cyrilzakka/clinical-trials huggingface dataset:
Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.


Eligibility Criteria:
Inclusion Criteria:

all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

* age at time of initial diagnosis or relapse diagnosis, respectively

  ≤18 years
* indication for allogeneic HSCT
* complete remission (CR) is achieved before SCT
* written consent of the parents (legal guardian) and, if indicated, the minor patient via "Informed Consent Form"
* no pregnancy
* no secondary malignancy
* no previous HSCT
* HSCT is performed in a study participating centre.

Exclusion Criteria:

* not signed inform consent of the parents (legal guardian)
* pregnancy
* secondary malignancy
* previous HSCT
Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 50 years old
* Patient requiring bilateral cataract surgery
* Regular corneal astigmatism \>0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.
* Expected postoperative astigmatism ≤ 0.75D diopter
* Corneal astigmatism ≤4D
* IOL spherical equivalent power requested between 15D and 25D
* Signed informed consent
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Non inclusion Criteria:

* Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.
* Amblyopia with a visual acuity potential of less than 5/10
* IOL power needed outside the spherical equivalent diopter range: 15 to 25D
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Irregular astigmatism
* Subject with postoperative astigmatism, expected \> 0.75 D.
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Patients with chronic uveitis
* Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil\>4mm or \<2.5 mm in photopic conditions))
* Narrow anterior chambers (ACD ≤ 2.5 mm)
* Any corneal pathology potentially affecting the topography (eg. Keratoconus),
* Monophthalma patients
* Phacodonesis

Exclusion criteria:

* Complicated surgery
* Inability to place the intraocular lens safely at the location planned
* Subjects with zonular laxity
* Postoperative endophthalmitis
PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in HIV-Seropositive Patients With (MCMD)

The purpose of this protocol is to measure a receptor in the brain using positron emission tomography (PET) that is involved in inflammation.

The peripheral benzodiazepine receptor (PBR) is distinct from central benzodiazepine receptors associated with GABAa receptors. Although PBR was initially identified in peripheral organs such as kidneys, endocrine glands and lungs, later studies identified PBR in the central nervous system. In normal conditions, PBR is expressed in low levels in some neurons and glial cells. PBR can be a clinically useful marker to detect neuroinflammation, because activated microglial cells in inflammatory areas express much greater levels of PBR than in microglial cells in resting conditions.

PBR has been imaged with positron emission tomography (PET) using \[11C\]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide (PK11195). However, this classical ligand provides low levels of specific signal. Recently we developed a new ligand, N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine \[11C\]PBR28, which showed much greater specific signal than \[11C\]PK11195 in non-human primates. ln the present protocol we plan to perform a kinetic brain imaging study with \[11C\]PBR28 in HlV-seronegative controls, HIV-seropositive, non-impaired patients, and HlV-seropositive patients with minor cognitive motor disorder(MCMD). Each subject will recieve a brain-dedicated PET scan with 20 mCi\[(11)C\]PBR28.

Eligibility Criteria:
* INCLUSION CRITERIA:

Inclusion criteria (healthy control subjects) aged 18 50 years with history/physical exam, ECG, and laboratory tests, plus inclusion criteria listed will be included in the protocol.

1. HIV-seropositive based on ELISA and Western blot (except the HIV-seronegative subjects, who will have ELISA screening).
2. Capable of providing informed consent.
3. Ambulatory at initial visit.
4. If cognitively impaired, the degree of impairment will be MCMD, and not frank HIV-associated dementia.

EXCLUSION CRITERIA:

1. Current psychiatric illness or severe systemic disease based on history and physical exam
2. Current dependence on alcohol or substances other than nicotine.
3. Laboratory results from blood or urine tests that show clinically significant abnormalities.
4. Previous radiation exposure (X-rays, PET scans etc.) that would exceed research limits.
5. Pregnancy and breast feeding.
6. A history of brain disease.
7. Cannot lie on your back for long periods since the pictures will be taken for about 2.5 hours during which time you will have to lie still on the scanner bed.
8. More than moderate hypertension.
9. Positive result on urine screen for illicit drugs.
Hemorrhoids and Metalloproteinases, Observational Study

An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and different stages hemorrhoids.

The study provides potentially important insights to the understanding of the natural history of Hemorrhoids and MMPs and NGAL regulation.

Introduction. An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between the levels of MMPs and NGAL and different stages hemorrhoids.

Methods. In a multicenter, open-label, prospective study, patients with hemorrhoids were recruited and represented the Group I (patients with symptomatic hemorrhoids - Grade I to IV sec. Goligher), a further group of healthy volunteer subjects were also recruited as the control group (Group II).

Enzyme-linked immunosorbent assay and Western blot analysis will evaluate the levels of immunoreactive MMPs and NGAL in all patients with hemorrhoids.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemorrhoids of both sex

Exclusion Criteria:

* Patients with cancer
* Hepatic failure
* Infectious or autoimmune diseases
* Arthritis
* Arterial aneurysms
* Hernias
* Chronic venous disease
* Nephritis, vascular ulcers, fibrosis, and other diseases associated with increased levels of MMPs were excluded from the study.
* Patients treated with corticosteroids or cytostatic drugs were also excluded.
Comparitive Effects of Elliptical Training vs Resistance Training on Cardiopulmonary Parameters in Post CABG Patients

COMPARATIVE EFFECTS OF ELLIPTICAL TRAINING VS RESISTANCE TRAINING ON CARDIOPULMONARY PARAMETERS IN POST CABG PATIENTS

Coronary artery bypass grafting (CABG) has been widely and increasingly used since the 1960s as a common surgical procedure to restore blood flow into the stenotic coronary arteries

. It is one of the effective ways to treat coronary artery disease, which can significantly relieve patients' myocardial ischemia and hypoxia symptoms and improve their quality of life.

Data were collected from Itefaq hospital, sehat medical complex Lahore. Borg dyspnea and quality of life (SF12) questioner were used before and after the intervention.

Assessment was done through the tool before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female age 45-55 years.
* Post Coronary Artery Bypass Grafting (CABG) patients at phase III cardiac rehabilitation were included .
* Patients who had physically active lower limbs were included .

Exclusion Criteria:

* Participants who had psychological conditions that may influence understanding or answering of questionnaire.
* Patients with other cardiac lesions combined with simultaneous surgical management, such as valvular lesions, macro vascular lesions, and ventricular wall tumors.
* Patients diagnosed with emergency CABG, minimally invasive CABG, or recurrent cardiac surgery.
* Patients with severe dysfunction of important organs such as the lung, liver, and kidney.
* Patients with recent major surgery or trauma of other parts of body.
* Pregnant or lactating women.
Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

The aim of this study is to examine the effect of transcutaneous pulsed radiofrequency current in the treatment of carpal tunnel syndrome.

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. Wrist splint is the first-line treatment option for CTS. Pulsed radiofrequency therapy is used in the treatment of chronic pain.

60 carpal tunnel syndrome patients diagnosed with electroneuromyelography will be included in the study. 30 patients will wear wrist splints for 1 month. In the other 30 patients, pulsed radiofrequency current will be given through the wrist median nerve trace. RF current will be applied through transcutaneous pads. It will be applied once a week for a total of 2 sessions, 8 minutes each. Boston carpal tunnel syndrome questionnaire with visual analog scale (VAS) will be applied to all patients before and after the treatment at 1 week and 1 month.

Our aim is to compare the effectiveness of wrist splint and pulsed rf therapy.

Eligibility Criteria:
Inclusion Criteria:

* Carpal tunnel syndrome detected by electroneuromyography
* Positive Tinel sign

Exclusion Criteria:

* Thenar muscle atrophy
* Weakness in the abductor pollicis brevis muscle
A Dose-Range Study of GSBR-1290 in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various GSBR-1290 dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 36-week period.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

Exclusion Criteria:

* Previous documented diagnosis of diabetes mellitus
* Self-reported change in body weight \>5% within 3 months before Screening
* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)
* Use of medications intended to promote weight loss, within 6 months prior to Screening
Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes

Hypothesis:

Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive Males, age 45 or older
* Any genotypic or phenotypic resistance except k65R, 69 insertion, integrase resistance, or resistance to rilpivarine or doravirine.
* Receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir \> 12 months and with viral load \<50 copies/ mL on at least one occasion within the six months prior to switch.
* Suppressed viral load as defined by one plasma HIV RNA level \< 50 copies/mL within previous 6 months.
* Capable of providing informed consent

Exclusion Criteria:

* Any current or prior integrase inhibitor resistance
* Nucleoside reverse transcriptase (NRTI) mutation 69 insertion or k65R mutation
* Documented second generation non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance (rilpivirine or doravirine)
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 yrs. old

Exclusion Criteria:

* pregnant or lactating females

  * Contact site for additional information
Association Between Prescription of Antidepressants and Delirium in the Elderly : Analysis From the World Health Organization Global Database

Delirium is a frequent reason for hospitalisation of the elderly. Associations between the prescription of some medicines and the risk of delirium have already been demonstrated.

Antidepressants are widely prescribed in the elderly because of the frequency of anxiety-depressive symptoms in this population, where there are high pharmacokinetic and pharmacodynamic variability.

However, the association between antidepressants and the risk of delirium remains poorly understood.

Based on the analysis from the World Health Organization global database, the main objective of this study is to investigate the association between the different classes of antidepressants and the occurrence of the " delirium " event reported in the database.

A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of delirium.


Eligibility Criteria:
Inclusion Criteria:

* be over 65 years old
* taking antidepressants
* to have presented delirium

Exclusion Criteria:

-
Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy

Exclusion Criteria:

* ASA \>3, morbid obesity BMI\>40, Previous cardiac or ipsilateral thoracic surgery, Renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication
Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia Before and After PTBD

The purpose of this study is to detect differences in the enzymatic activity of matrix metalloproteinases in patients with malignant obstructive hyperbilirubinemia before and after percutaneous biliary drainage.

This study will be designed as a prospective cohort study involving the collection of peripheral blood samples before and one month after percutaneous biliary drainage for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity). Biochemical analyzes are preceded by the entry of data relevant to the research (demographic, anamnestic, clinical and biochemical).

Eligibility Criteria:
Inclusion Criteria:

pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1

Exclusion Criteria:

terminally ill patients, performance status \>2, hepatic decompensation, severe underlying cardiac or renal diseases and coagulation disorders.
Intraoperative M-Entropy Measurements

The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist will be using.

Depth of anesthesia monitors are increasingly used in clinical anesthesia practice. Bispectral Index (BIS) and M-Entropy are examples to these devices, both of which are available at our institution. Both BIS and M-Entropy use a unilateral, single channel of EEG to derive a number indicating the anesthetic depth. These devices have similar disposable skin probes that can be applied on either side of the forehead. Since the depth of anesthesia for an individual is the same over the whole brain cortex at a given point in time, BIS numbers obtained over the left and right side of the forehead should agree. The same should be true for M-Entropy as well.

A recent study, however, showed that two separate BIS probes, applied over the left and right forehead of the same patient at the same time, can give significantly different numbers. This has not been studied for M-Entropy. BIS and M-Entropy use different mathematical algorithms that process the raw EEG signal to compute a numeric value. Therefore, it is possible that M-Entropy may show different results in a similar study setup.

The aim is to investigate the same-patient reproducibility of M-Entropy by monitoring and recording Entropy variables over both the left and the right side of the forehead of patients under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to have surgery under general anesthesia, with a minimum of 60 minutes expected duration.

Exclusion Criteria:

* Non-English speaker
* Patients younger than 18 years of age
Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)

The purpose of this study is to evaluate the safety of two doses (6 Development Units \[DU\] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma)
* History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist \[SABA\] use per week; and not wakening more than twice a month at night due to asthma symptoms
* Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study

Exclusion Criteria:

* Unable to meet medication washout requirements
* History of chronic urticaria and/or chronic angioedema within prior 2 years
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen
* Unstable, uncontrolled or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing SABAs) at any time within prior 3 months
* History of chronic sinusitis during within prior 2 years
* Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
* Known history of allergy, hypersensitivity or intolerance to investigational medicinal products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or Dermatophagoides farina (D. farina) or self-injectable epinephrine
* Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial
Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage

All patients with acute aneurysmal hemorrhage are treated in accordance with our institutional protocol. After securing of the aneurysm, some smokers with acute aneurysmal hemorrhage are randomly assigned to transdermal nicotine replacement (NRT). The short- and long-term effect of NRT will be studied comparing non-smokers, smokers without NRT and smokers with NRT.

Various aspects of the study:

* Study cerebral circulation with transcranial Doppler ultrasonography (TCD) prior to and after NRT.
* Study cardiac output and peripheral vessel resistance minimally invasive (LiDCO) prior to and after NRT in patients that already have established LiDCO.
* Monitor intracranial pressure prior to and after NRT in patients that have established an intracranial pressure sensor.
* Register the frequency of cerebral vasospasm and complications in non-smokers, smokers without NRT, and smokers with NRT.
* Register the use of opioids, opioidanesthetics, propofol og psycholeptics in non-smokers, smokers without NRT, and smokers with NRT.

Eligibility Criteria:
Inclusion Criteria:

* aneurysmal subarachnoid hemorrhage after securing of the aneurysm and surviving the first 2 weeks.

Exclusion Criteria:

* manifest cerebral vasospasm at arrival at our department (i.e. before securing of the aneurysm)