cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction

The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:

Is it possible that the device can treat olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction?

Olfactory training is a new therapy that improves olfactory function by exposing patients to various types of odors through regular, repetitive active sniffing. However, there are still many problems with olfactory training in clinical practice, including poor patient adherence, lack of standardized and uniform procedures, and inconvenient carrying of devices.

Now, the investigators have initially developed an olfactory training device based on expiratory pressure, and the advantages of the improved device are as follows: bi-directional airflow, positive pressure and the function of voice prompts and automatic counting.

In this study, the investigators planned to recruit 72 patients and divided them into two groups for olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on the comparison of the outcomes of the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with olfactory disorder when TDI score was less than 30.75.
2. Patients would perform Sniffin' Sticks examination.
3. Voluntarily sign the informed consent form
4. Able to undergo olfactory training and participate in follow-up visits

Exclusion Criteria:

1. Smoking
2. Combined with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc.
3. Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks will be excluded.
4. Patients who cannot tolerate olfactory function testing and treatment
5. Severe coexisting diseases: such as malignant tumors, life expectancy \<2 years
6. Patients who are pregnant or planning to become pregnant
7. According to the researcher's judgment, the patient is unable to complete this study or cannot comply with the requirements of this study (such as memory or behavioral abnormalities, depression, heavy drinking, past breach of contract)
Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes

Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling sessions and nicotine replacement therapy (NRT)) or 2) standard care + contingency management (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers)

Participants will be recruited through the Thoracic Oncology Program and the Head and Neck Cancers Program. At the time of their initial surgical consultation, surgeons and their support staff in the Thoracic Oncology Program and Head and Neck Cancers Program will advise all of their patients about the present smoking cessation study as well as the Smoking Cessation Service at Smilow Cancer Hospital/Yale-New Haven Hospital and other resources in the community. Patients who express interest in the study and agree to quit smoking will be met at Smilow/YNHH for an intake appointment by a research assistant. Informed consent will be obtained prior to any other procedures, then during the intake session medical and tobacco use histories and breath carbon monoxide (CO) levels will be obtained from all participants. Study eligibility will be determined in concert with the surgeon and the principal investigator. As agreed upon by the surgeons, if participants meet eligibility criteria, their surgery will be scheduled for approximately 3 weeks after they enter the study.

Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling sessions and NRT) or 2) standard care + contingency management (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers). After this, all subjects will be met by a study therapist for their first counseling session, which is a preparation to quit session. The study counseling protocol will be based on practical counseling, which is a cognitive behavioral evidence based smoking cessation treatment modality (Fiore, Jaén et al. 2008). All participants will be asked to set a quit date within a week after this session. Consistent with the standard practice of the Smoking Cessation Service, all patients will receive pharmacotherapy in conjunction with counseling.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older,
2. smoking 5 or more cigarettes per day, and
3. diagnosed with any type of head, neck, or thoracic cancer,
4. agreement on a 3-week pre-surgical tobacco intervention by both patient and surgeon.

Exclusion Criteria:

1. Unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
2. history of allergic reactions to adhesives,
3. females of childbearing potential who are pregnant, nursing, or not practicing effective contraception.
Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms

To select among different dietary and clinical conditions the most appropriate to assess the impact of a fermented milk product on gas-related symptoms

To select among different dietary (mild or high flatulogenic diet) and clinical conditions (FGID or non-FGID population) as well as different measured parameters (self-completed questionnaires assessing gas related symptoms, digestive well-being and bowel functions, gas volume distribution in the colon by MRI, volume and composition of gas collected per anus and frequency of gas evacuations per anus), the most appropriate to assess the impact of a fermented milk product on gas-related symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 1=FGID group: Subject with body mass index (BMI) between 18.5 and 30.0 kg/m2 (bounds excluded); Subject with a functional gastrointestinal disorder according to ROME III criteria; Subject complaining of excessive intestinal gas evacuation (i.e. flatulence); Subject willing to follow strict dietary instructions; Subject who normally consumes dairy products;
* 2=Non-FGID group: Subject with body mass index (BMI) between 18.5 and 30.0 kg/m2 (bounds excluded); Subject with no functional gastrointestinal disorder according to ROME III criteria; Subject with no gastrointestinal disorders according to investigator's medical assessment; Subject willing to follow strict dietary instructions; Subject who normally consumes dairy products

Exclusion Criteria:

* 1=FGID group: Subject with any disease/disorder which can interfere with the gas collection; Subject with any antecedents of digestive surgery; Subject with any intake of antibiotics in the previous 2 months; Subject with any current use of any medication with potential central nervous system effects (except for chronic treatment with anxiolytics and antidepressants started at least 3 months before inclusion in the study); Subject taking drugs that might modify gastrointestinal function (except for chronic treatment with laxatives, started at least 3 months before inclusion in the study) ;
* 2=Non-FGID group: Subject with any disease/disorder which can interfere with the gas collection; Subject with any antecedents of digestive surgery; Subject with any intake of antibiotics in the previous 2 months; Subject with any current use of any medication with potential central nervous system effects; Subject taking drugs that might modify gastrointestinal function
Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective pancreaticoduodenectomy

Exclusion Criteria:

* Patients with chronic pain
* Patients with psychiatric disease
* Patients with nonsteroidal antiinflammatory drugs allergy
* Patients with renail dysfunction
* History of drug addiction
* Pregnant patient
* Inability to use a PCA device
Oral and Intravenous Methadone for Analgesia in Cardiac Surgery

The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

• Undergoing elective cardiac surgery as the first case of the day in an operating room

Exclusion Criteria:

* Chronic pain requiring opioid medications as an outpatient
* Opioid use disorder on medication assistance treatment
* Prolonged QTc \> 500ms
* Chronic kidney disease with eGFR \< 30mL/min
* Documented cirrhosis
* Intolerance to methadone
* Subsequent surgeries after index surgery
Motivational Assessment Program to Initiate Treatment

Substance abuse treatment in the criminal justice system can reduce drug use and related criminal behavior. Although drug and alcohol treatment are common mandates in criminal justice programs, only a minority of clients actually initiate treatment. This proposal will compare two intervention formats that target motivation to initiate and engage in treatment among a group of probationers who have drug or alcohol treatment conditions. Six hundred drug and alcohol offenders in two probation sites (Baltimore, MD and Dallas, TX) will be randomized to receive: 1) an in-person motivational interviewing session (MI), 2) a motivational computer program (MC), or 3) supervision intake and monitoring as usual (SAU). The MI condition will be structured along the lines of the "Check-Up" format which consists of an assessment and personalized feedback delivered in an MI style; the content of the MC condition will be drawn from previous literature on effective motivational computer programs. Both interventions will be delivered at the start of the probation process, with follow-up assessments at 2 and 6 months. Primary outcomes include engagement and participation in substance abuse treatment; secondary outcomes include drug and alcohol use, probation progress, criminal behavior, and HIV testing and care. This project will be the first to develop and test two interventions for encouraging criminal justice clients to follow through with treatment recommendations, with the goal of increasing treatment initiation, and reducing subsequent drug use and criminal behavior. It also contributes to ongoing partnerships with two large probation agencies-the Dallas County Supervision and Corrections Department and the Maryland Division of Parole and Probation.

Specific Aims

* Develop two intervention formats (Motivational Interviewing (MI) and Motivational Computer (MC)) for increasing motivation to initiate and engage in substance abuse treatment and/or HIV / AIDS testing and, if appropriate, HIV care.
* Test the efficacy of MI and MC on treatment initiation and participation, substance abuse, HIV testing/care, and recidivism, as compared to Supervision As Usual (SAU);
* Evaluate offender characteristics (e.g., risk level, gender, ethnicity, motivation) as potential moderators of the intervention effect; and,
* Assess the relative cost and cost-effectiveness of MI and MC on substance abuse treatment and/or linkage to or participation in HIV/AIDS care, supervision outcomes, recidivism, and substance abuse.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years old
* Drug or Alcohol use in the last 90 days

Exclusion Criteria:

* \<18 years old
* Cannot speak English
* Already participate in a substance abuse treatment
Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

This study aims to evaluate the efficacy and safety of adebrelimab combined with the AG regimen in patients with unresectable locally advanced or metastatic pancreatic cancer who have received at least one prior line of systemic therapy but have not undergone gemcitabine-based treatment.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent；
* Aged 18-75 years (inclusive)；
* Histologically or cytologically confirmed pancreatic cancer；
* Unresectable locally advanced or metastatic pancreatic cancer, as determined by the investigator；
* Disease progression after prior treatment with at least one systemic therapy;
* No previous immunotherapy;
* No previous gemcitabine-based chemotherapy;
* Have at least one measurable lesion (according to RECIST 1.1 criteria);
* ECOG 0\~1；
* The estimated survival time is greater than 3 months;
* Adequate Organ Function (within 28 days prior to first dose): Hematology: White blood cell count (WBC) ≥3.0×10⁹/L Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelets (PLT) ≥100×10⁹/L Hemoglobin (HGB) ≥90 g/L Liver Function: Aspartate aminotransferase (AST) ≤2.5×ULN Alanine aminotransferase (ALT) ≤2.5×ULN Total bilirubin (TBIL) ≤1.5×ULN Renal Function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥60 mL/min (calculated via Cockcroft-Gault formula). Coagulation: International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Cardiac Function: No clinically significant abnormalities on electrocardiogram (ECG)；
* Male subjects and females of childbearing potential must agree to use effective contraceptive measures from the first dose until 3 months after the last dose of the study drug.

Exclusion Criteria:

* The subject has any known active autoimmune disease;
* Subjects have any complications requiring systemic treatment with corticosteroids such as prednisone (\> 10mg/ day) or have used immunosuppressive drugs within 14 days prior to initial administration;
* Subjects received tumor vaccines or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to initial administration;
* Subjects are participating in another clinical trial or have received a drug intervention from another clinical trial within 4 weeks prior to the first dose;
* Subjects have other malignancies requiring treatment;
* Clinically significant cardiovascular disorders；
* Prior allogeneic organ transplantation or hematopoietic stem cell transplantation；
* Serologically confirmed HIV infection；
* Active hepatitis B (HBsAg-positive with HBV-DNA ≥10³ copies/mL). Active hepatitis C (HCV antibody-positive with detectable HCV RNA and requiring antiviral therapy)；
* Known hypersensitivity to monoclonal antibodies or any component of adebrelimab；
* History of severe allergic reactions to gemcitabine or nab-paclitaxel；
* Any situation that the investigator believes may compromise the validity of the trial or patient safety.
Factors Influencing the Deterioration From Cognitive Decline of Normal Aging to Dementia Among Nursing Home Residents

Background: A dearth of differential research exists regarding the determinants of mild cognitive impairment (MCI) and moderate cognitive impairment or dementia among nursing home residents. This study aimed to identify and examine the association between medical factors (number of comorbidities, hospitalization, disability, depression, frailty and quality of life) and moderate cognitive impairment or dementia in nursing homes residents.

Methods: A cross-sectional design was used in this study. Convenience sampling of 182 participants was conducted in nursing homes located in the central part of Jordan. Montreal cognitive assessment (MoCA) was used to screen both MCI and moderate cognitive impairment or dementia. Bivariate analysis, including t-test and ANOVA test, and logistic and linear regression models were used to examine and identify the medical factors associated with moderate cognitive impairment or dementia compared to mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Jordanian participants, aged 60 years and older, and living in nursing homes

Exclusion Criteria:

* neurological disorders, such as stroke or brain injury
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.


Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain.
* Taking oral, transdermal, intravenous, or subcutaneous opioids.
* Willingness to discontinue all pre-study laxative therapy and utilize only study permitted rescue laxatives.

Exclusion Criteria:

* History of chronic constipation before the initiation of opioid therapy.
* Other GI disorders known to affect bowel transit.
* Women who are pregnant, breast-feeding, or plan to become pregnant.
Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)

Assess the reproductibility of PC-MRI for cerebrospinal fluid movements through the interventricular foramina on volunteer subjects.

It is a monocentric interventional prospective study. Each subject will have to pass two MRI. Phase contrast MRI (PC-MRI) will be calibrated for each subject by assessing the optimal encoding velocity. Three sequences including the aqueduct and the two interventricular foramina (IVF) will be done. The signal will be analysed by syngo.via software after defining by two different investigators the region of interest (ROI) which correspond to the IVF or the aqueductal lumen. Descriptive statistics will test the intra-individual and inter-observer consistency based on 4 flow parameters.

Eligibility Criteria:
Inclusion Criteria:

* Mini-Mental State Examination score \> 28/30

Exclusion Criteria:

* MRI contraindication
* Medical or surgical history related to following pathologies: nervous system disease, cardiac arrhythmia, cardiac or respiratory insufficiency.
* Long-term medical treatment
* Ongoing pregnancy
Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18-55 years of age, inclusive.
2. Subject meets the following criteria for a diagnosis of BED:

   * Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating).
   * The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
   * Marked distress regarding binge eating.
   * The binge eating occurs, on average, at least 2 days a week for 6 months.
   * The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
3. Subject is consistently able to swallow a capsule.

Exclusion Criteria:

1. Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
2. Subject is receiving psychotherapy or weight loss support within the past 3 months.
3. Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
4. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
5. Subject has abnormal thyroid function.
6. Subject initiated treatment with a lipid lowering medication within the past 3 months.
7. Subject has a history of moderate or severe hypertension.
8. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
9. Subject has glaucoma.
10. Subject is female and pregnant or nursing.
11. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
The Effect of Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery

The purpose of this study was to investigate the effects of three different glycemic treatment conditions (tight, conventional, and standard) in the intraoperative period on: 1) postoperative surgical site infections, and 2) postoperative procalcitonin, and C-reactive protein levels in patients undergoing open-heart surgery. Secondary aims of the study were to investigate the effects of the three glycemic treatment conditions on: 1) intraoperative blood glucose; 2) intraoperative glycemic stability; and 3) intensive care unit length of stay, in patients undergoing open-heart surgery.

An experimental design with a multilevel, single factor, within-subjects design was utilized. Patients were nested within anesthesia provider teams. The design was counterbalanced by means of a Latin square, where each of three anesthesia provider teams dispensed each of three glycemic treatment conditions once.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 21
* on cardiopulmonary bypass or off cardiopulmonary
* elective or urgent coronary artery bypass graft (CABG) surgery
* CABG with or without combined valve surgery
* valve surgery

Exclusion Criteria:

* chronically immunosuppressed
* suffered from end-stage organ disease
* currently had active infections
* underwent emergent or salvage CABG surgery
* had an implanted insulin pump
* were in another interventional clinical trial.