cyrilzakka/clinical-trials huggingface dataset:
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD

This will be a randomized, open-label, active-controlled, single dose crossover study with either three or four treatment periods. Investigational treatment is with Dance 501 Human Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).

Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung disease (healthy subjects).

The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be compared to subcutaneous injection of insulin lispro.

Eligibility Criteria:
Inclusion Criteria:

* non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6 months prior to enrollment. BMI \<= 35 kg/m2. Fasting blood glucose \<= 125 mg/dL.

Exclusion Criteria:

* pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4 weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma or COPD within previous 3 months. Clinically significant medical condition. Current medications interfering with glucose metabolism.
Effect of Simplified Implant Placement Protocols on Failure Rate

The primary objective of this study is to evaluate the effectiveness of implant treatment in an unselected patient population as measured through implant failure.


Eligibility Criteria:
Inclusion Criteria:

* edentulism

Exclusion Criteria:

* ASA class 4
A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

The primary aim of this study is to assess the effect of EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive
* Screening body weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-323. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
* Positive for HIV or hepatitis
* Positive urine drug screen
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer.
* Drug sensitivity to midazolam, caffeine, rosuvastatin
Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis

This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with endometriosis. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to endometriosis for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, fluent in English, and have a formal diagnosis of endometriosis for at least 3 months.

Exclusion Criteria:

* Younger than 18 years of age, nonfluency in English, self-identified diagnosis, endometriosis duration of less than 3 months.
A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)

The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Patient who completed the CL2-95014-002 study
* Patient currently receiving clinical benefit from previous treatment with S95014 as per investigator's judgment
* Signed informed consent and assent, when appropriate
* Highly effective contraception method

Non-inclusion Criteria:

* Unlikely to cooperate in the study
* Pregnant and lactating women
* Participant already enrolled in the study (informed consent signed)
* Prior surgery or bone marrow transplant related to the studied disease
* History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
* Psychiatric illness/social situation that would limit compliance with study requirements
* Group "E" and "T-HR" patients according to ALL-MB 2015 protocol classification
* Major safety issue due to previous S95014 administration (e.g. non recovery of safety parameters, serious hypersensitivity, serious pancreatitis, serious haemorrhage, serious thromboembolic event)
* Significant laboratory abnormality or uncontrolled intercurrent illness (e.g. life-threatening acute tumor lysis syndrome, symptomatic congestive heart failure, cardiac arrhythmia, severe or uncontrolled active acute infection) likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
Endoscopic Quality Improvement System Study

We intend to develop intelligent quality control and management software based on the work of digestive endoscopic artificial intelligence in the Department of Gastroenterology, Wuhan University Renmin Hospital, to accurately and comprehensively assess the quality of gastrointestinal endoscopy and to provide a practical basis for improving the quality of digestive endoscopy in our endoscopic center.


Eligibility Criteria:
Inclusion Criteria:

Endoscopist:

1. Endoscopist with more than one year experience in gastrointestinal mirror operation;
2. Willing to further improve endoscopic quality through Endo.Adm feedback;
3. Ability to read, understand and sign informed consent; The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all research procedures and follow-up visits in conjunction with the research process.

Exclusion Criteria:

Endoscopist:

1. Have participated in other clinical trials;
2. Frequently attending in academic conference which is difficult to ensure the number of endoscopic operations;
3. Endoscopist who were either not present for both parts (phase1 and phase2) of the study.

Patients:

Colonoscopy:

1. Polyposis syndromes
2. Lumen obstruction
3. History of colorectal surgery
4. History of colorectal surgery

Gastroscopy:

1. Obstruction
2. History of gastric surgery
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia

This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia. Further, we will add an exploratory outcome to evaluate the neonatal body composition and anthropometric data to better understand neonatal impacts of maternal metabolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Recommended aspirin for pre-eclampsia prevention by OB/GYN or MFM specialist based on ACOG and USPSTF guidelines (1 high risk factor, 2+ moderate risk factors)

  * Willingness to adhere to aspirin therapy
  * Willingness to undergo 2h OGTT for serum and urine collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
  * Gestational age at enrollment \<16 weeks
  * Ability to speak, read, and communicate via English

Exclusion Criteria:

* Type 2 Diabetes Mellitus

  * Type 1 Diabetes Mellitus
  * Current gestational diabetes mellitus
  * Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)
  * Thrombophilia
  * Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)
  * Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)
  * Current or recent use of steroids
  * Current use of prophylactic or therapeutic anticoagulation
  * Medical contraindication to aspirin therapy
  * Molar pregnancy
  * Renal disease
  * Inability or unwillingness to give informed consent
  * Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
PreAsthmaControl (PAC)

The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma


Eligibility Criteria:
Inclusion Criteria:

* Children of asthmatic mothers form the COPSAC birth cohort study

Exclusion Criteria:

* Children born more than 4 weeks preterm
* children with other systemic illness that atopy/allergy
* Children requiring mechanical ventilation at any time since birth.
Observational Study on Implant Removal

Reporting of the reason for implant removal in a hospital setting over 20 years. retrospective design.


Eligibility Criteria:
Inclusion Criteria:

* all rehabilitated dental implants

Exclusion Criteria:

* implants with complications that were treated and didn't require removal for complication management.
* patients who could not undergo implant removal for reasons of general health
Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor

A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus inhalational anesthesia on perioperative period during transsphenoidal surgery. However, they have limitations especially for the phase of recovery after anesthesia: a fragmentary assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed to assess the degree of recovery, specially after anesthesia and surgery. In this study, the investigators aim to compare the quality of recovery after inhalational anesthesia and after TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for pituitary tumor under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients over age 19
* Scheduled to undergo transsphenoidal surgery for pituitary tumor
* ASA class I and II

Exclusion Criteria:

* Left ventricular ejection fraction \< 55%
* Third-degree atrioventricular block
* Second-degree atrioventricular block (P:QRS ratio of 3:1 or higher)
* Fever
* History of myocardial infarction, stroke or cardiac surgery within the previous 1 year
* Severe neurological disease
* Use of sedative, opioid or sleep-inducing drugs
* Allergic history of any study drug
* Pregnancy
A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.

The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly in cancer patients that are not receiving chemotherapy or radiation therapy.

This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. Hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study. Patients will receive a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin level.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of non-myeloid malignancy
* Baseline hemoglobin value of less than or equal to 11 g/dL unrelated to transfusion
* Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
* Female patients with reproductive potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

* Uncontrolled hypertension
* History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
* Transfusion within 28 days prior to first dose
* Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
* No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months
Advanced Platelet-rich Fibrin Combined With Open Debridement in Management of Suprabony Periodontal Defects

in this clinical trial, patients with periodontal defects will be treated with advanced platelet-rich fibrin in conjunction with open debridement

two groups of patients with suprabony defects, one will be treated with advanced platelet-rich fibrin in conjunction with open debridement and the other will be treated with open debridement alone. subjects will be evaluated for evidence of bone formation after 6 months of therapy

Eligibility Criteria:
Inclusion Criteria:

* patients with periodontal suprabony defects.

Exclusion Criteria:

* pregnant females.
* smokers.
* systemic disease that contraindicate surgery
Kegel Exercises for Stress Urinary Incontinence

Study about a targeted group of women suffering from self-reported stress urinary incontinence, attend a Kegel exercise training program. The group was divided into two; supervised and unsupervised. Whilst both groups benefited from initially seeing a women's health physiotherapist for a pelvic floor muscle assessment and a bespoke Kegel exercise program, only the supervised group continued to see the physiotherapist for monthly bio-feedback training. The unsupervised group relied on their own motivation to perform their Kegel exercises as prescribed. At the end of the twelve week program, both groups had a final pelvic floor muscle strength assessment by the physiotherapist to determine any changes and subsequent improvements in urinary incontinence.

Aim : Investigate and compare the efficacy of supervised Kegel exercises with biofeedback on Stress Urinary Incontinence (SUI) and Pelvic Floor Muscle Strength (PFMS) compared to unsupervised Kegel exercises.

The primary goal of this study was to determine the effectiveness of supervised Kegel exercises using BT versus unsupervised Kegel exercises without biofeedback training, on SUI. A secondary outcome was to establish whether an improvement was observed in PFMS and subsequently, the effect of this on SUI. It was hypothesized that regular support and visual motivation and direction of BT from the physiotherapist, would provide greater results.


Eligibility Criteria:
Inclusion Criteria:

* being female
* aged over 18 years
* suffer from SUI (their subjective disclosure was based on a description provided for their reference)
* did not perform Kegel exercises
* be available for duration of 12-week program

Exclusion Criteria:

* pregnancy and breastfeeding
Serum Magnesium Levels in Desalination Tap Water and Outcomes in Acute Myocardial Infarction Patients

Association between serum magnesium and clinical outcome in patients with acute MI (AMI) with 1 year follow-up in 300 patients in regions supplied by desalinated drinking water (DSW) (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW) (Nahariya MC).

Extensive seawater desalination in Israel may decrease magnesium in drinking water (DW), causing hypomagnesemia and adverse health effects. We study the association between consumption of desalinated drinking water (DSW) and serum magnesium in acute MI (AMI) patients, Subjects 35-75 years of age with the first AMI will be prospectively recruited during 1 year from 2 regions; the Departments of Cardiology at the Sheba Medical center (300 patients, predominantly served by DSW) and the Nahariya Medical Center (150 patients, served by non-DSW). Questionnaire will be developed to collect data on demographic variables (at home and work), water and beverages consumption habits (tap water, mineral water), dietary sources of Mg and Mg supplementations. Mg levels will be measured in DW from the patients' homes and in their serum on admission.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with first AMI
2. Age 35-75

Exclusion Criteria:

1. Patients \> age 75
Risk Factors for Pediatric Emergence Agitation and Analysis of Serum or Urine Metabonomics in Children With Agitation

It is known that some factors are associated with emergence agitation(EA), and investigators are still unable to predict accurately those who undergoing maxillofacial surgery are at great risks.This study intend to identify the risk factors for EA and to explore the mechanism of EA , which is helpful for early prediction, prevention and treatment in children.

This study was divided into two parts. The first part, multivariate regression analysis were conducted to identify the risk factors for pain and EA following maxillofacial surgery in children. The second part, metabolomics research was used to explore the relationship between metabolites and EA in children.

Eligibility Criteria:
Eligibility Criteria in Part I

Inclusion Criteria:

1. Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face.
2. Aged between 3 years and 12 years.
3. American Society of Anesthesiologists(ASA) class I-II.

Exclusion Criteria:

1. Patients with developmental delays.
2. Patients with mental disorders.
3. Patients with severe liver and kidney damage,or other heart and lung disease.
4. Reject to participate in the trials.

Eligibility Criteria in Part II

Inclusion Criteria:

1. Patients who underwent adenoidectomy or adenotonsillectomy in part I of this study.
2. Aged between 3 years and 7 years.
3. American Society of Anesthesiologists(ASA) class I-II.
4. Patients who underwent sevoflurane anesthesia maintainance.

Exclusion Criteria:

1. Patients with developmental delays or mental disorders.
2. Patients with neurological or psychiatric diseases.
3. Patients with severe liver and kidney damage,or other heart and lung disease.
4. Patients with metabolic diseases or family inherited diseases.
5. Patients who received drug treatment or intravenous nutritional supports.
Observational Retrospective Study of Evaluation of Prognostic Factors in Advanced Pancreatic Cancer Patients Treated With FOLFIRINOX

The aim of this study is to identify new prognostic factors in patients affected by advanced pancreatic carcinoma treated with first line chemotherapy with FOLFIRINOX regimen. Primary objective is the identification of clinical, laboratory and pathologic factors affecting overall survival of these patients.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* citologically or histologically confirmed pancreatic carcinoma
* disease stage III or IV according to the American Joint Committee on Cancer (AJCC) staging system
* access to clinical informations collected before first-line starting
* availability of objective response evaluation and survival data
* written informed consent

Exclusion Criteria:

* diagnosis of other neoplasia than pancreatic carcinoma
* treatment with drugs other than FOLFIRINOX
* treatment with experimental drugs in combination with FOLFIRINOX
* unavailability of clinical and pathological data
Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')

The initial trial examined if fish oil supplementation during pregnancy could reduce the risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in pregnancies that were at increased risk of these complications. The study was designed as a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.


Eligibility Criteria:
Inclusion Criteria:

* There were six subgroups with different inclusion criteria:
* The low dose (prophylactic) section enrolled women who after 16 weeks of gestation had been identified with an uncomplicated pregnancy, who in an earlier pregnancy had experienced preterm delivery (this was subgroup 1)
* Intrauterine growth retardation (subgroup 2) or pregnancy induced hypertension (subgroup 3)
* Women who had been identified with twin pregnancies (subgroup 4)
* The high dose ('therapeutic') section enrolled women with threatening pre-eclampsia (subgroup 5) or suspected intrauterine growth retardation in the current pregnancy (subgroup 6).

Exclusion Criteria:

* Diabetes mellitus in or before pregnancy
* Diagnosed severe fetal malformation or hydrops in current pregnancy
* Suspicion in current pregnancy, or occurrence in an earlier pregnancy, of placental abruption
* Drug or alcohol abuse
* Regular intake of fish oil or of non-steroidal antiinflammatory agents or other drugs with an effect on thombocyte function or eicosanoid metabolism
* Allergy to fish products.
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina

This study is designed to assess the distribution and spread of four different vehicle formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation at various time points after insertion of the gel into the vagina.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 year old women
* non-pregnant
* healthy

Exclusion Criteria:

* abnormal finding on pelvic exam
* pregnant or breastfeeding
* allergy to intravaginal products
* history of claustrophobia
Mechanical Structure Complications After Acute Myocardial Infarction

To determine the incidence and factors associated with heart rupture (HR) in acute myocardial infarction patients.

We compared characteristics and angiographic patterns of heart rupture and without heart rupture patients enrolled in the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patients be admitted for acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

1. Non-cardiovascular comorbidity for AMI