cyrilzakka/clinical-trials huggingface dataset:
A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected.

This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug.

There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Part A: Overtly healthy PMP females
* Part B: PMP women who are currently taking oral bisphosphonates
* Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m\^2)

Exclusion Criteria:

* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* Have known allergies to blosozumab, its constituents, or related compounds
* Have an abnormality in the 12-lead electrocardiogram (ECG)
Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

Aims of the study:

This is a single blind randomized-controlled trial to test the feasibility and the effects of a task oriented training on locomotor function, mobility and balance in multiple sclerosis subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not be treated with a specific physical therapy (usual care).

Subjects and methods:

60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic (Azienda Ospedaliero-Universitaria di Ferrara).

Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented training (experimental group) or usual care (control group) through a randomization stratification approach, according to a block randomization of 6.

The experimental group will receive 10 task-oriented training sessions over 2 weeks (5 sessions/week=intensive training). Three subjects with a supervisor physiotherapist will take part at the TOCT.

Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy outcome measures will be clinical test for gait speed (10m walking test), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); a structured interview for the performance(Lower Extremity Mal); self-assessment questionnaire for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical and psychological impact (multiple sclerosis impact scale MSIS-29), walking ability (multiple sclerosis walking scale MSWS-12).

Outcome measures will be assessed the week before the treatment (T0), after the treatment (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded to the treatment.


Eligibility Criteria:
Inclusion Criteria:

* males and females,
* community dwelling,
* age 18 or older
* diagnosis of multiple sclerosis in a stable phase, with relapses \> 3 months prior to study enrollment
* moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5

Exclusion Criteria:

* neurologic conditions in addition to multiple sclerosis that may affect motor function
* medical conditions likely to interfere with the ability to safely complete the study
* impaired cognitive functioning: Mini Mental Status Examination \< 24
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies


Eligibility Criteria:
Inclusion Criteria:

* Age is over 18 years old
* Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies
* ECOG performance status (PS) 0 \~ 1
* Expected survival of \> or = 3 months

Exclusion Criteria:

* The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)
* Received any other anti-cancer treatment within 4 weeks
* Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption
* Allergy, or known to have a history of allergy to the drug components
Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients

This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.

This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.

Eligibility Criteria:
Adult male and female patients with cancer who developed neuropathic pain in the affected area secondary the surgical procedure, chemotherapy or radiation that meet the following Inclusion/Exclusion criteria:

Inclusion Criteria:

Pain on the side of the lesion

* Spontaneous pain with a score for "worst pain in the last 24 hours" \>4 on a numeric scale 0-10
* Must present the following symptoms and signs:

  * Continuous burning, shooting, or lancinating pain.
  * Presence of hyperesthesia
  * Presence of hyperalgesia (to pinprick) and/or allodynia (to light touch)

Exclusion Criteria:

* Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
* Pain/painful conditions unrelated to the cancer or related treatment
* Pregnancy
* History of seizures/epilepsy
* Any implanted devices (e.g. a cardio stimulator, etc)
* Active illegal drug/alcohol abuse
* Unable to follow directions or complete tools in English
Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery

The purpose of this research is to compare a single shot long acting local anesthetic to catheter infusion of local anesthetic in patients undergoing video assisted thoracoscopic (VAT) surgery.

The purpose of this research is to compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% bolus followed by 0.2% infusion of local anesthetic using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are age \> 18, undergoing video thoracoscopic surgery and following Guthrie Robert Packer Hospital's Enhanced Recovery After Surgery (ERAS) protocol for Thoracic Surgery.

Exclusion Criteria:

* weight \< 50 kg, pregnant subjects,
* left ventricular ejection fraction \< 30%,
* history of drug or narcotic abuse,
* history of allergic to amide local anesthetic,
* presence of contraindication for erector spinae plane block (local skin infection, sepsis, severe coagulopathy)
* unable to provide consent,
* unable to use pain rating scales as demonstrated by verbal feedback
* preoperative chronic pain on narcotics,
* history of renal insufficiency ( Creatinine \> 1.5 mg/dl),
* preoperative mild liver impairment ( i.e. AST/ALT above 1.5 times the upper normal limit)
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 65
* Must have mild or moderate asthma (Part III only)
* Nonsmoker for at least 6 months

Exclusion Criteria:

* History of stroke, chronic seizures or major neurological disorder
* You are nursing
* Drink more than 3 glasses of alcohol a day
* Have allergy to or not able to tolerate lactose
* Have a history of drug abuse in the last 5 years
* Drink more than 6 beverages containing caffeine a day
* Have had surgery, donated blood or participated in another investigational study in the last 4 weeks
Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise program on grip strength, movement speed, coordination, functional status, depressive status, and quality of life in patients with a myoelectric prosthesis with upper limb amputation. In the literature review, There is no robot-assisted exercise program applied in patients using upper extremity myoelectric prosthesis.

The expected benefit from this study is to show that the functional status, depressive status, and quality of life of the patients who received robot-assisted biofeedback exercise were better than those who had a home exercise program only.

The study was planned as a randomized prospective clinical study. The study was planned to include 16 patients. New amputation patients will be excluded from the study. The patients in the study group will have 5 sessions of exercise in the hospital for a week. The control group will receive a home exercise program.

Statistical analysis Student t-test will be used for the comparison of descriptive statistical methods (mean, standard deviation, median, frequency, and ratio) and normal distribution parameters between groups. Pearson chi-square test, Yates Continuity Correction, Fisher-Freeman-Halton Exact Test, Fisher Exact Test, and Marginal Homogeneity Test will be used to compare qualitative data. The results will be evaluated at 95 % confidence interval and p \<0.01 and p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Upper elbow amputation
* Being using myoelectric prosthesis for amputated upper extremity
* Be literate
* To be able to complete and complete the tests at the level of mental and physical activity
* Being 18-65 years old

Exclusion Criteria:

* Patients with neurological sequelae
* Patients who could not cooperate
National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.

The objective of the study will be to understand whether a supplementation of the diet with an active symbiotic, i.e. characterized by a mix of probiotics and a specially selected fiber with prebiotic activity combined with a vegetable extract with beneficial activities on carbohydrate and lipid metabolism, can reduce the relative inflammatory potential and improve absorption, intestinal motility and bowel habit of patients with various pathological conditions, such as ALS, ADHD and bronchial asthma.

Clinical survey conducted for research and study purposes, multicenter, focusing on ALS patients, elderly patients with chronic diseases, and pediatric patients with neurodevelopmental disorders. For each of the diseases treated, patients will be randomized into the two treatment arms (Study Group, GS; Control Group, GC) according to a block randomization, with a block size of 4 and an allocation ratio of 1:1. The randomization will be double-blind.

* Study Group or GS: These subjects will be given an active symbiotic preparation consisting of two sticks of 1500mg each and of different colors.
* Control group or GC:These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each.

Eligibility Criteria:
Population 1 : ALS

Inclusion Criteria:

* Age at enrollment ≥18 years;
* ALS diagnosis defined or probable according to El Escorial criteria (Brooks et al., 2000);
* Respiratory function with FVC% \>50%.

Exclusion Criteria:

* Subjects unable to give informed consent to the study;
* presence of psychiatric disease or severe cognitive impairment;
* presence of tracheotomy; presence of severe pre-existing gastrointestinal disease (e.g., ulcerative rectocolitis; Crohn's disease).

Population 2: ADHD

Inclusion Criteria:

* children between 6 and 16 years old
* children with ADHD, diagnosed with DSM-5 criteria and in accordance with the protocol shared by the Regional ADHD Reference Centers Lombardy.

Exclusion Criteria:

* presence of intellectual disability (QIT\<70),
* presence of neurological diseases, epilepsy
* presence of genetic syndromes
* treatment with drug therapies.

Co-diagnosis with other psychiatric or neurodevelopmental disorders (i.e. Autism, Anxiety, Depression etc) will not be considered a criterion of exclusion.

Population 3: Bronchial Ashtma

Inclusion Criteria:

* adults above 18 years of age
* diagnosed with Bronchial Ashtma following ERS-ETS criteria

Exclusion Criteria:

* life expectancy less than 18 months
* active respiratory infections
* cognitive disorders that prevent participation to the study (MMS \<24)
Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair.

Comparison of treatment efficacy of Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV).

Open-label, randomized controlled trial comparing the Epley maneuver with the 360 maneuver using the TRV chair in both scenarios. Patients diagnosed with posterior BPPV will be randomized to receive treatment with either the Epley maneuver or the 360 maneuver.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Confirmed unilateral p-BPPV (canalithiasis and cupulolithiasis)
* Understand written and spoken Danish

Exclusion Criteria:

* Pregnancy
* Weight ≥ 150 kg and or Height ≥ 2m
* Not possible to attend follow-up visits
* Insufficient cooperation during diagnostic testing or treatment in the mechanical rotational chair
* Have received treatment for BPPV in a mechanical rotational chair within the last 6 months
* Sedative antihistamines are taken within the past 7 days
* Comorbidities: Heart failure (EF\<40), known cerebral aneurysm, cerebrovascular events (\<3 months), and dissection disease
* Spontaneous or gaze evoked nystagmus.
Optimal Management of Urinary Catheter in Gyn Onc

This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* female gender
* undergoing pelvic surgery for benign or malignant indications by a gynecologic oncologist

Exclusion Criteria:

* Age less than 18 years of age at the time of surgery
* pregnant
* individual is a prisoner
Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence.

Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal.

The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.

The individual patient is informed about the condition and if meets criteria is offered to take part in the study. Written information and informed consent always noted. Questions about the patients general medical condition is noted and if the person has had problems with perianal abscesses before.

Eligibility Criteria:
Inclusion Criteria:

* perianal abscess that needs surgical treatment, over the age of 18

Exclusion Criteria:

* Under the age of 18 or unable to understand study information because of language difficulties or dementia.
MANTIS Endoscopic Clipping Study

This study is intended to document clinical effectiveness and safety pertaining to use of a new endoscopic clipping device MANTIS™ when used for hemostasis, closure, anchoring and marking.

To document clinical effectiveness and safety when used per indication within the GI tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for:

   * Mucosal/sub-mucosal defects \< 3 cm
   * Bleeding ulcers
   * Arteries \< 2 mm
   * Polyps \< 1.5 cm in diameter
   * Diverticula in the colon
   * Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
4. As a supplementary method, closure of GI tract luminal perforations \< 20 mm that can be treated conservatively

Eligibility Criteria:
Inclusion Criteria:

* Subject indicated for endoscopic clipping per local standard of practice.
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

* Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
* Subjects who the investigator deems at risk for study device or procedure related complications per the Instructions for Use (IFU). where commercially available or the Investigator Brochure (IB) for countries where the study device is not approved.
D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia

evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.

The following will be done for enrolled patients:

1. Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions.
2. Clinical examination Vital data Local chest examination
3. Measurement of oxygen saturation using pulse oximeter
4. Laboratory investigations:

   Complete blood count with differential count Liver and kidney functions D-dimer level Coagulation profile
5. Radiology work up ( Chest X-ray-High resolution computed tomography of the chest- computed tomography of the chest with pulmonary angiography as needed)
6. Sepsis-induced coagulopathy score (SIC score)
7. Sequential organ failure score (SOFA score)
8. Patients will receive treatment according to the hospital guidelines for different disease stratification severity

Eligibility Criteria:
Inclusion Criteria:

* All adult (\>18 years) patients from both sexes with COVID-19 pneumonia with positive nucleic acid test for severe acute respiratory syndrome Coronavirus (SARS-CoV-2) hospitalized either in the ward or intensive care unit

Exclusion Criteria:

* Patients with absolute contraindication of pharmacological thromboprophylaxis and/ anticoagulation
* Congenital hemorrhagic disorders
* Hypersensitivity to heparin
* Personal history of heparin-induced thrombocytopenia
* Active major bleeding or conditions predisposing to major bleeding. Major bleeding is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g.intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level (Hb) of ≥2g/dL in a 24h period, or c) leads to transfusion of 2 or more units of whole blood or red blood cells (13).
* Suspected or confirmed bacterial endocarditis
* Ongoing or planned therapeutic anticoagulation for any other indication
* Platelet count \<50,000/μL within the past 24 hours or Hb level \<8g/dL
* Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
* Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
* Fibrinogen \<2.0 g/L
* Severe renal impairment (CrCl\<30 mL/min) or acute kidney injury
* Use of dual antiplatelet therapy
* Pregnancy
* Unwillingness to consent
The International PNH Interest Group PNH Registry

The aim of this International PNH Interest Group (IPIG) registry is to develop an international database to prospectively collect data on patients with PNH covering clinical outcomes, patient reported outcomes (PROs), and health-resource utilization (HRU) on all enrolled patients, as well as long term safety data.

The International PNH Interest Group (IPIG) PNH Registry is an international, observational database collecting real-world health information about PNH patients over time. The registry is owned and managed by IPIG, a not-for-profit network of international PNH experts dedicated to improving care and treatment for PNH patients. Several pharmaceutical partners are collaborating with IPIG to fund the registry, which will provide data to support their post-approval regulatory commitments.

The IPIG PNH Registry aims to collect data about all PNH patients including clinical outcomes, patient reported outcomes and health resource usage, as well as long term safety data for patients treated with anti-complement therapies.

The IPIG PNH Registry is comprised of a 'core' PNH disease registry collecting a defined set of core variables on all patients with PNH. In addition, there are several product-specific 'silos' initiated by marketing authorization holders including patients treated with PNH-specific therapies. The silos collect both the core dataset and additional variables to address specific objectives or requests from regulatory authorities (e.g. post-authorization safety data).

Data is collected at enrollment and at 6 monthly intervals during follow-up.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44).

Eligibility Criteria:
Inclusion Criteria:

* Patients with PNH confirmed by flow cytometry.
* Patient and/or parent/legally authorized representative provide written informed consent/assent to participate in the registry in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations.

Exclusion Criteria:

* Participating in an interventional PNH clinical trial. Note: A patient included in the registry, who enrolls in an interventional PNH clinical trial during the course of the registry, will be kept in the registry but data collection will be paused in the registry during their involvement in the clinical trial/extension study. Data collection in the registry will continue after patient involvement in the clinical trial/extension study has ended or trial protocol mandated data collection ceases.