cyrilzakka/clinical-trials huggingface dataset:
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.

The study mainly focused for the following objectives:

To determine the effect of semaglutide on ovulation and menstrual regularity. To determine the effect of semaglutide on androgen levels, namely testosterone, sex hormone binding globulin, and changes in hirsutism.

To determine changes in weight, body mass index (BMI), and Glycated Hemoglobin( HbA1c) with semaglutide therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Body mass index(BMI) \> 30
* Diagnosis of PCOS
* Normal thyroid stimulating hormone, prolactin, follicle-stimulating hormone (FSH), estradiol, and normal progesterone

Exclusion Criteria:

* Medications excluded: any hormone-containing contraceptive - oral contraceptive pills, Progesterone-only pill, depo-provera, oral provera, progesterone-containing intrauterine contraceptive device
* Letrozole, clomiphene citrate, FSH therapy
* Androgen receptor blockers
* 5α reductase inhibitors
* Insulin
* Hysterectomy
* Endometrial ablation
Project LEaH: Learning to Eat at Home

The investigators are trying to determine if delivery a feeding intervention program using videoconferencing technology is feasible.

The investigators hope to recruit 10 participants who have a diagnosis of autism spectrum disorder and food selectivity. A Multidisciplinary feeding assessment will be conducted and factors which contribute to the participant's feeding challenges will be identified. Treatment goals will be identified using the Canadian Occupational Performance Measure (COPM). Intervention geared to address the goals identified by parents will be delivered by the clinician(s) via videoconferencing. Participants will participate in up to 12 weekly 1hr visits over the study period.

Eligibility Criteria:
Inclusion Criteria:

* Age: 2-5 years of age
* Diagnosed with Autism Spectrum Disorder
* History of mild to moderate food selectivity
* Access to internet service
* Access to a Windows based laptop with a web camera
* One Parent is available to participate in a 1 hour intervention program within the home environment once per week over a 12 week period.
* English speaking participants
* Parent consents to use of Ontario Telemedicine Network (OTN) technology within in the home.
* Parent is able to use a laptop
* Access to a telephone in order to trouble shoot problems that may arise in setting up OTN technology.

Exclusion Criteria:

* Age: \> 6 year of age (rationale being most children will be enrolled in school during the week thus not available for intervention services).

  * History of severe food selectivity
  * No access to internet service and/or laptop
  * History of dysphagia or other swallowing difficulties
  * Oro-motor abnormalities such as cleft lip and palate, macroglossia
  * Presently has a G-tube insitu
  * Participants on medications that may significantly alter appetite such as stimulants and antipsychotic medications.
  * Currently enrolled in a feeding intervention program.
Proximal Vs Distal Radial Artery Cannulation

Intraarterial cannulation is important for continuous blood pressure monitoring and blood gas analysis throughout the surgical procedure and in intensive care patients. Ultrasonography (USG) has gained popularity in vascular cannulations and facilitates intraarterial interventions. Radial artery is one of the most preferred arteries. Our aim in this study is to compare proximal and distal radial artery cannulations by USG in terms of procedural success, procedure time and complications.

After the patients are admitted to the operating room, routine monitoring (electrocardiography, noninvasive blood pressure and peripheral oxygen saturation) will be performed. After appropriate vascular access is provided to the patients, the induction phase of general anesthesia will begin. Anesthesia induction will be left to the choice of the primary anesthesiologist and no protocol will be followed. In case of \>25% drop in blood pressure, 0.1 mcg/kg noradrenaline will be administered intravenously. After the appropriate position is given to the arm of the patient to be treated, radial artery cannulation will be performed with USG obeying asepsis rules. Patients will be divided into 2 groups by closed envelope method. The first group will be the patients who will be cannulated at the level of the distal radius (styloid process) and the second group will be the patients who will be cannulated proximally by measuring 5 cm from the styloid process. Demographic and clinical characteristics of the patients will be recorded. Catheterization success rates, procedure duration, number of interventions, vessel diameter, hematoma at the site of intervention on the 1st postoperative day, circulatory disturbance will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* American Society of Anaesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Emergency surgery
* ASA IV or above
* Peripheral vascular disease
* Vasopressor use
* Anatomical abnormality at the cannulation site
* Infection at the cannulation site
* Coagulation defect
The Relationship Between FAPI Results and Myocardial Fibrosis After Acute Myocardial Infarction

FAPI is a new method to discover the fibrosis of cardiac myocardium in some conditions, like myocardial infarction or cardiomyopathy. This purpose of this study is to find the relationship between FAPI results and myocardial fibrosis through some clinical serum inflammatory factors level. Meanwhile, it is the first time to provide the prognostic value of FAPI in the progression of acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria: acute myocardial infarction 1) after the successful primary intervention ;2) normal EF value; -

Exclusion Criteria: acute myocardial infarction 1) primary PCI failure; 2) EF reduced; 3) death during the hospitalization;

-
Screening Protocol

The objective of this study is to collect data for the development and validation a screening process using aggregate data.

In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective).
* For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
* BCVA 20/40 or better (each eye).

Exclusion Criteria:

* For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing.
* Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases.
* History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted)
* Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included.
* Unreliable VF testing and/or poor-quality OCT scans.
* Poor fixation.
Effectiveness of Varenicline: Testing Individual Differences

The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs to 55 yrs
* smoker

Exclusion Criteria:

* Medical Contraindications
Self Selected Exercise Intensity in PAD Patients

Although the benefits of supervised walking training in patients with peripheral arterial disease (PAD) and symptoms of intermittent claudication (IC) are well established, one of the main problems found in this type of protocol is low adherence to training, which is possibly related to pain during training. In addition, little is known about the impact of performing exercise with pain on cerebral blood flow and cardiovascular health indicators. Thus, the objective of the present study will be to analyze the acute effects of walking exercise with self-selected intensity on the cardiovascular health indicators of patients with PAD. Therefore, 17 patients with PAD will undergo three experimental sessions: exercise with self-selected intensity, exercise until maximum pain and control. The responses of the cardiovascular variables (heart rate variability, blood pressure, heart rate, arterial stiffness and endothelial function) will be obtained before and after the sessions. In addition, during the session cardiovascular responses (cerebral blood flow, blood pressure and heart rate), perceptual and affective responses, as well as information about the exercises performed during the session will be obtained. The responses before and after exercise will be analyzed using the two-way analysis of variance for repeated measures (ANOVA) and the Newman-Keuls post-hoc test. The value of P \<0.05 will be considered significant.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral artery disease in one or both limbs (ankle brachial index \<0.9);
* Claudication symptoms in six-minute walking test;
* who can walk at least 90 meters without interruption;
* that have physical conditions to perform the exercise sessions;

Exclusion Criteria:

* do not finish three experimental sessions;
Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent by the parents or legal guardians of the patient
* Outpatients
* Good health with the exception of asthma
* Documented diagnosis of asthma for more than 6 months
* Use of rescue medication only or pretreatment with a controller drug

Main Exclusion Criteria:

* Concomitant severe diseases
* Diseases contraindicated for the use of inhaled steroids
* Other relevant lung diseases causing impairment in pulmonary function
* Recurrent, episodic wheezing only
* History of life-threatening asthma
* History of any mechanical ventilation
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Premature birth (\< 32 weeks gestation)
Comparison Between Two Techniques to Reposition the Maxilla After le Fort 1

clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)

Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess.

Exclusion Criteria:

cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)

Thus study is a clinical trial for Measles and Rubella vaccine that will be used inIndonesian National Program of Immunization. The study design will be randomized, observer blind, prospective intervention study.

The objectives of the study are:

* To assess the protectivity rate of Bio Farma's Measles/Rubella (MR) vaccine in infants
* To describe antibody response to Measles and Rubella after 1 dose of Bio Farma's MR vaccine as a primary dose in infants
* To assess the safety of Bio Farma's Measles/Rubella (MR) vaccine in infants
* To evaluate immunogenicity and safety one dose of Bio Farma's MR vaccine compare to registered MR vaccine.
* To evaluate immunogenicity and safety in three consecutive batches of Bio Farma's MR vaccine in infants .

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Infants, 9-12 months
2. Parents have been informed properly regarding the study and signed the informed consent form
3. Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \> 37.5 Centigrade).
3. Known history of allergy to neomycin, kanamycin or erythromycin or any component of the vaccines.
4. History of immunodeficiency disorder or disorders like HIV infection, leukemia, lymphoma, or generalized malignancy that can alter immune response.
5. Subjects who have previously received any measles and/or rubella containing vaccines.
6. Subjects who had a clinical history of measles/rubella infection.
7. Subjects who has received in the previous 3 months a treatment likely to alter the immune response (intravenous immunoglobulin, blood-derived products or long term corticosteroidtherapy (\> 2 weeks).
8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Subject already immunized with any vaccine within 4 weeks prior vaccination.
Tracheal Intubation and Prehospital Emergency Setting

In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.

National and international guidelines have the objective to optimize the airway management modalities and to minimize the risk of complications in relation to this procedure. In contrast to the operating-room where intubation is performed daily in standardized conditions, in prehospital emergency setting, the environment and circumstances are variable and have an impact on the gesture as has been demonstrated. However, there are few studies about this issue, and these one are relatively ancients although that orotracheal intubation procedures in emergency are now well defined and that the algorithms for the management of difficult intubation have been well diffused in the emergency area these last 10 years. The last study about this topic has been published in 2012 involving more than 600 patients included between 2008 and 2010.

Difficult intubation rate, defined with a number of attempts over 2 or the use of an alternative technic was 11%. Another study with more than 2000 patients had found a rate of 6%. A study comparing the intubation difficulty scale score between two types of blades in 800 patients had found a rate of difficult intubation from 9 to 12%. The algorithms of the management of difficult intubation were largely based on the result of studies performed by anesthesiologists in operating ward. The objective will be to describe the quality of intubation and to measure risk factors of difficult intubation. The investigators are going to collect data about all patients intubated in prehospital emergency setting with the objective to measure the difficult intubation rate and to describe variables associated with difficult intubation. The follow up will be restricted to the area of prehospital emergency setting.

Eligibility Criteria:
Inclusion Criteria:

* all patients intubated by Emergency Medical System (EMS) team

Exclusion Criteria:

* none
Smart Textile Technology for Scoliosis

The investigators hypothesize that a garment-integrated sensing system will be able to detect with clinical accuracy the position of the spine. The investigator will evaluate this using healthy adult volunteers, who will don sensing garments and assume a series of spinal postures. Concurrent with garment sensing, the participant's spine position will be measured using a motion-capture system that uses reflective markers to detect positions of markers in 3D space.

The motion-capture system provides a gold-standard reference measure to which the sensing garments will be compared. Because the investigators are evaluating the accuracy of the sensing garment, it is only necessary that the investigator test the garments on participants with subtly different body shapes. Healthy adult volunteers provide an adequate input to the sensing signal.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Under age 18 or over age 65
* Any medical condition that impairs movement or makes movement painful or difficult.
Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children

Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or ventilation tubes insertion in children.

A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for further evaluation and recommendations before surgery.

The purpose of this study is to summarize the causes of referrals in a cohort of 200 children and to assess the further laboratory analysis preformed and the results obtained.

Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery.

The data will include cause of referral, laboratory analysis performed and results.

If the data allows the outcome of the operation and bleeding complications, will also recorded.

Eligibility Criteria:
Inclusion Criteria:

* All the patients referred to the pediatric hematology unit for evaluation due to coagulation abnormalities before minor surgery

Exclusion Criteria:

* No exclusion are applicable
Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma

Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma.
* Eligible for autologous stem cell transplantation.
* 18 to 75 years of age at time of enrollment.
* Adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 x 10\^6 CD34+ cells/kg based on patient body weight
* ECOG performance status ≤ 2
* Normal organ function as defined below:

  * Creatinine clearance \> 40 ml/min
  * Total bilirubin ≤2.0 x IULN
  * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  * LVEF \> 40% (by ECHO or MUGA)
  * FEV1 \> 50% of predicted and DLCO \> or = 50% of predicted
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

* A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
* Currently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollment.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan HCl for injection (propylene glycol-free), Captisol, or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
* Known HIV-positivity. These patients are excluded because of the potential for pharmacokinetic interactions with the study regimen and their antiretroviral therapy and because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. .
Dabigatran Etexilate in Patients With Mechanical Heart Valves

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.


Eligibility Criteria:
Inclusion criteria:

1. Patients aged 18-75
2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding
An Age-Stratified Data Collection Study to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

To collect three dimensional retinal measurements of the optic disc and the macula lutea on healthy normal subjects using the 3D OCT-1000 Mark II for the purpose of developing a normative database that is stratified by age.


Eligibility Criteria:
Inclusion Criteria:

* Male and Females at least 18 years of age;
* Must be a member of one of the 3 ethnic groups: Caucasian, Hispanic or African American. Asians, Eastern Indians, and Native Americans have been excluded from this study;
* Signed, written informed consent obtained for the study;
* BSCVA of 20/40 or better in both eyes;
* Intraocular pressure (IOP) ≤ 21 mm Hg in both eyes.

Exclusion Criteria:

* Ocular disease;
* Cataract on slit lamp exam with a corresponding loss of BSCVA worse than 20/25;
* Corneal surface disruption precluding imaging;
* Prior ocular surgery except uncomplicated phacoemulsification or strabismus surgery;
* Prior corneal refractive surgery of any type;
* Family history of glaucoma among first generation relatives;
* Current history of an acute or chronic disease or illness that would confound the normative outcome(s) of the study;
* Current use of systemic medications that may confound the outcome of the study;
* Nystagmus or any other condition that would prevent a steady gaze during study tests or measurements;
* Current history of inflammation or infection of the eye or eyelids; injury to the eye.