cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Cognitive Behavioral Smoking Reduction Program

The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for ambulant patients in a three-armed study design. Study participants will be randomized to one of the following three study groups: experimental group: 5-week lasting cognitive behavioral reduction program ("smoke_less"); active comparator: 15 minutes counseling interview; waiting group: no intervention.

The three follow-up measures take place after the reduction program in week 6, 17 an 29. After the finalisation of the last follow-up, participants from the active comparator and waiting group get the chance to take part at the smoking reduction program at no charge.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years
* Result Fagerström-Test \>= 3
* Consumption of at least 10 Cig./day
* carbon monoxide \>= 8 ppm
* Wish, to reduce smoking but no intention to stop smoking within the next 4 weeks
* Agreement, to resign to nicotine replacement therapy, other therapies for smoking reduction, e-cigarettes or non-smoking tobacco products during study time

Exclusion Criteria:

* severe psychiatric disorder
* severe neurologic disease
* alcohol, drug or medication abuse (acute or in anamnesis)
* severe cardiovascular disease
* severe cancer disease
* severe internal disease
* Consumption of psychopharmacological medication
* acute suicidal tendency
* pregnancy or lactation
* consumption of medication therapy for smoking reduction in the last 3 month
Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC

This is a phase I, open label, dose escalation study to evaluate tolerability, safety , pharmacokinetics and efficacy in patients with KRAS mutant NSCLC by using HL-085 and Docetaxel.


Eligibility Criteria:
Inclusion Criteria:

1. KRAS mutation NSCLC.
2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment.
4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
5. ECOG performance status of 0-1.
6. Life expectancy ≥ 3 months.
7. Ability to take the medicine orally.
8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Hypersensitivity to study drug ingredients or their analogues.
2. Prior therapy with MEK-inhibitor.
3. Receiving any other anti-cancer therapy at the same time .
4. Active central nervous system (CNS) lesion.
5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
7. Uncontrolled concomitant diseases or infectious diseases.
8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
9. History of HIV,HCV,HBV infection.
10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
11. Serum HCG test is positive.
12. Other conditions that increase the risk of study and influence the result.
Bananas as an Energy Source During Exercise: a Metabolomics Approach

This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress, and innate immune function using traditional and metabolomics-based profiling.

Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min). Pre-, post-, and 1-h-post-exercise blood samples were analyzed for glucose, granulocyte (GR) and monocyte (MO) phagocytosis (PHAG) and oxidative burst activity, nine cytokines, F2-isoprostanes, ferric reducing ability of plasma (FRAP), and metabolic profiles using gas chromatography-mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Ages 18-45 years
* Cyclists, road racing experience.
* Willing to avoid the use of supplements, herbs, medications during the study.

Exclusion Criteria:

* Female
* Over the age of 45 years
* No cycling racing experience
* Using supplements and medications during the study
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa

Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (\~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.


Eligibility Criteria:
Inclusion Criteria:

* For participants across all three aims are:

  * Female sex
  * Aged 15+
  * Pregnant and presenting antenatal care at the Gugulethu MOU
  * HIV-negative
  * Recent PrEP initiation (\<1 month ago) or PrEP adherence challenges, either documented (\>2 weeks late to pick up PrEP refill) or self-reported
  * Moderate to severe symptoms of posttraumatic stress and/or depression (defined as a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and/or a score of ≥13 on the Edinburgh Postnatal Depression Scale (EPDS). Cutoff scores may be adjusted by 3-5 points to facilitate recruitment.

Exclusion Criteria:

* There are no exclusion criteria with respect to parity or gravidity.

  * Participants who are unable to provide informed consent or assent in English or Xhosa
  * Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Positive symptoms of active psychosis or mania will be assessed by the research assistants. They will be trained to identify delusions, hallucinations, disorganized or pressured speech, flight of ideas, and grandiosity as they speak to potential participants.
  * Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
the Role of Ivabradine in Causing AF in Patients With Chronic Coronary Syndrome

This study is aiming to detect the possibility of Ivabradine's role in the development of atrial fibrillation in chronic coronary syndrome patients with No structural heart disease.

Ivabradine is a heart rate-lowering agent best characterized by its negative chronotropic effect on the sinoatrial node. Its unique mechanism selectively blocks the pacemaker funny channels, which are responsible for spontaneous depolarization in the sinoatrial node that regulates heart rate during sinus rhythm. It has been well established that controlling the heart rate is the main target when treating coronary artery disease and heart failure and is associated with a beneficial effect on mortality and morbidity.

According to the European Society of Cardiology guidelines for Chronic coronary syndrome, ivabradine should be considered as an anti-anginal agent in patients with sinus rhythm and heart rate of ≥70 BPM in combination with beta-blockers or when beta-blockers are not tolerated.

The If current, which is affected by ivabradine, was found to be present in the pulmonary vein myocardial sleeves, the well-recognized triggers for AF.

This may explain the risk of AF in patients receiving this drug. However, AF is commonly associated with HF and ischemic heart disease, the current two clinical indications for the use of ivabradine, hence AF in this patient population may be an association rather than a drug-induced effect.

Previously, ivabradine's heart rate reduction was thought to be exclusively due to inhibition of If channels in the sinoatrial node. However, emerging data have shown channels that maintain the If current in the free wall of both atria. These findings support the idea that the If current plays a role in the pathophysiological procedure that initiates and maintains AF.

Eligibility Criteria:
Inclusion Criteria:

* age range from 18 to 70 years.
* diagnosed with Chronic Coronary syndrome according to European association guidelines of 2019.
* Normal structural heart disease (as evident by 2D transthoracic echocardiography).
* in sinus rhythm.

Exclusion Criteria:

* Patient with heart rate below 70 bpm at the start of treatment.
* Smokers.
* hyperthyroidism.
* Hypertensive patients
* Patient with bradycardia arrhythmia (sinus Bradycardia, advanced degree of heart block).
* history of Atrial fibrillation.
* history of Myocardial infarction, Previous PCI, or CABG.
* Patient with Valvular heart disease.
Human Tissue Repository for Wound Care

The objective of this study is to create a Human Tissue Repository to be used as a resource for future tissue repair research at KCI USA, Inc.

The study design is a multicenter study involving the collection of human biological specimens in Subjects with various wound classifications and types for the purpose of a Human Tissue Repository to be used as a resource for future tissue repair research at KCI USA, Inc. Subjects participating in this study will have a 6mm tissue punch biopsy or equivalent tissue specimen harvested from the healthiest margin of the wound. Tissue collection may occur at Visits 2, 3, 4 and 5. Visit 2 may be combined with Screening, Visit 1. Subjects will have a minimum of one (1) and a maximum of four (4) specimen collection visits. Specimens may be collected from one or multiple different tissues (connective tissue, muscle, bone, and dermis) at any or all visits. Each specimen will be placed in a separate appropriate vial. Necrotic tissue with eschar and bodily fluids such as blood, wound fluid or sputum will not be collected. Tissue from healthy, healing wounds will also be accepted. Tissue collection visits shall occur at least twenty-four (24) hours apart. Ten (10) to twenty-five (25) percent of the sites will be selected to collect all the specimens in cryovials containing a pre-aliquoted amount (1.5mL) of RNAlater. Ten (10) to twenty-five (25) percent of the sites will be selected to collect all the specimens in cryovials containing a pre-aliquoted amount of HypoThermosol. The remaining sites will collect all the specimens in a vial containing no diluents. All samples will be coded by the collection site prior to shipment to KCI.

Eligibility Criteria:
Inclusion Criteria:

* Subject's wound is acute or chronic and classified as one of the following wound types: diabetic, pressure ulcer, burn, traumatic or dehisced, and Subject signs the separate informed consent form for the study. The consent process for tissue collection should occur separately from any surgical consent.
* Subject is reported to be physically and mentally able and willing to comply with the Protocol.
* Subject is between 18 - 75 years old.

Exclusion Criteria:

* Reported presence of Human Immunodeficiency Virus.
* Reported presence of Acquired Immune Deficiency Syndrome.
* Reported presence of Hepatitis.
* Reported presence of cancer in the wound.
* Reported presence or suspected presence of infection (indicated by signs and symptoms of infection such as redness/swelling, or a positive culture, etc.)
* Presence of untreatable osteomyelitis.
* Presence of any other severe concurrent disease, which, in the judgment of the investigator, would make the subject inappropriate for entry into the study.
* Necrotic tissue with eschar present that cannot be debrided.
* Subject is unwilling or unable to comply with the protocol.
* Subject is a suspected or known intravenous drug user.
* Donation of tissue which, in the judgment of the investigator, may pose venous or arterial compromise.
Electronic Prescribing and Electronic Transmission of Discharge Medication Lists

The purpose of this study is twofold:

1. to measure the effects of transitioning from one electronic prescribing system to another in the ambulatory setting on medication errors and human-computer interactions
2. to evaluate the impact of electronic transmission of discharge medication lists to the ambulatory setting on medication discrepancies and adverse drug events


Eligibility Criteria:
Inclusion Criteria:

* Physicians or nurse practitioners with at least 4 clinic sessions per week
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders

Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. Fecal microbiota transplantation (FMT) is a process in which a presumed healthy and diverse microbiome is transplanted to a patient using a nasogastric tube, colonoscopy, or enema, or Fecal capsule to remodel the intestinal flora balance. At present, there are few clinical studies on the treatment of FGID in children with FMT. The investigators prospectively enrolled functional children who met the Rome IV standard, and divided them into conventional treatment group or FMT group with open choice. The efficacy of the two groups was collected and compared at different time points, and the flora of children in the FMT group before and after treatment was collected to monitor FMT-related adverse reactions

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children

Exclusion Criteria:

* organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.)
* other chronic disease
* growth failure
A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711

This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged from 18 to 55 years.
* BMI from 18.5 to 28.0 kg/m2
* Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance.

Exclusion Criteria:

* Subjects with clinical significant diseases
* Subjects with allergic disease history
* Subjects with gastrointestinal disease history that can affect study drug absorption
* Subjects with drug abuse history
Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease

Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).

22 PD patients were randomized into LCIG monotherapy (n-OPC 11 patients) and LCIG+OPC (add-OPC 11 patients), further divided according to OPC adding time (E-OPC within one month and L-OPC after one month from LCIG implant).

Data on PD clinical aspects, Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS), Unified Dyskinesia Rating Scale (UDysRS), electroneurography (ENG), and pharmacological therapy (Levodopa Equivalent Dose-LEDD) were collected before LCIG implanted (T0) and in the following 12 (T1) months.

Eligibility Criteria:
Inclusion Criteria:

1. LCIG implantation not longer than 30 months before the study enrollment,
2. Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (\> 2), or/and
3. Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( \>2 ).

Exclusion Criteria:

1. Hoehn \& Yahr (H\&Y) \>4,
2. Cognitive decline (MOCA\< 17),
3. more than 30 months after LCIG positioning,
4. not compliant with treatment and follow-up visits.
mHealth-supported Coach

A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk.

Aim: To evaluate the effects of a personalised mHealth-supported coach programme on the adoption of health-promoting behaviours in the middle-aged group, in comparison with usual care.

Design: A 24-month prospective two-arm, parallel-group, single-blinded, repeated-measure randomised controlled trial will be conducted.

Participants: People who aged between 40 and 64, mentally competent, have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher, communicable in Chinese and free from stroke and transient ischemic attack (TIA) or other cardiovascular disease will be eligible to the study. A total of 164 participants will be recruited through a district community centre and randomly assigned on 1:1 ratio to the intervention group or the control group.

Intervention: A theory-based mHealth-supported coach programme, including individual consultation sessions and a mobile application with a virtual sharing platform, is developed by a multidisciplinary team for the intervention group over three months, whereas the control group receives usual care.

Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnic
* able to read Chinese and communicate in Cantonese/Mandarin
* with non-laboratory IHRS score 10 or higher

Exclusion Criteria:

* mentally incompetent
* previously diagnosed with stroke, TIA, MI, coronary heart disease, heart failure or atrial fibrillation
* with eye or retinal disease
* with terminal disease with an expected life expectancy less than six months
* being pregnant
* have enrolled in other lifestyle-based or exercise-based projects
* do have mobile devices or internet service to access the mobile application
Does Muscle Mass At Intensive Care Unit Admission Determine Mortality: the Memo Study

This retrospective monocentric study aims to investigate whether a low muscle mass at ICU admission and its loss over the ICU stay predicts mortality, and in what proportion we can counteract it by nutritional support.

The study hypothesis is that a low muscle mass at ICU admission, measured at the level of L3 on CT scans performed for clinical routine, and its change over the ICU stay predict the prognosis of the patient, especially the 30-day mortality, that it may at least be partly counteracted by nutritional support and that it is related with higher ICU and hospital costs.

The objectives of this retrospective study are to determine:

1. the link between baseline body composition at ICU admission and outcomes, such as 30-day, ICU and hospital mortality and LOS, and infections. If this is confirmed, we aim to evaluate the added values of body composition to ICU severity scores to predict 30-day mortality
2. the link between baseline body composition vs. other locations to predict outcomes
3. the impact of body composition changes on the afore-mentioned outcomes. If this is confirmed, we aim to evaluate the added value of changes in body composition to changes in ICU severity scores to predict 30-day mortality
4. the impact of nutritional support on body composition changes

Eligibility Criteria:
Inclusion Criteria:

* Associations of baseline body composition with clinical outcomes:

Adults ≥ 18 yrs, hospitalized in the ICU of the HUG between January 1st 2010 and December 31st 2022 and Abdominal, or thoraco-abdominal CT scan measured 48 hours before to 96 hours after ICU admission in the HUG

* Associations of body composition changes with clinical outcomes, nutritional support or medico-economic paratemers:

Identical as for the associations of baseline body composition with clinical outcomes and At least one additional CT performed during the hospital stay

Exclusion Criteria:

* Associations of baseline body composition with clinical outcomes:

CT scans of low quality or CT scans performed outside of the HUG or Presence of a documented refusal

* Associations of body composition changes with clinical outcomes, nutritional support or medico-economic paratemers:

Additionnally: oral nutrition, because we cannot assess the quantity and composition of oral intakes retrospectively
Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)


Eligibility Criteria:
Major Inclusion Criteria:

* Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrolment as confirmed by medical history.
* Documented prior objective evidence of heart failure
* Screening ejection fraction ≥50%.
* Adequate bone marrow reserve and organ function at the Screening
* Receiving standard of care heart failure therapy at stable doses for at least 30 days prior to Screening.

Major Exclusion Criteria:

* Participant in any other study and has received any other investigational drug within 30 days prior to screening or 5-half-lives, whichever is longer, or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments.
* Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy.
* Persistent or permanent atrial fibrillation and is not therapeutically anticoagulated for at least the 4 weeks prior to the initial screening visit or is not adequately rate controlled within 6 months prior to informed consent according to investigator discretion.
* Other medical or psychiatric conditions that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the objectives of the study.