cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

This is a multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study followed by an optional open-label extension to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q4 weeks as an add-on to background treatment in participants with Sjögren's disease.

The primary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) scores at 28 weeks.

The key secondary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) at 28 weeks.

Approximately 80 participants who have a diagnosis of Sjögren's disease according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria will be randomized with approximately 40 participants in the sibeprenlimab group and 40 participants in the placebo group.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with Sjögren's disease.
* ESSDAI score (which measures disease activity) must be 5 or higher.
* Salivary flow rate must be at least 0.05 mL/min.
* Serum IgG level must be higher than 900 mg/dL.
* Must be able to communicate well with the investigator and agree to follow the trial requirements.
* Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
* Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
* Test positive for anti-Ro52 and/or anti-Ro60 antibodies.

Key Exclusion Criteria:

* Another active autoimmune rheumatic disease.
* Prior use of B-cell depleting therapy or prohibited immunosuppressants.
* Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
* Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).
Unilateral vs Bilateral Total Hip Arthroplasty

The purpose of the present study was to determine whether unilaterally operated total hip arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and to what extent medial femoral head offset (FO) influenced hip abductor strength.


Eligibility Criteria:
Inclusion Criteria:

* Undergone hip surgery 3-5 years ago
* Age \< 70 years

Exclusion Criteria:

* Heart or lung diseases
* Malign diseases
* No muscle/skeletal diseases that compromises testing
Acute Myeloid Leukemia Registry

All acute myeloid leukemia (AML) patients diagnosed after 1 Jan 2020 will be included to this study.

This is a non interventional prospective disease registry, 250 prospective patients diagnosed with AML across 20 centers in Turkey.

Participating sites will consist of hematology clinics and routine follow-up procedures will be followed-up.

All patients diagnosed after 1 Jan 2020 as AML will be included and patients will be enrolled during 24 months of period and will be followed-up 36 months. Study will be completed in 60 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as AML after 1 Jan 2020
* Patients signed informed consent form

Exclusion Criteria:

* Patients under 18 years old
Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia

The purpose of this study is to develop a more physiological approach to the management of children and adolescents with salt wasting Congenital Adrenal Hyperplasia.

We will administer the glucocorticosteroid via insulin infusion pump to see whether this treatment will improve the serum hormone concentrations.

The adrenal gland is a small organ of the body. It produces very important chemicals called hormones. One of these hormones, cortisol (the stress hormone) helps the body fight diseases. The other hormone is the aldosterone helps to maintain the normal amount of salt and water in the body. The third type of hormones are the androgens or male hormones, which cause some of the changes during puberty, like the growth of body hair and pimples.

The salt wasting Congenital Adrenal Hyperplasia or CAH disease is a disease of the adrenal gland. Patients with this disease cannot make cortisol or the aldosterone. As a result, their body cannot fight diseases and cannot keep normal amounts of salt and water in the body. At the same time, the gland makes too much of the male hormones, which is bad for the body because too much male hormone slows down growth, increases the growth of body hair, and causes pimples and abnormal period in girls.

Patients with this disease have to take medications every day. However, the treatment does not work very well, because usually the patients do not have the right amount of hormone in their body. Usually the body gets too much hormone right after taking the pills. A couple of hours later the body has too little of the hormones, because in the meantime the body gets rid of the medication.The healthy adrenal gland makes the hormones throughout the day in different amounts. The patients with this disease take the medication only a couple of times a day. They take the Florinef tablet once a day and the Cortisol tablet two or three times a day. The treatment that we use today by mouth cannot copy the natural hormone productions of the adrenal gland. Because of this it does not make much of a difference in the patient's life.

We would like to improve the treatment and find out the effect of a new treatment. In this study we will try to imitate the body's normal hormone production and will give the medication via an insulin pump to see if this treatment method will decrease the male hormones in the blood. This study will help us to develop a new and better treatment for children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Children with salt wasting CAH otherwise healthy without other chronic disease
* Age: between 3 and 18 years of age
* Body weight 23 kg (50 lbs) or above
* Hemoglobin equal to or higher than 12 g/dl before the study
* Supportive family environment

Exclusion Criteria:

* Age less than 3 or older than 18 years at the time of study
* Other chronic disease
* Hemoglobin less than 12 g/dl
* Non-supportive family
* Allergy to local anesthetics

Criteria for study termination: If the subject's parents are unable to manage/operate the pump, the subject will be withdrawn from the study.
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)

Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

This study will assess the effectiveness of T-DXd, patient demographic and clinical characteristics, and treatment patterns in patients with advanced HER2-positive advanced gastric or GEJ adenocarcinoma.

This non-interventional study will investigate the effectiveness of T-DXd, the patients demographic and clinical characteristics, treatment patterns including prophylactic medications and interventions for reduction of serious adverse events (SAEs), serious adverse drug reactions (ADRs) and safety event of interest (SEIs), tolerability, and patient survey of T-DXd, in cases with advanced HER2-positive gastric or GEJ adenocarcinoma receiving T-DXd as second line of treatment and beyond treatment option. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No investigational drug will be administered in this study.

Data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) will also be collected in a disease registry part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patient (age ≥ 18 years) with HER2 + advanced gastric or GEJ adenocarcinoma who have received a prior trastuzumab based regimen
* Histological or cytological confirmed diagnosis of advanced HER2 positive gastric cancer or GEJ
* Documented HER2 + status (archival sample or recent sample prior 2L therapy)
* Decision to newly initiate monotherapy T-DXd or conventional therapies per SMPC according to the physician's choice
* Written dated and signed Informed Consent (ICF) to participate in the study

Exclusion Criteria:

* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded
* Pregnancy or breastfeeding

No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children

Refugees live in camps under unusual living conditions. The children in the camps may not have enough safe facilities to play. If an injury occurred in these children, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.

Fractures of the distal forearm (especially radius) are the most common fracture reported in childhood and a frequent reason for visiting the emergency unit and orthopedic clinic in hospitals. Because of the age of patients and proximity to the joint, these fractures heal well and have a good ability to remodel the bone even with mild displacement. Therefore, most of these fractures are treated conservatively by a short arm cast with frequent visits to the orthopedic clinic within 4-6 weeks without significant complications. Several studies report successful treatment of these fractures by removable splint as a substitute for the cast. The splints proved to be safe and cost-effective in managing these common minor injuries in children under usual living conditions.

Refugees live in camps under unusual living conditions. The children in these camps may not have enough safe facilities to play. If they got an injury, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 2-12 years old age.
* Sex: both male and female.
* Address: living in one of the refugees' camps in the Duhok Government.
* Duration of symptoms: less than 7 days.
* Type of injury: fracture at the distal end of radius proofed by a radiograph film in two views (posteroanterior and lateral).
* Type of fracture: it may be any of the followings:

  * torus (buckle) fracture,
  * undisplaced or minimally displaced fracture distal radius physis (type 1 and 2 only) that do not need reduction.
  * undisplaced or minimal displaced metaphyseal fracture that does not need reduction. Note: The minimally displaced fracture will be considered when the fracture fragments have a tilt of fewer than 15 degrees and shift less than 5 millimeters at the fracture site in both views.

Exclusion Criteria:

* open fractures
* pathological fractures
* displaced fractures that need reduction
* delayed presentation beyond 7 days
* associated fracture of the ulnar bone
* polytraumatic cases.
High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury

Brain injuries are a significant cause of loss of movement. It has been shown that physical therapy can help patients to regain movements. The purpose of this study is to see if it is possible to perform a new exercise program that will help patients regain movement. This new exercise program will involve practicing walking, stairs, jumping and running. Participation in this study will involve physical therapy 1 to 2 times a week for 12 visits over 6 to 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Referred to physical therapy with an Acquired Non-Progressive Central Neurological Injury (traumatic brain injury, stroke, brain tumor, spinal cord injury) for 3 months or more
* capacity to consent
* ability to read and write English at the sixth grade level
* able to walk twenty meter without physical assistance or an assistive device, however they can use a brace.
* self-selected gait speed of 0.6 m/s or greater when performing 10 meter walk test.

Exclusion Criteria:

* Adults subjects diagnosed with a progressive central or peripheral neurological disorder or an acute non progressive central neurological disorder (less than 3 months)
* Subjects who require physical assistance or an assistive device to walk twenty meters or demonstrate self-selected gait speed less than 0.6 m/s
* Subjects who are already able to run independently in the community
* Participants who are unable to complete the 12 physical therapy visits at prescribed skill level as established by protocol
* Participants who reports \>4/10 on NPRS with lower extremity weight bearing.
Outpatient Evaluation of Patients With Known or Suspected Heart Disease

This study is designed to screen patients with heart diseases who may qualify to participate in other research studies being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI).

Patients participating in this research study will be seen on an outpatient basis and undergo a general medical evaluation, including blood tests, urine, examination, chest x-ray and electrocardiogram (EKG). In addition, patients may be asked to have an echocardiogram (ultrasound scan of the heart) and to perform an exercise stress test.

Patients participating in this study will not receive any investigational treatments.

This protocol permits outpatient screening of patients with cardiovascular diseases who may be candidates for participation in current Cardiology Branch research protocols. No investigational treatments will be administered on this protocol.

Eligibility Criteria:
Must not be enrolled in an active Cardiology Branch research protocol.

The patient must be of scientific interest to the Cardiology Branch, as determined by the investigator.

Patient is being screened for participation in an active protocol.
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 years of age
* Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
* Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
* Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
* Serum potassium \<=4.8 mmol/L

Exclusion Criteria:

* Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
* Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)
* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit \[class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)\]
* Dialysis for acute renal failure within 12 weeks of Run-in visit
* Renal allograft in place or scheduled kidney transplant within next 12 months
* Glycated hemoglobin (HbA1c) \>12%
Use of a Compression Device for Ring Removal: A Prospective Trial

The usual treatment for stuck rings includes a variety of techniques including use of ice to reduce swelling, use of lubricants, and sometimes the use of string or ring cutters. The success rate of these techniques is variable and cutting the ring is usually reserved as a last resort. Sometimes removal of a ring can take time, and can cause some small injury to the patient. Because of this, it is important to consider other methods for ring removal.

This study is looking at using a device that uses compression to reduce swelling of the finger causing the ring to be stuck. This device has been approved for use in Canada. The purpose of this study is to evaluate how effective a compression device is at removing stuck rings.

The study question is: how effective is a compression device at removing stuck rings?

A Compression Device (CD) is a device that uses circumferential compression to reduce swelling around a stuck ring. The device is used by placing it near, but not over-top, the offending ring, and then is inflated compressing the finger. The device is applied, and the hand elevated, for approximately five minutes. The device is then removed, and with a small amount of lubricant, the ring is removed.

All patients requiring ring removal at the QEII emergency department, if a compression device can be used safely, will be asked if they would like to be included in the study and have their ring removal attempted by a compression device.

Following removal attempt, the clinician will document information about the ring removal. This will include some questions regarding the patient's experience with the removal. No identifying information or personal health information will be recorded.

The investigators plan to collect information about use of the compression device for a period of one year. Following this time, the data will be analyzed to determine how effective the compression device is at removing rings including statements regarding patient experience. This information will be documented in a manuscript intended for publication and may be presented at academic conferences or other continuing education events.

The investigators will be measuring the success rate of ring removal with the compression device.

In addition, the investigators will record information on any side effects of use of the compression device, as well as patient experience including pain and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting to the QEII emergency department with a chief complaint of a stuck ring on a finger, or with heath conditions that necessitate removal of a ring that cannot be removed without clinician assistance.

Exclusion Criteria:

* Contraindications to compression device use including certain bone, nerve or blood vessel conditions.
A Study to Test How Healthy Men Tolerate Different Doses of BI 1595043

The primary objectives of this trial are to investigate safety and tolerability of BI 1595043 in healthy male subjects following administration of multiple rising doses over 14 days.

Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
  * Sexually abstinent
  * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply