregnancy
* Disease within two weeks prior to inclusion
Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain.

This study investigates genicular artery embolization (GAE) as a minimally invasive alternative to ntra-articular corticosteroid injections (IA) or treating knee osteoarthritis (OA) pain. Designed as a randomized controlled tria, the study compares pain relief effectiveness and safety between GAE and IA over a 12-month follow-up. Eligible participants are aged over 40 with symptomatic knee OA resistant to conservative treatment. Primary outcomes focus on pain reduction (NRS score), while secondary measures include function, quality of life, imaging findings, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years
2. Symptomatic knee pain, with numeric rating scale (NRS) ≥ 4.
3. Insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment.
4. Weight bearing X ray of knee: osteoarthritis of Kellgren-Lawrence grade 1, 2, or 3.

Exclusion Criteria:

1. History of trauma in recent 6 months.
2. Bleeding tendency.
3. Poor renal function (serum creatinine \> 2.0 mg/dL).
4. Pregnancy or breast-feeding.
5. Severe peripheral arterial occlusive disease (PAOD).
6. Local infections or inflammatory arthritis of knee.
7. Rheumatoid arthritis or other rheumatological diseases.
8. Prior knee surgeries (arthroscopic surgery, menisci repair, cruciate ligament reconstruction, arthroplasty of knee) due to knee pain.
9. Malignancy
10. ECOG \> grade 2
11. Life expectancy less than 2 years.
12. Any other condition related to the patient's health, regarded exclusionary in the opinion of the investigator.
The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption

In this study, we aimed to examine the association between personality traits and amount of anesthetic drug consumption,of the patients who will receive sedoanalgesia for the oocyte retrieval procedure. As well as determining the anxiety scores in the preoperative period, the time to reach the desired sedation level, hemodynamic parameters in the perioperative period, peripheral oxygen saturation, EtCO2 value, postoperative pain, postanesthetic recovery, analgesic drug need, unconscious movement, and patient satisfaction.

Different personality traits, anxiety disorders, depression, and somatoform disorders are frequently encountered in women with infertility problems. Although there are many studies evaluating the relationship of anxiety with variables such as hemodynamic parameters, need for anesthetic medication, recovery times, postoperative pain and analgesic requirements, the relationship between personality traits and these variables has not been investigated.

In our study, considering that the anesthesia needs of these patients with a stressful negative factor such as infertility may be at different levels, preoperative evaluation of the patients with a personality questionnaire will provide better perioperative management, a better quality recovery and possibly a higher quality oocyte aspiration. In this study, it was aimed to investigate the amount of anesthetic agent consumption, recovery times, postoperative pain scores, analgesic requirements, involuntary movement, time to reach sufficient sedation depth, and patient satisfaction of patients thought to have sedation.

All patients will fill out Personality Belief Scale-Short Form (PBQ-S1) and Beck Anxiety Scale one day before the procedure and they will be registered.

Eligibility Criteria:
Inclusion Criteria:

* 18- 50 year-old elective patients who signed the informed consent form from ASA I-II patients scheduled for oocyte retrieval.
* Patients with sufficient education and mental capacity to complete in assessment scales and questionnaires.
* Patients without neurological disorders, psychological illnesses, or drug or alcohol abuse
* Patients without stimulant drug and alcohol consumption
* Absence of significant cardiovascular, respiratory, kidney or liver disease.

Exclusion Criteria:

* Psychiatric or neurological disorder
* Psychiatric drug use or alcohol consumption
* Pregnancy
* Presence of severe cardiac, hepatic or cerebrovascular disease
* History of allergy to local anesthetics or systemic opioids
* History of chronic pain
* Patients who are unable to evaluate scales and questionnaires
Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder

The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6\~18 years with chronic tic disorders or Tourette's disorder


Eligibility Criteria:
Inclusion Criteria:

1. Patients who can provide an assent form signed by themselves and informed consent form by their legal representatives prior to performing of any study procedures.
2. Male or female children and adolescents aged 6 to 18 years
3. Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's disorder according to DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition)(using K-SADS-PL-K (Kiddle-Schedule for Affective Disorders and Schizophrenia,Present and Lifetime Version-Korean version)) and require drug therapy.
4. The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity Scale)is more than 22 at baseline

Exclusion Criteria:

1. Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism
2. Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70
3. Patients with a history of neuroleptic malignant syndrome
4. Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months
5. Patients with a history of allergy or hypersensitivity reaction to aripiprazole
6. Patients with a history of resistance to treatment with antipsychotics
7. Patients who have participated in another clinical study within 1 month prior to screening
8. Patients who have previously taken aripiprazole or participated in a clinical study with aripiprazole