cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Gastric volume (≥ 0.5 mL/kg) and pH (\<2.5) values are shown to be determinants in the occurrence of pulmonary complications .

The hypothesis of this study was that preprocedure candy and chewing gum use may have no effects on gastric residual volume and pH. For this purpose, we analyzed the gastric residual volume and gastric pH values of patients who were given gum and candy before the procedure.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III,
* oriented
* cooperative
* scheduled for elective gastroscopy

Exclusion Criteria:

* body mass index is (BMI) \>30 kg/m2,
* full stomach predicted patients (obstruction, stenosis, bleeding, ascites, urgency),
* patients with diabetes
* patients with who underwent bowel cleansing
* patients who did not want to give consent to participate
A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural

Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.

After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief.

Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied

Eligibility Criteria:
Inclusion Criteria:

-nulliparous women

* 38th week of gestation

Exclusion Criteria:

* patient refusal to have an epidural
* patient refusal to participate
* contraindication for epidural
* ASA\>3
* neurologic deficit/impairment
* allergy on local anesthetic chronic pain syndromes
Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children

THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER

The study was conducted experimentally to determine the effect of black mulberry lollipop and sodium bicarbonate used in oral care on prevention of oral mucositis in children followed up due to the diagnosis of cancer. Sodium bicarbonate and black mulberry treatment were compared to prevent oral mucositis in 69 children receiving chemotherapy due to cancer. While 35 children were assigned to the experimental group (sodium bicarbonate + black mulberry lollipop application), 34 were assigned to the control group (sodium bicarbonate application).

Eligibility Criteria:
Inclusion Criteria:

* Being in the age group of 3-18 years
* Being hospitalised for chemotherapy treatment
* Not having oral mucositis
* No using another method to protect oral mucosa during the study period
* Not having the history of black mulberry (similar fruit berries, blackberries, etc.) allergy
* Not having intolerance to cold

Exclusion Criteria:

-Not having food in mouth
Clinical Study of in Situ Regeneration of Endometrium

Thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.


Eligibility Criteria:
Inclusion Criteria:

1.Patients with thin endometrium (4mm≤ EMT \<7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to participate in follow-up

Exclusion Criteria:

1. Endometrial thickness \<4mm or scarred endometrial area\>70%
2. Uterine cavity out of shape and the cavity depth\<6.5mm
3. Abnormal chromosome karyotype
4. Uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
5. Systemic diseases: hypertension, diabetes, and so on
6. Contraindications to pregnancy
7. Contraindications to hormone replacement therapy
8. Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies

10. Unable to adhere to the follow-up
Hemodynamic Effects of Spironolactone in Patients With Heart Failure

To determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action.

Randomized, two group placebo controlled, single blind study.


Eligibility Criteria:
Inclusion Criteria:

* CHF
* 21 - 80 years
* Serum creatinine \< 2 mg/dL
* Serum potassium 2.7 - 4.5 mg/dL measured within past 4 weeks

Exclusion Criteria:

* Less than 21 years
* Pregnancy
Comparing Exertional Heat Illness Risk Factors Between Patients and Controls

The arduous nature of military training and operations require personnel to encounter high heat load, e.g., during intense physical exertion, particularly in the heat. These conditions reduce operational effectiveness and expose personnel to a risk of incapacitation and death from exertional heat illness (EHI). The primary aim of this study is to compare putative 'chronic' EHI risk factors between a cohort who have suffered a history of EHI and a control cohort with no EHI history. The secondary aim is to examine the influence of these EHI risk factors on thermoregulation during a standard heat tolerance assessment.

Military training and operations present a risk of incapacitation and death from Exertional Heat Illness (EHI). However, widely accepted EHI risk factors are absent in almost half of all United Kingdom (UK) military EHI cases, indicating that a significant number of EHI cases in military personnel involve alternative risk factors. Risk factors for EHI can been classified along a spectrum ranging from acute (e.g. recent poor sleep) to chronic (e.g. low fitness), with the role of chronic risk factors supported by the observation that individuals who have suffered an EHI are at a substantially increased risk of subsequent EHI. The primary aim of this study is to compare putative 'chronic' EHI risk factors (e.g. composition of gastrointestinal (GI) microbiome, infection and inflammation, trait-like psychological factors) between a cohort who have suffered a history of EHI and a control cohort with no EHI history. The secondary aim is to examine the influence of these EHI risk factors on thermoregulation during a standard heat tolerance assessment.

Eligibility Criteria:
Inclusion Criteria:

Individuals with a history of EHI:

* Previous EHI episode
* Normal resting ECG
* Male or female
* 18 - 40 years

Control participants:

* No previous history of EHI
* Normal resting ECG
* Male or female
* 18 - 40 years
Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults

Previous research has found improvements in performance (VO2max) and clinical (insulin resistance) with cycling REHIIT. In some populations (e.g. obese, arthritic) aquatic exercise is a safer, more enjoyable option. However, to date, no study has yet examined whether aquatic REHIIT confers the same benefits as land-based REHIIT. Therefore, the purpose of this study is to determine whether there are significant differences in clinical and performance outcomes between a land-based and comparable aquatics based Reduced Exertion High Intensity Interval Training (REHIIT) protocol.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* sedentary individuals; Sedentary will be defined as less than 150 minutes of exercise/week as defined by the CDC and American College of Sports Medicine
* All subjects will be screened with a resting 12 lead EKG to ensure they are safe to exercise

Exclusion Criteria:

* Any vulnerable populations will be excluded including adults unable to consent/Cognitively Impaired
* individuals who are not yet adults
* pregnant or nursing women
* prisoners or other detained individuals
Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.

A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included.

Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.

They will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years old, female and male
2. pathological confirmed adenocarcinoma
3. the distance from anal verge ≤ 7 cm
4. pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
5. refuse radical surgery
6. without pelvic or distance metastases
7. KPS \>=70
8. with good compliance
9. microsatellite repair status is MSS/pMMR
10. without previous anti-cancer therapy or immunotherapy
11. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. pathological confirmed signet ring cell carcinoma
3. history of other malignancies within 5 years
4. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
5. immunodeficiency disease or long-term using of immunosuppressive agents
6. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
7. DPD deficiency
8. allergic to any component of the therapy
Safe Limits in Saturation (SLIM-study)

A study consisting of a prospective and retrospective cohort in the ICU, ER and pulmonary department in a university hospital in Amsterdam and a teaching hospital in Alkmaar, the Netherlands.

The relationship between the oxygen saturation measured by pulse-oximetry and the arterial PaO2 is investigated in order to investigate which transcutaneous saturation values are safe when administering oxygen in relation to hyperopia and hypoxia.

This study consists of two parts a prospective and a retrospective part.

1. Prospective part: Patients in the ICU, the emergency room and the pulmonary function department of the VU university medical centre will be included. Arterial blood gas analysis is a tool often used to determine PaO2 in regular care. When an arterial blood gas analysis is performed for regular patient care, the corresponding SpO2 is measured. Information such as blood pressure, heart rate, amount of administered fluids and shock-related-parameters are obtained from the patient files. For the ICU patients capillary refill, acra temperature and the mottling scores are examined. The peripheral flow index and temperature index is measured. When more arterial blood gas samples are drawn over time in one patient, multiple datasets can be included per patient, as long as the samples are drawn two hours apart.
2. Retrospective part: Patients with a (suspected) pulmonary disease who underwent pulmonary function tests with arterial bloodgas sampling in the VU medical center and Medical Centre Alkmaar in the last 25 years. The PaO2 and corresponding SpO2 will be obtained from the test and parameters such as blood pressure, heart rate and administered oxygen will be retrieved from the databases with these test results.

Eligibility Criteria:
Inclusion criteria for all inclusions:

* Age: 18\>
* Requiring arterial bloodgas analysis

Exclusion criteria for all inclusions:

* Hyperbilirubinemia (\>20 μmol/L)
* CO-Hb (\>1,5%)
* MetHb (\>1,5%)
* Unreliable pulsatile SpO2 curve

Additional inclusion criteria:

- Prospective, ICU - VUmc: On mechanical ventilation. Arterial line in place.

Additional exclusion criteria:

* Prospective, ICU - VUmc: On extracorporeal membrane oxygenation. Therapeutic hypothermia.
* Retrospective, Pulmonary function departments: Uncertainty whether SpO2 was measured exactly during arterial bloodgas sampling.
Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel cleasing. Currently, there were three predicting models of inadequate bowel preparation eatablished based on patient-related factors. It remains unclear which model perfroms better in predicting bowel preparation quality. Futhermore, althought those predicting models only composing of patients-related factors are useful for identifing high-risk patients, the preparation-related factors may also be valuable for prediciting inadeqaute bowel preparation before the procedure of colonoscopy.

This study aimed: 1) to compare the values of three availlable models (based on patient-related factors) in predicting inadeqaute bowel preparation in a prospective, multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new model based on preparation-related or a combined model based on patient-related and preparation-related factors is comparable to previous models based on patient-related factors.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80
* Using PEG for bowel preparation before colonoscopy

Exclusion Criteria:

* Not undergoing standard bowel preparation due to emergency, bleeding or unsuitable for preparation
* Colon resection
* Suspected bowel obstruction
* Hemodynamically unstable
* Lactating or pregnant women
* Unwilling to provided informed content
Bronchoalveolar Lavages for Cytologic Assessment in Intensive Care Unit Patients

Little is known about bronchoalveolar lavages performed for cytological assessment during bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual contribution to diagnosis and therapeutic decision, and complications have not been extensively assessed.

The primary objective of this multi center, prospective, observational study is to describe the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill patients, identify their indications, assess their contribution to diagnosis and therapeutic decisions, and estimate the frequency of induced respiratory events.

Secondary objectives will be to

* assess the frequency of poor quality bronchoalveolar lavages (as defined by either more than 5% bronchial epithelial cell count to less than 50,000 alveolar cells per mL)
* assess the contribution of a given bronchoalveolar lavage to the diagnostic work up
* assess the contribution of a given bronchoalveolar lavage results to therapeutic decision
* assess the induced short term respiratory side effects
* identify risk factors for poor respiratory tolerance

Eligibility Criteria:
Inclusion Criteria:

* adult patient (\> 18 yr-old) hospitalized in intensive care unit with acute and/or chronic lung disease that need bronchoalveolar lavage as part of routine diagnostic work up
* patient's or family consent

Exclusion Criteria:

* consent not obtained
* patient already included at previous bronchoalveolar lavage of during previous hospitalization
* absence of social security number
* age \< 18yr
* pregnant woman
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.

This study is a phase 4 study, to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China, and only collect the safety data.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment.
2. No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
4. Adequate organ function as defined by the following criteria

Exclusion Criteria:

1. Use of any anticancer drug subsequent to crizotinib prior to study entry
2. Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors
3. Use of drugs that are known potent CYP3A4 inducers
4. Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices, associated with life threatening arrhythmias
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

The duration of treatment is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee which requires treatment with medication for pain relief

Exclusion Criteria:

* Any known allergy to the study drugs
Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer

RATIONALE: Learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.

OBJECTIVES:

* Determine the correlation between the Vulnerable Elders Survey (VES-13) and the battery of Comprehensive Geriatric Assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting.
* Assess and compare the abilities of the VES-13 and the battery of Comprehensive Geriatric Assessment tools to predict chemotherapy adherence among these patients.
* Examine the validity of the VES-13 screening tool to identify increased risk of death from all causes at one year after initial VES-13 screening in these patients.
* Examine the validity of the VES-13 screening tool to identify increased risk of functional decline at one year after initial VES-13 screening in these patients.

OUTLINE: Patients complete the Vulnerable Elders Survey (VES-13) and a Comprehensive Geriatric Assessment at baseline and 12 months later. Variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality.

Patients are followed for 1 year for chemotherapy adherence and survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast or colon cancer

  * Newly diagnosed disease
  * Any stage disease
* Undergoing treatment at the Ireland Cancer Center, University Hospitals Case Medical Center Site
* Scheduled to start a new chemotherapy regimen (objective II only)
* Not concurrently enrolled in a GEM trial (objectives II, III, and IV)
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Understands English
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Diseases Characteristics
Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture

The objective of the trial is to compare between of polyamide and rapidly prototyped (3D-printed) complete denture bases regarding retention, patient satisfaction, masticatory efficiency and microbial adhesion.

completely edentulous male patients will be selected from the out patient clinic of Removable Prosthodontic Department, Faculty of Oral and Dental medicine Al-Azhar University (Boys), Cairo, Egypt. patients will be selected and divided into randomly two equal groups and each patient will receive two sets of complete dentures: Group I: First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Group II: First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed. Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval. Patient satisfaction will be measured for all patients after 1 and 3 months follow up through a validated questionnaire. Masticatory efficiency will be measured by measuring muscle activity of the masseter and anterior fibers of the temporalis muscle on both sides for both dentures at one week, one month and three months after delivery using electromyography with three types of test foods. Microbial adhesion Samples will be collected one month after delivery of dentures, swaps will be taken from the fitting palatal surface of the upper denture, this will be done immediately after removal of the denture.

Eligibility Criteria:
Inclusion Criteria:

1. Completely edentulous male patients ranging from age 45 to 60 years.
2. Angle's Class I skeletal relationship.
3. Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.
4. Last extraction took place six months ago.
5. Normal facial symmetry.
6. Cooperative patients.

Exclusion Criteria:

1. Temporomandibular disorders.
2. Uncontrolled diabetes.
3. Flabby tissues or sharp mandibular residual ridge.
4. Smokers.
5. Patients with neuromuscular disorders.
6. Patients on chemotherapy or radiotherapy.
7. Severe psychiatric disorders.
8. Angle's class II and III skeletal relationship