cyrilzakka/clinical-trials huggingface dataset:
Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response

Alterations of acid-base equilibrium are very common in critically ill patients. Thus, understanding their pathophysiology and the possible compensatory mechanisms acting in different organs may play an important role in better set the consequent clinical treatment. The lung and the kidney are the two principal actors of such regulations. Although the respiratory response to acid-base alterations is well understood, less information are available for what the renal system is concerned. Such lack of information is partially due to: 1) the historical consideration of the kidney as a "slow" organ, in response to variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess renal response.

Our group has recently developed a monitoring system aimed at analyzing, in a quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium).

The investigators hypothesize that the renal system reacts to large as well as to minimal variations of the acid-base equilibrium (especially induced by a variation in the respiratory function) in a very fast way, modifying the urinary concentration (and therefore the urinary excretion) of ammonium and some electrolytes (especially chloride).

Primary aim:

To investigate the acute renal response to respiratory alterations of acid-base equilibrium in order to better understand the underlying physiological mechanisms and to evaluate the validity of a renal monitoring system to indirectly assess the effectiveness of the respiratory function.

Secondary aim:

To collect data on the chronic response of the renal system in patients affected by chronic obstructive pulmonary disease (COPD), as well as on the acute response to acute variation of the chronic respiratory acidosis characterizing patients affected by COPD exacerbation.

Study protol:

Mechanically ventilated patients will undergo controlled variation of the ventilatory setting (hyperventilation vs. hypoventilation) in order to induce a controlled reduction or increase in arterial partial pressure of carbon dioxide (and an increase or reduction of arterial pH), within normal range of pH (7.35 - 7.45) During the variations, urinary concentrations of electrolytes and pH will be monitored.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of mechanical ventilation
2. Presence of arterial and central venous line
3. Presence of urinary catheter

Exclusion Criteria:

1. acute or chronic renal failure with anuria
2. presence of continuous renal replacement therapy
3. hemodynamic instability
4. less than 16 years of age
Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation

The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after liver transplantation (LT).

Very limited data in the literature about how to apply Ramadan fasting in the post liver transplant setting. The timing of Ramadan is changeable according to the lunar year and according to time of down and sunset in each country. In Egypt, for example, Ramadan fasting this year started 17th of May and finished 14th June with average fasting hours of 15-16 hours The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after LT.This prospective study included 45 recipients who underwent LT at Ain Shams Center for Organ Transplant (ASCOT), Cairo, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* • Recipients completed their first year after LDLT

  * Normal liver and renal functions at least in the last 3 months before fasting
  * No reported rejection episodes in the last 6 months before the study
  * Recipients wishing to fast Ramadan
  * Informed consent about the study

Exclusion Criteria:

* • First year of LDLT

  * Recipients transplanted for Budd Chiari syndrome
  * Recipients with vascular stents (hepatic artery , portal vein or hepatic vein stents) requiring long life anticoagulation
  * Creatinine clearance \<60 ml/min or serum creatinine \>1.5 mg/dl at time of initial enrolment in the study.
Comparison Between Early and Late Mobilization After Cardiac Device Implantation

Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.

Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients.

Patients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure.

Primary outcome: lead malfunction, patients' satisfaction

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing device implantation and are hemodynamically stable

Exclusion Criteria:

* hemodincamically unstable
* patient's request
A Study of Japanese Rheumatoid Arthritis Participants

The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.


Eligibility Criteria:
Inclusion criteria

* Have given written informed consent
* Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
* Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 \[Study H9B-JE-BCDK (BCDK)\]

Exclusion criteria

* Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in
* Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine
Prospective Robotic Global Research Study (PROGRESS)

The purpose of this study is to prospectively review outcomes of patients who have surgery with the ExcelsiusGPS™ robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and a maximum age of 85 years
* Require surgery that includes posterior stabilization with screws to be inserted in cervical, thoracic, lumbar spine or sacrum
* Able to sign Informed Consent

Exclusion Criteria:

* Previous fusion or fusion attempt at index level(s)
* DEXA score of -2.5 or below (only if clinically indicated - optional)
* Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
* History of substance abuse (drugs or alcohol)
* Mentally incompetent or prisoner
* Worker's compensation
* Pregnant or intention to become pregnant
Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators design and implement this study is to assess efficacy of acupuncture therapy performed in the CP/CPPS .

This study is a multi-center, placebo-controlled, randomized trial comparing acupuncture and placebo needle among patients with CP/CPPS, which will be conducted in Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Yantai Chinese Medicine Hospital from November 2015 to May 2017. 68 patients will be recruited in total through the advertisements spreading by newspaper, television and internet. After participants have completed a baseline evaluation and meet the selection criteria, one professional statistician uninvolved with treatment and data collection will assigns the participants by using a computer generated, blocked random allocation sequence randomly and acupuncturist will be blinded to the process of randomized assignment.Treatment group will use acupuncture and control group will use placebo needle, for treatment, Zhongliao (BL 33), Shenshu (BL 23), Guiyang (BL 35), Sanyinjiao (SP 6) acupuncture points will be used, the treatment sessions are 24 weeks after baseline, 3 times a week and each time the patients will accept a 30 minutes treatment, to control group, participants will receive placebo needle treatment at the same acupuncture points and the duration and frequency of sessions are same to the real acupuncture group. The primary outcome measure of this study is the decreasing in (National Institutes of Health Chronic Prostatitis Symptom Index) NIH-CPSI total score from baseline to week 8, and secondary outcomes include NIH-CPSI sub scales at week, (International Prostate Symptom Score) IPSS total score, Global response assessment, expectation degree and satisfaction degree. The first three secondary outcomes will be measured at 4,8,20 and 32 weeks, expectation degree will be measured at baseline, and the satisfaction degree will be measure at 8, 20, 32 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. History of pain perceived in the region of the prostate and absence of other lower urinary tract pathology for a minimum of 3 out of the past 6 months. In addition, associated lower urinary tract symptoms, sexual function, psychological factors should be addressed.
2. Age 18 to 50 years
3. NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score≥ 15 (scale 0-43, and 0 means no symptom).

Exclusion Criteria:

1. Other urologic disease (for example, acute prostatitis, bacterial prostatitis, benign prostatic hyperplasia, prostate cancer, urinary tuberculosis, urinary tract infection)
2. Serious or acute diseases with heart, liver, kidney and blood system.
3. Patients who had received acupuncture or medication (including alpha-blockers or pain killers) treatment in the week prior to the baseline assessment
4. Patients without telephone number who cannot be connected during the follow-up
HCT With PTCy in Higher-risk MDS

This study is conducted to evaluate the efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation (HCT) in patients with higher-risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of the GVHD-free, relapse-free survival.

The secondary end points of the study include engraftment, relapse incidence, non-relapse mortality, graft-versus-host disease, donor chimerism, immune reconstitution, infections, and survivals (overall and event-free).

This study is conducted to evaluate the efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation (HCT) in patients with higher-risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of the GVHD-free, relapse-free survival.

The secondary end points of the study include engraftment, relapse incidence, non-relapse mortality, graft-versus-host disease, donor chimerism, immune reconstitution, infections, and survivals (overall and event-free).

Eligibility Criteria:
Inclusion Criteria:

* MDS defined by WHO classification, CMML, or AML evolving from MDS A. International Prognostic Scoring System (IPSS) \> 1.0 or bone marrow blast ≥ 5% at any time points before HCT or B. AML progressed from MDS or C. CMML with bone marrow blast ≥ 5% at any time points before HCT
* Patients receiving first HCT
* Patients with appropriate hematopoietic cell donors A. HLA-matched sibling donor B. Unrelated donor C. HLA-mismatched familial donor
* 15 years old or older , under 75 years
* Adequate performance status (Karnofsky score of 70 or more)
* Adequate hepatic function (AST or ALT \< 3 x upper normal limits and bilirubin \< 1.5 x upper normal limit).
* Adequate renal function (creatinine \< 2.0 mg/dL or creatinine clearance ≥ 50 mL/min)
* Adequate cardiac function (left ventricular ejection fraction ≥ 50% on heart scan or echocardiogram)
* Adequate pulmonary function: DLCO, FEV1, and FVC ≥ 45% predicted by pulmonary function tests
* Signed and dated informed consent must be obtained from both recipient and donor.

Exclusion Criteria:

* Presence of significant active infection
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
* Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
* Presence of contraindications to cyclophosphamide (patients receiving pentostatin, symptomatic cystitis, urinary tract obstruction, with a history of hypersensitivity reactions to the component of the drug)
Effects of DPP4 Inhibition on COVID-19

The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus (T2DM) as per American Diabetes Association (ADA) guidelines
* Age ≥ 18
* Confirmed COVID-19
* Mild COVID-19 defined as any of the following: fever, malaise, cough, headache, sore throat, myalgia, nasal congestion, diarrhea
* Moderate COVID-19 is defined as \> 2 of the following in non-intubated patients: any symptom of mild disease, radiographic imaging (chest x-ray or lung ultrasound) with bilateral ground glass opacities or bilateral consolidations, SpO2 \<90% up to 5L Nasal Cannula (NC)
* No additional signs or symptoms of severe COVID-19.

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM) diabetes, as per ADA guidelines
* History of Diabetic Ketoacidosis (DKA)
* History of acute pancreatitis
* Chronic or Acute Renal Failure with Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 m2

Exclusion Criteria:

T1DM diabetes, as per ADA guidelines, History of DKA, History of acute pancreatitis; Chronic or Acute Renal Failure with eGFR \< 30 ml/min/1.73 m2
Effect of a Mobile Health Intervention on Treatment Adherence

This is a randomized clinical trial across the whole of the patients who attend the HIV Unit of the Hospital Civil Viejo, a sample calculated in 43 patients for each group (intervention and control). Patients who have HIV infection and are starting antiretroviral treatment (ART), who are between 18 and 50 years old and have a mobile device, will be included in the study. The messages will consist of medical appointment reminders and adherence and motivational messages for a period of six months.


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed with HIV infection

  . starting with antiretroviral therapy and haven't taken ART before
* Patients with the status of "lost to follow up" who return to re-initiate ART

Exclusion Criteria:

* Patients who are participating in other study
* patients above 18 years old
* Patients who does not have signal phone at their residency
* Those who refuses to participate in the study
Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence

This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.


Eligibility Criteria:
Inclusion Criteria:

* Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study IMP24011.
* Inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and inflammatory in nature.
* Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care.
* Female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either:

  * Being post-menopausal or surgically sterile, or
  * Using an accepted form of contraception.
* Confirmation that the subject was not pregnant had to be established by a negative urinary hCG test at SD1. A pregnancy test was not required if the subject was post-menopausal or surgically sterile.
* Outpatient status at the time of enrolment.

Exclusion Criteria:

* Disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.
Feasibility of Action Observation Training [AOT] in Infants After Unilateral Brain Lesion

The study examines whether infants with a perinatal unilateral brain lesion can perform an "Action Observation Training" \[AOT\] at the age of 9-12 months . AOT is the targeted and concentrated observation of movements and actions to learn new motor skills. In adults with hemiplegia after a stroke and in older children with hemiplegia, AOT can lead to an improvement in the functions of the affected hand/arm. Infants with early unilateral brain damage are at increased risk of developing a hemiplegia and thus impaired upper limb function. There is little known about treatment options to promote arm and hand skills in early childhood and their effectiveness. In particular, there is a lack of knowledge whether AOT could also be used in infants. It is known that even in infants at an early age brain activity can be measured while they are observing movements and infants learn a lot about observing and imitating.

Knowledge about the measurement of manual skills is also reduced. So far, tests have been used to observe and evaluate how infants use their hands when playing (e.g. Mini-Assisting Hand Assessment). The aim of this study is to investigate whether measurements with motion sensors can also be used in infants.

In the pre-post study, about 5 to 10 toddlers will be examined. During four weeks, the parents should give the child 20 minutes of AOT per day at home. A therapy diary will be completed for this purpose. During six weeks, the parents will use movement sensors on two days a week for the upper limb of the infants. Finally, three questionnaires about the AOT and the motion sensors will be completed by the parents.


Eligibility Criteria:
Inclusion Criteria:

* Premature and term-born infants aged 9-12 months
* Perinatal unilateral brain damage due to cerebral hemorrhage or stroke
* Informed consent to study participation by the parents or legal representative

Exclusion Criteria:

* Infants with impaired vision
* Other diagnoses than early childhood brain damage affecting the functions of the upper extremities (e.g. plexus palsy)
* Infants who participate in other studies of upper extremity interventions
* Parents do not understand the study and the intervention due to foreign language skills
Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS)

Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly information processing speed (IPS) which also influences with other cognitive functions such as attention, working memory and executive functions. The investigators validated a computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT), a test of the IPS, and two measures of episodic memory. On the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test of visual episodic memory.

Purpose: to establish the screening value of a brief computerized cognitive assessment (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as compared to a reference battery (MACFIMS).


Eligibility Criteria:
Inclusion Criteria:

Patients :

* Aged 18-64 years
* Francophone
* MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
* Having signed an informed consent (later than the day of inclusion and before any examination required by research)
* Being affiliated to health insurance

Controls:

* Aged 18-64 years
* Francophone
* Having signed an informed consent (later than the day of inclusion and before any examination required by research)
* Being affiliated to health insurance

Exclusion Criteria:

Patients:

* Other neurological diseases with impact on cognitive functions.
* Severe psychiatric disease or severe depression.
* Current Dependence on alcohol or drugs.
* Modification or stop of psychotropic treatment in less than a month.
* Modification of MS treatment in less than a month.
* Visual, visual-motor and / or motor impairments excluding the ability to perform cognitive tests.
* Pregnant

Controls:

* Neurologic disease and known chronic systemic with impact on cognitive functions.
* Severe psychiatric disease or severe depression.
* Current Dependence on alcohol or drugs.
* Psychotropic treatment
* Cognitive complaint
* Prior cognitive testing with the same tests less than one year.
* Pregnant
Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

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Eligibility Criteria:
Inclusion Criteria:

* full term pregnancy
* undergoing labored, non-emergent cesarean section
* patient in labor

Exclusion Criteria:

Azithromycin contraindicated:

* Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications.
* liver dysfunction
* Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin
* A history of a cardiac dysrhythmia (irregular heartbeats)
* Known hypersensitivity to iodine
* Patients carrying fetuses with known congenital anomalies
* Immunodeficiency
* Patients who are not in labor at the time of delivery
* Non-english speaking subjects or subjects with language barriers