cyrilzakka/clinical-trials huggingface dataset:
The Effect of Auditory and Tactile Stimuli in Traumatic Coma

This study focused on examining the effects of auditory and tactile stimuli to reduce sensory deprivation on consciousness, oxygen saturation and mean arterial pressure in traumatic coma patients.

Background: One of the most important problems experienced by patients treated in the intensive care unit due to traumatic coma is sensory deprivation.

Aim: In this study, it was aimed to examine the effects of auditory and tactile stimulus to be used in the prevention of sensory deprivation on consciousness, oxygen saturation and mean arterial pressure.

Study Design: The study was planned as a randomized controlled single-blind experiment with three groups. In the study, the patients in the Control group will be given a routine application, the patients in the Intervention A group will be given auditory stimuli, and the patients in the Intervention B group will be treated with tactile stimulus. Interventions will be administered once a day for seven days, for a total of seven times. The "block randomization method" was chosen as the randomization method. In this study, hospitals were taken as a block. An equal number of patients will be recruited from two hospitals and 15 patients will be distributed to three groups from each hospital using the "simple randomization method". 30 patients in each group and 90 patients in total will be included in the study.

Methods: The researcher applied to the patients hospitalized in the intensive care unit for 24-72 hours for seven days, once a day (seven times in total) between 10:00 and 15:00 (Intervention A: 10 minutes of audio recording will be played with headphones. Intervention B: 10 minutes) (5 minutes for one foot) foot massage will be applied. Glaskow Coma Score, oxygen saturation and Mean Arterial Pressure will be measured before and after each intervention (twice daily).

Eligibility Criteria:
Inclusion Criteria:

* Being treated in the intensive care unit for at least 24 hours due to traumatic coma,
* 18 years and older
* Relatives of those who agreed to participate in the study
* GCS score between 3-8 (GCS: 3-8 indicates coma)
* Without hearing impairment
* Having no authority for auditory stimulus
* No problem for foot massage (Lower extremity fracture, infection)

Exclusion Criteria:

* Who are under the age of 18
* Those whose relatives do not agree to participate in the research
* GKS score above 8
Prescribing Patterns of Antihypertensive Drugs in Uncomplicated Hypertension

Hypertension incurs substantial cardiovascular morbidity and mortality, particularly in primary prevention settings. General practitioners (GPs) play a pivotal role in the management of hypertension in primary care, yet variations exist among GPs. The determinants shaping GPs' antihypertensive medication (AD) prescription patterns in the setting of hypertension remain ambiguous. This investigation sought to elucidate how GPs' characteristics and professional activities influence AD prescriptions. A cross-sectional study utilizing a sample of 2,165 GPs was conducted in Normandy, France, in 2019. The ratio of AD prescriptions to overall prescription volume was computed for each practitioner. GPs were classified as 'low' or 'high' AD prescribers based on the median of this ratio. The ratio was examined in relation to GPs' demographic and professional variables such as age, gender, practice setting, years of experience, consultation frequency, the demographics and socioeconomic status of their patient panels, and prevalence of chronic conditions in patients. These associations were explored using both univariate and multivariate analyses.


Eligibility Criteria:
Inclusion Criteria:

* All patients who had at least one visit to their GP in 2019 were included, but minors were omitted.

Exclusion Criteria:

* minors
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of chronic hepatitis C.
* Liver biopsy performed within 2 years of Day 0 or during screening.
* Infected with hepatitis C virus genotype 1.
* Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
* Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
* Have compensated liver disease.

Key Exclusion Criteria:

* Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
* History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
* Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
* Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
* A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
* Active seizure disorder within the last 2 years.
* Organ transplant other than cornea and hair transplant.
* Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
* Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
* Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
* Received any experimental agent within 28 days prior to Day 0.
Evaluation of Saliva IL-6 Levels and Periodontitis

The aim of this study was to analyze the association between salivary IL-6 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced salivary IL-6 levels

Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary IL-6 levels. The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between salivary IL-6 levels and clinical periodontal parameters.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery

The goal of this study is to prevent blood clots from forming during surgery and a few days after total knee replacement surgery. This study will help us identify whether using a blood thinner in the operating room will stop blood clots from forming during the operation.

Venous thromboembolism is a major cause of morbidity and mortality after lower limb orthopaedic surgery in the adult patient. If, as suggested, DVT formation begins intra-operatively then targeting this period to prevent clot formation could substantially reduce DVT rates in the TKA population. The present study aims to determine whether this intra-operative regional heparinization technique is effective in preventing the intra-operative formation of DVT following TKA, as evidenced by venography in the early post-operative period.

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing unilateral primary total knee arthroplasty
2. Males and non-pregnant females ages 18-90 (pre-menopausal females will undergo a serum pregnancy test at screening)
3. Full weight bearing status (of non-operated leg) following surgery
4. Patient able to understand and willing to sign informed consent

Exclusion Criteria:

* 1) Known hypersensitivity to contrast media 2) Patients taking Metformin 3) Serum creatinine above 180Fmol/L 4) Platelets \&lt; 100 x 10 9/L, INR/PTT \&gt; 1.5 x normal 5) History of heparin induced thrombocytopenia 6) Allergy to heparin or fish 7) Prior use of protamine sulfate (i.e., protamine-containing insulin) 8) Vasectomized or infertile males 9) History of bleeding disorder 10) Bilateral total knee arthroplasty 11) History of stroke or myocardial infarction in previous 6 months 12) Traumatic spinal anaesthesia (two or more attempts and/or bloody) 13) History of previous DVT/PE 14) Active peptic ulcer disease (e.g., GI bleed, rectal bleed) 15) Currently on chronic anticoagulant therapy 16) Contra-indication to heparin 17) Patient is taking part in any other investigational study 18) Previous contralateral TKR or hip replacement
Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain

Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology.

The present study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female (≥ 18 years).
* Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet
* Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast.
* Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated.
* All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment).
* Patients who have previously received at least one systemic treatment for moderate to severe plaque psoriasis.
* Patients who have not previously been treated with a biological agent for moderate to severe plaque psoriasis.
* Patients who agree to participate in the study by signing the informed consent.
* Patients who are able to understand and complete the questionnaires specified in the study protocol.

Exclusion Criteria:

• Patients participating in another study at the time of entering the study.
Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.

For female patients, breast cancer patients have a high risk of developing depression, and approximately 20%-45% of breast cancer patients suffer from postoperative depression. Esketamine is an anesthetic in analgesia, and has presently become more and more popular for treating anti-depression, particularly for resistant depression.

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline

Eligibility Criteria:
Inclusion Criteria:

* At least18 years and pre-menopausal;
* scheduled to undergo elective breast cancer operation;
* American Society of Anaesthesiologists (ASA) risk classification I-II.
* Montgomery-asberg Depression Rating Scale (MADRS) score ≥22

Exclusion Criteria:

* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Inability to conform to the study's requirements
* Ongoing participation or participation in another study \<1 month ago
Scientific Information and Beliefs About Psychological Therapy

The success of psychological therapy can be impacted by patients' beliefs, such as their belief in their own ability to complete therapy and their belief that therapy will work. The goal of this clinical trial is to learn whether and when scientific information about distress and coping can affect beliefs about psychological therapy in adults who experience anxiety. This study will compare two different types of scientific information in a one-hour study. Participants will view educational videos for 30 minutes and complete surveys, including quiz questions about the videos and surveys about their beliefs about psychological therapy.


Eligibility Criteria:
Inclusion Criteria:

* Probable anxiety disorder based on the Overall Anxiety Severity and Impairment Scale (OASIS) score
* Fluent in English
* Willingness and ability to comply with the protocol
* Age 18-80
* The ability to enroll in the study through Prolific.com

Exclusion Criteria:

* Having previously seen the study's videos
Cerebrovascular Autoregulation During Sepsis

The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.


Eligibility Criteria:
Inclusion Criteria:

* clinical symptoms of sepsis, severe sepsis and septic shock
* possibility for measurement of transcranial doppler ultrasound
* age over 18 years

Exclusion Criteria:

* preexisting cerebrovascular disease
* preexisting immunological disease
* traumatic brain injury
* intracranial infectious disease
* pregnancy
Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer

RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.

PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the feasibility and safety of TORS (Transoral robotic surgery), including: total operative time, blood loss, hospitalization time, need to convert to an open procedure, intra-operative as well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic outcomes, disease free survival, local control rate and overall survival. II. To collect normative data regarding objective functional outcomes (FO) which may impact quality of life in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy tube placement and tracheostomy placement, and with regards to speech, swallowing function and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral robotic microsurgery. After completion of study treatment, patients are followed up periodically for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space
* Surgical access is amenable to treatment with conventional transoral surgical procedures
* ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach
* Patients should have no serious acute infection
* Patients must sign a study-specific informed consent form

Exclusion Criteria:

* Evidence of distant metastases (below the clavicle) by clinical or radiographic measures
* ASA score \> 4; ECOG PS score \> 3
* Pregnancy (during first or 3rd trimester - due to risks of anesthesia)
* The presence of medical conditions which contraindicate general anesthesia
* Unexplained fever or untreated, active infection
* Inability to obtain exposure to allow performance of the planned transoral surgical procedure
* Proposed surgical site with history of prior treatment: radiation
* Tumor adherent to carotid artery or jugular vein
* Fixation to pre-vertebral tumor
* Mandibular invasion
Effect of Electroacupuncture on SAP With MODS

1. Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial
2. Research center: single center
3. Design of the research: A randomized, double-blind and parallel controlled study
4. Object of the research: The patients over 18 years that met the criteria of SAP and with more than 2 organs failure.
5. Sample size of the research: A total of 220patients,110 cases in each group
6. Interventions: The acupuncture points for electroacupuncture are Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) points . Participants in the treatment group underwent 30 minutes acupuncture (0.30mm×70mm) at above points once a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of treatment. Participants in the control group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
7. Aim of the research: To investigate the effect of electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome.
8. Outcome #Primary outcomes: All-cause 28-day mortality. Secondary outcomes: Duration of organ failure; The incidence of pancreatic necrotic tissue infection; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay
9. The estimated duration of the study#2 years.

This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) were selected for electroacupuncture treatment, accompanied with evaluating the effects on 28-day mortality in SAP patients with MODS, as well as the duration of organ failure, the incidence of pancreatic necrotic tissue infection and length of hospital stay . To clarify the effect of electroacupuncture on SAP patients with MODS is of great significance to the clinical applications and popularization of traditional acupuncture treatment across the world.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnosis of severe acute pancreatitis (Atlanta diagnostic criteria), within 1 week of onset
2. Combine 2 or more organ failures at the same time, and the duration is greater than 48h
3. Age ≥18 years old;
4. Obtain informed consent.

Exclusion Criteria:

1. Pregnancy pancreatitis;
2. Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension;
3. Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.).
4. Those who have a medical history of acupuncture and moxibustion or are not sensitive to acupuncture and moxibustion.
5. Those who refuse to participate in the research