cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Smartphone App for Smoking Cessation in China

This study aims to evaluate the efficacy of cognitive behavioral therapy (CBT)-based cigarette smoking cessation smartphone app for treatment seeking smokers in China.


Eligibility Criteria:
Inclusion Criteria:

1. Cigarette smokers (smoked more than 100 cigarettes in their lifetime, and currently smoke five or more cigarettes a day)
2. 25 years of age or older
3. Being able to read and write in Chinese
4. Owning a smartphone
5. Have experience of using apps
6. Expressing an interest in quitting smoking within the next month
7. Willing to provide informed consent to participate in the study

Exclusion Criteria:

1. Nonsmokers
2. Only use electronic cigarettes
3. Smokers without attempts to quit smoking
4. Participants with severe mental illness
5. Participants who had already started their quit attempt or using any smoking cessation treatment at the time of registration
6. Unable to use smartphone and apps
7. Unable to read and write in Chinese
Safety and Tolerability of Lu AG06479 in Healthy Young Men

The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.

Part A: randomized, sequential

Part B: open-label, cross-over

Eligibility Criteria:
Inclusion Criteria:

* Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.

Other in- and exclusion criteria may apply
Laboratory Smoking of Marijuana "Blunts"

This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.


Eligibility Criteria:
Inclusion Criteria:

* Currently living in Baltimore City or Baltimore County, MD;
* Able to read, understand, and sign informed consent;
* 18-55 years old;
* Currently smokes marijuana blunts;
* Designation of Medically Healthy for Research by the Study Physician; and
* Willing to abstain from illicit drug use other than marijuana for the duration of the study.

Exclusion Criteria:

* BAC \> 0.020% as measured by alcohol breathalyzer;
* Meets DSM-5 criteria for severe current or lifetime Cannabis Use Disorder;
* Meets DSM-5 criteria for any current Axis I disorder, other than current mild or moderate Cannabis Use Disorder;
* Self-reported current desire to stop marijuana use;
* Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation;
* Has difficulties with blood draws or poor venous access;
* History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;
* Among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant;
* Acute illness which will require participant to be rescheduled
The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults.

Thoracotomy is a surgical procedure associated with severe post operative pain during the first day of surgery and is responsible for prolonged hospital stay, patient dissatisfaction and delayed return to normal activities along with increased morbidity and mortality. Investigators intend to compare the efficacy of two analgesic interventions (continuous infusion of paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose) on postoperative thoracotomy pain. The results of this study will direct the investigators to find the best practice methods which will reduce the postoperative thoracotomy pain, the overall cost of pain management and length of patient's hospital stay.

Objective To compare the safety, efficacy for pain relief and hemodynamic changes of two analgesic interventions(continuous infusion of Paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose)

Eligibility Criteria:
Inclusion Criteria:

* All ASA I-IV adult patients between the ages of 18-70 years scheduled for elective thoracotomy
* Either sex

Exclusion Criteria:

1. Neurological or psychiatric diseases
2. Emergency Procedures.
3. Language barrier
4. Patients under chronic treatment with opioids
5. Patients with hypersensitivity to bupivacaine
6. Coagulation disorders.
7. Unwilling to participate.
8. Patient previously involved in other studies
Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants

The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Parts 1 and 2: Healthy individuals with body-mass index (BMI) \>= 18.0 to \<= 32.0 kg/m2, rounded to the tenths decimal.
* Part 3: Healthy Japanese, Han Chinese individuals with BMI \>= 18.0 to \<= 30.0 kg/m2, rounded to the tenths decimal.
* Condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead ECG.

Exclusion Criteria:

- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
Flupirtine as Oral Treatment in Multiple Sclerosis

Flupirtine, a non-opioid analgesic drug, that has been shown to have additional neuroprotective functions, is given twice daily as an oral medication in patients with relapsing remitting multiple sclerosis over a period of 12 months. Neuroprotection is assessed by magnetic resonance imaging, magnetic resonance spectroscopy, optical coherence tomography, and clinical examination.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
* EDSS ≤ 4.0
* Stable treatment with Interferon-β1b for at least 6 months
* Sufficient birth control (Pearl-Index \<1)

Exclusion Criteria:

* Any other MS-course than RRMS
* Clinically relevant gastrointestinal disease
* Clinically relevant pulmonary, cardiological, infectious or CNS-disease
* Clinically relevant disease of liver or bile system, pathological value for transaminases, gamma-GT or bilirubin.
* Hepatitis (except uncomplicated hepatitis A with complete remission
* Clinically relevant dysfunction of kidneys (creatinine \>180 µmol/l) or bone marrow (HB \< 8.5 g/dl, WBC \< 2.5/nl thrombocytes \< 125/nl)
* Myasthenia gravis
* Oral anticoagulation (phenprocoumon)
* Treatment with carbamazepine or paracetamol
* Drug or alcohol abuse
* Pregnancy or lactation period
* Treatment at any time before or during study with complete lymphoradiation, monoclonal antibodies (e.g. anti-CD4, Campath 1H, natalizumab), mitoxantrone, cyclophosphamide, cyclosporin, azathioprine
* Treatment within 6 months before randomization with any other immunomodulatory substance than interferon-β1b or intravenous methylprednisolone
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).

This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children \<12 months of age with Alagille Syndrome \[ALGS\] or Progressive Familial Intrahepatic Cholestasis \[PFIC\].

This is an open label study where all participants will receive maralixibat treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Body weight of ≥2.5 kg
2. \<12 months of age at the baseline visit (ROW). \>31 days and \<12 months of age at the baseline visit (US).
3. Gestational age ≥36 weeks at birth. For children born with gestational age between 32 and 36 weeks, a postmenstrual age of ≥36 weeks is required.
4. Diagnosis of PFIC or ALGS

Exclusion criteria:

1. Predicted complete absence of bile salt excretion pump (BSEP) function
2. History of surgical disruption of the enterohepatic circulation
3. History of liver transplant or imminent need for liver transplant
4. Decompensated cirrhosis
5. Presence of any other disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, including bile salt metabolism in the intestine (e.g., inflammatory bowel disease), per investigator discretion
6. Presence of other significant liver disease or any other conditions or abnormalities which, in the opinion of the investigator or medical monitor, may compromise the safety of the participant or interfere with the participant's participation in or completion of the study
Periodonitis and Alzheimer's Disease

The main objective of this study is to assess whether Periodontal Disease is more prevalent in adult patients diagnosed with Alzheimer's Disease compared to adult patients without Alzheimer's Disease.

The secondary objective is to describe and characterize the microbiological and biochemical profile of adult patients diagnosed with Alzheimer's Disease and compare with adult patients without Alzheimer's Disease.

To assess the possible association of Periodontal Disease with Alzheimer's Disease, I propose to carry out an observational, paired and cross-sectional study.

It will be evaluated whether adult patients diagnosed with Alzheimer's Disease have a higher prevalence of Periodontal Disease when compared to adult patients without Alzheimer's Disease.

As well, it will be evaluated whether adult patients with different stages of Alzheimer's disease have different stages of severity of Periodontitis.

The study sample will be obtained from the Associação Portuguesa de Alzheimer, in the Lisbon region, consisting of adult patients diagnosed with Alzheimer's Disease (test group).

The control group sample will consist of patients who attend consultations at the Faculty of Dental Medicine, University of Lisbon, matched for age, gender and other confounding factors, such as tobacco and systemic diseases (diabetes).

Eligibility Criteria:
Inclusion Criteria:

Will be included in the study all individuals who attend the Portuguese Alzheimer's Association, diagnosed with Alzheimer's Disease, who:

1. have voluntarily given their consent to participate;
2. due to cognitive or functional disability, they were unable to give free and informed consent, but they had this consent given by their representative
3. individuals who have participated in the cognitive assessment (only for the test group)

Exclusion Criteria:

* a) refused oral observation.
18F-FAPI PET in the Diagnosis of Liver Fibrosis

It is an open label observation clinical trial, all participants are chronic liver disease. The investigators deem to make a novel evaluate criteria to hepatic fibrosis. The point of the clinical trial is to evaluate the novel biomaker 18F-FAPI-04 by PET-CT scan in the evaluation of the hepatic fibrosis.

Participants are with clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc.

Participants are without liver tumor and other liver disease besides liver fibrosis Participants has no history of malignant tumors Participants agree to performe FAPI PET and liver biopsy

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed chronic liver disease,including chronic viral hepatitis, autoimmune hepatitis, liver disease after liver transplantation, nonalcoholic fatty liver disease, alcoholic hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and congestive hepatopathy etc.
* Without liver tumor and other liver disease besides liver fibrosis
* No history of malignant tumors
* Agree to performe FAPI PET and liver biopsy

Exclusion Criteria:

* Pregnancy
* With anti-hepatic fibrosis treatment in 6 months
* With contraindications to percutaneous liver biopsy,for such as uncooperative patient, severe coagulopathy, extrahepatic biliary obstruction,etc.
Survey of Lifelong Food and Nutrition Assistance (LIFANA) in Stroke Patients and Caregivers

Many elderly suffer from nutritional problems that can cause (or can be caused by) a number of complications such as weakened immune systems and chronic health conditions (diabetes type 2, high blood pressure, cardiovascular diseases or even osteoporosis).

Through appropriate adjustments in the diets, on the basis of nutritional advice, the burden of established diseases as well as the risks of developing further conditions can be diminished. The goal of our proposed project LIFANA is to develop and evaluate the LIFANA Nutrition Solution to support healthy nutrition.. This may include general preferences, such as culture, taste, and budget, but more importantly automated and personalised nutritional recommendations based on advice provided by professional nutritionists and allergists. This is a national project co-funded by the European Union.

One of the activities of the project is to collect information through a survey with patients. These questions will contribute to creating solutions that can explore the perspectives of patients.

Patients will be approached in the clinic by a neurologist and health care professionals. The questionnaire will take place at cereneo. The group will consist of 25 participants and last between 1h. The Survey will be conducted by a clinician who will take notes. Semi-structured discussion guide will be used. With regard to the communication, the moderator will identify factors that will influence communication in a positive or negative way.

The health professionals will perform content analyses on the transcripts; the schema of categories will be oriented towards the research questions, using open questions, directly addressing quiet participants, and handling the discussion guide in a flexible way.

Eligibility Criteria:
Inclusion Criteria:

* stroke patients undergoing rehabilitation
* caregivers of stroke patients

Exclusion Criteria:

* Severe aphasia
* Severe cognitive deficits
Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes

The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.

The objective of this study is to conduct a double-blind prospective randomized control trial to determine if individualized hCG titration based on a patient's serum hCG level above or below the predetermined serum hCG level improves IVF outcomes, primarily sustained implantation rates. Patients who fall below the desired serum hCG threshold will be randomized to either maintaining their current dose of low dose hCG or being increased.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose physicians plan to prescribe low-dose hCG for ovarian stimulation
2. Age 18-46
3. Negative serum hCG prior to start of COH
4. BMI \>18 and \<35
5. Plan for ejaculated sperm use
6. Plan for PGT testing with euploid embryo transfer

Exclusion Criteria:

1. Administration of low-dose hCG during frozen embryo transfer cycle
2. Concomitant Menopur administration during ovarian stimulation or during frozen embryo transfer cycle
3. BMI \<18 or \>35
4. Age \<18 or \>46
5. Presence of hydrosalpinxes that communicate with the endometrial cavity
6. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), and persistent endometrial fluid
7. Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
8. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
9. Use of surgical procedures to obtain sperm
10. Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
11. Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
12. Declination of PGT testing
Assessment of the Age, Reasons, Oral Health Status and Dental Treatment Needs of Children in Their First Dental Visit

to asses the age, reasons, oral health status and dental treatment needs of children in their first dental visit.

We are going to provide each parent or guardian whose children fulfilling the inclusion criteria attending to Department of Paediatrics Dentistry at Cairo University to fulfil questionnaire which include multiple MCQ questions. The state of oral health and dental treatment needs will be assessed based on clinical examination, according to recommendations of the World Health Organization. The total number of teeth and number of teeth affected by decay (d, D) in every child will be recorded. The intensity of caries will be estimated based on the average dmf/DMF number, i.e. caries intensity index.

The dental treatment needs of each child will be assessed based on the following categories:

1. None: no restorative treatment required.
2. Simple: preventive treatment required, such as scaling and brushing, oral hygiene instruction (OHI), application of topical fluoride and fissure sealant.
3. Moderate: one or more of teeth require one or two surface restoration.
4. Complex: one or more teeth require three or four surface restoration / stainless steel crown, endodontic therapy and crown, and /or extraction(7) .

Reasons for first dental visit will be categories as :

a. Adaptive visit dental check-up preventive purpose. b. Tooth pain. c. Emergency case (tooth injury, abscess, infection). d. Decay noted by parent.

e. Any Other. We will explain to the parents and legal guardians the aim of the study without any guiding to prevent any information bias which may occur. The questionnaire will be given before the treatment and will be collected after it. Any children whose records will include missing information will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Children with Primary and mixed dentition.
* Children visiting the dentist for the first time (first dental visit

Exclusion Criteria:

* Children with systemic diseases or physical and mental problem.
* Children whose parents refuse participation
Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings

The purpose of this study is to correlate the link between palpatory findings of somatic dysfunction and gastrointestinal endoscopic evidence of changes in mucosa. The investigators' hypothesis is that there is a direct connection between somatic palpatory changes and intestinal mucosal changes via a somatovisceral/viscerosomatic mechanism.

The study protocol is limited to an extra physical examination (the focused structural exam) prior to a scheduled routine or diagnostic endoscopy. Immediately prior to the scheduled endoscopy, subjects enrolled in the study will be palpated by a Neuromuscular Medicine (NMM)/Osteopathic Manipulative Medicine (OMM) specialist for spinal tenderness, tissue texture changes and asymmetry or restricted range of motion as well as tenderness of Chapman points. The entire spine from the occipitoatlantal joint to the sacrum will be evaluated along with specific intercostal abdominal and lower extremity areas. The positive structural examination findings of spinal tenderness, tissue texture changes and asymmetry or restricted range of motion will be compared to the visual and pathological findings recorded in the operative report of the endoscopy procedure and the pathological report of any biopsies obtained during the endoscopic procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients already scheduled for upper or lower endoscopy at Kirksville Family Medicine Clinic
* Must be 21 years of age or older
* Subjects must be able to lie in the prone position for 30 minutes

Exclusion Criteria:

* Subjects cannot have history of spinal fractures or surgical intervention of the spine that could alter the palpatory findings of the spinal and paraspinal regions
* Subjects who are wards of the state or are unable to sign the consent form on their own behalf will be excluded
* Subjects will be excluded if they are unable to lie prone for 30 minutes
* Subjects will be excluded if they are not already scheduled for an endoscopy
Monitoring of Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Procedures

The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation.

The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Man or woman
* Patient cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level between 01/06/2020 and 30/09/2020
* Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Patient who expressed their opposition to the reuse of their data for research purposes
* Vertebroplasties of more than one level
* History of spinal surgery or vertebroplasty near the level concerned
Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"

The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

The primary objective of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment.

The secondary objective of this study is to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

Eligibility Criteria:
Criteria for Inclusion:

* Willingness to participate
* Ability to provide informed written consent
* Willingness to follow study protocol
* Eighteen years or older at the time of signing the consent form
* Cochlear implant experience for 12 months or greater
* Spoken English as the first language
* Access to a home computer which meets the minimal requirements to run appropriate program or the ability to use an electronic reader depending on which group the participant is assigned to.
* Reports being comfortable using a computer if in the LACE group

Criteria for Exclusion:

* Unable or unwillingness to sign informed written consent
* Unable or unwillingness to follow study protocol
* Non-English speaking or English as a second language
* No access to a computer if assigned to the LACE study group
* Reports not being comfortable using a computer if assigned to the LACE study group.