cyrilzakka/clinical-trials huggingface dataset:
Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI

study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI

This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled .

Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol

Eligibility Criteria:
Inclusion Criteria:

* infertlity indicated for ICSI
* Ovarian factor
* Tubal factor
* Unexplained infertility
* poor responders

Exclusion Criteria:

* Expected high responder
* Endometriosis
* Male and uterine factors
* Ovarian mass or cyst
Establishment of an Artificial Larynx After Total Laryngectomy

This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.


Eligibility Criteria:
Inclusion Criteria:

* Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy

Exclusion Criteria:

* Less than 18 years
* Contraindications to general anesthesia
* Any situation considered by the physician operator as an exclusion
* Pregnant women
* Lactating women
* Subglottic or basi-lingual tumor extension more than 1 cm
* Prior radiotherapy
* Severe coagulation disorders
Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)

SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.


Eligibility Criteria:
Inclusion Criteria:

* Have DED in both eyes for ≥ 6 months prior to Visit 1/Screening.
* Total score ≥ 40 on the SANDE questionnaire.
* Tear break-up time (TBUT) of ≤ 6 seconds in both eyes.
* Anesthetized Schirmer's test tear volume ≥ 4 mm and \<10 mm in both eyes.

Exclusion Criteria:

* Ocular surface corneal disease, other than DED.
* Lid margin disorder other than meibomian gland dysfunction (MGD).
* Any previous reconstructive or cosmetic eyelid surgery that may affect the normal function of the lids
* Any previous invasive glaucoma and/or corneal surgery
* Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
* Cataract extraction within 90 days prior to Visit 1/Screening.
* Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening
* Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments
Effects of Myofascial Release With and Without Thiele Massage

Dysperunia is caused by chronic discomfort during sexual intercourse causing pain during vaginal intercourse.Sexual pain causes relationship decreasing quality of life following anxiety and depression.Myofascial techniques with and without Thiele massage will be used via randomised controlled trial following sample size of 38.

Dyspareunia is characterised by recurring or chronic discomfort during sexual intercourse that causes distress. Dyspareunia can be superficial, causing pain when vaginal insertion is tried, or profound. Women who experience sexual pain are more likely to experience sexual dysfunction, relationship distress, decreased quality of life, anxiety, and depression. One in five nulliparous women (a female who has never given birth to a baby) experiences moderate dyspareunia. Myofascial pain is typically treated using manual manipulation (Manual manipulation involves using skilled, hands-on maneuvers to perform soft tissue mobilization, myofascial release and more) or Thiele massage. In this study the aim is to find the individual and combined effect of these techniques. The study will be Randomized Controlled Trial (RCT). Non probabiity convenient sampling technique will be used to assign randomly half of patients in group A for the experimental group and half in group B who will meet the inclusion criteria. Group A will include participants who will receive myofascial releases and Thiele massage. Whereas Group B will include participants who will receive myofascial releasing techniques but not Thiele massage.

Both group will have 1 session per week for 12 weeks. Numeric pain rating scale, Female sexual function index, Functional pelvic pain scale would be used as an outcome measure tools.

The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25

Eligibility Criteria:
Inclusion Criteria:

Age 23-40

1. Dyspareunia symptoms for more than 6 months
2. Females with tenderness of pelvic muscles from last 6 months
3. Nulliparous women

Exclusion Criteria:

1. Any pelvic organ prolapse
2. Any current genital malignancy
3. Cases of chronic pelvic pain due to any other issue
4. Any traumatic conditions around the pelvis and lower limbs, any infectious, tumors conditions around the pelvis.
5. Pregnant females
6. Any lower limb abnormalities, any recently underwent abdominal and low back surgery.
Biomarker Development in Sturge-Weber Syndrome

This is a study of 40 individuals with Sturge-Weber Syndrome (SWS) brain and/or eye involvement. It will examine the test-retest reliability of the following clinical tests:

1. Quantitative EEG
2. Transcranial Doppler
3. Medical Rehabilitation Scales
4. Optical Coherence Tomography

Sturge-Weber Syndrome (SWS) is a rare disorder presenting at birth with a facial port-wine birthmark and later in infancy with seizures and strokes that result in weakness on one side of the body, cognitive disabilities, glaucoma, and visual field deficits. Approximately 10-50% of infants born with a facial port-wine birthmark on the upper part of the face will also have SWS brain and/or eye involvement. Early detection and treatment of the disease is necessary to improve an SWS patient's outcome, and early biological indicators need to be discovered to make this possible. We believe the following tests can serve as non-invasive biomarkers to improve early diagnosis, monitor response to treatment, and to predict outcome:

1. Quantitative EEG
2. Transcranial Doppler
3. Medical Rehabilitation Scales
4. Optical Coherence Tomography The first step of this process is to determine how much the results of these tests vary between individual tests.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with SWS and brain involvement (Aims 1-3): for the purposes of this study SWS brain involvement is defined as having shown on MRI imaging evidence of the typical vascular malformation which includes the following: leptomeningeal angioma, choroid plexus glomus, and associated venous angioma/malformation.
2. Individuals with SWS and eye involvement (Aim 4): for the purposes of this study SWS eye involvement is defined as individuals with a port-wine birthmark in the V1 dermatomal distribution
3. Able (or parents able) to provide informed consent
4. Able to cooperate with tests
5. Age 6 months to 21 years (Aims 1-3 only)

Exclusion Criteria:

* Subjects unable to cooperate with the studies will be excluded.
App-based Stress Management with the MHealth Application "harmony"

The purpose of this study is to investigate the efficacy of app-based stress prevention via the harmony application in a prospective, interventive, monocentric, explanatory pilot randomized controlled trial (RCT), with participants' subjective stress experience as the primary endpoint.

Research question: Does usage of the app harmony have a positive impact on the subjective experience of stress of its users? Do usage frequency, intensity or width of content engagement influence the efficacy of the intervention?

Hypothesis: We expect improvement of participants' subjective stress experience, stress-related symptoms, subjective well-being, resilient coping, self-efficacy, life satisfaction and goal-attainment.


Eligibility Criteria:
Inclusion Criteria:

* Increased stress level (PSS-10 \&gt;= 19; corresponds to one standard deviation (SD 6.42)) above the mean (PSS-10 = 12.57) in a representative sample of the German population (Klein et al., 2016)
* Fulfillment of technical minimum requirements (internet and smartphone access with suitable operating systems)
* German language skills at a native level or the ability to use the language at at least B level
* Written informed consent to participate in the study after being informed about the study

Exclusion Criteria:

* Inclusion criteria not met.
OS Anesthesia Followup of All Bariatric Procedures at One Hospital

Database registering demographic patient data, anesthesia and surgery information, post operative recovery and complications if any.

Every patient undergoing a bariatric procedure is entered in the data base after the procedure is finished, based on the information available in the medical records.

the study has no end point and keeps collecting data as long as procedures are performed.

The data is analyzed intermittent when medical questions arise on quality and outcome changes due to changes in clinical treatment taken in order to improve individual patient care.

Eligibility Criteria:
Inclusion Criteria:

* all bariatric procedures

Exclusion Criteria:

* none
Warm Patch Decrease Propofol Injection Pain

Propofol causes injection pain is still a common clinical unsolved problem. Mixing a small amount of lidocaine with propofol or injecting lidocaine in advance can reduce the pain caused by propofol injection. Using an air warmer to warm the arm can also reduce the pain caused by propofol injection. Investors suspect that treatment with a warming patch (covering the injection site) can also reduce the pain caused by propofol injection.

This is a single-center randomized controlled clinical study. Purpose of this study is to explore whether the coverage of the warming patch (for 5min before injection) can reduce the pain induced by propofol injection.

The patients included in the study were randomly divided into two groups. The group W used a warming patch to cover the injection site, and the group C used a cotton pad to cover the injection site. After 5 minutes of coverage, the propofol injection was induced, and the patient's complaint of pain (calling or arm withdrawal) during propofol injection was observed, and the patient's recall of the pain score during induction after the patient recovered. After the patients regained consciousness, the data of the two groups were compared to determine whether the use of the warming patch could reduce the pain caused by propofol injection.

Eligibility Criteria:
Inclusion Criteria:

* No peripheral phlebitis
* No history of Raynaud's syndrome
* No history of smoking or alcoholism
* Body mass index BMI\<28 kg/cm2

Exclusion Criteria:

* Refusal of anesthesia
* Previous injection pain caused by propofol
* Difficulty in exposing the veins on the back of the hand or difficulty in venipuncture
* Complained of pain after normal saline infusion.
Epidemiological and Demographic Data From 150 Patients Diagnosed With Coronavirus Disease 2019 Pneumonia

In this study, the investigator examined epidemiological and demographic characteristics, risk factors and 28-day mortality of patients admitted to the intensive care unit with the diagnosis of coronavirus disease 2019 pneumonia.

The patients with intensive care requirements were admitted from emergency department and coronavirus disease 2019 wards to our units. The criteria for intensive care requirement was identified as oxygen saturation\<90%, partial oxygen pressure\<70 mmHg, respiratory rate\> 30/min or PaO2/FiO2(partial oxygen pressure/fraction of inspired oxygen) \<300 despite conventional oxygen treatment of 5lt/min. Primary objective was the effect of defined data on 28-day mortality, and secondary objective was the impact of lymphocyte count, lactate dehydrogenase, ferritin, D-dimer and procalcitonin levels, and SOFA(Sequential Organ Failure Assessment) score on prognosis, which are among the risk factors determined by previous studies. All data were evaluated and recorded using the standardized International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) case report forms, complemented by electronic records of the hospital, nurse observation records, and missing information was completed by telephone interviews with patients' relatives.

Eligibility Criteria:
Inclusion Criteria:

* The study was planned retrospectively, cross-sectionally and observationally with 193 patients hospitalized between 16 March 2020 and 15 May 2020 in five different coronavirus disease 2019 intensive care units in two campuses of our hospital.

Exclusion Criteria:

* Health workers, patients hospitalized less than 24 hours, patients with negative polymerase chain reaction tests, and patients who returned to intensive care unit after discharge were excluded from the study.
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM

The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.


Eligibility Criteria:
Inclusion Criteria:

* No self-reported history of diabetes or pre-diabetes defined as per ADA criteria
* Age greater than 18 years
* Scheduled to receive HbA1c in participating clinic
* Able and willing to give legally effective consent
* Able and willing to participate in patient questionnaires(attached)

Exclusion Criteria:

* Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded.
* Baseline HbA1c level above 5.7
* Severe Anemia (defined as Hb less than 8gm/dL)
* Patients with hemoglobinopathies
* Pregnancy
* Polycystic ovarian disease
Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery

The purpose of this study is to establish the surgical risk factors and differences between different diseases in elderly patients submitted to elective surgery in our institution.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 65 years of age
* All necessary data to calculate p-possum and saps II

Exclusion Criteria:

* Patients with incomplete data
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis since 3 months or longer
* hemodialysis frequency 3 times weekly
* stable phosphate binder dose since one month at screening
* serum phosphate level \< 2,42 mmol/l at screening
* serum phosphate level \> 1,52 mmol/l after wash out phase
* stable treatment with vitamin D analogues since one month at screening

Exclusion Criteria:

* congestive heart failure
* acute bleeding complications
* acute myocardial infarction
* peptic ulcers
* serious liver damage
* poorly controlled diabetes
* severe visual impairment
* uncontrolled high blood pressure
* thrombocyte count \< 120/nl
* difficulties in swallowing or dysphagia
* diminished intestinal motility, megacolon, pseudo- or mechanical obstruction
* gastroparesis
Y402H Comlement Factor H Polymorphism and Age-Related Macular Degeneration in the Austrian Population

The aim of the study is to show a higher expression of the Y402H polymorphism in the complement factor H in patients with AMD compared to healthy individuals.

Additionaly a correlation between a subsided infection with chlamydia and patients with AMD and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma level shall give more hints into the pathomechanism of AMD.


Eligibility Criteria:
Inclusion Criteria:

* man and women over 18 years old
* Filled out informed consentBereitschaft zur Teilnahme
* Diagnosis of non-exudative/ exudative age related macular dgeneneration

Exclusion Criteria:

* inherited retinal diseases
* other aquired retinal/ macular
* missing informed consent
Relationship Between Atelectasis on Ultrasound and PaO2/FiO2

The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding on intraoperative lung ultrasound.

Patients aged 20\~65 with ASA class (American Society of Anesthesiologists physical status classification) 1 or 2 who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation will participate in this study. The patients with abnormal chest x-ray finding, pregnancy, arrhythmia, ischemic heart disease will be excluded from this study as well as the patients who are scheduled to undergo lung or heart surgery.

After 5 minutes preoxygenation, patients will be monitored with pulse oxymetry, noninvasive blood pressure. General anesthesia will be proceeded with typical method and endotracheal intubation and arterial cannulation will be proceeded. After ventilator adjustment (tidal volume as 8 times of the patient's ideal body weight), airway pressures(peak and plateau) will be recorded. Subsequently, arterial blood sampling will be proceeded while examination of the atelectasis findings on lung ultrasound before surgery. Lung ultrasound examination will be proceeded on 6 sections of patient's basal segments of the lung, including anterior, lateral, posterior segment. Juxtapleural consolidation, loss of A lines, presence of B lines, air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding will be investigated and recorded.

Same ultrasound examination and arterial blood sampling will be followed after surgery ends.

The results of PaO2/FiO2 on arterial blood samplings will be compared with findings on lung ultrasound before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20\~65
* with ASA class 1 or 2
* who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation

Exclusion Criteria:

* The patients with abnormal chest x-ray finding,
* pregnancy,
* arrhythmia,
* ischemic heart disease
Building Skill in Heart Failure Self-care: A Community Based Intervention

The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral intervention to improve heart failure self-care among community dwelling older adults.The primary aim of this study is to test the effect of the intervention on improving heart failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We will test three hypotheses comparing 60 older adults with heart failure randomly assigned to either the intervention or a control group:

Hypothesis 1. Participants in the intervention group will have significantly improved heart failure self-care than control participants.

Hypothesis 2. Participants in the intervention group will have significantly improved knowledge about heart failure and heart failure self-care than control participants.

Hypothesis 3. Participants in the intervention group will have significantly better Health Related Quality of Life than control participants.

A secondary exploratory aim is to assess and describe implementation feasibility of providing a heart failure self-care intervention in a community group setting.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic HF
* able to read and speak English or Spanish
* over age 50

Exclusion Criteria:

* history of prior neurological event (e.g., stroke, head injury, encephalopathy) that could cause dementia
* unable to perform tests or participate in the intervention session (e.g., inability to communicate verbally, major visual impairment, or severe and uncorrected hearing loss).
* living in a nursing home or other long term care facility
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation

The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.


Eligibility Criteria:
Inclusion Criteria:

Recipient Day of Transplant

* Registered male or female primary heart transplant candidate
* ≥18 years old
* Signed, written informed consent document and authorization to use and disclose protected health information

Donor Hearts

* \<60 years old
* Mean systolic blood pressure \>60 mmHg at the time of final heart assessment
* Satisfactory echocardiography assessment defined as:
* Ejection fraction \>40%
* Absence of severe segmental wall motion abnormalities
* Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall thickness \<1.3 cm)
* Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)

Exclusion Criteria:

Recipient Day of Transplant

* \>4 previous sternotomies
* Chronic renal failure as defined by chronic serum creatinine \>3.0 mg/dL for more than 2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for fluid overload)
* Ventilator dependence at the time of transplant
* Use of a ventricular assist device for \> 30 days and the presence of any of the following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia
* Panel reactive antibodies \> 40% with a positive prospective cross match and/or virtual cross match
* Use of an investigational drug or device, other than OCS, during the study.
* Simultaneous transplant of non-heart allograft, except for concurrent kidney transplant

Donor Hearts

* Abnormal coronary angiogram defined as \>50% stenosis, requiring coronary bypass
* Donor-to-recipient body weight ratio of \<0.6
* Inotrope support at time of final heart assessment including, but not limited to:

  * Dopamine \>10 ug/kg/min
  * Dobutamine \> 10 ug/kg/min
  * Milrinone \>0.3 ug/kg/min
  * Epinephrine \> 0.03 ug/kg/min
  * Norepinephrine \> 0.03 ug/kg/min
  * Any bolus dose of the above prior to explants that would result in exceeding the above stated criteria
* Presence of any exclusion criterion based on the standard practice of the investigational site