cyrilzakka/clinical-trials huggingface dataset:
Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study.

Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.


Eligibility Criteria:
Inclusion Criteria:

T2DM

* T2DM inadequately controlled with metformin
* BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)
* HbA1C of 7% to 10% (53-86 mmol/mol)
* FPG ≤270 mg/dL (15 mmol/L)

Obesity

* BMI ≥30.0 kg/m2
* HbA1C ≤6.4% (47 mmol/mol)
* FPG ≤126 mg/dL (7 mmol/L)

Exclusion Criteria:

* Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)
* Use of pharmacological agents with approved indication for weight loss
* T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;
* Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS
* Clinically significant cardiovascular conditions
* Uncontrolled blood pressure
* Personal or within first-degree relative family history of MTC or MEN2
* Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
* Any of the following central lab results: Fasting C-peptide \<0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin \>ULN or T Bili \>1.5x ULN except when participants have a history of Gilbert syndrome ; TSH \>1.5x ULN or \<LLN; Serum calcitonin \>ULN; Serum amylase or serum lipase \>ULN; eGFR \<45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs
The Oncoflavour Study

Oral nutritional supplements (ONS) are often prescribed for malnourished patients to help improve nutritional status. Commonly in cancer patients taste and smell alterations and side effects of treatment can affect the palatability and compliance to ONS. A variety of flavours and styles are available of ONS however research of the palatability of these in cancer patients is limited. This study aims to evaluate specific flavours created based on the taste changes occuring during treatment.

We aim to evaluate the patient liking and evaluation of 5 flavors in 3 different types of flavour-sensations:

* Warming/spicy sensation: to trigger the senses and bring new sensations
* Cooling/fresh sensation: to have a fresh mouthfeel and lighter base perception
* Neutral: to avoid that patients experience additional flavour and let them the opportunity to mix it with other food


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Ability to complete and comprehend questionnaires provided
* Undergoing systemic cancer treatment (chemotherapy or concurrent chemoradiotherapy, radiotherapy, targeted therapy or immunotherapy)

Exclusion Criteria:

* Uncertainty about the willingness or ability of the patient to comply with the protocol requirements (no impairment and no cognitive impairments)
* Coexisting-morbidities affecting taste or smell function
* Lactose Intolerance or Galactosaemia
* Dysphagia
* Diabetics
* Food allergies/intolerances to ingredients present in the product
* No rejection of lemon, red fruits, exotic fruit, yellow fruit flavours.
Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients

To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content. In its latest recommendations, the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting. The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients using ultrasound (US) scanning of the stomach (antrum).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective orthopedic procedures.

Exclusion Criteria:

* Patients with BMI \> 35 kg.m-2, age \<18y, ASA physical state \>II, fasting more than 6hs, or with gastric diseases will be excluded
Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis

Patients with neuropathic pain had longer duration of symptoms increased severity of pain, functional limitation and disability as compare to the patient with general knee osteoarthritis.

Objective: To find out the effects of corrective exercise training for improving neuropathic pain and function in knee OA patients.

This study was a Quasi experimental study. It was conducted at Horizon Hospital Johar Town Lahore. The study was completed in Six months. Consecutive sampling technique was used to collect the data. The sample size of 16 patients was taken in this study to find out the effects of corrective exercises training for improving neuropathic pain and function in patients with knee osteoarthritis. For descriptive analysis we used frequency, percentages and charts. For quantitative measure. Repeated Measured ANOVA was used.

Eligibility Criteria:
Inclusion Criteria:

* ACR Criteria for osteoarthritis
* Neuropathic pain
* Age over 65
* DN4 cut off value is 4/10
* Less than 30 minutes of morning stiffness
* Grade I and II
* Crepitus on active motion
* Bony tenderness
* Bony enlargement
* No palpable warmth of synovium

Exclusion Criteria:

* Knee complain that require urgent medical attention (fracture and infection)
* Diabetes mellitus
* Patients with malignancies
* Neurological disorders
* Systematic musculoskeletal diseases (Parkinson's, rheumatoid arthritis etc)
* Incapability of understanding implication of participants
A Lactation Study in Women Receiving Treatment With Ozanimod

The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.


Eligibility Criteria:
Inclusion Criteria:

* Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information.
* Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation).
* Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit 1.
* Infant participant has normal weight for gestational age (above tenth percentile) at birth.

Exclusion Criteria:

* Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method.
* Adult participant is not breastfeeding or pumping milk.
* Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment.
* Infant participant was born less than 37 weeks gestation

Other protocol-defined criteria apply.
Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery

The aim of this study is to compare the efficacy of the pressure controlled ventilation volume-guaranteed (PCV-VG) versus volume-controlled ventilation (VCV) modes as regards lung compliance and oxygenation index in obese patients undergoing laparoscopic assisted surgery especially in Trendelenburg position.

Obesity, defined as a Body Mass Index (BMI) \>30 kg.m-2", is characterized by increased airway resistance, labored breathing and decreased respiratory system compliance. An increased rate of obese patients undergoing laparoscopic assisted surgery (LAS) is a health care concern due to anesthesia and ventilation difficulties in the obese population. Therefore, understanding the physiology and pathophysiology of lung function is an important issue during long-lasting LAS.

Carbon dioxide pneumoperitoneum with steep Trendelenburg positioning leads to a cranial displacement of the diaphragm and an increased volume of atelectasis, with a consequent decrease of total lung volume, lung compliance, and functional residual capacity. Thus, alleviation of increased airway pressure, improvement in oxygenation and CO2 elimination are the main goals during anesthetic management in laparoscopic assisted surgery.

In pressure controlled ventilation volume-guaranteed (PCV-VG) mode, the ventilator regulates the Peak Inspiratory Pressure (PIP) to achieve the optimal TV. To achieve the target volume, ventilator parameters are regularly changed without adjusting airway pressures. Hence, PCV-VG has the advantages of both Volume-Controlled Ventilation (VCV) and pressure controlled ventilation (PCV) to preserve the target minute ventilation while maintaining a low incidence of barotraumas.

PCV-VG is a type-controlled ventilation mode with a dual character as it has the criteria of both PCV and VCV. This recent ventilation mode which is one of the pressure regulated volume controlled (PRVC) that include Auto Flow ventilation, offers the ability to reduce the inspiratory pressure and as a result the incidence of barotrauma

Eligibility Criteria:
Inclusion Criteria:

1. Age: 16 - 60 years old.
2. Sex: both males and females.
3. Undergoing elective Laparoscopic Surgery.
4. Obese patient with Body Mass Index between ≥30 Kg/m2.
5. American society of Anesthesiologist (ASA) class I/ II.

Exclusion Criteria:

1. Patient refusal.
2. American society of Anesthesiology (ASA) III or IV.
3. Intraoperative hemodynamic instability.
4. Patients with pulmonary hypertension.
5. Obese patients on home O2 therapy
6. Pneumoperitoneum with CO2 with intra-abdominal pressure exceeding 15mmHg.
7. Anti-Trendelenburg position.
8. Asthmatic Patients.
9. Patients with advanced liver disease.
10. Patients with advanced renal disease.
11. Patients with advanced malignancy.
12. Pregnant females.
Impact of Anti-static Chamber/Mask

To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children.

Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold.

Objective -- to determine whether an anti-static chamber increases the one-hour steady-state fluticasone plasma concentration, which is an indirect measure of airway delivery and direct measure of systemic exposure. Twelve children 1-6 yrs with well-controlled persistent asthma were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily. The drug was administered by conventional polycarbonate or anti-static valved-holding chambers with masks in an unblinded, randomized, crossover manner each for at least three days. A blood sample was collected one hour after the last dose when adherence documented by electronic monitor was 100%. FP plasma concentrations were measured by liquid chromatography mass spectrometry assay. Results evaluated using regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* children 1-6 years old; adequately controlled persistent asthma; currently receiving FP delivered by CFC MDI attached to valved-holding chamber/mask; ability to use chamber with mask effectively

Exclusion Criteria:

* inadequately controlled asthma: nocturnal awakening \> 2 nights/month, prn albuterol use \> 2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days
A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)

The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy
* have FEV1 greater than or equal to 40% predicted normal for age and height

Exclusion Criteria:

* have obtained a confirmed diagnosis for the current suspicious lung tumor
* have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening
* have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing
Gut Microbiota Dysbiosis and Translocation During IBD and Parkinson

Inflammatory bowel diseases (IBD) and Parkinson disease (PD) are complex and multifactorial pathologies. Gut microbiota seems to play an active role. Indeed the digestive microbiota of patients with IBD or PD exhibits different compositions compared with asymptomatic subjects.

Bacterial translocation from gut to blood has been reported.

The investigators designed a case-control study to investigate the digestive microbiota and bacterial translocation during IBD and PD. The investigators want to evaluate gut microbiota bacteria involved in dysbiosis and bacterial translocation during IBD and PD. The investigators want to identify bacterial populations that can serve as biomarkers for clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* PD patients : age \< or = 60 years
* asymptomatic subjects : no chronic disease
* asymptomatic subjects : no treatment

Exclusion Criteria:

* severe anemia (Hb\<7g/L)
* people who don't read french
* pregnant women
* people treated by antibiotic, probiotic or prebiotic during the 2 month before inclusion
* people with any diagnosed or treated pathology
Complications and Clinical Response in Cancer Patients Treated with Anti-VEGF-Related Therapies

This study collects information about complications and clinical response in cancer patients treated with anti-VEGF-related therapies. This study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-VEGF related therapy. This may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.

PRIMARY OBJECTIVE:

I. To explore the incidence of clinical complications associated with anti-VEGF-related therapies in cancer patients treated at Emory University and the University of Texas M.D. Anderson Cancer Center (MDACC).

SECONDARY OBJECTIVES:

I. To explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-VEGF-related therapies.

II. To explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-VEGF-related therapies.

III. To investigate the validity of a novel multi-parameter-based blood pressure scoring system and to determine if the new scoring method is concordant with the current Common Terminology Criteria for Adverse Events (CTCAE) method.

OUTLINE:

Patients' medical records are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to understand and be willing to sign a written informed consent document
* Patients must be receiving any anti-VEGF-related regimen in monotherapy or combination therapy
hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy Rates, and Morphokinetics

hCG is a hormone produced very early by the embryo, but not by the oocyte. It has a pivotal role in the trophoblast differentiation, and embryo implantation as well as the corpus luteum support. In spite of its well-known role, the literature about it is scarce.

The aim of this retrospective study is to evaluate the relationship between the hCG concentration in peripheral maternal blood measured 11 days after embryo transfer, embryo morphokinetics pattern and the abortion and ongoing pregnancy rates.

We will study patients having transference of blastocyst cultured in time lapse monitored incubators and will check all the morphokinetics parameters with the IVI database.

Human chorionic gonadotrophin is a two subunits (alpha and beta) glycoprotein hormone secreted by blastocyst trophoblastic cells.

It plays a role in progesterone secretion by corpus luteum, endometrium invasion and fusion by trophoectoderm, angiogenesis, and induction of trophoblast differentiation Shortly after embryo implantation, trophoblastic hCG is detectable in maternal blood, and its concetration depends on the number and functionality of trophoectoderm cells. Therefore, hCG concentration in maternal blood is measured as an early pregnancy marker.

However, hCG concentration in several women showed high variability, and embryo implantation also depends on endometrial receptivity, what means that in early stages, everything affecting endometrial receptivity, may affect hCG concentration.

Early high hCG concentration has been related with higher pregnancy rate and it has been proposed that hCG concentration may be related to the time of embryo implantation and the viable trophoectoderm cell number.

Eligibility Criteria:
Inclusion Criteria:

* Donors age \< 32.
* IMC\< 30kg/m2.
* Antral follicle count higher than 8.
* Single Blastocyst transference.
* 5% oxygen embryo culture,
* time-lapse monitoring incubation KID embryos.

Exclusion Criteria:

* Müllerian anomalies,
* Hydrosalpinx.
* Any indication of oocyte vitrification.
* Severe male factor.
* Embryos transferences where a tenaculum was required, or more than one attempt was needed.
The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease

Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in BD. The aim of this study was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.

Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-65
* fulfilling the international diagnostic criteria for Behçet's disease

Exclusion Criteria:

* to have another systemic disease
Nebulizer Intervention for Minority Children With Asthma

To determine if teaching parents and children to identify the child's asthma symptoms early and if teaching the appropriate use of a nebulizer will result in a decrease in emergency department visits.

Nebulizer use in young children is common with prevalence of 33-71% in children under age 12 years. Nebulizers are used primarily to administer SABA medications, (i.e., albuterol) and some anti-inflammatory medications (i.e., budesonide, cromolyn). Parents may prefer nebulizer delivery due to the inability of young children to coordinate respiration with aerosol delivery and many parents lack confidence in administering metered-dose inhaler (MDI) medications to young children. Physician preference for nebulizer administration of asthma medications is low, but is favored due to direct medication delivery to the respiratory system despite studies indicating MDIs with spacers are as effective as nebulizers in delivering asthma medications to young children. Although national guidelines recommend a nebulizer with mask for children 2 years or younger most asthma educational programs lack specific content addressing appropriate nebulizer technique including when and what symptoms to treat at home, optimal length of a nebulized medication session, prevention of SABA overuse and appropriate cleaning and maintenance of the device. Because the overuse of home nebulizer SABA medications has been associated with fatal asthma, instruction and supervision of nebulized rescue medication delivery in addition to appropriate preventive medication use may reduce asthma morbidity and mortality .

The current study was conducted to determine the effectiveness of a home-based nebulizer educational intervention (NEI) for young children with asthma. The intervention was designed to teach early symptom recognition, appropriate medication use and nebulizer technique for home treatment of acute asthma episodes. Study outcomes included symptom frequency, activity limitation, emergency department (ED) visits and hospitalizations, appropriate asthma medication use and nebulizer practice. We hypothesized that children receiving the NEI would demonstrate improvement in appropriate nebulizer and asthma medication use and decreased asthma symptoms, activity limitation, ED visits and hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed asthma, use of nebulizer in past 30 days, wheezing or cough symptoms at least weekly during the past 30 days.

Exclusion Criteria:

* Participation in another asthma study or having other respiratory illness such as cystic fibrosis, BPD
Teriparatide Treatment in Patients With Inherited Osteoporosis

The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* inherited low-turnover osteoporosis
* lumbar spine or hip BMD T-score ≤ -2.5
* a written informed consent.

Exclusion Criteria:

* age less than 18 years
* generally accepted contraindications for the treatment