cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease

This study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of Traditional Chinese Medicinal Mixture in Parkinson's disease (PD) patients. The treatment phase includes 12 months period of Traditional Chinese Medicinal Mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes Traditional Chinese Medicinal Mixture tid or matched placebo.

Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.

The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS).

The hypothesis of this study was that Traditional Chinese Medicinal Mixture improves the overall wellbeing of PD patients and thus may leads to an improvement of parkinsonian symptoms in PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease according to the UK Brain Bank criteria
* Hoehn \& Yahr stadium Ⅰ～Ⅲ
* Age over 50 years
* Taking only levodopa and/or dopamine agonists when recruiting
* Consistent with the liver kidney deficiency type by Traditional Chinese Medicine (TCM) standard
* Patients voluntarily take part in this study and signed the informed consent

Exclusion Criteria:

* Modified Hoehn-Yahr scale are higher than 4
* Had other serious illness such as liver/kidney failure, serious infection etc
* Allergic to the study drug
* Had been participated in other clinical trials during the last 3 months prior to study inclusion.
* Taking Coenzyme Q10, MAO-B inhibitors, or vitamin E, all of which might improve the symptom or slowdown the progression of PD.
* Taking herbal medicine that can nourish the liver and kidney by TCM standard.
* Had serious mental disorder and could not describe his/her symptom.
The Swiss Neurodevelopmental Outcome Registry for Children With CHD

Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Since multiple risk factors contribute to neurodevelopmental alterations, a nationwide registry collecting data on medical characteristics, interventions, clinical course and neurodevelopment until school-age is needed to improve the quality of management, identify risk- and protective factors affecting neurodevelopment, and facilitate multicenter trials.

Methods and analysis: The Swiss Outcome Registry for CHIldren with severe congenital heart Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed (1) to collect baseline characteristics and clinical data of CHD patients operated with bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to monitor long-term neurodevelopment, and (3) to relate clinical characteristics and neurodevelopment to identify risk and protective factors in these children. This registry started data collection relating to pregnancy, birth, preoperative course, catheter-based and surgical treatment, postoperative course and reinterventions in 2019. The primary outcome includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and 5.5 to 6 years. Investigators expect to include 80 to 100 children per year. Correlation and regression analyses will be used to investigate risk- and protective factors influencing neurodevelopment.

Ethics and dissemination of results: Swiss ORCHID received support by the Accentus Charitable Foundation, the Anna Mueller Grocholoski Foundation, the Swiss Society of Pediatric Cardiology, and the Corelina - Foundation and was approved by the cantonal ethics committees. Findings will be presented at national and international scientific meetings, and published in peer-reviewed journals. Results will also be shared with patient organizations, primary health care providers, and public health stakeholders to ensure a widespread dissemination of the results.


Eligibility Criteria:
Inclusion Criteria:

* Neonates (including preterm born children) with severe CHD
* Requiring an invasive cardiac intervention (including heart-lung-machine) within the first 6 weeks of life.

Exclusion Criteria:

* Neonates (including preterm born children) with simple CHD
* Requiring simple cardiac surgery or catheter intervention such as closure of patent arterial duct or simple repair of aortic coarctation without heart-lung-machine and low impact on neurodevelopmental outcome.
Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance

The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance. Is wanted to know the cause of the indication of the diagnostic test based on MRI.

MRI is currently infra indicated in patients with cardiac stimulation devices and for this reason, the request for this imaging technique in these patients is complicated and, often, the MRI-based test is replaced by a CT scan that may not be so beneficial for the diagnosis.

Current data indicate that, with cardiological control and maintaining basic safety precautions, MRI could be performed in patients with peacemakers and Implantable Cardioverter Defibrillators (ICD) that require it for clinical reasons, although it should be noted that currently, due to lack of data published, the absolute safety of an MRI in these patients and the protocol used in each case cannot be guaranteed.

This registry proposal is to have data of all patients implanted with Biotronik cardiac stimulation devices and evaluate how many of them have an indication for an MRI-based diagnostic test, how many of them are already undergoing this diagnostic test, how many are given an tomography as an alternative to avoid subjecting patients to an MRI

Eligibility Criteria:
Inclusion Criteria:

* Patients carrying a cardiac stimulation device
* Patients able to understand the nature of the procedure
* Patients who give informed consent

Exclusion Criteria:

* Epicardial cables
* Abandoned cables
* Non-BIOTRONIK cables
* Age \<18 years
* Pregnant and breastfeeding
* Subjects with irreversible brain damage caused by a pre-existing brain disease
* Heart transplant 6 months prior to recruitment or expected within the next 3 months
* Cardiac surgery 3 months prior to recruitment or planned for the next 3 months
* Life expectancy less than 12 months
Effect of D-amphetamine on Reward Functioning

The purpose of this study is to establish the dose-response curve for therapeutic doses of d-amphetamine on tasks of motivation and reward learning in the same participants and to use d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in reward-related decision-making.


Eligibility Criteria:
Inclusion Criteria:

- Healthy individuals

Exclusion Criteria:

* Individuals with a body mass index (BMI) \<19 or \>26, as this alters dosing requirements
* Individuals with high blood pressure, abnormal Electrocardiography (EKG), any medical condition requiring regular medication (except birth control), any other regular use of a drug or supplement with potentially hazardous interactions with d-amphetamine (e.g. St. John's wort), or any other medical contraindication to amphetamine administration as determined by our study physician
* Individuals who report no prior experience with recreational drugs of any kind (including alcohol), or who report a previous adverse reaction to amphetamine
* Individuals with a current Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) Axis I diagnosis, excluding mild Substance Use Disorders (≤ 3 symptoms)
* Individuals with a lifetime history of moderate to severe Substance Use Disorder (≥ 4 symptoms), mania or psychosis.
* Women who are pregnant.
* individuals smoking more than 10 cigarettes per week will also be excluded, to avoid confounding the effects of nicotine withdrawal with the effects of the study drugs/procedures, as participants will not be allowed to smoke during the sessions.
* individuals with less than a high-school level of education or fluency in English will be excluded as our questionnaires require high-school level fluency in English, and have not been translated and validated in other languages.
Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study

This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing. The focus of this study is to evaluate the flow of liquids of varying consistency in the head and neck cancer population.

Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx.

This study explores this question in individuals who have undergone radiation treatment for head and neck cancer, specifically located in the oropharynx.

Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, and mildly thick) using commercially available food thickeners. Swallowing will be observed under videofluoroscopy.

Eligibility Criteria:
Inclusion Criteria:

* An initial cancer diagnosis of cancer in the base of tongue region of the oropharynx (Tumor staging T2,T3 \& T4; Nodal staging N0 orN1; Human Papilloma Virus + or -).
* Completion of bilateral radiation therapy to the neck 3 months prior to enrollment
* No longer requiring primary enteral feeding for nutrition.

Exclusion Criteria:

* Prior history of swallowing, motor speech, gastro#esophageal difficulties, chronic sinusitis or taste disturbance.
* Previous radiation to the head and neck (prior to current illness);
* Previous cancer diagnosis;
* Prior or planned neck dissection;
* Trachestomy in situ;
* Neurological difficulties unrelated to spinal disorder (e.g. Stroke, Parkinson disease, etc).
* Cognitive communication difficulties that may hinder ability to participate.
* Current use of mechanical ventilation
* Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load).
* Known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection).
* Occupational exposure to radiation exceeding 10 mSv in the past 6 months.
* Current pregnancy.
Virtual Environments in Patients Receiving Treatment for Cancer

The mood disturbances that lung cancer patients experience during and after chemotherapy have a debilitating effect on their quality of life. The goal of the proposed project is to develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to combat the adverse psychological/emotional consequences of receiving treatment for cancer. Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested. In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention. A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.

Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested. In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention. A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they had a histopathological diagnosis of cancer (different types are allowed)
* were 18 years or older, on active treatment and were receiving care at the hospital as inpatients
* Eligible participants will need to be able to speak and understand Greek and they had given written informed consent
* Participants should also have a score of \>60 on the POMS total mood disturbance scale, a \>50 on the Karnofsky Performance Scale Index
* a mean of \>50 on the Attentional Function Index (AFI)

Exclusion Criteria:

* Patients were excluded if they were receiving palliative care
* they had an impaired cognitive ability or
* they had an impaired visual ability
Acamprosate Treatment: Mechanisms of Action

This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. This will be followed by a four- day inpatient period when withdrawal will be monitored. Additional drinking information will be obtained at a three month followup interview.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol abuse or dependence.
* Able to read English at 6th grade level or higher and to complete study evaluations.
* Average weekly alcohol consumption of standard drinks of at least 25 drinks for men and 20 drinks for women.
* No more than 3 days abstinence/week.

Exclusion Criteria:

* Current abuse or dependence on other substances, other than nicotine and marijuana.
* Positive test results for opiates, cocaine, benzodiazepines and barbiturates.
* Regular use of psychoactive drugs including anxiolytics and antidepressants.
* Psychiatrically disabled.
* Hepatocellular disease or a history of cirrhosis.
* Medical conditions that would prevent the consumption of alcohol, increase the risk of complicated alcohol withdrawal, or prevent the use of acamprosate such as a history of neurological trauma or disease, seizures, delirium, or hallucinations, hepatic, cardiovascular, metabolic, endocrine, gastrointestinal, or kidney disease.
* Individuals who have had any significant physical illnesses during the two weeks prior to receiving study medication or during the medication treatment period prior to the withdrawal study.
* Medically detoxified from alcohol more than once within the past five years.
* Alcohol withdrawal symptoms requiring management with benzodiazepines.
* Females who are pregnant, nursing or not using a reliable method of birth control.
* Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past six months.
* Individuals who report disliking spirits and have taken investigational drug or naltrexone within 4 weeks immediately preceding admission to study.
* Individuals who report any daily drug use during the thirty days prior to randomization for the following: anxiolytics, beta blockers, central nervous system stimulants, hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with psychotropic activity or drugs which cause excessive sedation.
* Subjects who have donated blood within the past six weeks.
Effects of Cognitive Intervention Therapy on Postoperative Delirium

This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients aged 65 and above.
* Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.
* Patients scheduled for arterial catheterization.

Exclusion Criteria:

* Patients with uncontrolled systemic conditions such as diabetes and hypertension.
* Those with visual impairment.
* Patients with cognitive impairment based on the MMSE-DS criteria.
* Individuals experiencing difficulty in communication.
* Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).
* Patients diagnosed with alcohol or substance addiction.
Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.

Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.

To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.

Eligibility Criteria:
Inclusion Criteria:

* volunteers with minimum 20 natural teeth without restoration.
* cooperative
* motivated and committed to participate in the trial period.

Exclusion Criteria:

* Antibiotic or anti-inflammatory therapy in previous month.
* Any known allergy/ hypersensitivity to any product used in trial.
Impact of Rifabutin on the Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor

This is a prospective, single-center, fixed-sequence, nonrandomized, open-label study in healthy adults to investigate the impact of rifabutin on the pharmacokinetics of trikafta.

Trikafta (Elexacaftor \[ELX\], Tezacaftor \[TEZ\], Ivacaftor\[IVA\]) is contraindicated with concomitant use of strong inducers as co-administration of rifampin decreased the area-under-the concentration time curve (AUC) of IVA by 89%, creating a therapeutic challenge to the treatment of non-tuberculosis mycobacteria (NTM) infection in people with cystic fibrosis (CF). While rifabutin also induces CYP3A4 activity, its effects appear to be more moderate when compared with rifampin. Therefore, we hypothesize that rifabutin can be co-administered with an adjusted dose of ELX/TEZ/IVA in patients being treated for NTM pulmonary disease.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign informed consent prior to any study-related activities.
* Male or female participants between 18 and 65 years of age inclusive.
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, and clinical laboratory test results
* Body mass index (BMI) of 17.5 to 30.5 kg/m2, inclusive; and a total body weight \>50kg (110 lbs).
* Willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: Grapefruit, grapefruit juice, St. John's Wort.
* Participant must use a reliable method of birth control while they are participating in the study; for instance an intrauterine device (IUD), condom with spermicidal gel or foam, diaphragm with spermicidal gel or foam, vasectomy, tubal ligation, hysterectomy or abstinence or female must be post-menopausal for at least one year.

Exclusion Criteria:

* Female subjects of childbearing potential with positive urine pregnancy test at screening.
* Female subjects who are breastfeeding.
* Use of CYP3A modulators (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, azole drugs, telithromycin, clarithromycin, erythromycin)
* Any significant acute or chronic medical illness that might confound the results of the study or pose an additional risk in administrating study drugs to the subject, as determined by the investigator.
* Any condition that could affect drug absorption (eg, gastrectomy, pancreatitis).
* Any major surgery within 4 weeks of study drug administration.
* Blood donation of approximately 1 pint (500 mL) within 56 days before study drug administration.
* Known hypersensitivity to rifamycins
* Patients with hepatic impairment (Child-Pugh Class B or C) and/or with history of hepatobiliary disease or liver function test elevations.
* Renal insufficiency (eGFR \< 60 mL/min)
* History of uveitis and/or current eye or vision problems with the exception of corrective lenses.
* Contact lens use during study drug administration.
Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers

Sample Collection Study

This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years of age or older at enrollment
2. Pregnant women with a viable singleton gestation
3. Able to provide written, informed consent
4. Able to provide 20 mL of whole blood
5. Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.

   1. Preeclampsia with severe features is defined as:

      Proteinuria: Excretion of ≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated to the 24 hour urine value or a protein/creatinine \[both in mg/dL\] ratio of at least 0.3 or a qualitative determination of (urine dipstick) of ≥1+ WITH Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on at least 2 occasions 4 hours apart while on bedrest but before the onset of labor OR Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on 1 occasion but before the onset of labor, if antihypertensive therapy is initiated due to severe hypertension OR New onset hypertension defined as: Systolic BP ≥140 mmHg or diastolic ≥90 mmHg with one or more of the following features: Thrombocytopenia (\<100,000 plts/mL); impaired liver function (AST/ALT 2X ULN); newly developed renal insufficiency (serum creatinine \>1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease); pulmonary edema; new onset cerebral disturbances or scotomata
   2. Fetal Growth Restriction defined as:

   Estimated fetal weight by ultrasound at ≥ 19 0/7 weeks gestational age \< 5%ile or 5-10%ile with abnormal umbilical artery Doppler examination (S/D ratio \>95%ile for gestational age, absent end diastolic flow or reverse end diastolic flow)
6. Gestational age between 20 0/7 and 33 6/7 weeks determined by ultrasound and/or LMP per ACOG guidelines1. A subject diagnosed with preeclampsia without severe features prior to 33 6/7 weeks gestation and who is managed expectantly and develops severe features after 34 weeks may be included.

Exclusion Criteria:

1. Known malignancy
2. History of maternal organ or bone marrow transplant
3. Maternal blood transfusion in the last 8 weeks
4. Chronic hypertension diagnosed prior to current pregnancy
5. Type I, II or gestational diabetes
6. Fetal anomaly or known chromosome abnormality
7. Active labor