cyrilzakka/clinical-trials huggingface dataset:
Diaphragmatic Thickness and Functional Exercise Capacity in Lobectomy Surgeries With Thoracotomy and VATS

The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. The aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (VATS).

The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. The aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (VATS). In this study we will evaluate respiratory muscle strength, functional exercise capacity, diaphragmatic thickness, postoperative pulmonary complications, pain, dyspnea, pulmonary function, functional status, anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* Being a lung cancer patient scheduled for standard thoracotomy, muscle sparing thoracotomy, or lobectomy with VATS,
* Being clinically stable,
* Volunteering to participate in the study,
* be between the ages of 18-75,
* To be cooperative in the tests to be done.

Exclusion Criteria:

* Having an orthopedic and neurological condition that prevents walking, - Having undergone any surgery on the thoracic wall,
* Diagnosed with small cell lung cancer.
Opioid Withdrawal Symptoms in Critically Ill Patients

Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU). Opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. However, prolong administration of opioids especially in mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly weaning or acutely disruption. The opioid withdrawal symptoms (OWS) are well reported in critically ill children that cause discomfort and prolong weaning from mechanical ventilation. Weaning opioids and treatment of withdrawal symptoms are needed in order to decrease ventilator days, ICU and hospital length of stay. Conversely, there is lack of knowledge about incidence, clinical presentation, time course and appropriated assessment tool for withdrawal detection. Therefore, we conduct the study to explore an incidence of OWS, to identify factors associated OWS, to establish the assessment tool for OWS, and to report efficacy of the pharmacological treatment for OWS, in adult critically ill patients.

The primary objective of the study is to explore incidence of OWS in adult critically ill patients. The secondary objectives are 1) to identify factor associated OWS, 2) establish the assessment tool for OWS for adults and 3) to report efficacy of the pharmacological treatment in OWS in adults patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* On mechanical ventilator at least 24 hours
* Received continuous infusion of opioid at least 24 hours
* Patient or legal surrogate who is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion Criteria:

* Severely disturbed behavior pattern on account of underlying neurological disease (status epilepticus, encephalopathy, head trauma, brain injury, spinal cord injury)
* Preexisting psychiatric diagnosis
* Substance abuse prior to ICU admission
* Chronic alcohol drinking
* Pregnancy
* End-of-life care
* Death during ICU admission or during opioid IV infusion
Effects of Hypotensive Anesthesia on Thiol Disulphide Balance

Oxidative stress at the cellular level and the effects of the antioxidant system on the anesthetic drugs make the anesthesia method more important. Hypotensive anesthesia or controlled hypotension is an anesthetic technique routinely used in many operations (ENT, orthopedic, plastic surgery, etc.) to reduce intraoperative bleeding and to provide a more open surgical area.

In this study, investigators aimed to investigate the effects of hypotensive anesthesia on thiol / disulfide balance from oxidative stress markers.

Hypotensive anesthesia is caused by hypoperfusion and hypoxia-induced oxidative stresses at the tissue level and can initiate cell damage. Many methods can be used alone or in combination to create hypotensive anesthesia. İnvestigators will investigate whether hypotensive anesthesia causes an effect on the cellular level.

This study will be performed prospectively with 80 participants with ASA 1-2, aged 18-60 years, undergoing hypotensive anesthesia in the operation of the septoplasty in Recep Tayyip Erdoğan University Medical Faculty Training and Research Hospital. Participants with uncontrolled hypertension, diabetes mellitus, cerebrovascular disease, cogulopathy, morbid obesity (BMI ≥35) and renal disease will not be taken. Anesthesia induction and management will be standardized. Hypotension in the participants will be maintained by reducing the mean arterial pressure (MAP) by 30% or 55-65 mmHg according to the initial value. In the study, the heart rate (HR), MAP, peripheral O2 saturation (SpO2), ETCO2 (end-tidal carbon dioxide) values, and BIS (Bispectral index) values showing anesthesia depth are to be followed. Participants will receive venous blood sample of up to 2 ml before the anesthesia induction and 10 minutes to finish of the hypotensive anesthesia, from the untreated vein. Thiol disulfide levels from this blood sample will be studied in the biochemistry research laboratory using the method developed by Erel et al.

Eligibility Criteria:
Inclusion Criteria:

(American Society of Anesthesiologists) ASA Classification I - II controlled hypotensive anesthesia applied septoplasty operations

Exclusion Criteria:

Patients with uncontrolled hypertension, Diabetes Mellitus cerebrovascular disease, coagulopathy, morbid obesity ((BMI ≥35) and those with renal disease will not be taken
Mandibular Single Implant Overdenture: a Prospective Clinical Trial

Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture.

In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture.

Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous residents of nursing homes treated in the mobile dental unit 'Gerodent'.
* They have to be willing to commit to 1.5 year of participation in the study.
* They have to be edentulous for at least one year before starting the implant procedure.

Exclusion Criteria:

* Medical conditions contraindicating implant surgery (unregulated diabetes type II, bisphosphonates)
* History of radiotherapy in the head and neck region
* Insufficient bone for an implant of at least 10 mm length and 4 mm diameter
* Previously treated with dental implants
Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies, such as QS21, use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have small cell lung cancer that has responded to initial therapy.

OBJECTIVES: I. Compare the antibody response after immunization with polysialic acid keyhole limpet hemocyanin (PSA-KLH) conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 in patients with small cell lung cancer. II. Assess the clinical toxicities resulting from these regimens and from the immune response in this patient population.

OUTLINE: Patients receive polysialic acid keyhole limpet hemocyanin (PSA-KLH) conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 subcutaneously weekly on weeks 1-4 and on weeks 8 and 16 for a total of 6 vaccinations. Patients are followed at 2 weeks, and then every 3 months for up to 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer Must have completed initial therapy with or without radiotherapy and have achieved a complete response or partial response to therapy without subsequent evidence of disease progression Must have completed any radiotherapy including prophylactic cranial radiotherapy as part of the planned primary therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Lymphocyte count at least 500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Not specified Cardiovascular: No New York Heart Association class III or IV heart disease Other: No known immunodeficiency or autoimmune disease No other active malignancies within the past 5 years except nonmelanoma skin cancer No clinically significant peripheral neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered Endocrine therapy: See Disease Characteristics At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered No concurrent corticosteroids Radiotherapy: See Disease Characteristics At least 4 weeks but no more than 12 weeks since prior initial therapy and recovered No prior radiotherapy to the spleen Surgery: No prior splenectomy
Depression, Anxiety and Stress in High School

Background: Social isolation secondary to the pandemic can predispose the population to mental health issues in the future, especially teenagers. The Depression, Anxiety, and Stress Scale (DASS) is a valuable self-report scale since it may be used to screen for anxiety, depression, and stress in one questionnaire. In the last years, it has been observed effective in detecting these symptoms in teenagers.

Aims: Identify the prevalence of depression, anxiety, and stress in high school students during the COVID-19 pandemic This is an observational cross-sectional study.

For this study, the validated Spanish version of DASS-21 will be used. Qualitative variables will be evaluated through central tendencies, such as mean, standard deviation, and frequencies. The inferential analysis of categorical variables will be performed using the chi-squared test, analysis of variance (ANOVA), or Kruskal Wallis test as appropriate. For quantitative variables, Student's t-test or Mann Whitney U test will be performed depending on their distribution.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents from 14 to 22 years old.
* That they voluntarily agree to participate, and consent.

Exclusion Criteria:

* Adolescents with depression, anxiety, and stress disorders previously detected
* Patients in psychiatric treatment for depression, anxiety, or stress.
* Participants who don´t consent to participate
Hematoma Block for Distal Radius Fracture

The purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal radius fracture reduction.

Hematoma blocks are safe and effective in providing analgesia for fracture reduction1-4. They involve injecting lidocaine directly into the fracture line for analgesia. The physician aspirates blood prior to injection to confirm placement in the hematoma created by the fracture. However, the procedure can be technically difficult if the fracture line is difficult to palpate, for example, due to significant swelling or body habitus. Ultrasound has been shown to improve efficacy in other analgesic procedures such as peripheral nerve blocks5 and also in identifying fracture lines6. There have been case reports and case series which have shown the feasibility and effectiveness of ultrasound guided hematoma blocks for analgesia in patients undergoing reduction for distal radius fractures7,8. To our knowledge there are no randomized controlled trials comparing the use of ultrasound guided hematoma blocks versus traditional hematoma blocks in achieving analgesia for distal radius fracture reduction.

In this study, we will determine if ultrasound improves the efficacy of analgesia when performing hematoma blocks for reduction of distal radius fractures.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥ 18 years old presenting to the emergency department with complaint of distal radius fracture

Exclusion Criteria:

* High acuity/distress per the Attending ED physician
* Altered mental status or intoxication
* Aphasia, mental retardation, dementia, or insurmountable communication barrier
* Acute psychiatric illness
Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients

The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone), on older adults who reside in a nursing home and have poor sleep as determined by wrist actigraphy.

Older people living in nursing homes do not sleep very well for many reasons including pain, sleep disorders like sleep apnea (when someone briefly stops breathing during sleep) and night time urination, as well as the environmental disturbances caused by living in the nursing home, such as noise and disruptive care routines. Previous studies' attempts to improve sleep by modifying the nighttime nursing home environment have shown limited improvements in sleep.

This study will evaluate how well eszopiclone (Lunesta) works to improve sleep in nursing home residents with poor sleep. Eszopiclone is FDA approved and has been tested on older adults living in the community, but not on older adults living in nursing homes. We expect sleep to improve on the study drug, in comparison to the placebo. Based on adverse events reported in previous samples of older subjects, we expect the study drug to cause very few side effects.

We will evaluate how well eszopiclone works by measuring sleep at night and during the day. After consenting and final determination of eligibility, participants will complete a baseline phase to assess typical sleep, as well as daytime alertness and activity, thinking, memory and mood. Sleep at night and during the day will be objectively assessed with wrist actigraphs for all subjects. Approximately half will also receive polysomnographic studies to assess nighttime sleep. Subjects who sleep more than 75% of the time they are in bed will not continue in the study. Subjects will be randomized to one of two treatment groups-one will receive the active drug and then a placebo and the other will receive the placebo first and then the active drug. Following randomization, subjects will complete a brief run-in phase and then enter the treatment phase. Assessment of sleep and other measures will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Nursing Home Patients
* Age 65 and above

Exclusion Criteria:

* Under age 65
* Anticipated short stay (short term or hospice)
* Severe behavioral disturbance
* Unstable drug regimen in prior 2 weeks
* Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic

  * once per week in prior 2 weeks
* Use of a potent inhibitor of CYP3A4
* Parkinson's with uncontrolled tremor
* Severe Dementia
* Severe Sleep Apnea
* Inability to tolerate wrist Actigraphy
* Sleep Efficiency \>75%
* Sleep apnea
* Sleep efficiency of greater than 75% during the night.
The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients

In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* Age 1.5-6 years

Exclusion Criteria:

* known or predicted difficult airway
* body mass index \> 35 kg m-2
* risk of aspiration
Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?

During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use the postoperative antibiotics after surgery. However, there is no consensus regarding the actual need of postoperative antibiotics in these cases and the use of postoperative antibiotics remains controversial.

Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the patients who has no evidence of systemic infection, according to the usage of postoperative antibiotics or not. The investigators expect that the routine use of postoperative antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have no effects on the postoperative morbidity.

Primary outcome of this study is the confirmation of safety in the cases of acute cholecystitis without postoperative antibiotics usage after laparoscopic cholecystectomy. For this purpose, the investigators compare the surgical infectious outcomes including the wound infection or abdominal infections according to the usage of postoperative antibiotics after laparoscopic cholecystectomy.

Secondary outcome of this study is the confirmation of efficacy according to skip the use of postoperative antibiotics after laparoscopic cholecystectomy.

The investigators estimate the efficacy using the comparing the outcomes such as duration of hospitalization according to the use of postoperative antibiotics or not.

Eligibility Criteria:
Inclusion Criteria:

* grade I Tokyo guideline for acute cholecystitis
* grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation

Exclusion Criteria:

* chronic cholecystitis
* gallbladder polyp or gallbladder cancer
* the patient who underwent reduced port surgery
* the patient who underwent common bile duct exploration during the operation
* the patient who underwent concurrent operation
* the patient who had past history of upper abdominal surgery
* the patient who had a immunodeficiency state
* the case which had a suspicion of delayed bile leakage
* the case which had a incomplete cystic duct ligation
* the patient who underwent open conversion surgery during the operation
* the patient who had a high risk of bleeding
Effect of Indoor Plants on Cardiopulmonary System

This is a randomized controlled human exposure crossover study, aims to explore the health benefits of indoor plants on cardiopulmonary system on adults.

The researchers will conduct a randomized cross-controlled trial involving 48 healthy adults in Hangzhou, China. These participants will be randomly assigned into two groups, each comprising 24 individuals. Each participant will undergo two separate exposures in an office setting: one exposure without any plants present, and another exposure with 34 to 38 potted plants. A washout period of at least 4 weeks will be implemented between the two exposures. Questionnaires, physical examinations and the collection of biological samples will be conducted prior to exposure and after exposure. In addition, the monitoring of negative air ion, air pollutants and noise exposure, as well as collection of environmental microbial samples, will be conducted on weekdays. Researchers will gather samples of blood, urine, nasal secretion, and exhaled breath condensate from participants.

Eligibility Criteria:
Inclusion Criteria:

* Living in Hangzhou during the study period;
* Non-smoking, no history of alcohol or drug abuse;
* Staying indoors in daytime we required.

Exclusion Criteria:

* Current or ever smokers;
* Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects with chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects with a history of major surgery;
* Medication use or dietary supplements intake in recent two months;
* Unable to cooperate with follow-up.
Operational Assessment of Point-of-Care Diagnostics in Primary Healthcare Clinics

Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South Africa during the last 10-15 years. The investigators sought to determine the existing availability, current usage and future need of POC tests among rural primary healthcare (PHC) clinics in South Africa's KwaZulu-Natal Province.

Several new diagnostics generation devices are specifically designed to assist clinical staff replacing the equivalent laboratory tests and allowing a wide range of disease diagnoses to be performed immediately at the POC. The clinical impact of POC diagnostics has been shown in a variety of diseases conditions, particularly HIV/AIDS and TB. The World Health Organisation (WHO) called for new clinical diagnostics methods that are designed to function in setting with limited access to laboratory services. Thus, leading to an increase in marketing, manufacturing and development of POC diagnostics instruments and reagents for use in clinical POC. The advent of POC tests in South Africa has led to an improved control of infectious diseases such as HIV and mycobacterium tuberculosis (TB), in this era of drug-resistance. Increased availability of POC test in rural and resource-limited settings is encouraged.

To maximize the impact of novel diagnostics on patient outcomes in resource-limited settings, the implementation of new diagnostics must be performed within a given context and culture. However, the population-level of diagnostic utility in South Africa is not known. The investigators aim to estimate the level of POC diagnostic availability, usage and need in rural South Africa, using a cross sectional survey of rural primary healthcare (PHC) clinics in KwaZulu Natal (KZN). The survey focused on the conditions for which the respondent considered a POC test might help improve their clinical decision making during patient care. Determining the current accessibility, availability, usage and need for POC diagnostics in rural and resource limited settings can help inform developers and implementers of POC diagnostic services on context-specific deployment and implementation of POC diagnostics to address the unmet needs of patients in these settings.

Eligibility Criteria:
Inclusion Criteria:

* Primary Healthcare clinics located in rural and semi-rural settings

Exclusion Criteria:

* Primary Healthcare clinics located in urban settings