cyrilzakka/clinical-trials huggingface dataset:
Assessment of Reward Responses to Erythritol Using Flavor Preference Learning

The aim of this project is to investigate the reward responses to oral erythritol compared to sucrose and sucralose using flavor preference learning in healthy participants. In addition, the release of GI hormones, glycemic control, appetite-related sensations, and emotional state in response to erythritol will be investigated.

This trial is a randomized, double-blind, cross-over study; the project set-up will be single-centre, national. The study is composed of six visits: one screening visit, one pre-test visit, three conditioning visits, and one post-test visit. The screening and pre-test will last about two hours, the conditioning days and the post-test day about 4 hours each. During the screening participants take part in a 6-n-propylthiouracil (PROP) sensitivity test to exclude potential supertasters. Moreover, the participants will rate explicit liking and explicit wanting of 10 non-caloric flavored and colored beverages in a randomized order (flavor preference learning). The pre-test visit consists of two parts. First, a chemosensory sweetness matching will be performed, during which we will establish dose-response relationships for perceived sweetness of sucrose, erythritol, and sucralose using equisweet watery solutions across a range of concentrations. Second, the participants will perform a triangle test to ensure that they cannot distinguish the matched erythritol and sucralose solutions from a 10% sucrose solution.

During the 3 conditioning visits, participants will be presented with three conditioning trials (at t = 0, 45, and 90min), each consisting of drinking 100mL of the flavored drink (CS) paired with one of the sweet substances (US = erythritol, sucrose, or sucralose).

In post-test visit, preference for each of the 3 flavored CS drinks will be assessed and a computerized forced choice task will be completed by the participants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy normal weight participants with a body-mass index (BMI) of 19.0-24.9 kg/m2
* Age 18-55 years
* Stable body weight (±5%) for at least three months
* Able to give informed consent as documented by signature
* 3 drinks rated as neutral and novel (from the flavor preference learning)

Exclusion Criteria:

* Non-taster (deficits of taste and smell) or supertaster
* Fructose intolerance
* Shift worker
* Pre-existing regular consumption of erythritol and/or sucralose and/or aspartame (\>1/week)
* Substance abuse (more than 1 glass wine/beer per day; consumption of cannabis, cocaine, heroin, etc.)
* Regular intake of medications, except contraceptives
* Chronic or clinically relevant acute infections
* Pregnancy: although no contraindication, pregnancy might influence metabolic state.
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Pre-existing diet (vegetarian, vegan, sugar free)
* Inability to follow procedures due to psychological disorders or insufficient knowledge of project language (German)
* Calculated dose of erythritol outside the range of 30-60g (per 300mL) (from the sweetness matching)
PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

The study aims at exploring the potential benefit of a PARP-inhibitor, Niraparib, in metastatic breast cancer developing in germline-PALB2 mutations carriers. This study is designed as a multicentre one-arm two-stage phase 2 clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years
* PALB2 germline heterozygous mutation carrier, wild type BRCA1\&2 (breast cancer 1\&2) affected with metastatic breast cancer in first metastatic treatment line or beyond
* Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
* Triple Negative breast cancer; Patients affected with triple negative cancers should have received anthracyclines and taxanes in neo/adjuvant therapy.
* Or patients with Hormonal receptor positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) breast cancer, with treatment failure after a second line of therapy; Estrogen Receptor/ProgesteroneReceptor breast cancer positive patients must have received and progressed on currently recommended therapies in this indication (endocrine therapy, CDK4/6 inhibitors (adjuvant or metastatic)), or have a disease form that the treating physician believes to be inappropriate for recommended therapies in this indication.
* Prior therapy with an anthracycline and a taxane in an adjuvant setting.
* Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting, at least 12 months elapsed from last dose to study entry.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate bone marrow, kidney and liver function.
* Patients without visceral crisis

Exclusion Criteria:

* Patients with HER2 positive disease.
* Untreated and/or uncontrolled brain metastases.
* Patients in visceral crisis requiring chemotherapy
* Cytopenia, defined with the following thresholds: (i) Neutrophil count \< 1500/mm3; Platelet count\< 100 000/mm3; Hemoglobin \<9g/dL
* Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS) or stage I grade 1 endometrial cancer allowed.
* Known HIV (Human Immunodeficiency Virus) infection.
* Pregnant or breast-feeding women.
* Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
Pain and Visual Outcome in Intravitreal Bevacizumab Injection

In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Those with the history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness measurements using optical coherence tomography (OCT). Patients are randomly assigned to each group .Each participant receive one injection in one eye in this study. Pain is measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would be checked again at month one.


Eligibility Criteria:
Inclusion Criteria:

* diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions

Exclusion Criteria:

* history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS)
The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT

* To identify the incidence of LIT among critically ill patients, as limited studies have only addressed this population.
* To evaluate the impact of several factors on the incidence of LIT, the time to onset of LIT, and the time to recovery of platelets.
* To study the effect of concurrent medications (enoxaparin, unfractinated heparin, piperacillin, carbapenems, tigecycline, fluconazole or voriconazole, digoxin, amiodarone, acetaminophen, tirofiban, statins, and antiepileptics) frequently used in critically ill patients on the incidence of LIT.
* To investigate the impact of possible medications with an antioxidant effect on the prevention of LIT.
* To assess the impact of LIT on composite end point (mortality, bleeding, and length of stay)


Eligibility Criteria:
Inclusion Criteria:

* All adult patients, age \> or = 18 years old, admitted to the ICU with different indications.
* candidates for intravenous linezolid therapy for \> or =1 day.

Exclusion Criteria:

* Taking any myelosuppressive drug.
* Baseline platelets \< 50000.
* Patients with hematological malignancy.
* COVID-19 patients.
* Patients with immune thrombocytopenia
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion

Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with a negative antibody result will also be followed in the study. All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts. This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts.

This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers will serve as a control group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for CABG (males or non-pregnant females)
2. \> 18 years old with at least one vein graft planned
3. Able to provide written informed consent

Exclusion Criteria:

1. Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status
2. Documented history of allergy to iodinated contrast media, warfarin, or argatroban
3. Chronic renal impairment with CrCl\<60 ml/min
4. Recent bleeding episode
5. Congestive Heart Failure (EF\< 30%)
6. Bleeding diathesis or known thrombophilic disorder
7. Atrial fibrillation or other condition requiring anticoagulation at the time of enrollment
8. Documented history of heparin induced thrombocytopenia
9. Clinical suspicion of HIT at the time of randomization, defined as 50% decrease in Platelet count from last heparin exposure or Platelet count \<100,000/ml
10. Hepatic dysfunction (defined as LFTs \> 3 times the upper limit of normal)
11. Patients with a history of bleeding complications post-CABG
12. Hemorrhagic stroke
13. Gastrointestinal bleeding
14. Requirement for fresh frozen plasma
15. Recent central nervous system or ophthalmic surgery
16. Aneurysm
17. History of psychosis or senility
18. Malignant hypertension
19. Clinically significant pericarditis or pericardial effusion
20. Bacterial endocarditis
21. Hematocrit \< 24%
22. Valve replacement or repair at time of CABG
23. Subjects with signs or symptoms of possible Transient Ischemic Attack or stroke
Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study

Hypertension is extremely common amongst the elderly, typically manifesting as a silent disease with potentially devastating consequences if left undetected and untreated. Such consequences include stroke, myocardial infarction, kidney and eye disease. Opportunistic screening for hypertension is therefore standard in clinical practice. Currently, the standard of care for screening in the western world is with 24-hour ambulatory cuff-based devices which are often intolerable, particularly for elderly patients.

Several novel cuffless wearables have been developed to overcome the limitations of cuff-based monitors. These devices offer significant advantages over cuff-based devices, including improved patient tolerance and user acceptability. Numerous cuffless monitors are now commercially available. However, validation of such devices is challenging as there is no current universal standard for validating such devices.5 This is highlighted by the heterogenous and often inadequate study methods used to demonstrate accuracy of commercially available cuffless devices for blood pressure measurements. Indeed, the uncertainty about their merit is reflected in international guidelines. The 2023 European Society of Hypertension guidelines currently do not recommend routine use of such devices in clinical practice for evaluation of blood pressure.

There are limited clinical trials comparing 24-hour cuff-based devices directly to cuffless devices, and even fewer specifically in an elderly population where they may be particularly advantageous due to design features that improve tolerability. This study thus aims to address this important gap in the literature to better understand if cuffless devices provide reliable blood pressure measurements in the elderly population by directly comparing these devices to the current standard of care in blood pressure evaluation. The Aktiia device will be used as a surrogate for cuffless wearables while a standard 24-hour ambulatory cuff-based device will represent cuff-based devices. The Aktiia device is a cuffless solution worn as a bracelet on the wrist. It contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. This device is commercially available and clinically validated for use in patients up to age 85.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>65 years old
* Enrolled on Sligo/Leitrim ICPOP programme
* Participants (or carers) must have access to a smart phone compatible with the Aktiia app

Exclusion Criteria:

* Cognitive impairment or diagnosis of dementia
* Adults unable to provide informed consent
* Life-expectancy less than one year
* Patient's unlikely to comply with trial protocol in opinion of investigator's
Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

A tele-health treatment study for individuals with early stage ALS with the aim to improve communication, cough response, and respiratory strength. All participants complete a respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150) device from the comfort of their homes for 6 weeks.

The investigators are looking for people with early stage ALS to participate in a completely tele-health (no in-person visits required) treatment study examining the effects of an Expiratory Muscle Strength Training device (EMST-150) on communication, cough, and respiratory strength. Participants will be required to attend 2 virtual baseline assessment sessions followed by 12 additional virtual training sessions (2 per week for 6 weeks). Participants should plan to be actively enrolled in the study for \~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training). Participants will also be required to fill out a series of questionnaires assessing the EMST's effectiveness via tele-health.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS
* Within the early stages of disease progression (i.e., able to talk, breathe, and eat independently)
* Speaker of English
* Have a family member/caregiver willing to assist as needed
* Have access to an electronic device and internet for tele-health

Exclusion Criteria:

* A history of neurological disease (besides ALS)
* A history of asthma or respiratory problems (e.g., COPD, emphysema)
* A history of head, neck, or chest surgery (except mastectomy)
* A history of smoking within the last 5 years
* Reliance on mechanical ventilation (including CPAP)
Functional Endoscopic Evaluation of Swallowing

The investigators objective is to describe functional endoscopic evaluation of swallowing findings in children with cerebral palsy.

Cerebral palsy (CP) is a predominantly motor disorder and dysphagia is a frequent complaint. Functional endoscopic evaluation of swallowing (FESS) involves anatomic and functional observation of the larynx and pharynx, evaluation of swallowing and maneuvers to improve it, also testing the laryngeal sensitivity. We evaluated nine patients with CP of both sexes, which age varied from 1 to 10 years old, attended at dysphagia multidisciplinary clinic, at NAMI (Integrated Medical Assistance Nucleons).

Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of cerebral palsy.

Exclusion Criteria:

* medical diagnoses not associated with cerebral palsy that affect swallowing.
A Prospective Evaluation of Iodinated Contrast Flow Patterns in Caudal Epidurography With Intentional Lateral Caudal Approach

Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigators hypothesize that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.


Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral radiculopathy

Exclusion Criteria:

* patients with sepsis
* chronic infection
* coagulopathy
* local infection near the sacral hiatus
* the allergy of the contrast
* history of spine surgery, scoliosis and kyphosis
Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy

The study will be conducted to see the potential benefits of home based exercise program comprising routine physical therapy and traditional massage in the management of spastic cerebral palsy (CP). It will be a randomized controlled trial having two groups, RPT group and Massage group. Both groups will be provided with routine physical therapy treatment comprising stretching of spastic muscles, strengthening of weak muscles, positioning and posturing strategies. Massage group will also receive traditional massage in addition to routine physical therapy. Parents/Caregivers will be trained to perform routine physical therapy and traditional massage at home. Data will collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Measure (GMFM),Gross Motor Function Classification System (GMFCS) and CP Child's Caregiver Priorities \& Child Health Index of Life with Disabilities at baseline, after 6th and 12th weeks of intervention.

CP is among the most common type of physical disabilities presenting itself in children across the globe. Although its incidence range has been reported from 2 to 2.5 cases per 1000 live births globally, however it may be many folds in poor counties due to lack of reporting and absence of CP registries at national level . Many interventions are in use to manage the disabling and lifelong consequences of this condition. However majority of these interventions remain beyond the reach of poor population especially in under developed countries with poor socio-economic status like Pakistan. This creates a need for search to such interventions which should be locally available, accessible, low cost, affordable, and doable by the poor population so that disabling consequences of this condition may be minimized. RPT and traditional massage performed by parents at home after proper training fall in the category of such low cost interventions. Hence there is dire need to investigate the potential benefits of such interventions. That is why this RCT has been planned.

Eligibility Criteria:
Inclusion Criteria:

* Child should have established diagnosis of spastic cerebral palsy (diplegic types only).

Exclusion Criteria:

* Children having moderate to severe contractures.

  * Children having moderate to severe mental retardation and with multiple disabilities.
  * Children with Attention Deficit Hyperactive Disorder (ADHD), uncontrolled seizures and behavioral disorders
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea

Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study has investigated the reliability of this technique, demonstrating moderate-substantial interrater and test-retest reliability. This research has also compared DISE findings to those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not responded to previous sleep apnea surgery. These papers have been published and available through PubMed. Additional research is ongoing, with examination of DISE findings, comparison to other evaluation techniques, and the association between DISE findings and surgical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with OSA considering surgical treatment

Exclusion Criteria:

* Minors
* Pregnant women
* Patients unable to provide informed consent in English themselves
* Prisoners
* Allergy to propofol, soybean oil, egg lecithin or glycerol
* Other contraindication to use of propofol (decision of anesthesiologist or otolaryngologist.)