cyrilzakka/clinical-trials huggingface dataset:
Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.

We proposed the following primary hypotheses:

1. Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo.
2. Cue-provoked cravings (self-report and physiological responding) would be lower in participants receiving varenicline versus placebo. (Secondary indices of craving include heart rate and skin conductance.)
3. The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) would be lower in participants receiving varenicline versus placebo. (Secondary indices of nicotine reinforcement include smoking topography variables.)

A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation).

Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* Smoke at least 15 cigarettes daily
* Expired-air carbon monoxide (CO) \> 10 ppm
* Medically eligible to receive Varenicline.

Exclusion Criteria:

* Patients who are pregnant or lactating
* Who show evidence of renal dysfunction (BUN \> 25 mg/dL, or creatinine \> 1.3 mg/dL)
* Are using other smoking cessation medications
* Have current psychiatric disorders (i.e. major depression, manic depression, and/or psychotic episodes) as determined by the Structured Clinical Interview for DSM Disorders (SCID) (First et al., 1996), will be excluded
Artificial Intelligence vs Physicians for Breast Cancer Patients' Information

Chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. The use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health.

In clinical studies, chatbots are useful in gathering information through questionnaires directly submitted during conversations or through keyword analyzes. There is no longer any delay between the moment the patient notices a side effect, for example, and the moment when the patient announces it during a consultation. The responses given by the chatbot do not constitute medical advice and only provide information on the treatments envisaged or in progress in the context of the management of breast cancer.

The main objective of the study is to show that the chatbot Vik's answers to the common questions asked by breast cancer patients about their therapeutic management are at least as satisfactory as answers given by a committee of multidisciplinary doctors

A total of 20 most frequently asked questions will be defined on a cohort of 150 breast cancer patients. These questions will be asked on the one hand to the chatbot Vik and on the other hand to a multidisciplinary medical committee (surgeon oncologist, medical oncologist and oncologist radiotherapist). The scientific quality of the responses of the two groups will be validated by a second multidisciplinary group of physicians, independent of the first.

A cohort of 150 patients will then be randomized blind and in 1 to 1 to receive the responses of the chatbot Vik and the answers of the doctors' committee. Each patient will then have to answer the EORTC QLQ-INFO255-7 questionnaire, evaluating the quality of the medical information.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* paitents with breast cancer

Exclusion Criteria:

* Patient unable to formulate his opposition
* Patient with cancer other than breast cancer
A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis

The study is a Worldwide Survey on the Understanding of Psoriatic Disease among Patients with Psoriasis and Psoriatic Arthritis.

This is a cross-sectional, quantitative online survey of patients with psoriasis with or without concomitant psoriatic arthritis. Following assessment of participant eligibility via a 5-minute online screener, the 25-minute internet-based survey will be conducted without any follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who self-report to have been diagnosed with Psoriasis or Psoriasis and Psoriatic Arthritis before or at the time of data collection
2. Patients 18 years of age or older at the time of data collection
3. Patients who did not participate in surveys regarding Psoriasis or Psoriatic Arthritis in the last 4 weeks
4. Body Surface Area (BSA) of \>5 to \<10, with psoriasis affecting sensitive and/or prominent body parts: face, palms, hands, fingers, genitals, soles of feet or nails or a BSA of 10 and above, when psoriasis was at its worst
The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome

The purpose of this study is to thoroughly investigate how the interaction between black rice and human gut microbiota affects metabolic diseases, this study will recruit patients with Metabolic Syndrome (MS) and provide them with dietary supplementation of black rice (50 g/day) for 3 months to observe its effect on the development of MS. The focuses of this project are to elucidate how black rice consumption affects the composition and metabolism of intestinal bacteria as well as the development of MS, and to further analyze whether the changes in intestinal bacteria are associated with the changes in MS improvements.


Eligibility Criteria:
Inclusion Criteria:

* individuals meeting at least 3 of the following 5 criteria will be chosen:
* abdominal obesity: using the waist standard for Asians: waist≥90 for male and ≥80 for female
* high blood sugar: fasting plasma glucose≥5.6mmol/L (100mg/d L) or individuals diagnosed with diabetes and being treated
* hypertension: systolic blood pressure≥130 mm Hg or diastolic blood pressure≥85 mm Hg or individuals diagnosed with hypertension and being treated
* dyslipidemia: fasting total triglycerides≥1.70 mmol/L(150 mg/d L) or individuals undergoing lipid-lowering therapy
* fasting plasma high-density lipoprotein cholesterol\<1.03mmol/L (40mg/dL) for male or \<1.3mmol/L (50mg/dL) for female.

Exclusion Criteria:

* having current or former cardiovascular disease, including coronary heart disease (e.g., angina pectoris, myocardial infarction, coronary revascularization, abnormal Q waves in ECG), stroke (e.g., congestive, hemorrhagic, or transient ischemic stroke), and intermittent claudication caused by peripheral arterial diseases;
* severe clinical conditions that may compromise patients' participation in experiments, e.g., digestive diseases leading to inability to maintain black rice uptake, patients receiving parenteral nutrition supply, malignancies in progress, and mental illness;
* immunodeficiency disease or AIDS, chronic inflammation conditions
* drug abuse or alcoholism (\>80g/d).
Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)

The purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. The study will determine if differences in these genes will change the concentration of risperidone in the blood over time in children in relation to side effects and clinical response to risperidone.

To the knowledge of the investigators there are no studies documenting the pharmacokinetics and pharmacogenetics of risperidone in children with PDD. Currently the PPRU network is conducting a PK study whose aim is to establish a new enantio-selective micro-assay methodology and to generate preliminary population PK data of risperidone and its metabolites in PDD. This study focuses on pharmacogenetic evaluation of PDD patients having little or no effect, those that are unusually sensitive and those experiencing drug toxicity/adverse events at standard risperidone dosages.

In this study two 5 ml blood samples will be drawn at a regulary scheduled PK visit. Alternatively pooled waste blood samples or a buccal swab can be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 4 and 21 years.
* Patients meeting DSM-IV criteria for autistic disorder, Pervasive Developmental Disorder (PDD), or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS) and about to initiate clinical treatment or currently clinically treated with risperidone.
* Patients about to initiate clinical treatment or currently clinically treated with risperidone, or currently on risperidone as a participant in one of the multi-site Research Unit for Pediatric Psychopharmacology (RUPP) protocols.

Exclusion Criteria:

* Children taking psychotropic or other medication that will significantly interact with target CYP 450 isoenzyme activity, such to the discretion of the principal investigator (PI).
* Patients with known renal or hepatic dysfunction (e.g. serum creatinine, and transaminases or bilirubin exceeding age specific upper range limits) are not eligible.
* Failure of the parent/legal guardian to give informed consent.
Three-Dimensional Breathing Patterns in Postpartum Stress Urinary Incontinence

\*\*Clinical Trial\*\* The purpose of this clinical trial is to determine whether three-dimensional breathing training is effective in treating postpartum stress urinary incontinence (PPSUI). The main question it aims to answer is: Can three-dimensional breathing training improve or treat postpartum stress urinary incontinence?

Participants will:

* Receive one-on-one verbal health education covering the causes and risk factors of PPSUI, benefits and precautions of pelvic floor exercises and breathing, and implementation methods.
* Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.

User Experience Quality Control

1. Establish a dedicated technical team for system testing and quality control to ensure stable operation of the APP and accurate data.
2. Regularly update and optimize the virtual characters to guarantee the best user experience.

Data Security and Privacy Protection

1. Ensure that all user data is encrypted to protect user privacy and data security.
2. Comply with relevant regulations and standards to ensure the lawful use and protection of user data.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-35 years
2. Postpartum: 42 to 49 days
3. Diagnosed with pure postpartum stress urinary incontinence (PPSUI) by an experienced obstetrician/gynecologist during the first postpartum check-up, according to the International Continence Society (ICS) standards.

Exclusion Criteria:

1. BMI \&gt; 30 kg/m²
2. Cesarean section
3. Multiparous women
4. Pathological conditions or deformities of the spine
5. History of lumbopelvic surgery
6. Urogenital prolapse of grade 2 or higher
7. Professional athletes
8. Severe cardiopulmonary conditions during pregnancy or postpartum
9. Neurological diseases or cognitive impairments
10. Individuals unable to meet study requirements
Optimal Planning Target Volume With Stereotactic Radiosurgery

The purpose of this study is to estimate the rate of local control at the treated site of the metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (GTV). Each lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions randomized to each arm.

Stereotactic radiosurgery (SRS) is used either as definitive treatment alone or as a "boost" in combination with whole-brain radiotherapy (WBRT) for the treatment of brain metastases. To establish a target for SRS, the gross tumor volume (GTV) is typically defined as the contrast-enhancing volume on T1-weighted axial MRI images. In turn, the volume chosen for treatment (the planning target volume or PTV) is generated by expanding the GTV to account for microscopic extension of tumor beyond the MRI-visualized volume and deviations in patient positioning at the time of treatment., However, the optimal PTV in patients undergoing SRS of brain metastases has not been established.

This pilot randomized study of approximately 49 patients (representing a total of 80 brain lesions) should be sufficient to explore the effect of margin expansion around the GTV for brain metastases. The patients enrolled in this study will undergo radiosurgery to a planning treatment volume generated by expanding the GTV of each lesion by either a 1mm or 3mm margin. Each lesion, not each patient, will be randomized to receive either the 1mm or 3mm margin with 40 lesions randomized to each arm (a patient with multiple lesions potentially could have a lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm). The primary outcome of 12-month local recurrence and the secondary outcome of the rate of radionecrosis at the SRS treatment site will be lesion-specific outcomes. All other secondary outcomes will be patient-specific outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Life expectancy of at least 6 months.
* Karnofsky Performance Score greater than 70
* Graded prognostic assessment (GPA score 0.5 or greater
* 1 to 3 brain metastases unresectable
* Maximum tumor diameter no larger than 4cm

Exclusion Criteria:

* Primary lesion with radiosensitive histology (such as: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma.
* Metastases in the brain stem, pons or medulla or within 5 mm of optic apparatus
* Previous cranial radiation
* Pregnancy
Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes

The aim of this study is to determine the effect of chronobiological nutrition approach on the growth and breastfeeding processes of premature babies. It will be carried out in a randomized controlled experimental design. In the study, it is planned to have 2 groups as experimental and control. As a result of the power analysis using the G Power 3.0.10 program, 90% power; A total of at least 78 samples were found to be sufficient in the study with a 5% margin of error (n1: 39; n2: 39). However, considering that the case could be lost, it was decided to increase it by 20% to 94 babies. Infants will be assigned to groups using a stratified sequential block randomization method. Premature babies will be stratified by week of gestation, birth weight and sex, and then an equal number of babies will be assigned to each group by blocking.

The appointment of premature infants will be decided by sequential block randomization.

After the descriptive information of the babies assigned to the groups is recorded in the questionnaire, the experimental group will be fed by applying the chronobiological nutrition approach. The control group will be fed without applying the chronobiological nutrition approach. The discharge times will be calculated for both groups.


Eligibility Criteria:
Inclusion Criteria:

* Being treated in the NICU
* Gestation week is between 30 and 36
* The delivery took place in the hospital where the study was conducted.
* 70% of the daily enteral feeding is done with breast milk

Exclusion Criteria:

* The baby is less than 30 weeks of gestation and greater than 36 weeks of gestation.
* Having neurological sequelae
* Having Grade 4 intraventricular bleeding
* The development of problems such as sepsis, NEC, which may change the general condition
* Being followed in invasive mechanical ventilation
* Receiving narcotic analgesics and sedation
* The baby has been shipped from outside
* Having undergone gastrointestinal (GIS) surgery or having GIS anomaly
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159

The whole study includes 2 parts. Both the SAD study and MAD study are randomized, double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of CS0159. The SAD part also involves a pilot food effect (FE) study, designed to assess the food effect on single-dose PK profile in healthy subjects.

A total of 48 healthy subjects will be allocated to 1 of 6 cohorts (cohort A1\~A6) in the SAD study, each cohort including 8 subjects (6 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single oral dose of CS0159 or placebo.To ensure the safety for all SAD cohorts (including A3 in both treatment periods).

The MAD study will enroll 32 healthy subjects, allocated to 1 of 4 cohorts (cohort B1\~B4) and each cohort including 8 participants (6 subjects will receive IND products and 2 receive placebo). Subjects will be randomly assigned to orally receive the IND product or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and non-pregnant female volunteers
2. In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations

Exclusion Criteria:

1. Subjects with special dietary requirements and cannot follow a uniform diet.
2. Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
3. Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.
4. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients

This single-center observational prospective longitudinal study will assess cognitive, physical, and nutritional performance in acute leukemia patients undergoing intensive chemotherapy. Patients will provide informed consent prior to enrollment. Hematologists will oversee clinical management and approve evaluations, while physical and rehabilitation medicine specialists and a nutritionist will conduct assessments. Performance will be evaluated at admission, discharge, and three weeks (21 days) after starting chemotherapy.

This is an observational prospective longitudinal single-center study. All patients will be required to agree to participate in the study and to sign an informed consent prior to enrollment.

During the course of the study, the hematologists will manage the patients as per clinical practice and give clearance to perform each evaluation. All functional assessments and tests will be carried out by trained healthcare personnel with experience in the field of rehabilitation (either a Physical and Rehabilitation Medicine Resident, a Specialist, or a physiotherapist). A nutritionist will take care of assessing the nutritional aspects.

The aim of this study is to analyze the cognitive, physical and nutritional performance of AL patients hospitalized to receive intensive chemiotherapy (IC). Each item will be assessed at admission and discharge from the ward and after three weeks from the start of chemotherapy. Modifications of the considered items will be annotated and compared throughout the courses of chemotherapy, as well as relationship with indices of response and survival (Disease Free Survival, Overall Survival) will be explored. Such an effort will help further understanding how hematologic inpatients perform during IC treatment and what are the consequences on their quality of life and activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Patients affected by Acute Leukemia
* Inpatients performing intensive chemotherapy
* Patients with no restrictions on mobilization
* Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.

Exclusion Criteria:

* Age \<18 years
* Any medical condition that the attending doctor judges as limiting to perform study related tasks
PLR and NLR as Predictor Factors for Semen Abnormality

The aim of this study was to evaluate the relationship of seminal parameters with the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR), which are inflammatory markers, in men with an abnormal semen analysis and men with normozoospermia.


Eligibility Criteria:
Inclusion Criteria:

* adult above 18 years primary not do varicocelectomy

Exclusion Criteria:

* young secondry infertility recurrent varicocele
Feasibility Study of a Temporary Peripheral Nerve Stimulator

A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Are between 18-65 years old
* Have a Sunderland II-V peripheral nerve injury of the upper extremity
* Are receiving surgery within 14 days of injury

Exclusion Criteria:

* Nerve plexus injuries (e.g. brachial plexus)
* Nerve gap requiring graft/conduit, or extreme joint flexion
* Polyneuropathies
* Cognitive impairment and non-English-speaking
* Uncontrolled diabetes
* Surgical intervention \> 14 days of injury
* Co-enrollment in another clinical trial
* Pregnant women
Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection

Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing.


Eligibility Criteria:
Inclusion Criteria:

Suspected infection of bone tumour and biopsy taken for analysis

Exclusion Criteria:

Patient doesn't consent
Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries

The goal of this randomized clinical trial is to compare how the incorporation of Virtual Reality could influence in proprioception, kinesiophobia, functionality and catastrophism in people that are undergoing a rehabilitation treatment after a wrist fracture. The principal questions it aims to answer are:

* Evaluate the effect of using virtual reality added to standard rehabilitation of wrist injuries in proprioception impairment.
* Evaluate the effect of using virtual reality on psychological factors as kinesiophobia and catastrofism.
* Evaluate the effect of using virtual reality in functionality on wrist-injured patients.

Intervention will be:

* Control group: participants of this group will receive conventional rehabilitation of the wrist, plus a specific proprioceptive exercise program.
* Experimental group: participants of this group will receive the same treatment as the control group but adding virtual reality games at the end of the session.

Researchers will compare control and experimental group to see if an implantation of Virtual Reality could had benefits on function, kinesiophobia, catastrofism and proprioception.


Eligibility Criteria:
Inclusion Criteria:

* Adult (equal or more than 18 y/o).
* Suffering wrist injury
* Agree and sign informed consent.

Exclusion Criteria:

* Not had suffered a wrist injury
* Suffer from any mental, cognitive, neurological or musculoskeletal disorder
* Have cervical pathology/impairment
* Have visual or balance problems