cyrilzakka/clinical-trials huggingface dataset:
Preoperative Prediction of Difficult Laryngoscopy in Diabetic Patients: Importance of the Palm Print Test

The investigators assessed upper airway management at the pre-anaesthetic consultation using the usual clinical criteria. On the day before surgery, diabetic patients were assessed for the palm print sign to predict difficult laryngoscopy. After induction of anesthesia, laryngoscopy was performed with a Macintosh metal laryngoscope blade. At this stage of the study, patients were categorized into two groups: difficult and easy laryngoscopy.

During pre-anesthesia consultation, all participants were assessed for airway conditions using usual clinical tests (Mallampati classification, Thyromental distance, mouth-opening test, upper lip biting test (ULBT), Head extension and Prayer sign). Demographic characteristics, diabetes duration, Blood glucose regulation and diabetes-related complications were also recorded.

On the day before surgery, patients were assessed for the palm print sign during preoperative evaluation rounds. On the day of surgery, after an intravenous line (IV) and complete monitoring, induction of anesthesia was initiated, and a muscle relaxant was used to facilitate intubation. Laryngoscopy was performed with a Macintosh metal laryngoscope blade by an anesthesiologist who had more than 2 years of intubation experience. McGrath® videolaryngoscope, McCoy laryngoscope, LMA Fastrack®, or i-gel® airway were kept ready for emergency situations. At this stage of the study, patients were categorized into two groups: difficult and easy laryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus
* aged more than 18 years
* undergoing surgery under general anesthesia with endotracheal intubation.

Exclusion Criteria:

* physical or intellectual disabilities preventing cooperation
* Malformations, trauma, tumors, or infections of the maxillofacial region and upper airways,
* a history of burns or cervicofacial irradiation
* neurosurgical conditions causing temporomandibular pseudoankylosis.
* hand joint stiffness (e.g., carpal tunnel syndrome, Dupuytren's disease, scleroderma, rheumatoid arthritis)
* restricted cervical mobility (due to osteoarthritis, ankylosing spondylitis, or cervical trauma),
* a history of difficult intubation
* pregnancy (including up to six weeks postpartum)
Combining PAS to Non-invasive VNS

Vagus nerve stimulation (VNS) and paired associative stimulation (PAS) have been shown to have efficacy in improving the results of motor rehabilitation after stroke and spinal cord injury, respectively. Here we will investigate in healthy subjects the synergistic effect of these stimulation modalities on motor-evoked potential (MEP) potentiation.


Eligibility Criteria:
Exclusion Criteria:

* contraindications to TMS (e.g. brain pathology, implanted devices)
* contraindications to MRI (e.g. MRI incompatible implants)
* continuous use of CNS-active drugs
* neurological, psychiatric or cardiovascular disease
* drug abuse
Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.

Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 and ≤ 80 years of age
* Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
* Body mass index (BMI) ≤ 45 kg/m2
* Glycated Hemoglobin (HbA1c) \> 6.5% and ≤ 10.0%
* Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry
* Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months
* Office spirometry at the investigator site

  * Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted
  * Forced vital capacity (FVC) ≥ 65% NHANES III predicted
  * Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)

Exclusion criteria:

* Current or prior treatment with prandial or PreMix (70/30) insulin
* History of insulin pump use within 6 weeks of Visit 1
* Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
* History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
* Any clinically significant radiological findings on screening chest x-ray
* Use of medications for asthma, COPD, or any other chronic respiratory conditions
* Evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy)
* Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure \[New York Heart Association {NYHA} Class III or IV\])
* Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
* History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)
Evaluation of Outcomes From Treatment of Benign or Malignant Pancreatic Diseases

This study will be a retrospective chart review of patients who have been diagnosed with the benign or malignant pancreatic disease under the practice of Dr. Rohan Jeyarajah, M.D., Dr. Houssam Osman M.D., and Dr. Edward Cho M.D., Sc.M. at Methodist Health System Hospital in Richardson, TX. The investigators plan to conduct an analysis of patients meeting the inclusion criteria from 2005 to present. Study will also be conducted by the PI, Sub-Is, surgery fellows, office staff and clinical research coordinator who are delegated to do by the PI. Data will be obtained by looking through either investigator's patients or through a national database. Data will be analyzed primarily by the study conductors.

It is reported in the literature that the treatment of any pancreatic disease process, whether benign or malignant, continues to be a huge challenge. For example, patients with adenocarcinoma continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. The investigator's goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality, and morbidity.

The main aim of this study is to evaluate and compare the outcomes from the investigator's decisions on multiple treatments of benign or malignant pancreatic diseases.There is a need to understand and improve the current diagnosis and treatment algorithm for pancreatic pathologies. Continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.

All past patients who were treated for a particular benign or malignant pancreatic disease process under evaluation from 2005 to present will be included in this study.

Eligibility Criteria:
Inclusion Criteria:

* • All patients diagnosed and treated for pancreatic diseases, benign or malignant from 2005 to present

  * Age ≥18 years

Exclusion Criteria:

* • Patients that are not diagnosed with or treated for pancreatic diseases

  * Age \< 18 years
Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

Breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease.

Hormone replacement therapy is contraindicated and other pharmacological options may also include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence climacteric symptoms by affecting the regulation of body temperature. In this study, the regular self application of hydrotherapy after initial training by a professional will be evaluated for its efficacy, practicability, and compatibility.

Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis
* Menopausal complaints score \> 14 (MRS II)
* End of last chemotherapy or radiotherapy \> 2 months
* Expected stable disease for the next 6 months

Exclusion Criteria:

* Regular intake of glucocorticoids
* Regular practice of hydrotherapy before inclusion
* Start or change of other treatments/changes of lifestyle in order to influence menopausal symptoms
* Psychiatric disorders with possible influence on compliance and adherence to the protocol
* Other severe or progressive diseases with influence on compliance and adherence to the protocol
* Contraindications to hydrotherapy (severe heart failure, relevant dermatological diseases, Raynaud's Phenomenon \[M. Raynaud\], peripheral arterial occlusive disease Fontaine stage IIb \[VK IIb\] or more, acute thrombosis, or thrombophlebitis)
Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia

Investigators hypothesized that propofol dose for pituitary somatotroph patients might differ from nonfunctioning pituitary tumor, and investigators will evaluate a target controlled infusion (TCI) effect site concentration (Ce) of propofol for BIS score of 40 and LOC (loss of consciousness) in pituitary somatotroph patients in comparison with non functioning pituitary tumor patients.

On arrival in the operating room, standard monitoring devices, including electrocardiogram, pulse oximetry, noninvasive blood pressure cuff, and bispectral index (BIS) will be applied to the patients. Propofol with the modified Marsh pharmacokinetic parameters using a keo of 1.2/min will be administered through TCI pump (OrchestraBase Primea, Fresenius Vial, France). The initial target Ce of propofol will be chosen as 3.0 mg/mL (0.5 mg/mL of incremental size) based on an earlier study.

The sedation of patients will be assessed with BIS score and the modified observer's assessment of awareness and sedation (OAA/S). LOC was defined as an OAA/S lower than 2 (loss of response to spoken command to eye opening and loss of response to mild prodding or shaking). The primary end point of this study is the Ce of propofol when the BIS score is 40. The secondary end point of this study is the Ce of propofol at LOC.


Eligibility Criteria:
Inclusion Criteria:

* patients with pituitary somatotroph tumor and with nonfunctioning pituitary tumor in transsphenoidal pituitary surgery
* American society of anesthesiologists classification 1 or 2

Exclusion Criteria:

* left ventricle ejection fraction \< 55% 3RD degree AV block, 2nd degree AV block with P:QRS \> 3:1
* serum Creatinine \> 1.0mg/dl
* myocardial infarction or cerebral stroke in 1 yrs
* fever \> 38C
* dementia, cognitive disorder, confused mental status
* pregnant patients
* allergic to propofol
* illiteracy or foreigners
Glycemic Holter Study (Continuous Glucose Monitoring) -

The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions.
* HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months

Exclusion Criteria:

* Age \>= 80 years
* BMI \<= 22 and \>=40 kg/m2
* Secondary T2 DM
* Hepatic failure, ASAT/ALAT\>3 ULN, and moderate/severe renal failure (CI \< 50 ml/min) CHF III \& IV

Other protocol-defined inclusion/exclusion criteria may apply
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration


Eligibility Criteria:
Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions
PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.

Diabetes in Mexico is considered a national emergency given its high prevalence, incidence, mortality and costs. Mexico has one of the highest prevalence of diabetes; in only 6 years (2000 to 2006) this prevalence increased from 7.5% to 14.4%. In 2015, 151 deaths per 100,000 inhabitants occurred in Mexico due to diabetes complications.

Metformin is a hypoglycemia drug and it´s the first line medication for the treatment of type 2 diabetes.There is currently a significant amount of evidence that metformin administration reduces the progression from pre-diabetes to diabetes and, despite its monotherapy being less effective than lifestyle changes, the good biosafety profile and low cost have made it the drug of choice in a joint treatment.

The PRuDENTE study proposes to perform this intervention in a real environment in the clinics of the first level of care of the Ministry of Health of the Government of Mexico City, in order to provide evidence about the cost-effectiveness of metformin as a public health intervention for the prevention of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Having received primary care in the chosen health center (ideally two or more visits to that clinic in the prior year).
* Subscribers to "Seguro Popular" ( Mexican national health insurance)
* Body mass index \>=30 kg / m2
* Results of fasting serum glucose with values for pre-diabetes diagnosis (glucose between 100 and 125 mg / dl)

Optional:

* Family history of DMT2 (1st grade relative).
* Previous diagnosis of hypertension or dyslipidaemia.
* Have received antihypertensive medication and / or for cholesterol / lipids.
* History of gestational diabetes mellitus.

Exclusion Criteria:

* Renal insufficiency (Glomerular Filtration Rate (GFR) \<30 ml/min).
* Known hepatic impairment or altered liver enzymes (aspartate aminotransferase (AST) AST or alanine aminotransferase (ALT) three times above normal values)
* Active alcoholism or drug addiction
* Allergies or previous known intolerance to exercise or metformin.
* Current pregnancy.
* Plans to leave the area in the next three years.
* Previous diagnosis of type 2 diabetes mellitus
The Number of Blastocysts Formed in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate

A prospective study of the blastulation rate in the outcome of the Freeze all strategy

A prospective study of the blastulation rate in women under the age of 40 years following Freeze all strategy, according to AMH levels and sperm parameters.

Study group 1: number of vitrified blastocysts 0-4 Study group 2: number of vitrified blastocysts 5-7 Study group 3: number of vitrified blastocysts \>7

Eligibility Criteria:
Inclusion Criteria:

* primary infertility
* age 20-39 years;
* body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35days,
* presumed to be ovulatory;
* \>1mil/ml spermatozoa;
* short antagonist protocol

Exclusion Criteria:

* poor responders;
* age ≥40;
* TESE sperm;
* PGS cycles;
* donor oocytes;
* donor sperm
Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese

This is a prospective, single-center study to assess the long- and short-term outcomes of ticagrelor vs clopidogrel in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention. Patients will undergo face-to-face interviews, phone calls, or/and chart reviews at 7 days, 1 month, 6 months and 12 months. When 4500 patients have completed the follow-up, an interim analysis will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. diagnosed as acute coronary syndrome;
3. underwent successful percutaneous coronary intervention.

Exclusion Criteria:

1. participate in any drug clinical trials within 3 months;
2. patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
3. serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
4. previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
5. patients refused to comply with the requirements of this study to complete the research work.
Efficacy and Safety for Cimicifuga/Hypericum Product

Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.

2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life.

The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator.

This protocol was performed for the best of our volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Climacteric women 45-60 years old - pre and postmenopausal
* Climacteric complains for at least 3 months
* No treatments for at least 2 months
* MRS score 0.4 or more for at least 3 items
* Hamilton's Scale score from 15-23

Exclusion Criteria:

* Hormon Therapy or any other for the last 3 months
* Antidepressive and Hypnotic medication for the last 3 months
* Sever illness (cardiac, hepatic, renal, digestive or metabolic) or TSH alteration
* History for allergies and hipersensitivity to any component of the drugs formulations
* No knowledge for reading or writing
* Suicide risk
A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.

The incidence and prevalence of pulmonary disease due to Non-tuberculous mycobacteria (NTM) is increasing worldwide, and this trend has been confirmed in Korea. Treatment of NTM pulmonary disease is difficult and usually requires more than two years of long-term treatment, and the antibiotic regimens used in treatment vary. Therefore, it is difficult to track the natural history of patients with NTM pulmonary disease, to evaluate the treatment outcome, and to understand the effect of specific medicines on the outcome. Establishing a prospective registry of patients with NTM pulmonary disease is expected to accurately evaluate the progress, treatment modality, and treatment outcome of NTM pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of NTM pulmonary disease.
2. The causative agent of NTM pulmonary disease includes: M. avium complex, or M. abscessus subspecies abscessus, or M. abscessus subspecies massiliense, or M. kansasii.
3. Patients who starts new treatment (those who have previous history of treatment are eligible)

Exclusion Criteria

1. Patients who have been treated for more than 4 weeks.
2. The causative agent of NTM pulmonary disease is none of M. avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii.
Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

The hypothesis of this study is that many plasma proteins are altered in concentration and structure in preeclampsia and the elucidation of these alterations will add to the poorly understood pathophysiology of preeclampsia. In this study we will compare the maternal plasma proteomes of early-onset severe preeclampsia versus healthy controls, compare protein expression and quantification of the maternal plasma proteome at the time of diagnosis of EOS-preeclampsia to the plasma proteome of the same affected subject at 48 hours post delivery and we will verify the placental expression of differentially expressed or post-translationally modified proteins found in the plasma of women with EOS-preeclampsia.

Preeclampsia affects 7-10% of all pregnancies and is directly responsible for 50,000 maternal deaths and 900,000 perinatal deaths each year. Preeclampsia remains unpredictable and incurable except through premature delivery of the fetus. It is essential that a better understanding of preeclampsia is obtained.

Proteomics offers a methodology for identification and quantification of each protein fraction found in human plasma in both disease and health. Since proteins are the basic elements of human biology, it is anticipated that alterations in protein posttranslational modification or total protein expression would be indicative and diagnostic of a disease state. Because proteins are recognized to act as messengers through hormone action, act as enzymes to catalyze important organic reactions and serve as structural components of the human body, they are the most representative of the current state of metabolic and structural activity in both the naive and disease state.

Two groups of patients will be enrolled: (1) Patients with EOS-preeclampsia (N=60) and (2) healthy patients with normal pregnancies (N=240). The patients with EOS-preeclampsia will be matched (1:4) with contemporaneous control patients who are carrying a singleton gestation at a similar gestational age. To measure changes in proteins, we will compare proteins in the blood plasma of women with EOS-preeclampsia before and after pregnancy. We will also compare the blood plasmas of healthy versus EOS-preeclamptic women for differences in plasma proteins. Finally, we will examine the placental RNA of patients with EOS-preeclampsia and healthy patients delivered at 35-37 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* 20-34 weeks completed gestational age

Exclusion Criteria:

* Multiple gestation
* Chronic hypertension
* Diabetes
* Lupus
* Tobacco Use