cyrilzakka/clinical-trials huggingface dataset:
Synchronization of Ovarian Stimulation for in Vitro Fertilization With Follicular Wave Emergence

Ovarian stimulation is an important phase of in vitro fertilization (IVF) treatments. The harvest of a larger number of viable eggs per cycle compensate eventual laboratory difficulties and allow for the selection of embryos with higher implantation potential. In the current protocols, based on the most prevailing theory of ovarian follicular development, stimulation drugs are usually started on the second or third day after the beginning of menses. The follicular phase of the menstrual cycle is believed to be the only favorable moment for follicular development.

In the early 2000's a new model of human ovarian follicular development (follicular waves) has been proposed based on frequent transvaginal ultrasound observations between two ovulations. It has been shown that ovarian antral follicles develop in synchronous groups, two to three times in a cycle. In fact the follicular wave phenomenon has been initially described in the 80's on domestic animals, like the mare and the cow. Moreover, studies in these animals have shown that synchronizing the start of the ovarian stimulation drugs with the beginning of a follicular wave yields better results for assisted reproductive treatments. Consequently in ovarian stimulation protocols for animal assisted reproduction it is important to control the initiation of a follicular wave.

Current protocols of ovarian stimulation for IVF in women do not consider the start of a follicular wave to begin drug administration. Therefore the purpose of this study is to evaluate two methods to control the emergence of a follicular wave (ovulation induction and dominant follicle aspiration) and to investigate the effects of synchronizing ovarian stimulation for IVF with follicular wave emergence in women compared to one of the current stimulation protocols (flexible GnRH protocol).


Eligibility Criteria:
Inclusion Criteria:

* age \< 35 years old
* body mass index: 19-30 kg/m2
* tubal or male factor infertility with indication of in vitro fertilization
* antral follicle count: 10-20
* normal uterus in transvaginal ultrasound scan
* FSH on the third day of the menstrual cycle below 12mUI/mL and estradiol below 80pg/mL
* male partner with at least 5 million motile sperm and 1% normal strict morphology on semen analyses

Exclusion Criteria:

* ovarian factor infertility
* non identification of one or both ovaries in the transvaginal ultrasound scan
* non treated endocrine disorders
* smoking habit
* endometriosis stage III -IV
* severe male factor infertility (less than one million sperm per mL of semen)
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis

This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Positive specific IgE to house dust mites
* Atopic dermatitis according to Hanifin/Rajka
* Chronic course of Atopic dermatitis
* SCORAD larger than 25 points

Exclusion Criteria:

* Erythrodermia
* Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks
* History of specific immunotherapy with mites
* UV radiation
* Group 4 topical corticosteroids (European classification)
Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Postmarketing Surveillance Study in Korea

The purpose of this PMS study is to evaluate the safety and effectiveness of BELKYRA Inj. used according to the dose specified in the instructions for use, for the treatment of patients with SM fullness due to SMF, through active investigation under routine clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Eligible and consenting Korean patients
* Patients who have consented to the study and who have signed the private information protection act form or ICF

Exclusion Criteria:

* Patients having infection at the infection sites
* Patients presenting evidence of causes of enlarged submental area other than localized submental fat (E.g.: thyroid enlargement, enlarged submental salivary glands, cervical lymphadenopathy, etc.)
* Patients participating in an interventional clinical study, currently or within 30 days before enrollment, will not be eligible for inclusion in the study
* Pregnant women
* Renal impairment patients
* Hepatic impairment patients
* Patients with severe laxity
The Effect of Sevoflurane and Desflurane on Clara Cell Protein on the Lung

Inhalation anesthesia; It means that the anesthetic drugs taken by the respiratory tract pass into the blood through the lung alveoli, reach the brain tissue, and create an anesthetic effect according to the density in the brain tissue. All inhalation anesthetics affect organ functions to varying degrees. Clara cell has been shown to have cell regeneration, immunomodulatory, anti-inflammatory and antioxidant activity in the bronchial epithelium. It is also thought that some substances accumulated in the respiratory system participate in the detoxification. Clara cell protein acts as a protein marker that indicates the severity of airway injuries after exposure to irritants. In this study, we planned to investigate the effect of inhalation anesthetics on Clara cell protein in liver transplant donors who will undergo hepatectomy surgery.

Inhalation anesthesia is still an important source of chemical hazard in the hospital environment due to its widespread use in operating rooms. Factors affecting the presence of anesthetic gases in the environment; device leakage, ventilation, fresh gas flow, and operation of the air cleaning system. Long-term exposure to anesthetic gases is known to adversely affect the health of employees in the operating room.

Clara cell plays a reliable role as a large bronchiolar progenitor cell that can contribute to cell regeneration in the bronchial epithelium. Thus, it contributes to the protection of the normal epithelium of the distal conductive airways. Additionally, it has been shown to have immunomodulatory, anti-inflammatory, and antioxidant activity. It is thought that some substances accumulated in the respiratory system participate in the detoxification.

Operations of patients undergoing hepatectomy usually take 4-6 hours. Inhalation anesthetics are widely used during this surgery. In this study, we thought to show the effect of long-term inhalation anesthesia exposure by performing this surgery on patients in this group. In this study, we aimed to investigate the effect of sevoflurane and desflurane inhalation anesthetics on clara cell protein in liver transplant donors scheduled for hepatectomy surgery.

Eligibility Criteria:
Inclusion Criteria:

* living liver donors

Exclusion Criteria:

* smoking
* under 18 years
* over 65 years
* Patients who refused written informed consent forms
Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis

This study will investigate the concurrent validity and intra-rater reliability of using smartphone in assessing joint position sense in patient with knee osteoarthritis.

Knee osteoarthritis is the most common arthritis. Such disease is complicated by many musculoskeletal dysfunction such as disturbed joint position sense, which impairs their ability to perform their regular daily activities. As rehabilitation should target impairment in function, it is essential that therapists assess joint sense during baseline and follow-up evaluation of patients to decide on needed therapeutic interventions. Joint position sense can be assessed by various methods such as motion tracking systems and the isokinetic dynamometer, yet these equipment are expensive and are not readily available at regular clinical settings.

Smartphone has been introduced as an assessment tool in rehabilitation of musculoskeletal disorders. For the knee joint, smartphone has been validated for measuring range of motion and joint position sense in healthy population, yet it has never been validated in patients with knee osteoarthritis. Therefore, this study will investigate smartphone validity and reliability as an assessment tool of knee position sense in patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be referred to the outpatient clinic of the faculty of Physical Therapy and Medicine, Cairo University with a confirmed diagnosis of unilateral or bilateral osteoarthritis of the knee and having one or more of the following criteria (ASo, 2000).
* Morning stiffness for less than 30 minutes.
* Crepitus on active knee movement.
* Bony enlargement either palpable or visible in radiographs.
* Bony tenderness at joint margins.
* Age 40-60 years old.

Exclusion Criteria:

* Steroid injection within 2 months prior to inclusion.
* Presence of neurologic disorders (e.g., stroke, Parkinson's disease, or poliomyelitis). •Presence of other rheumatoid or orthopedic disorders in the lower extremity or spine. •A recent history of a lower extremity fracture with in the past year.
* History of ligament deficiency, such as anterior cruciate ligament or meniscal injury.
* Severe pain with active movement.
* Poor memory or cognitive function.
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease

The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease
* On donepezil (Aricept)
* Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

* Unstable medical illnesses or significant hepatic or renal disease
* Other primary psychiatric or neurological disorders
The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With COPD

The effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. Therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise.

Chronic obstructive pulmonary disease (COPD), one of the major causes of morbidity and mortality, is a preventable and curable disease characterized by irreversible airflow limitation. The progressive lung involvement, systemic inflammation, respiratory and peripheral muscle dysfunction, loss of muscle mass, and the dysfunction of the remaining muscles occur in COPD. Muscle dysfunction, which is defined as loss of strength or loss of endurance characteristics in muscles, is a comorbidity associated with poor outcomes such as frequent hospitalization and decreased survival, as well as adversely affecting exercise capacity and quality of life. Exercise increases mitochondrial activity and requires antioxidant defense to achieve cellular redox regulation. The effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. Oxidative stress, inflammatory markers, and metabolic responses to different acute exercise modalities in COPD patients need to be examined and clarified. Therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise. Detection of biomolecules that change with acute exercise may also contribute to the identification of exercise-related pathways.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (clinically stable)
* Being 40-80 years of age
* Able and willing to complete the informed consent process.

Exclusion Criteria:

* To have severe neuromuscular, musculoskeletal and rheumatic problems
* Unable to cooperate
Pilot Study of IFN α2b for Melanoma Patients

The presence of malignant cells in lymph nodes is a critical parameter in the staging of melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology alone. The long-term survival of melanoma cancer patients who have Stage IB disease (no known lymph node involvement with a tumor greater than 2 cm) is lower than patients who are Stage IA (no known lymph node involvement with a tumor less than 2 cm). Likewise, the survival rates of patients who are judged to be Stage II based on histologically positive level-one lymph nodes is often no better than that of higher stage patients who have level-two lymph node involvement. These observations suggest that micrometastases are often present in lymph nodes that are not detectable by histological assessment.

The collection of Sentinel Lymph Nodes (SLN) and non SLN material outlined in this proposal will permit both targeted and exploratory studies, without compromising the patient's diagnosis, on specimens that represent central engines of the immune response and whose function in the context of tumor progression is largely unknown.

With the advent of an array of new methodologies that utilize minimum material for both molecular and cellular assessments, acquiring up to 20% and in general the investigators anticipate the use of 5% on average of SLN and/or non SLN tissue for research purposes, may prove to be critical to understanding the impact of nodal tumor involvement on patient outcome and survival.


Eligibility Criteria:
Inclusion Criteria:

* Primary melanoma with the following Breslow thickness and stage

  * less than or equal to 2 mm
  * Patients with recent (within 12 wks) biopsy of primary melanoma that has not been widely resected will be eligible for study according to the above-specified criteria for tumor thickness and stage.
* Age 18 years or older.
* Patients must have documented hemoglobin level of 10g/dL or higher and normal organ function tests including BUN, Creatinine, and liver enzyme panel to include AST, ALT, and Bilirubin. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
* Negative serum pregnancy test
* Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.

Exclusion Criteria:

* Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, inflammatory bowel disorders, severe renal disease.
* Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
* Active infection or antibiotics within one-week prior to study.
* Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.
Post-Discharge Smoking Cessation Strategies: Helping HAND 4

This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.

This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN). All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator. Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months. One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline. The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor. Both groups will receive at least 1 month of nicotine replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Current cigarette smoker (\>=1 cigarette in the week before admission and \>=1 cigarette/day when smoking at a baseline rate in the month prior to admission)
* Admitted to a study hospital
* Seen by hospital smoking counselor during inpatient stay
* Plans to try to quit smoking after hospital discharge

Exclusion Criteria:

* Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis)
* Life expectancy \<12 months
* Medical instability
* No reliable telephone access or inability to use telephone
* Non-English speaking
* Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.
Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants

In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.

Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).

Eligibility Criteria:
Inclusion Criteria:

* postmenstrual age \<30 wks GA at study time
* on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV)
* at least 4 desaturations (SpO2 \<80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)

Exclusion Criteria:

* postnatal age \<96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
* congenital cyanotic heart disease
* no decision for full treatment support
* Average FiO2 during the last 24h bevor the active study phase \>0.60
* Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...)
* Clinically clear evidence for seizures
* Ongoing Sepsis (CRP \> 10mg/l, or positive blood culture, requirement of catecholamines)
* Need of blood-transfusion during study
Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients

The purpose of the study is to investigate whether a high phosphorous containing meal causes acute changes in p-phosphate levels in patients with dialysis-dependent kidney failure.

Disturbances in the mineral metabolism and especially the phosphate metabolism is associated with increased risk of cardiovascular disease and death in patients with kidney failure. In the healthy population the kidney compensates for a high phosphorous intake by increase renal excretion of phosphate, but this is not possible for patients with kidney failure. Due to this monitoring and controlling phosphate levels is an important clinical goal in treatment of kidney failure, and it is often achieved with a phosphorous poor diet and phosphate binders.

Currently this monitoring of the phosphate level is complicated by a poor understanding of how plasma phosphate acutely reacts to a phosphate rich meal. Often patients may have consumed a phosphate rich meal shortly before their blood test is taken, which may have an acute impact on the plasma phosphate level in the blood test and complicated the task of assessing their chronic phosphate levels.

To examine this problem, the investigators wish to conduct a randomized cross-over trial, where peritoneal dialysis patients are recruited and randomly assigned to consume either a meal either high or low in phosphate on the first day of trial and the opposite in the second.

With blood tests just before and during 5 hours after the meal, the investigators will examine plasma-phosphate levels as well as other blood parameters of importance to the mineral metabolism to determine, whether a meal rich in phosphate causes significant changes in these test parameters compared to a meal poor in phosphate.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Currently treated with peritoneal dialysis (APD or CAPD)
* Serum ionized calcium between 1.10 and 1.40 mmol/L for \>3 months
* Plasma phosphate between 0.7 and 3.0 mmol/L for \>3 months

Exclusion Criteria:

* Earlier parathyroidectomized
* Other conditions, which hinders the participation in the trial
Systematic Evaluation of Protamine Doze in Cardiac Surgery

The precise amount of protamine required to neutralize unfractionated heparin (UFH) remains unknown. This study will systematically identify the doze needed to neutralize UFH following cardiopulmonary bypass (CPB).

The precise dose of protamine needed to neutralize unfractionated heparin (UFH) is unknown. Research suggests that low dose protamine is associated with decreased need for transfusions in cardiac surgery. The ATS guidelines recommend that half of the total UFH dose given for cardiopulmonary bypass (CPB) should be neutralized with protamine. However, it is unknown if this is routinely followed by anesthesiologists. Furthermore, the reference standard for UFH has changed recently and it is unknown how this has affected the dose of protamine in the perioperative period. Protamine does have a very short life and heparin rebound occurs very commonly.

It is common practice to divert the suctioned mediastinal blood following CPB while the patient is still anticoagulated. The traditional practice is that once half dose protamine has been given, suction to the cardiotomy reservoir is turned off. All surgical field blood loss is then diverted to wall suction. The inherent risk of letting too much protamine into the CPB reservoir is that UFH therein may get neutralized and predispose to clot formation in the venous reservoir. This precludes an emergency 'crash' on to CPB, should that be required for some reason. Experience of the Investigators indicates that most surgeons will turn off suction leading to the cardiotomy reservoir once half the total protamine dose has been administered. The concern with this is that "half dose" protamine may be quite different for different anesthesiologists.

The research investigators hypothesize low dose protamine is sufficient to neutralize the effects of UFH as monitored through activated clotting time (ACT). Anesthesiologists administer varying doses of protamine to neutralize UFH in cardiac surgery and the rationale behind such decisions is unclear.

Thus, the primary objective of this study is to evaluate the dose of protamine required to neutralize UFH following CPB. Secondary objectives are 1) to assess the amount of protamine needed to neutralize UFH in intravenously administered cardiotomy reservoir blood. 2) To examine the amount of residual heparin postoperatively in the cardiac surgery ICU; 3) to examine, through semi-structured interviews, the decision-making processes involved in managing (anti)coagulation in cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery patients \> 18 years age who can provide written consent for the study.

Exclusion Criteria:

* History of any known coagulopathies, liver dysfunction, previous cardiac surgery, preoperative abnormal coagulation profiles, recent exposure to heparin (unfractionated or low molecular weight), warfarin, clopidogrel or other direct thrombin inhibitors in the preceding 7 days.
* History of heparin resistance
* History of adverse reactions to protamine
* Patients identified as having heparin resistance
* Anticipated CPB time \> 2-2.5 hrs