cyrilzakka/clinical-trials huggingface dataset:
Alternative Options to Minimize Niacin-Induced Flushing

Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.


Eligibility Criteria:
Inclusion Criteria:

* An adult between 21 and 70 years of age.
* Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
* Able to speak and read English.
* Willing to comply with study specific instructions, and complete all study procedures according to protocol.
* Able to understand study rationale and sign informed consent.

Exclusion Criteria:

* Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
* History of gout
* History of diabetes mellitus
* History of coronary heart disease
* History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
* History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease
* Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)
* History of migraine or cluster headaches
* Currently using antihistamines, aspirin or NSAIDS on a consistent basis
* Presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation.
* Lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation.
* Currently taking medication that might be contraindicated with the study drug or Niacin or study procedures (including Niacin, lipid-lowering drugs, chronic aspirin or laxative use).
* Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.
COPD Breathing Record Study 2

The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). The patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. The data will also be examined to assess the predictive possibility of a non-invasive self-care personal CO2 monitoring device to identify COPD exacerbations.

Study Design: This is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the N-Tidal C Data Collector Device in patients with COPD.

Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Those patients who are classified as COPD with appropriate inclusion criteria (below) will be invited to participate. Patients who give informed consent will be screened for the study.

The N-Tidal C Data Collector Device will be explained to the patients and they will be trained how to use it. All patients will complete a short daily diary record.

Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. The study will not interfere with routine management of the patient's condition.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 40 years and over.
2. Diagnosis of COPD (Primary) and at least one moderate exacerbation within 12 months of the start of the study period.
3. Able to provide signed informed consent.

Exclusion Criteria:

1. Patients who, in the opinion of the investigator, are unlikely to comply with the requirements of the study, use the device correctly or keep the diary records;
2. Diagnosis of neuromuscular disorders or Kyphoscoliosis;
3. Diagnosis of other Respiratory disorders that, in the opinion of the investigator, would impact the conduct of the study e.g. clinically significant bronchiectasis, asthma;
4. Patients who have experienced an exacerbation of their COPD that has required treatment with antibiotics and/or oral corticosteroids within 2 weeks prior to the study start.
A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
* Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
* Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria:

* Known or suspected Richter's transformation at any time preceding enrollment
* Prior therapy with a non-covalent (reversible) BTK inhibitor
* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
* Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
* Prior therapy with venetoclax
* Central nervous system (CNS) involvement
* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
* Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
* Active hepatitis B or hepatitis C
* Known active cytomegalovirus (CMV) infection
* Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
* Significant cardiovascular disease
* Vaccination with a live vaccine within 28 days prior to randomization
* Patients with the following hypersensitivity:

  * Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
  * Prior significant hypersensitivity to rituximab
  * Known allergy to allopurinol and inability to take uric acid lowering agent
An Investigation of Heart Rate Recovery Responses to Repeated Active Stand Protocols

Study background:

Impaired heart rate recovery following active stand is associated with morbidity and mortality. Evidence for the repeatability of this measure is limited. This study seeks to determine the repeatability of the active stand procedure in eliciting heart rate recovery in healthy adults of all ages.

Research aims:

The aims of this study are to determine the repeatability of heart rate recovery in response to the active stand procedure among different age groups.

Study design:

This will be a repeatability study with between group comparison.

Study setting:

This study will take place in the Clinical Research Facility in St James's Hospital.

Participants:

Participants will be recruited from the staff and student population of Trinity College Dublin and St James's Hospital, from the Trinity Retirement Association and from the community in the St. James's Hospital catchment area. Participants will be healthy adults (over 18 years old). They will be invited to participate via an email and poster campaign. Participation will be fully voluntary. Participants who meet inclusion criteria will be selected. Informed, explicit voluntary consent will be obtained from each participant.

Data collection and processing:

Data collection and processing will be carried out by the Research Physiotherapist. A clinical visit for the participant will be arranged at a time most convenient for them. Participants will conduct the active stand assessment on three occasions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥18 (considering 18 is the age of legal consent).
* Fluent in English.
* Free of intellectual disability or cognitive impairment that would impair or impede the ability to give informed, explicit consent.
* Free of all exclusion criteria below.

Exclusion Criteria:

* Unstable or un-managed cardiac/respiratory/metabolic conditions (i.e. condition must be diagnosed and being managed as per medical input to be classified as stable and managed).
* Neuro- musculoskeletal disorders.
* Acute musculoskeletal injury or impairment (including acute pain).
* Malignancy.
* Mental illness.
* Chronic infectious disease (Hep C/ HIV/ AIDS).
* Acute systemic infection or illness.
* Taking medication that affects cardiovascular function.
* Exclusion for any other reason deemed appropriate by the research team.
Carbamazepine Treatment of Cocaine Dependence - 1

The purpose of this study is to compare the efficacy of carbamazepine in treatment of cocaine-dependence in patients with affective disorders.


Eligibility Criteria:
Please contact site for information.
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)

The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.

This is a post-marketing long-term specified drug use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Constipation (CC) (excluding constipation due to organic diseases) who have used linaclotide for the first time
A Study to Assess Adults with CIDP Transitioning from IVIg to Efgartigimod PH20 SC

This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and the local legal age of consent
* Is diagnosed with CIDP (confirmed or possible CIDP) according to the criteria of the European Academy of Neurology/Peripheral Nerve Society
* Is being treated with IVIg every 3-6 weeks, on a stable dose and dosing interval (between 0.5-2 g/kg) for at least 3 doses
* If receiving oral corticosteroids, this should be at a stable dose of less than 20 mg a day or less than 40 mg every other day, for at least a month.
* If receiving nonsteroidal immunosuppressive medication, this should be at a stable dose for at least 3 months

Exclusion Criteria:

* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk
* Types of other polyneuropathy other than CIDP
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus

Assess whether the application of electrical stimulation in patients undergoing subcutaneous colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of postoperative ileus, improving the results of morbidity and mortality, hospitalization and health care costs.

Prospective randomized study on the application of subcutaneous abdominal electrical stimulation in the postoperative of colonic surgery and its relationship with the appearance of postoperative ileus.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colorectal surgery.
* Signing informed consent.

Exclusion Criteria:

* Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
* Patients with contraindications for electrical stimulation.
* Psychiatric Disorders
* HIV
* Pregnant or breastfeeding
* intestinal obstruction
* uncontrolled infection
* ASA IV
* No acceptance or failure to follow protocol multimodal rehabilitation.
Aim 3 Particle Swarm Optimization PIGD

In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.

In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP. In this respect, the present protocol is similar to Protocol STUDY00008644. In fact, that protocol, and this one, cover different Aims of the same NIH-funded project. Protocol STUDY00008644 tested different neurostimulor settings for a few hours in the laboratory only; the present protocol also tests them for two weeks between laboratory testing sessions. This is essential, for several reasons. First, clinically relevant outcome measures, such as ADL (activities of dailly life) and QOL (quality of life) scales require observation for longer than a few hours in the laboratory. Second, DBS effects are not instantaneous, and prolonged observation is required to determine the full effect of neurostimulator settings. Third, we intend, if our hypothesis is confirmed (that activation of the PPN-to-GP pathway is most effective for the postural-instability / gait-disorder (PIGD) complex) to propose a clinical trial of neurostimulator settings designed to maximize activation of this pathway; the present protocol will yield data and experience essential for designing and proposing such a trial.

Eligibility Criteria:
* Diagnosis of Parkinson's Disease
* Bilateral DBS in STN or GP
* At least 3 months after lead implantation
* Montreal Cognitive Assessment (MoCA):

MoCA=23+

OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate.

* Between 18-85 years of age
* Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care).

8.2 Exclusion Criteria:

* Inability to walk in the off-med, off-stimulation condition (even with safety harness)
* Gait impaired significantly by a condition other than PD
* Breaks or shorts in active contacts
* IPG battery nearing end of life (in patients with primary-cell IPGs)
* Females who are nursing or pregnant
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance

The purpose of this study is to examine the effects of resveratrol on health and human performance. The study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks.

Measurements

* blood laboratory parameters
* cognitive assessment changes
* body composition changes
* vascular endothelial response

Eligibility Criteria:
Inclusion Criteria:

* men and women between 45 and 75 years of age
* Normal heart rate and Blood pressure
* Ability to use personal computer interface
* Successful completion of physical activity readiness questionnaire

Exclusion Criteria:

* Cardiovascular disease, uncontrolled hypertension, lung disease
* inability to tolerate exercise
* have taken grape related supplement in past 12 months
* current use of drugs or dietary supplements to enhance exercise performance
* allergy to wine, grape juice or grape seed supplements
Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section

After Institutional Review Board approval, we performed a retrospective cohort study among all women presenting for pregnancy-induced hypertension under Cesarean section in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020.Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, electrocardiogram, cardiac ultrasound, etc.), perioperative indicators, postoperative laboratory examination (blood routine, blood coagulation, liver and kidney function, etc.), postoperative follow-up and satisfaction survey of patients.


Eligibility Criteria:
Inclusion Criteria:

* all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation

Exclusion Criteria:

* no
The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery

Pharyngeal packing is a frequently used application to reduce the incidence and severity of postoperative nausea and vomiting (PONV) in patients who undergo nasal surgery. This study aims to research the effects of PP on gastric antral cross-sectional area (ACSA) and hence gastric volume as assessed by ultrasound, therewithal PONV and sore throat were evaluated as secondary outcomes in rhino logic surgeries (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery).

Postoperative nausea and vomiting (PONV) after nasal surgery (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery) is a very common complication (34-60%). Therefore, pharangeal packing was performed to prevent blood ingestion so as to decrease the incidence of PONV and the risk of aspiration. Also, gastric blood is known to be a powerful emetic. Actually, there is not any evidence in the literature reporting the quantitative values of gastric volumes due to blood ingestion. The aim of this study is to research the effect of pharyngeal packing on the perioperative gastric antral cross-sectional area (ACSA) so the gastric volumes.

Measurements were performed by ultrasound with convex probe in right lateral decubitus position, in order to evaluate the effectiveness of pharyngeal packing in patients undergoing nasal surgery, and to show its effects on PONV and sore throat.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective nasal or paranasal sinus surgery following overnight fasting
* 18-70 years of age
* accepting to join the study
* American Society of Anesthesiologist (ASA) classification system I-III
* Body mass Index (BMI) \< 30 kg/m2

Exclusion Criteria:

* ASA classification higher than III
* Age younger than 18 years
* BMI\>30 kg/m2
* Preoperative vomiting or antiemetic medication therapy
* Intubation needing more than two laryngoscopy attempts
* Not agreeing to participate in the study
* Coagulation disorders
* Diseases or conditions affecting gastric volume or motility
Family Centered Occupational Therapy on Play Skills and Participation of Children With ASD

Play skills and participation of children with Autism Spectrum Disorder (ASD) have been restricted by their core symptoms, resulting in heightened parenting stress and affected family daily life. This research aims to improve play skills and participation of children with ASD through 'family-centered occupational therapy', thereby leading to positive outcome for not only the child but also the whole family.

Play skills and participation of children with Autism Spectrum Disorder (ASD) have been restricted by their core symptoms, resulting in heightened parenting stress and affected family daily life. This research aims to improve play skills and participation of children with ASD through 'family-centered occupational therapy', thereby leading to positive outcome for not only the child but also the whole family.

60 children age 2\~6 with ASD will be recruited in our research, and divided into either experimental or control groups according to primary caregivers' (will be referred to as caregivers thereafter) decision whether to receive treatment in our hospital (NTUH) or not. Caregivers' decision is based on the convenience of transportation to NTUH. The children with ASD in the experimental group will receive family-centered occupational therapy three times a week for 6 months. The intervention goals, determined by discussing with caregivers, will often be the most important aspect of play skill and participation of children with ASD, which concern caregivers most. Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life. The outcome assessments will include : (1) The child's developmental skills and the severity of ASD as measured with Psychoeducational Profile, third edition (PEP-3) and Childhood Autism Rating Scale (CARS) respectively, (2) the child's play skill and participation as measured with Goal Attainment Scale (GAS), Vineland Adaptive Behavior Scale-Chinese version (VABS-C) and Revised Knox Preschool Play Scale (RKPPS) respectively, (3) Family related factors as measured with Parenting Stress Index Short Form (PSI/SF), Family Outcomes Survey (FOS), Family Empowerment Scale (FES) and Home Observation for Measurement of the Environment (HOME).

Pre- and post-intervention comparison on the outcome measures within the experimental group, and group comparison on the outcome measures will be conducted to examine the effectiveness of family-centered occupational therapy. Results of the study will provide empirical evidence for evidence-based occupational therapy practice in the field of play skills and participation of children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed with Autism spectrum disorder
* age 2\~6 years old

Exclusion Criteria:

* patient with other disease, like seizure or other systemic disease