cyrilzakka/clinical-trials huggingface dataset:
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®

* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
* Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
* A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
* Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.

Exclusion Criteria:

* A history and/or current diagnosis of asthma.
* Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
* A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.
Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.

In-vitro fertilisation (IVF) treatment involves women undergoing hormone stimulation (drug dosing) to produce more oocytes (eggs) to increase their chances of fertilisation. The information that IVF clinicians currently collect on a woman's hormonal response to IVF drug dosing comes from in-clinic blood testing. This requires patients to make a visit to the IVF clinic every few days to have the blood samples taken. The blood is then analysed in a laboratory for the hormone levels and the results are then sent back to the clinic. This monitoring process of frequent onsite visits and blood draws can often be quite inconvenient and disruptive for patients.

This observational study will assess a non-invasive in vitro diagnostic (IVD) device for measuring the common fertility hormones in urine. The test system is for use by both healthcare professionals in a clinical setting and nonprofessionals in a home care setting under the guidance of a health care professional. This study will provide pilot data on the usability of the IVD device from the intended end users as well as the correlation of urinary metabolite levels as measured by the IVD device and the serum concentration as measured by blood analysers.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing controlled ovarian stimulation treatment
* 30 to 40 years old (inclusive)
* Willingness to comply with study procedures for collection and testing of urine

Exclusion Criteria:

* Illiterate in English
* No access to smart phone that is compatible with App and/or is not connected to the internet
* Patients who are diabetic (Type I and Type II), have insulin resistance or a renal/liver disorder
* Patients who have taken oral contraceptives up to 4 days before the first stimulation day of the cycle
Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part A

Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease.

Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Similarly, neurophysiological assessment can provide evidences on the integrity of brain motor networks and mechanisms underlying cortical plasticity in the early disease phase, potentially providing a set of reliable prognostic factors of disease progression in early diagnosed PwMS.

Furthermore, disease progression might be delayed using physical activity, which is effective in PwMS with moderate disability to ameliorate mobility and promoting brain reorganization and seems promising also for PwMS in the early stages of the disease. Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity, thus, it can provide spatial information about changes in cortical activation patterns and it could represent a useful tool for studying the effect of exercise on cortical plasticity. The aims of the study in non-disabled PwMS are: 1) a) to assess the presence of subclinical balance and walking impairments using wearable devices and multimodal gait analysis and b) to investigate cortical activity during exercise, 2) to define prognostic factors associated to disease progression and 3) to study the efficacy of physical activity in preventing the worsening of mobility and stimulating brain functional adaptation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 17 years
* Stable disease course (without worsening over 1 point at the EDSS in the last 3 months)
* Expanded Disability Status Scale (EDSS) \<2.5

Exclusion Criteria:

* Major depression
* Mini-Mental State Examination \< 27
* Other cardiovascular or orthopedic diseases that interfere with physical exercise
* Undefined or not confirmed diagnosis of MS (Polman criteria)
* Progressive course of the disease
Use of Closed-loop Anesthesia in Pediatric Patients

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia


Eligibility Criteria:
Inclusion Criteria:

* class ASA I, II or III
* general anesthesia scheduled to last more than one hour
* intraoperative hemorrhage planned to be less than 15% of the blood volume

Exclusion Criteria:

* Combined general and regional anesthesia,
* Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,
* History of a neurological or a psychiatric disorder, or central brain lesion,
* Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
* Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
* Hypersensibility to remifentanil or to a derivate of fentanyl,
* Scheduled postoperative ventilation or sedation.
Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

To evaluate the feasibility and efﬁciency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.


Eligibility Criteria:
Inclusion Criteria:

* patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
* patients scheduled for robot-assisted laparoscopic nephron sparing surgery
* patients with normal contralateral renal function (diﬀerential renal function of \>40% as determined by radionuclide scintigraphy)
* patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

* patients' aged \>80 years
* patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
* patients not able to tolerate the robot-assisted laparoscopic procedure
* patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney
* patients with the renal tumor involving urinary collecting system
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia

The study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of sildenafil 50 \& 100 mg added to stable antipsychotic treatment in schizophrenia patients to assess whether this PDE5 inhibitor improves cognitive functioning (including verbal memory, fluency, attention, spatial memory, motor speed, and executive function) and clinical symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).

Specific Aims:

1. Evaluate the effects of single doses of sildenafil 50 \& 100 mg compared to placebo on cognitive functioning, including verbal memory, fluency, attention, spatial memory, motor speed, and executive function.
2. Evaluate the effects of single doses of sildenafil 50 \& 100 mg compared to placebo on psychotic, negative, and mood symptoms.
3. Assess self-reports of side effects of sildenafil 50 \& 100 mg.

Location and Subjects:

25 adult outpatients with schizophrenia will be recruited from the Massachusetts General Hospital outpatient clinic or the Freedom Trail Clinic of the Lindemann Center. All research procedures will be performed at the Psychopharmacology Clinic of the Massachusetts General Hospital. Subjects must be English speaking because the cognitive battery has only been validated in English.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of schizophrenia, any subtype.
2. Age 18-65 years
3. Male or female
4. Clinically stable without a medication change within 4 weeks
5. Able to complete cognitive testing (must be English-speaking)
6. Willing to use appropriate birth control during study participation (if female)

Exclusion Criteria:

1. Active substance abuse or dependence
2. PDE 5 inhibitor taken within 24 hours of study drug
3. Currently taking a drug that inhibits hepatic cytochrome P450 3A4 (eg. Nefazadone, fluvoxamine, erythromycin, ketoconazole, itraconazole, cimetidine, saquinavir, ritonavir, St. John's wort, or grapefruit juice).
4. Currently taking drugs that induce P45 3A4 (eg. phenytoin, carbamezapine, Phenobarbital, rifampin)
5. Unstable medical disease
6. Significant cardiac disease
7. Bleeding disorder
8. Peptic ulcer disease
9. Hepatic impairment
10. Moderate or greater renal impairment
11. History of migraines
12. Currently taking nitrates or alpha blockers
13. Resting blood pressure \< 90/50 or \>140/90 mm.
14. History of intolerance to PDE5 inhibitors
15. History of inappropriate sexual behavior (eg, masturbation in public, stalking, assault)
16. History of priapism
17. Pregnant or lactating
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors

The purpose of this study is to determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy

Until now, in trials it is common to stop therapy when progressive disease occurs; RECIST criteria are used, in which progressive disease is defined as \>20% increase of the sum of the longest diameter of the lesions, or occurence of new lesions. However, angiogenesis inhibitors have a rather cytostatic than cytotoxic effect compared to chemotherapeutics, as a result of which less frequently reduction of tumor volume is being seen.

Often in the centre of the lesion necrosis is shown. Sometimes accompanied with edema; so even tumor volume increase can be the result without real progression being the case. Recently, in our clinic, we found a number of patients, treated with oral angiogenesis inhibitors, a remarkable quickening of progressive disease and complaints after stopping this treatment. Reintroduction of the same or another type of angiogenesis inhibitor subsequently lead to a new stabilization. The causality of this phenomenon is unknown. Perhaps that the inhibitory effect of the angiogenesis is not fully exhausted at the moment that progressive disease on CT is observed. An alternative explanation is contra reaction of longterm angiogenetic inhibition through upregulation of proangiogenic factors with subsequent vascular expansion and edema. This study means to gain more insight information about the optimal treatment policy when progressive disease is found in patients treated with oral angiogenesis inhibitors. Because of the increase of patients that is being treated with these products, both in trials as in daily clinical practice, this is important to investigate.

Eligibility Criteria:
Inclusion Criteria:

* metastatic or advanced solid cancer that is treated with an oral angiogenesis inhibitor, with clinical indication to stop this therapy based on progressive disease as defined by the RECIST criteria on the CT scan. It needs a minimum of 1 previous evaluation of stable disease and the patient must have been treated with angiogenesis inhibitors for at least 12 weeks.
* age ≥18 years
* given informed consent

Exclusion Criteria:

* pregnant or lactating
* metastatic sites solely in bone or liver
* contraindication for CT or Avastin scan (claustrophobia, severe renal function disorder, allergy for contrast fluids, allergy for Avastin)
* insufficient condition to continue treatment with angiogenesis inhibitors.
* contraindication for dynamic contrast MRI (deteriorated renal functions with clearance \<60ml/min, metal in body, claustrophobia, pacemaker, defibrillator)
Hanover Humerus Registry

This register study collects data of patients with proximal humerus and humerus shaft fractures to monitor the healing process by assessing shoulder function and quality of life according to the treatment method (operative or conservative management).

This prospective data collection of patients with proximal humerus and humerus shaft fractures in a lifelong aftercare treatment plan is for analyzing the healing process in one patient and compared in the whole cohort.

According to actual scientific and clinical issues can this data collection be a basis in optimizing the treatment method.

Eligibility Criteria:
Inclusion Criteria:

* patients with trauma-related proximal humerus and humerus shaft fracture
* cognitively able to fill out a questionaire
* signed informed consent

Exclusion Criteria:

* patients with oncological-related proximal humerus and humerus shaft fracture
* cognitively not able to fill out a questionaire
* no informed consent
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 to 70
* Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview
* Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight
* Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5) Deemed to be symptomatically stable by the clinical staff in the last two months

Exclusion Criteria:

* Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates
* A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings
* Not capable of giving informed consent for participation in this study
* Ongoing pregnancy
* Known sensitivity to naltrexone
* A medical disorder that is known to cause obesity
* Use of sibutramine, topiramate, amphetamines or over the counter weight remedies
* Impaired liver functions (greater than 3 times the upper limit of normal)
* Diagnosed with polycystic ovary syndrome
* Currently being treated with insulin
* Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain
Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.

The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.

Transversus abdominis plane (TAP) block is a promising effective method for postoperative pain control after major abdominal surgery. TAP block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (T6-L1). Using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. Ultrasound-guided TAP block provides better results and fewer complications, but it requires experienced operators. Surgically administered TAP (sTAP) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. Also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects \[laparoscopic-assisted psoas (LAP) blockade\].

Eligibility Criteria:
Inclusion Criteria:

* Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last \>30minutes (eg. undescended testis and inguinal hernia repair).
* Written consent, free and informed

Exclusion Criteria:

* Significant respiratory, cardiac or renal disease
* BMI \>95th percentile for age.
Alpha -1- Microglobulin (α1M) as an Early Biomarker in Renal Extrahepatic Manifestations of HCV-infection

find the role of alpha one microglobulin (as an early renal tubular biomarker) to identify and evaluate the prevalence of early renal manifestations among patients with chronic HCV and compared these patients with HCV-negative healthy individuals

Hepatitis C \[HCV\] infection is known to cause renal manifestations, which are discovered at a late stage when chronic kidney disease (CKD) has already occurred .

HCV is both a consequence and cause of renal impairment: first, dialysis patients have an increased risk of infection related to medical procedures and, second, HCV causes pathological changes to the kidneys .

HCV seems to influence both renal tubular and glomerular cells as described by different proteinuria profiles and hematuria findings. Tubular cell damage may be the earliest sign of renal dysfunction caused by HCV and could potentially be used to identify patients with risk for progression. Routine urine analysis could be used to identify high risk HCV patients for early treatment.

Identifying patients early is of paramount importance in order to offer a prompt intervention and to improve the prognosis in both settings, for this purposes, novel biomarkers could be used One promising biomarker is alpha-1-microglobulin (α1m), a low molecular weight glycosylated protein of molecular weight synthesized by hepatocytes, freely filtered across the glomerulus, and then reabsorbed by the proximal tubule . it can signal proximal tubule dysfunction: higher Uα1m concentrations indicate impaired tubular reabsorption . Small studies have previously shown that Uα1m concentrations increase in Acute kidney injury (AKI), reflect severity of AKI, and are associated with the need for dialysis after nonoliguric AKI . Elevated Uα1m correlates with interstitial fibrosis and tubular atrophy on kidney biopsy, representing chronic kidney damage . Furthermore, Uα1m appears to predict kidney function decline and CKD progression , Acute kidney injury risk and also associated with early tubulointerstitial renal diseases in HCV-glomerulopathy .

Eligibility Criteria:
Inclusion Criteria:

Hepatitis C virus (HCV )-positive patients: HCV Antibody and status confirmed by HCV-RNA positive who are either treatment naïve or previously treated.

3. HCV-negative control at outpatients.

Exclusion Criteria:

- 1. HIV-positive patients or Hepatitis B positive (HbsAg) patients or both. 2. Previous renal diseases. 3. Diabetes mellitus, Hypertension, Systemic Lupus erythematosus, Rheumatoid arthritis.

4. patients with Active malignancy. 5. Alcoholics.
Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This study will investigate if adding a domiciliary respiratory physiotherapy treatment to standard care in patients with chronic obstructive pulmonary disease (COPD) can improve physical function (walking test) and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Severe COPD (FEV1/FVC \< 70% and FEV1 \< 50% pred.) associated to hypoxaemic chronic respiratory insufficiency (PaO2 \< 60mmHg) or
* Very severe COPD (FEV1/FVC \< 70% and FEV1 \< 30% pred.)

With the following characteristics:

* no signs of lung restriction (TLC≥80%)
* clinically stable for at least the last four weeks
* MRC ≥ 2
* no participation to PR programmes in the last year

FEV1= Forced expiratory volume in the 1st second FVC= Forced vital capacity TLC= Total Lung Capacity PaO2= Partial pressure of arterial oxygen

Exclusion Criteria:

* - Muscular-skeletal impairment that could limit the patient's participation to the exercise programme;
* Cognitive impairment that could limit the patient's participation to the activities of education and exercise, as assessed by the Mini Mental State (MMS) test \<26;
* Malignancies
TMJ NextGeneration(TM) Feasibility Study

The study is an open-label, prospective, single-center, non-randomized feasibility study of the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events and incidence of migraines and headache in subjects diagnosed with sleep bruxism.

The study will be conducted at one study center in the U.S. Subjects will be enrolled in the trial for a period of 8 weeks. The study will consist of a screening phase lasting up to 2 weeks and a follow up treatment period lasting 8 weeks. Subjects will visit the dental clinic twice during the screening period, then five times during the treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects at least 18 years of age;
2. Subject has had a diagnosis of sleep bruxism;
3. Subject has been medically screened and diagnosed by a physician as having headaches and/or migraines;
4. Subject is willing to comply with the usage instructions for the Bruxoff device;
5. Is able to read and understand the ICF and has voluntarily provided written informed consent.
6. Subject is able to open their mouth at least 17 mm to be fitted for the TMJ NextGenerationTM device;
7. Male Subjects are willing to have a clean shaven face on the nights that the Bruxoff device will be used;
8. Subject agrees that when using the Bruxoff device to keep their cellular phone in another room.

Exclusion Criteria:

1. Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol;
2. Subject has any sleep disorder other than bruxism;
3. Subjects who have had direct trauma to the jaw;
4. Subjects who have had prior TMJ or ear surgery;
5. Subjects who have a narrow ear canal or impression of the ear canal, which is prolapsed due to an anatomical shift or failure of the ear canal wall structure, or a canal that does not allow for the ear canal second turn to be identified;
6. Subjects with visible or congenital ear deformity as observed on targeted physical exam;
7. Subjects whose ear canal anatomy does not allow for fit of the study device;
8. Subjects who have a history of ear pain unrelated to TMJ;
9. Subjects who have a history of ear drainage in the past 6 months;
10. Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
11. Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
12. Subject has a pacemaker.