cyrilzakka/clinical-trials huggingface dataset:
Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies

The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.

this study was done on 40 American Society of Anaesthesiologist(ASA) I \& II live donors of either sex in adult age group undergoing laparoscopic live donor nephrectomy. After getting approval from institutes ethical committee and written informed consent, Donors were randomly allocated to either of two group. Anaesthesia was induced with injection morphine 0.1 mg/kg, injection propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Maintenance of anaesthesia was done with isoflurane and oxygen. After induction donors were placed into modified flank position with left side upward. Donors in Group A received Acetazolamide 5 mg/kg via orogastric tube soon after the induction of anaesthesia. Group S received saline as a placebo. investigator and subjects were blinded till the statistical analysis. Optic nerve sheath diameter was measured six times during perioperative periods by using high frequency ultrasound probe. Intra operative monitoring was done for Heart rate, Blood Pressure, pulse oximetry(Spo2), End Tidal Carbon Dioxide(ETCO2), Train Of Four(TOF) and Bi spectral index(BIS). Post operatively donors were reversed with injection neostigmine and glycopyrrolate.

once return of spontaneous ventilation was well established and patient becomes conscious oriented trachea was extubated and donors were shifted to post anaesthetic care unit(PACU). Postoperatively donors were monitored for Heart rate, Blood Pressure, Spo2, Comfort Score, Visual analog score for incisional site pain and shoulder tip pain, and Post operative nausea vomiting. Rescue analgesia was given to patients having comfort score less than 6.

After completion of study Optic nerve sheath diameter, pain scores and comfort scores was compared between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender
* 18-60 years of age
* Hemodynamically stable patients.

Exclusion Criteria:

* Patient's refusal.
* Ocular Defects/ Wounds /Previous ocular surgery.
* H/O Hypertension
* Patients having Double Renal Arteries.
* Laparoscopic Nephrectomies converted to Open Surgeries
Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)

This is a single-site feasibility pilot study to determine if patients with COPD with an increased risk of exacerbation will use an in-home COPD telemonitoring system for three months that collects lung measures, pulse oximetry, and medication compliance.

This is a single-site, prospective, open label trial evaluating home telemonitoring for patients with COPD and a history of increased exacerbation risk. The purpose of this study is to determine whether automated home monitoring of medication compliance and biometric parameters \[forced expiratory capacity in one second (FEV1), forced vital capacity (FVC), peak inspiratory flow rate (PIFR), inspiratory capacity (IC), pulse oximetry, and symptoms\] is acceptable to patients, can improve adherence, and may improve clinical outcomes and reduce exacerbations and avoidable 30-day readmissions. Slow spirometry will be performed Sundays, Mondays, Wednesdays, Fridays and Saturdays. Forced spirometry will be performed Tuesdays and Thursdays.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients
* 40 to 80 years of age
* English speaking
* Spirometry confirmed COPD (post-bronchodilator FEV1/FVC\<0.70) and post-bronchodilator FEV1% predicted \<80% at screening visit. (Target 50% of recruitment with post-bronchodilator FEV1\<50% predicted (severe obstruction))
* Increased COPD exacerbation risk defined as either of the following in the prior 12 months:

  * One hospitalization for COPD exacerbation
  * Two outpatient COPD exacerbations requiring treatment with steroids and/or antibiotics
* Signed informed consent

Exclusion Criteria:

* Unable to perform spirometry on their own following training.
* Planned discharge to a nursing home or other extended care facility
* Co-morbid conditions likely to result in non-preventable readmissions (e.g., terminal malignancy, cirrhosis or end-stage liver disease, chronic wound infections, etc.)
* Uncontrolled or untreated medical conditions that would predispose the patient to recurrent COPD exacerbations (i.e., bronchiectasis)
* Patient refusal to or inability to comply with monitoring requirements, for any reason including but not limited to dementia, a history of dementia, or other significant mental impairment
* Patients enrolled in any other clinical trials or therapeutic studies of drugs, devices, or biologics
Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or more, suffering from acromegaly
* Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA)
* Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects)
* In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy

Exclusion Criteria:

* Subject previously/currently treated with Lanreotide 120mg
* History of radiotherapy for acromegaly
* Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression
* Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists
* Active neoplastic disease
Danish Osteoporosis Prevention Study

Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in early postmenopausal women.

The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early postmenopausal women were divided into two groups: The first group accepted randomisation to HRT or not, and the second group was allowed to choose HRT or not.

The study was not blinded. Main measurements were fracture risk over 20 years, changes in bone mineral density over 20 years, and side effects, mainly breast cancer.

Aim: To study the ability of hormone replacement early after menopause on risk of fractures and changes in bone mineral density, and side effects.

The project was designed as a comprehensive cohort trial. One group accepted randomisation, and was randomised to hormone replacement therapy (HRT) or not (no placebo used).

502 were randomised to HRT, and 504 were randomised to no HRT) One group was allowed to choose HRT or not. A total of 221 chose HRT, and 789 chose no HRT.

First line HRT was oral sequential oestradiol/norethisterone in women with intact uterus and oral continuous oestradiol in hysterectomised women.

The study was initiated in 1990, and inclusion ended in 1993.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 45-58 years with an intact uterus
* Three to 24 month past last menstrual bleeding
* Hysterectomised women aged 45-52 years and having elevated FSH

Exclusion Criteria:

* Metaboliv bone disease including osteoporosis defined as non-traumatic vertebral fractures on X-ray
* Current estrogen use or estrogen use within the past three month
* Current or past treatment with glucocorticoids for more than 6 month
* Current or past malignancy
* Newly diagnosed or uncontrolled chronic disease
* Alcohol or drug addiction
Phase I Study of the Combination of Afatinib and Ruxolitinib in Patients With Treatment-refractory Non-Small Cell Lung Cancer (NSCLC)

This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.


Eligibility Criteria:
Inclusion Criteria:

1. Stage 4 NSCLC patients
2. disease progression after platinum doublet (all), EGFR TKI (if EGFR mutant), and crizotinib (if ALK positive)
3. Men and women aged 20 years or older
4. Recovery from previous drug-related toxicity: CTCAE 4.03 ≤ Grade 1
5. ECOG 0 or 1
6. able to orally take and retain drug
7. have a measurable or unmeasurable lesion under RECIST 1.1 Criteria
8. have proper hematological, renal, and hepatic functions
9. intention to use an acceptable contraception
10. able to read and understand the informed consent form

Exclusion Criteria:

1. previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days
2. Clinically significant gastrointestinal disorder or malabsorption syndrome
3. Acute digestive disorder
4. major organ failure
5. Significant cardiac disorders
6. major operation of a main organ in 4 weeks
7. Untreated symptomatic brain metastasis
8. pregnant or nursing
9. previously diagnosed Interstitial lung disease(ILD)
10. previously treated with irreversible pan-HER inhibitor including Afatinib or Ruxolitinib
11. previously experienced hypersensitivity to an ingredient of the study drug
12. must receive CYP3A4 inducer or inhibitor persistently during the study period.
13. HIV positive or active hepatitis
14. threatening patient's safety is predicted
Pneumococcal Post-Vaccination Titers

The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. It is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. Some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.

One hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the PPV-23 vaccine. They will then receive the vaccine. All subjects will be given the vaccination as standard of care. Approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.

Eligibility Criteria:
Inclusion Criteria:

Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be:

1. smokers between the ages of 19-80.
2. elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD or asthma.
3. COPD subjects between the age of 19 and 80, without a history of recurrent bacterial infections.
4. Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections.
5. individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency.

Exclusion Criteria:

The following groups will be excluded:

1. Subjects who are currently receiving or have ever received immunoglobulin replacement therapy.
2. subjects who are on immune suppressive agents.
3. Subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year.
4. subjects on antiepileptic agents.
5. Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women
Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)

This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.

Binge Eating Disorder (BED) affects a significant percentage of de national population (1.4%) in a portio 2-1 in woman compared with men, the repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique, which allows us to induce brain electrical activity by plating magnetic fields and it has been proven that at 10Hz it has an effect of improvement in the craving of food.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of both sexes.
2. Subjects from 18 to 45 years of age.
3. Subjects with diagnosis of binge eating disorder.
4. Subjects without changes in pharmacological treatment in the last 30 days.
5. Subjects who agree to sign the informed consent letter.

Exclusion Criteria:

1.Subjects with a history of traumatic brain injury with loss of consciousness. 2.Subjects with intracranial metallic objects or metal plates in the skull.

3.Subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases).

4.Patients with psychotic symptoms, bipolar affective disorders and substance dependence.

5.Subjects with alterations in electroencephalogram (epileptiform activity). 6.Patients with any type of chronic or neurological medical disease not controlled.
LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

LIRICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable iCCA after a downstaging/disease control protocol with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MR, especially in relation to lymph node locations, by correlating the results with histological examination after iliac lymphadenectomy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of iCCA
* First diagnosis of iCCA
* Recurrence after R0 hepatic resection, N0, M0 without macrovascular invasion
* Disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction
* Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study
* No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT and PET-MR (or PET-CT)
* At least six months have passed since the first diagnosis of iCCA (or recurrence) to the date of inclusion on the liver transplant waiting list
* The patient has received at least six months of SOC chemotherapy, achieving disease stability or partial response (according to RECIST version 1.1) at the time of listing for transplantation
* Hematochemical evaluation: Hb ≥ 9 g/dL, Leukocytes ≥ 3.0 X 109/L, Neutrophils ≥ 1.5 X 109/L, Platelets ≥ 100,000/mm3 (≥ 10 X 109/L), Total Bilirubin ≤ 3 mg/dL (≤ 51 umol/L), AST or ALT ≤ 5 times the upper limit of normal, Serum Creatinine and Urea \< 1.5 times the upper limit of normal
* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
* Patient's BMI ≥ 18 and ≤ 30 kg/m2
* Signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national/local regulations

Exclusion Criteria:

* Tumor involving nearby extrahepatic structures (including involvement of major hepatic vessels) by direct invasion (T4 per AJCC 8th edition)
* Tumor penetrating the visceral peritoneum (T3 per AJCC 8th edition)
* Previous extrahepatic metastatic disease
* Prior neoplasms, except those treated curatively for more than 5 years without recurrence
* Known history of human immunodeficiency virus (HIV) infection
* Known history of solid organ or bone marrow transplantation
* Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study or with the evaluation of study outcomes
* Pregnant or breastfeeding women
* Medical-surgical contraindications for liver transplantation
* Any reason for which, in the investigator's judgment, the patient should not participate in the study
Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.

Thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rTMS of the affected motor cortex. Each patient received 1000 rTMS pulses (1 Hertz at 110% of resting motor threshold) over the unaffected Broca's area and 1000 pulses (20 Hertz at 100% resting motor threshold) over affected left Broca's area for 10 consecutive days. LANGUAGE section of hemispheric stroke scale, Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H) and NIH stroke scale were assessed before, post sessions, 1 and 2 months after the last session . Motor threshold was assessed before and after the end of last session.

Eligibility Criteria:
Inclusion Criteria:

* acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.

Exclusion Criteria:

* head injury or neurological disease other than stroke,
* Unstable cardiac dysrhythmia,
* Fever,
* Infection,
* Hyperglycaemia
* Prior administration of tranquilizer
* Patients with no motor evoked response recorded from first dorsal interosseus (FDI) muscle of the affected hand
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery

Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after macular hole surgery


Eligibility Criteria:
Inclusion Criteria:

* The patients with macular hole

Exclusion Criteria:

* The patients with follow-up less than 6 months
Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T)

Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring.

FADOI Foundation (Italian Scientific Society of Internal Medicine) has promoted a study in collaboration with the ASL Roma 6, monocentric prospective controlled randomized in open-label in patients admitted to an Internal Medicine Unit and subsequently sent to the subacute or discharged care unit. Specifically, the recruitment will take place in the Internal Medicine of the Albano Hospital - Polo H2 of the ASL Roma 6. The aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring. 50 of the patients undergoing continuous monitoring come from the A group and 100 from group B, same ratio in the control patient group. In fact, the study consists of two patient settings, Group A and Group B. Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients discharged consecutively from the Internal Medicine Unit or transferred to the subacute ward within 7 days of hospitalization, with Blaylock Risk Assessment Screening (BRASS) ≥ 11 and at least two active pathologies
* Patients discharged consecutively from the UOC Internal Medicine or transferred to the ward of subacute within 7 days of hospitalization, with at least two active pathologies
* Signature of informed consent

Exclusion Criteria:

* Patients from RSA and Long-term care
* Terminal cancer patient
* Patients with severe cognitive disability or otherwise unable to tolerate the device
* Patients unable to express valid consent
Prognosis of Patients Who Presented With a State of Extreme Agitation.

The main objective is to assess the 6-month prognosis of patients who presented with extreme agitation in the emergency room.

The primary endpoint is the 6-month mortality of agitated patients.

Emergency services are confronted with emergency situations characterized by patients who are victims of significant agitation, in particular states of extreme agitation "excited delirium syndrome", which is constantly increasing and which seems to be associated with morbidity and mortality not negligible.

Patients meeting the inclusion and non-inclusion criteria are included on admission to the emergency room.

An evaluation at H1 and at the end of hospitalization is carried out. The patient is contacted by telephone at M1, M3 and M6.

The inclusion period is 24 months The duration of participation (treatment + follow-up) is 6 months The total duration is 30 months.

The research is multicentric and national with the participation of 8 centres.

Eligibility Criteria:
Inclusion Criteria:

* Agitated patient with the presence of three major criteria, namely,
* restlessness
* insensitivity to pain
* tachypnea (fr\>20)

and the presence of a minor criterion among

* sweating
* skin hyperthermia
* non-compliance with law enforcement
* tirelessness
* unusual strength
* inappropriate clothing, nudity

Exclusion Criteria:

* patient age \< 18 years
* head trauma
* pregnancy
* detained
* other obvious causes of pain leading to restlessness (renal colic, migraines, etc.)