cyrilzakka/clinical-trials huggingface dataset:
The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability

Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several different regimens are used to lower the patient's blood pressure, such as vasodilators, autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect that these agents may have on the QTc and Tp-e intervals may not be negligible. The investigators of the present study found that the high dose of commonly used hypotensive agents tend to prolong these variabilities to some extent. This study will be able to provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate hypotensive anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class 1
2. Adults over the age of 20
3. Patients requiring deliberate hypotensive anesthesia for orthognathic surgery

Exclusion Criteria:

1. Patient refusal
2. Patients with arrhythmia
3. Patients with cardiac anomalies or past history of cardiac surgery
4. Patients with abnormal electrolyte levels
5. Patients taking medications that are known to prolong QT intervals
6. Patients with QTc intervals greater than 440ms
7. Illiterate patients
Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis (AGPN): Effect on the Risk of Recurrence

The aim of this study is to evaluate the impact of the duration of antibiotic therapy on the risk of recurrence in kidney graft pyelonephritis. The secondary objectives are to identify the factors associated with the duration of antibiotic therapy in acute kidney graft pyelonephritis, identify the factors associated with recurrence of acute kidney graft pyelonephritis within 3 months, evaluate the impact of the duration of antibiotic therapy on antibiotic-related complications and assess the impact of the duration of antibiotic therapy on the progression of renal function after acute kidney graft pyelonephritis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Kidney transplant recipients with a functional graft.
* Hospitalization with acute pyelonephritis (APN) defined by fever OR chills (noted in the clinical records) AND bacteriuria AND exclusion of another obvious cause of fever. (For rehospitalizations, also include cases where antibiotic therapy was initiated based on suspicion, even in the absence of documented infection.)

Exclusion Criteria:

* Age \< 18 years.
* Vacationing patient or lost to follow-up with follow-up \< 3 months.
PLAIAR-Trial: Platelets in Inflammation and Resolution

Detection and determination of platelets in bronchoalveolar lavage fluid and blood in ARDS and non-ARDS-patients. Correlation with phenotype and inflammation parameters in blood and outcome parameters.


Eligibility Criteria:
Inclusion Criteria:

* Routine bronchoscopy
* Patient in perioperative setting
* Age \>=18 years
* Consent

Exclusion Criteria:

* Active or recent (in past 7 days) bleeding in upper airways
* Recent traumatic injury of the lung associated with (micro-)hemorrhage
* Blood aspiration
* Pregnancy
* Age\<18 years
* Acute kidney injury / Chronic kidney failure / Dialysis
* Transplantation
* HIV
* Hematologic diseases
* Immunosuppression
* Anti-Platelet-Therapy
Mocravimod As Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

This is a multi-center, randomized, double-blinded, placebo controlled trial.

The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations
* European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \[CRi\] is also allowable
* Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft
* Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
* Planned use of CsA-based or TAC-based GvHD prophylaxis
* age ≥ 18 years and ≤ 75 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Use of anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
* Diagnosis of macular edema during screening
* Cardiac/pulmonary/hepatic/renal dysfunction
* Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN); or total bilirubin \> 1.5 mg/dL
* Renal dysfunction with estimated creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula
Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.

Diabetes mellitus can be classified based on impairments in two different physiologic parameters, insulin secretion and insulin sensitivity. The investigator involved in this trial has previously defined GDM subtypes based on underlying physiology and demonstrated that women with GDM and predominant sensitivity defects have an elevated risk of adverse pregnancy outcomes, while women with predominant secretion defects do not appear to carry the same risk. This supports the idea that not all gestational diabetes is the same. Ideal treatment strategies may differ between GDM subtypes. In this trial, investigators will evaluate the postprandial glycemic response to two test meals with different macronutrient content in different GDM physiologic subtypes. Two test meals with different macronutrient proportions have been designed by research dieticians. Participants will eat test meals at home for breakfast in a randomized order after an overnight fast. Participants will complete food and blood sugar diaries, and will wear a continuous glucose monitor, which will measure postprandial glucose.

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of gestational diabetes

Exclusion Criteria:

* Known diabetes mellitus that preceded pregnancy
* Food allergies to components of the test meals
* Use of medications known to affect glucose tolerance
* Have extensive skin changes or diseases making CGM sensor use problematic
* Demonstrated allergy to CGM adhesive
* Inability to adhere to the swimming and bathing instructions
* Plan to have MRI, CT scan, X Ray or diathermy (heat treatment) during the 7-day CGM study period
* Inability to adhere to Vitamin C guidelines during study period (using more than 500 mg of Vitamin C/day which could interfere with the CGM)
* Use of medications known to affect glucose tolerance
* In the opinion of the principal investigator (PI), demonstrate any other factor likely to limit compliance with the protocol
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dry eye
* NaFl Corneal staining sum score ≥ 3 in either eye
* Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion Criteria:

* No contact lenses wear throughout the study period
* Must not have had punctal plugs inserted within 30 days preceding enrollment
Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder

This study investigates the mechanisms, through which physical exercise impacts positively on abstinence in tobacco use disorder, with fMRI and behavioral tests.

This study will test the hypothesis that physical exercise training modifies alternative reward cue reactivity and cognitive control in tobacco use disorder and that these modifications mediate the effect of exercise on abstinence. Continued physical exercise training was shown to reduce tobacco consumption and prevent relapse in tobacco use disorder (TUD). However, the psychological and neural mechanisms through which exercise training exerts its effects on tobacco consumption are not clear. The aim of this project is to identify the effects of a 12-week aerobic exercise training in TUD and to test how these exercise-related changes may mediate the effect of exercise training on abstinence. Investigations will focus on two potential mechanisms of regaining control: (1) modifications of tobacco and alternative reward cue reactivity and (2) improvement of cognitive control. Two aspects of cognitive control will be addressed: inhibitory control and cognitive down-regulation of craving. It is expected, first, that exercise training (compared to standard treatment) leads to desensitization towards tobacco cues and sensitization towards alternative reward cues, reflected in altered craving and neural (fMRI) cue reactivity. Second, it is expected that exercise training will lead to increased cognitive control (i.e., inhibitory control and cognitive down-regulation of craving), reflected in increased activation of prefrontal control regions (fMRI). Third, it is expected that effects of exercise on abstinence will be mediated by sensitization towards alternative reward cues and enhanced cognitive control. In an exploratory manner, gender differences in the effects of exercise training will be studied. Understanding the psychological and neural underpinnings will help to optimize and individualize exercise trainings in TUD.

Eligibility Criteria:
Inclusion Criteria:

* Tobacco use disorder according to DSM-5
* right-handedness
* sufficient ability to communicate with investigators
* ability to provide informed consent and to use self-rating scales
* seeking treatment for TUD
* no contra-indication for aerobic exercise

Exclusion Criteria:

* severe internal or neurological comorbidities
* axis I mental disorders other than TUD (except for mild depression, adjustment disorder and specific phobias) in the last 12 months according to DSM-5
* history of brain injury
* pregnancy
* exclusion criteria for MRI
* positive drug screening (opioids, benzodiazepines, cocaine, amphetamines)
* psychotropic medication within the last 14 days
Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program VS Task-Oriented Training (TOT) Improving Gross Motor Function in Children With Cerebral Palsy

To compare the Effects of Pediatric endurance and limb strengthening (PEDALS) program VS Task-oriented Training (TOT) improving gross motor function among children with Cerebral Palsy.

By integrating the Pediatric endurance and limb strengthening (PEDALS) exercises and Task Oriented training children can engage in more comprehensive therapy that simultaneously targets muscle strengthening, coordination and balance with in a context that stimulates real life activities. Task Oriented Training interventions can promote neural plasticity through repetitive task specific practice. It will have marked impact on improvement of ADLS in CP community. This study will play a vital role in improving the mobility of CP community. Hence improving the gross motor functions i.e. facilitating the CP child being more independent in sitting standing jumping and running.

Eligibility Criteria:
Inclusion Criteria:

* • Diplegic Cerebral Palsy children

  * Gross motor classification system level 1and level 2.
  * Age 6 to 12 years.
  * Male and female are included.

Exclusion Criteria:

* • Individuals with co-existing medical conditions that significantly impact motor function other than CP.

  * Participants who are unable to engage in the assigned interventions due to physical or cognitive limitations.
  * Gross motor classification system level 3.4 and 5.
  * Any contraindications to the assigned interventions, such as severe motion sickness or contraindications to physical exercise for pedal training.
  * Previous participation in similar interventions within a defined timeframe to avoid potential confounding effects.
Prophylactic Pregabalin Treatment Following Spinal Cord Injury

Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.

Patients arriving to rehabilitation up to 3 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.

Eligibility Criteria:
Inclusion Criteria:

* Up to 3 months following traumatic or non-traumatic SCL
* Ability to give informed consent and cooperate

Exclusion Criteria:

* Pregnancy
* Neurological or other medical conditions that may interfere with sensation
* Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)
* Being treated with Pregabalin
* Blood creatinine levels \>1.2 or creatinine clearance \<60
* Sensitivity to lactose
Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Provided signed, written informed consent.
* Has a positive result from an allergen-specific IgE antibody test.
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace

The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.

Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).

Eligibility Criteria:
Inclusion Criteria:

* rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement

Exclusion Criteria:

* infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve
* Renal dysfunction
* diabetes
* coronary artery disease
* hypertension
* peripheral vascular disease affecting the lower limb free of arteriovenous fistula
* receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively
Estimating Quality of Life in People With Asthma

The aim of this project is to estimate the quality of life for people with asthma and specifically the loss in quality of life associated with an asthma-related crisis event (accident and emergency (A\&E) attendance or admission).

Asthma is a serious respiratory condition which causes shortness of breath, chest tightness and wheezing. Quality of life can have an impact on asthmatics due to such symptoms. Previous studies capture quality of life at specific time points (e.g. baseline, 1 month, 3 months), and the assumption of a steady improvement is made. However, these assumptions and time points could miss an asthma event in between. Therefore, the investigators aim to provide a more accurate estimation of the loss in quality of life by following participants over an 8 week period from when the participants have attended A\&E or been admitted to hospital following an asthma attack. This will be done by using different quality of life methods, and analysed by calculating the difference between the quality of life scores from A\&E attendance / hospital admission and follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18 years old and over
* Has asthma alone, or asthma with Chronic Obstructive Pulmonary Disease (COPD) or asthma with a respiratory infection
* Speaks English
* Not in need of help from carer / guardian to complete questionnaires
* Not hypoxemic
* Not participated in the study before
* Able to give informed consent

Exclusion Criteria:

* Younger than 18 years old
* Does not speak English
* Has participated in the study before
* Remains hypoxemic despite oxygen therapy
* Impaired capacity to consent
Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema

This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).

This study is a pilot controlled randomized study with two arms.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of one or two legs.
* Patient with a lympedema stage II (persistent) or III according to the classification of the International Society of Lymphoedema (ISL)
* Patient aged 18 or more

Exclusion Criteria:

* Patient with a severe heart, kidney or liver failure,
* Patient with an advanced obstructive arterial disease
* Patient with a recent and progressive deep venous thrombosis
Expression of Endometrium During Window of Implantation

The aim of this study was to investigate the expression of endometrium during window of implantation between natural cycles and artificial cycles.

Due to progress of embryo vitrification in recent years, frozen embryo transfer (FET) of in vitro fertilization (IVF) has already been a world trend. The most used two protocols of FET are natural cycles (NCs) and artificial cycles (ACs). Recent studies showed that IVF outcomes of NCs were superior to ACs. We hypothesized that the result may be because of better endometrial receptivity of NCs compared to ACs. In NCs, no hormonal agents were administrated. Thus, endometrial receptivity was not disturbed by hormone and became better. However, there were few studies to explore the issue. Therefore, the aim of this study was to investigate the expression of endometrium during window of implantation (WOI) between NCs and ACs.

The study will be performed from July 1st, 2022 to December 31th, 2023 in our reproductive center. We plan to enroll 60 infertile women who have underwent IVF cycles and would like to receive endometrial receptivity assay. We divide the participants into two groups, NCs and ACs. In NCs, no hormonal agents will be used. We identify ovulation day via serial hormone data and sample endometrium during WOI (LH surge + 7 days). In ACs, first, estrogen will be given for 10\~14 days and then transvaginal sonography will be conducted. When endometrial thickness reaches 8 mm at least, progesterone will be prescribed. Endometrium is sampled during WOI (P4 + 5 days). We will record basic characteristics, infertility history, hormone data, ovarian reserve and endometrial thickness of infertile women in both groups. Endometrial samples will be assessed miRNA, implantation factors, uterine NK cells and T cells in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age: 30-44 years
* BMI: 18\~30 kg/m2
* Implantation failure at least two times

Exclusion Criteria:

* Primary ovarian insufficiency
* Congenital uterine anomaly
* Severe intrauterine adhesion
* Malignancy
* Donor cycle
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain

The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.

Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.

Eligibility Criteria:
Inclusion criteria:

* Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female
* Moderate (30-60 mm) to severe (\>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal training / sports activities
* 18 - 40 years of age
* injury occurred within 24 hours of the first dose of study medication
* Willing and able to give written informed consent
* Available for the duration of the study

Exclusion Criteria:

* Similar injury affecting the same joint within the past 6 months
* bilateral ankle injury
* bed rest, hospitalization, surgery use of a non-removable rigid cast
* Clinically important abnormality for screening laboratory tests
* Debilitating acute or chronic illness
* Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol
* History of sensitivity to any component of the study drugs
* Unwilling or unable to comply with all the requirements of the protocol
* Participation in other studies within 4 weeks prior to study entry and or during the study participation
* Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result