cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)

This is a study to evaluate the safety and efficacy of losmapimod in treating participants with Facioscapulohumeral Muscular Dystrophy (FSHD). Participants diagnosed with Facioscapulohumeral muscular dystrophy type 1 (FSHD1) or Facioscapulohumeral muscular dystrophy type 2 (FSHD2) will participate in Part A (Placebo-controlled treatment period) and will be randomized in a 1:1 ratio to receive losmapimod 15 milligrams (mg) or placebo orally twice daily (BID). Upon completion of Part A, participants will have the option to rollover into Part B (open-label extension) to evaluate the long-term safety, tolerability, and efficacy of losmapimod and will receive losmapimod 15 mg orally BID.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between 18 and 65 years of age, inclusive.
* Genetically confirmed diagnosis of FSHD 1 or FSHD 2.
* Clinical severity score of 2 to 4 (Ricci Score; Range 0-5), at screening. Participants who are wheelchair-dependent or dependent on walker or wheelchair for activities are not permitted to enroll in the study.
* Screening total RSA (Q1-Q4) without weight in the dominant UE assessed by RWS ≥ 0.2 and ≤ 0.7.
* No contraindications to MRI.

Exclusion Criteria:

* Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary.
* Participants who are on drug(s) or supplements that may affect muscle function, as determined by the Investigator: participants must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study.
* Known active opportunistic or life-threatening infections including Human Immunodeficiency virus (HIV) and hepatitis B or C.
* Known active or inactive tuberculosis infection.
* Acute or chronic history of liver disease.
* Known severe renal impairment.
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s); or history or evidence of abnormal ECGs.
* Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or currently participating in a study of an investigational device.
* Current or anticipated participation in a natural history study. Previous participation is allowed but participants cannot continue after enrollment in Study 1821-FSH-301.
* Known hypersensitivity to losmapimod or any of its excipients.
* Previous participation in a Fulcrum-sponsored FSHD losmapimod study (FIS-001-2019 or FIS-002-2019).

Note that all other inclusion and exclusion criteria are listed in the protocol and only key are presented.
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.


Eligibility Criteria:
Inclusion Criteria

* Documented COPD diagnosis for ≥ 12 months
* History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
* Post-bronchodilator FEV1 ≥ 20% and \< 80% of predicted at screening
* Post-bronchodilator FEV1/FVC \< 0.70 at screening
* Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
* Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
* On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
* Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

Exclusion Criteria

* Current documented diagnosis of asthma
* History of clinically significant pulmonary disease other than COPD
* Diagnosis of 1-antitrypsin deficiency
* History of long-term treatment with oxygen at \> 4.0 liters/minute
* Lung volume reduction surgery or procedure within 12 months prior to screening
* Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
* History of lung transplant
* Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
* Upper or lower respiratory tract infection within 4 weeks prior to or during screening
* Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
* Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
Veteran's Perceptions of Ketamine-Assisted Psychotherapy for Depression and End-of-Life

The goal of this exploratory, mixed-method design study is to gather qualitative and quantitative data obtained through interviews and questionnaires with veterans who are currently enrolled at the VA for healthcare. The main question this study aims to answer is: How do veterans aged 65+ who are enrolled for care at the VA understand ketamine assisted psychotherapy for depression and for end-of-life distress? Using a story-completion approach, participants will be provided with a brief story starter involving a fictitious character and scenario and asking them to complete the story. Few contextual details will be offered about the character. In responding to ambiguous cues, participants are thought to project their conscious and subconscious perceptions about the phenomenon in question onto the story, a useful method for exploring stigmatized topics. The purpose of this exercise is to ascertain the participants attitudes and perceptions regarding ketamine assisted psychotherapy.

Veterans will be informed of the study by their VA providers (Behavioral Health Clinic, Primary Care, etc). Veterans who are interested will have their contact information passed on to the study investigators. Once screened and enrolled in the study veterans will complete a brief demographics form, and three brief symptom screening questionnaires: Patient Health Questionnaire 9, Ten Item Personality Inventory, and the Death Anxiety Questionnaire. Participants then engage in the recorded interview during which they are provided with a brief story starter, as described above. In the story, a fictitious veteran with a diagnosis of depression is offered an opportunity to engage in ketamine assisted psychotherapy (KAP). The veteran then receives a cancer diagnosis and is again offered a chance to consider KAP. Participants are asked to share what questions, concerns, hopes, and expectations may be present for the fictitious veteran in the story. Interviews will then be transcribed and the PI and the collaborators will read all transcriptions and generate recurring themes that can be reliably coded. The investigators will then code the transcripts for the presence of themes. Data analytic plans include calculating the prevalence of each theme and examining their correlates with measures of severity of symptoms as well as any demographic variables. It is hoped that this data can inform educational and other roll-out efforts within the VA system around KAP.

Eligibility Criteria:
Inclusion Criteria:

* Veterans enrolled in VA care.
* Age 65 or older.
* Fluent in written and spoken English.

Exclusion Criteria:

* Cognitively impaired to the extent that patient cannot comprehend the survey.
Ultrasound Guided Pericapsular Nerve Block Versus Iv Sedation Analgesia in Reduction of Shoulder Dislocation

When someone experiences a shoulder dislocation, it can be extremely painful. Emergency physicians often choose to use conscious sedation to help reduce the pain. However, some patients may not be able to tolerate conscious sedation due to concerns about their ability to breathe properly or the risk of inhaling fluids. A recently developed technique called Ultrasound-guided Pericapsular Nerve Group (PENG) block is used to block the articular branches of the shoulder and the pericapsular spread around the glenohumeral joint. The PENG block is commonly used in hip surgery and is effective in providing motor-sparing analgesic results.

When someone experiences a shoulder dislocation, it can be extremely painful. Emergency physicians often choose to use conscious sedation to help reduce the pain. However, some patients may not be able to tolerate conscious sedation due to concerns about their ability to breathe properly or the risk of inhaling fluids. In an ideal scenario, the surgeon could achieve complete pain control and muscle relaxation without compromising the patient's airway. There are various techniques available to facilitate shoulder reduction, including interscalene block, general anesthesia, and intravenous analgesia. All of these methods can help the surgeon ease the patient's pain and reduce the likelihood of complications.1 When choosing the anesthesia method for reducing ASD, the top priority is ensuring the patient's comfort through pain management. The anesthesia helps to relax the muscle spasms, making it easier to reduce the ASD. The goal is to relocate the shoulder with minimal risk of complications.

A recently developed technique called Ultrasound-guided Pericapsular Nerve Group (PENG) block is used to block the articular branches of the shoulder and the pericapsular spread around the glenohumeral joint. The PENG block is commonly used in hip surgery and is effective in providing motor-sparing analgesic results.

Eligibility Criteria:
Inclusion Criteria:

* (ASA )classes I and II
* patients of either sex, above the age of 18
* patients will undergo dislocated shoulder

Exclusion Criteria:

* the patient's refusal to participate
* coagulation disorders
* allergy to local anesthetic
* history of daily opioid intake
* patients with cognitive impairments
Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy

Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.

This prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. Cases to whom TAP block with ultrasound was applied after standard general anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was applied, were determined as Group 2.

Eligibility Criteria:
Inclusion Criteria:

* Liver transplantation donors

Exclusion Criteria:

* Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance
Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD

In this study, 51 subjects include 17 freezers,17 non-freezers and 17 aged-matched healthy subjects will be recruited. We will compare the cortical excitability, gait performance, and stepping-in-place performance before and after intervention of auditory cues combined with gait training. The cortical excitability will be assessed by transcranial magnetic stimulation (TMS). The purpose in this study is to investigate the effects of auditory cues with gait training on cortical excitability and rhythmic movements in patients with Parkinson's disease.

Background: Parkinson's disease is a common neurodegenerative disease and movement disorder. Due to the degeneration of basal ganglia, patients with Parkinson's disease also demonstrate internal rhythm dysfunction, thus will lead to difficulty in rhythmic movements such as ambulation. To improve the rhythmic movement problems, auditory cues are often used in clinical setting and have been revealed providing benefits in ambulation and freezing problems for PD subjects. Besides, treadmill training is another common intervention to improve gait performance for PD. However, lack studies investigate the effects of auditory cues with locomotion training on brain neurophysiology and scarcer studies investigate the different effects of auditory cues between the freezers and non-freezers.

Objective: To investigate the effects of auditory-cued training on cortical excitability and motor performances in patients with PD. To investigate whether different effects of auditory cues on cortical excitability and motor performance between the freezers and non-freezers.

Methods: We will recruit 17 freezers, 17 non-freezers and 17 healthy elderly. Each participants will receive the trainings under two conditions in random order. There is one week wash-out period between two-trainings. Two-training are (1) treadmill training with concurrent auditory cues: participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min. (2) treadmill training without any auditory cues: participants should walk in comfortable speed on the treadmill for 30 min. Assessments consist of cortical excitability through transcranial magnetic stimulation (TMS), stepping-in-place test, and walking test, and they will be done before and after training.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 20 y/o
* Diagnosed with idiopathic Parkinson's disease
* No hearing impairment
* Able to walk independently without aid
* MMSE above 24

Exclusion Criteria:

* Other neurological disease
* Orthopedic problems affect gait performance
* Psychological disorder
* Unstable cardiovescular and respiratory status
* Dementia
* Visual disturbance affects gait performance
* Contraindication of transcranial magnetic stimulation: family history of epilepsy; head injury; head surgery or metal implant; pacemaker; syncope or migraine with unknown reasons; pregnancy
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign informed consent before screening examinations are performed and before the study drug is administered
* Females \> 18 years of age
* Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration \> 3 hours and \< 45 days) at the time of randomization
* Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure \> 90 mmHg and diastolic blood pressure \< 105 mmHg)

Exclusion Criteria:

* Pregnancy and lactation
* Acute myocardial infarction and cerebrovascular accidents
* Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV
* Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
* Concurrent antiarrhythmic treatments
Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

Scoliosis is a 3-dimensional, structural deformity of the spine. Idiopathic scoliosis is the most common type and it constitutes 75-80% of all scoliosis. Surgical methods are the most effective way to correct the deformity in patients who cannot achieve adequate improvement with supportive therapy. Adolescent idiopathic scoliosis surgeries are among the most invasive surgeries performed on children and adolescents. Large surgical incision and massive tissue damage cause severe postoperative pain. In this study, we aim to compare posterior instrumentation (PE) and vertebral body tethering (VBT) surgeries performed in adolescent idiopathic scoliosis patients in terms of anesthetic management and postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* ASA score 1-3 patients
* Adolescent idiopathic scoliosis patients
* Patients who accepted to be included in the study and received written parental consent

Exclusion Criteria:

* Patients with vertebral anomaly due to a secondary reason
* Patients with a diagnosed syndrome
* Patients with a Cobb angle below 40.
* Patients who undergoing reoperation
Evaluating the SUBLOCADE Treatment Exit Strategy

The purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to discontinue MOUD.

This is a Phase IV, observational, multicentre, open-label, study in participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have had disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and both healthcare provider and participant plan to discontinue MOUD treatment.

Eligibility Criteria:
Inclusion Criteria

Participants must meet all of the following criteria:

* The participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop MOUD treatment, and the participant meets the following criteria:

  * Has been treated with at least 12 injections of SUBLOCADE.
  * In the opinion of the investigator, has had their OUD symptoms (ie, overdose, illicit/nonmedical use, withdrawal) controlled for at least 9 months.
  * In the opinion of the investigator, has had any other substance use disorder (excluding alcohol, nicotine, or cannabis) symptoms controlled for at least 9 months.
* Is willing to complete the Baseline Visit 4 to 8 weeks after the last dose of SUBLOCADE.
* Has signed the ICF and is 18 years of age or older.
* Is not currently using opioids to treat a diagnosis other than OUD.
Training Methods for a Doctrine Of Life With Healthy Heart

This study is an interventional study which was conducted in the field. The investigators intended to develop an efficient and economically valuable method which can decrease the risk factors for prevention of cardiovascular diseases. Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and cheap methods to decrease risk factors.

In this study, the aim of preparing the Group II training material was to enable the individual to see his or her risks as unique, and to proceed with life by adapting personal behaviors. Group II's training material was formatted as a prescription. Because giving a prescription for a doctor is very important in low socioeconomical group person.

This study showed that social programs oriented towards individual behavioral changes assume an important role in decreasing cardiovascular risk factors.

Background:

Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and economical methods to decrease risk factors.

Methods:

This study was conducted in three stages in a semi-rural region of Eskisehir, Turkey. In the first stage, individuals selected by random sampling were evaluated in terms of social-demographic characteristics and the risk factors present for cardiovascular diseases. A scale comprised of 19 questions was implemented for data assessment. In the second stage, training materials were randomly distributed. Group I's training material consisted of a brochure containing pictures and general information on heart disease; Group II members additionally received a personalized letter that further explained their individual risk factors and suggested measures for increased protection and prevention - in short, Group II's training material was formatted as a prescription. In the third stage, the subjects were screen against the cardiovascular risks factors one year later to assess and determine if there had been any changes in their attitudes towards the dangers of the cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Over 40 years of age were contacted.
* Individuals who were literate or had at least one literate person in the household were selected through random sampling via the records of local health care units.

Exclusion Criteria:

* Under 40 years of age and immigrants
Effects of Agility Training With and Without Foot Mobilization In Patellofemoral Pain Syndrome.

Patellofemoral pain syndrome (PFPS) is referred to as peripatellar or retro-patellar pain, which is characterized by alterations in the physical and biomechanical features of the patellofemoral joint. Risk factors for PFPS include: anatomic anomalies, mal-alignment and altered biomechanics of the lower extremity, muscle dysfunction, patellar hypermobility, poor quadriceps, or iliotibial band flexibility, surgery, tight lateral structures, training errors or overuse and trauma. The aim of this study is to compare the effects of foot mobilization with and without agility training on pain, balance and functional performance in patellofemoral pain syndrome.

A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore, Al Rehman Hospital, through convenient purposive sampling technique on 42 patients which will be allocated through using simple randomization into Group A and Group B. Group A will be treated with agility training and foot mobilization in patellofemoral pain syndrome and Group B will be treated with agility training without foot mobilization in patellofemoral pain syndrome thrice a week for 6 weeks. Outcome measures will be conducted through pain (NPRS), Kujala patellofemoral pain scale, Y balance test and Navicular droop test before and after 6 weeks. Data will be analyzed using SPSS software version 25.

Eligibility Criteria:
Inclusion Criteria:

Clinical signs of patellofemoral pain syndrome such as retro patellar pain, crepitation, and pain with patellar grinding more than 6 months.

* Both genders of 20-40 years of age.
* Presence of pain on step down from a 25 step or double leg squat and sitting with knee bent greater than 15 min.
* Pain more than 4 on NPRS scale.
* Individual with anterior left/right asymmetries greater than 4 cm on Y balance test
* Excessive calcaneal eversion measured at 6° in the relaxed posture(6).

Exclusion Criteria:

* History of ligament and meniscal injury.
* History of lower limb fractures.
* History of post-surgical condition of lower limb
* History of systemic, connective tissue or neurologic condition