cyrilzakka/clinical-trials huggingface dataset:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Sweden

This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via Easypod™.

Subjects will be enrolled in a multicenter longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the Easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via Easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™
* To identify adherence subject profiling based on age, gender, self injection or not, time on treatment, medical history at time of enrollment
* To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Other Objectives:

• To assess the impact of adherence on average blood glucose (HbA1C)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the EasypodTM electromechanical device according to Summary of Product Characteristics (SmPC)
* Over the age of \> 2 years old
* Under \< 18 years of age, or over 18 years of age without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the registry , with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in an interventional clinical study
Weight Approximation in Stroke Before Thrombolysis

Thrombolysis using Alteplase (tPA) is still the only approved specific therapy for acute ischemic stroke (AIS). Current guidelines in western countries recommend an tPA dose of 0.9mg/kg up to a maximum dose of 90mg for patients weighing more than 100kg. However, larger dose-finding rtPA trials for intravenous thrombolysis in AIS are missing. Based on results from research on myocardial infarction only a few open label studies with low case rates were initiated to evaluate the optimal dose for tPA in cerebral ischemia. These studies suggested a narrow therapeutic range with decreased efficacy in lower dosages and an increased risk for thrombolysis related intracerebral hemorrhage (ICH) at doses above 0.95mg/kg. The ECASS-1 trial which used a dosage of 1.1mg/kg rt-PA showed significantly higher rate of large parenchymal hemorrhages compared to trials using 0.9mg/kg. Therefore accurate dosing is crucial. In the acute phase two aspects complicate rtPA dosing in AIS: First, unlike in other diseases many stroke patients are unable to communicate information on their body weight (BW) because of their stroke symptoms (e.g. aphasia, decreased consciousness). In addition motor symptoms prohibit easy weighing procedures in many patients. Second, the ultra-early and narrow time window for treatment does not allow time loss to weigh each patient in the emergency situation. Therefore routinely the attending physician has to make a visual estimation of the patient's BW. This may be inaccurate and may cause dosing errors which has been shown for other weight based emergency medication. There is little data on tPA-dosing errors in stroke patients and prospective data are lacking. The aim of our study is to evaluate availability of BW-information, accuracy of estimations and final dosing of tPA in a routine clinical setting. Therefore the investigators evaluate different sources of body weight estimations and also compare visual estimation with recently proposed anthropometric measurements for body weight approximation. Finally, impact of dosing errors on safety and efficacy are analyzed.

The initial phase will consist of 100 enrolled patients as a pilot phase for further power calculations. Based on the results of the pilot phase enrollment will continue. The envisioned inclusion target is up to 800 patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients receiving intravenous thrombolysis with tPA for acute ischemic stroke

Exclusion Criteria:

* common exclusion criteria for intravenous thrombolysis
Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA

You are invited to participate in a study designed to investigate the effects of diabetes mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a possible participant because you fit into one of the following categories. a) you are either healthy and competent, are not pregnant and you have no known medical disease and therefore your glucose metabolism will be typical of a normal person, or b) you have diabetes.

Glucose is a major fuel for most organs in the human body, particularly the brain. How and where the body uses glucose is regulated by a number of hormones, for instance insulin and glucagon. In a number of diseases, in particular diabetes mellitus, the glucose supply to the brain may be different than normal, which may be a cause for reduced glucose awareness.

The purpose of this study is to determine the effects of altered glucose metabolism on the brain. For example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain.

To measure these effects, we will use intravenous infusions of glucose and insulin.

Eligibility Criteria:
Inclusion Criteria:

* well controlled type 1 diabetes (hemoglobin A1c \<7.5%)
* age 18-65
* healthy controls

Exclusion Criteria:

* history of stroke, seizures, neurosurgical procedures, or arrhythmias
* use of drugs that can alter GABA metabolism (such as benzodiazepines).
* Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.
Role of Famotidine in the Clinical Improvement of COVID-19 Patients.

This study is aimed to investigate the effect of Famotidine in the clinical recovery of COVID-19 patients. COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there is no specific medication against it. Like other countries of the world, Besides antiviral drugs, immunosuppressive agents, and symptomatic therapy like H2 receptor blocker FAMOTIDINE came to the limelight due to its role in reducing the symptoms of COVID-19 patients. The study will include COVID-19 participants to confirm by RT PCR or an HRCT chest. Detail history of each participant with comorbidity will be taken and will be examined carefully. The hospitalized patients admitted to the HDU/ICU units will be enrolled in this study. Critically ill patients who require ventilator support will not be included in this study. The outcome of the Famotidine treatment will be evaluated and compared with a control group.


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 infection confirmed by RT PCR or CT Chest.
* Severe COVID-19 patients require hospitalization under HDU/ICU.

Exclusion Criteria:

* Patients with severe and/or uncontrolled medical conditions with significantly compromised organ function.
* Patients who were hospitalized from the before due to other reasons.
* Contraindication / possible drug interaction with Famotidine with existing therapy.
* Immunocompromised patients.
* Pregnancy, Pulmonary Tuberculosis, AIDS
Effect of an Exercise Program Designed for Orchestral Musicians

This study is a randomized clinical trial evaluating the effect of an exercise program designed specifically for orchestral musicians on performance-related musculoskeletal problems (PRMPs). Professional and conservatory-level orchestral musicians will be recruited. Half of the subjects will participate in an 11-week home exercise program and attend three group exercise sessions and an educational presentation on injury prevention, while the other half of the subjects will receive no intervention, and continue their usual activities.


Eligibility Criteria:
Inclusion Criteria:

* professional or freelance orchestral musician, or tertiary-level full-time music student majoring in an orchestral instrument
* able to commit to performing exercises 2 times per week over an 11-week period
* medical condition permitting participation in an exercise program (ie. no serious heart or lung condition that may be exacerbated by physical exertion)

Exclusion Criteria:

* presence of musculoskeletal injuries definitively non-related to musical practice or performance
* fewer than 15 hours per week playing their instrument
* corticosteroid infiltration in the 6 weeks preceding recruitment
* prescribed anti-inflammatory drugs or neurontin in the 3 weeks preceding recruitment
Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition

OBJECTIVES:

I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.

PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled study.

Patients receive either daily choline chloride in their total parenteral nutrition (TPN) solution or their usual TPN. The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly. Therapy continues for 24 weeks. Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance. Additionally, all patients record the type and amount of their food intake on a daily basis.

Patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning with week 12 for the remainder of the 24 weeks, and then again at week 34.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Receiving nightly total parenteral nutrition (TPN) for greater than 70% of nutritional needs for a minimum of 8 weeks prior to study entry; Receiving no greater than 38 kcal/kg/day/ideal body weight; Receiving lipid emulsion as part of TPN regimen

Expected to require TPN for at least 34 weeks after study entry

Hepatic steatosis documented by prestudy CT scan

Consistent daily amount of intravenous amino acids, dextrose, or lipid received for 3 weeks prior to study entry

--Prior/Concurrent Therapy--

No concurrent cholinergic medications

--Patient Characteristics--

Hepatic: Albumin at least 3.5 g/dL; No hepatic failure; PT no greater than 2 times upper limit of normal

Renal: No renal failure requiring hemo- or peritoneal dialysis

Other: No AIDS; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Educational Program for Knee Osteoarthritis

Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes and the Transcutaneous Nerve Electro-Stimulation device - being performed twice weekly, for 5 weeks for 40 minutes each session; and control group who only underwent treatment with the Transcutaneous Nerve Electro-Stimulation in the same parameters as experimental group. The evaluations were performed at the beginning of the treatment, 4 and 12 weeks after the beginning of the treatment using a numerical pain scale; WOMAC; IDATE and SF-36 questionnaires; and 6-minute walk test.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria;
* Age between 40 and 80 years;
* Both genders;
* Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters.

Exclusion Criteria:

* Systemic inflammatory diseases or any condition that prevents the practice of physical activity;
* Regular physical activity started or changed in the last twelve weeks;
* No ambulation;
* Joint injection in the knee in the previous twelve weeks;
* Previous knee surgery or surgery planned for the next twenty-four weeks;
* Physiotherapy in the last twelve weeks;
* Other disease that affects the lower limbs;
* Open wounds at the electrode application site;
* Planned trip in the next twelve weeks.
Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease

This study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature males or females, aged 21 to 65 years old, inclusive.
* Single, or adjacent, 2-level degenerative disc disease at C3-C7, inclusive.
* Subject is a surgical candidate for an anterior approach to the cervical spine.
* Minimum of 6 weeks of unsuccessful conservative treatment.
* Subject with at least moderate preoperative pain and functional impairment
* Subject is mentally and physically able to comply with protocol, postoperative compliance instructions, and follow-up schedule through 2-years.
* Subject must understand and sign the written Informed Consent form.

Exclusion Criteria:

* Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
* An active infection at the operative site or active systemic infection at the time of surgery.
* Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
* Previous spinal fusion at the involved, or adjacent, cervical level(s).
* Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
* Significant osteoporosis in the cervical spine.
* The investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation:
* Cervical facet degeneration of the involved C3-C7 levels.
* Previous trauma to, or fusion in, the C3-C7 levels.
* Cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays.
* Radiographic findings of a fused or total collapsed disc.
* Significant global cervical kyphosis (≥15º on Cobb angle measurement) or significant reversal of lordosis.
* Female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years
Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Weiqi decoction on Chronic Atrophic Gastritis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic Atrophic Gastritis
* Male of female patients between 18-65 years old
* Written informed consent

Exclusion Criteria:

* Combine with malignant pathology on epithelial dysplasia of gastric mucosa
* Combine with duodenal ulcer or gastric ulcer
* Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
* Pregnancy or breast feeding women, or unwilling to have contraception.
Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments

This study is a prospective interventional study. It will be conducted at a single center with participants who have neuromotor impairments. The primary objective is to assess and measure the clinical and psychosocial effects of a season of power wheelchair soccer among its participants presenting with severe motor impairments due to neuromuscular lesion.

A maximum of twenty participants will be recruited and included in the same group. Data collection will be performed before, during, and after the wheelchair soccer season. The study will span the entire season, starting in November 2023 and ending in June 2024.

Clinical and psychosocial assessments will be conducted every 3 months. Each assessment session will last 2 hours per participant. Before and after the wheelchair soccer season matches, we will evaluate parameters related to the physical load of the sport. These evaluations will last 10 minutes per participant.


Eligibility Criteria:
Inclusion Criteria:

* Being a male or female between the ages of 12 and 50.
* Presenting with severe motor impairments due to neuromotor and/or musculoskeletal impairment.
* Using a power wheelchair in everyday life.
* Being part of a power wheelchair soccer team.
* Committing to participating in the 2023-2024 season of their sport within the team.

Exclusion Criteria:

* Practicing another adaptive sport outside of power wheelchair soccer in a regular way (once a week or more).
* Occasionally practicing power wheelchair soccer (twice a month or less).
* Presenting with severe cognitive impairments affecting understanding of instructions on how to answer questionnaires and undertake tests.
* Presenting with contraindications towards the practice of an adaptive sport such as power wheelchair soccer.

  * Participating in another study at baseline.
A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic Syndrome

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Cryopyrin-Associated Period Syndrome (CAPS). Approximately 10 patients will take VTX2735 Dose A or VTX2735 Dose B.

The study consists of a screening/washout period of up to 28 weeks, a 2 week treatment period, a treatment withdrawal period of up to 2 weeks, another 2 week treatment period, and a 4 week follow up period. The maximum length of treatment is 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of CAPS and FCAS subtype and mild clinical phenotype
* At least one flare during screening/washout
* Women must not be of childbearing potential or must agree to use two methods of highly effective contraception during the study and for 30 days after the last dose of the study product
* Men with a partner who is of childbearing potential must agree to use condoms plus another highly effective form of birth control during the study and for 90 days after the last dose of study product

Exclusion Criteria:

* Unwilling to comply with washout of anti-IL-1 therapy and tolerate symptoms of disease flare
* Moderate or severe CAPS manifestations or significant damage or any CAPS feature that presents a contraindication to washout of anti-IL-1 therapy
* Has a history of chronic or recurrent infectious disease
* Has a known immune deficiency or is immunocompromised
* Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB)
* Has another clinically important medical disorder that would compromise safety
Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend)

The purpose of this study is to evaluate the pharmacokinetic properties and safety of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 20-45 years of age
* Weight of ≥ 60kg ≤ 90kg with BMI of ≥ 19 and \< 27 (BMI(kg/m2)= weight(kg)/{height(m)}2
* Voluntary written informed consent

Exclusion Criteria:

* History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
* Drug allergies to Voriconazole
* Recent history or evidence of drug abuse
* Recent participation(within 2 months) in other clinical studies
* Recent donation of blood(within 2months), plasma(within 1month) or transfusion(within 1month)
SGM Evidenced-Based Mental Healthcare Implementation

The purpose of the proposed study is to identify effective strategies for implementing lesbian, gay, bisexual, transgender, and queer (LGBTQ)- affirmative Cognitive-Behavioral Therapy (CBT) at LGBTQ community centers across the United States.

The purpose of the proposed study is to identify effective strategies for implementing lesbian, gay, bisexual, transgender, and queer (LGBTQ)-affirmative CBT (cognitive-behavioral therapy) at LGBTQ community centers across the United States. This study will specifically compare the effectiveness of three implementation strategies: (1) training materials only, (2), training materials and direct training from our expert trainers, and (3) training materials, direct training, and local supervision from a clinical supervisor. The proposed prospective study will utilize a type 3 hybrid implementation-effectiveness trial. This design is used to compare the impact of two or more implementation strategies while also gathering effectiveness data and is recommended when there is already strong evidence for the intervention's effectiveness, strong basis that the implementation strategies are feasible, and strong implementation momentum. Randomization will occur on the center-level, so that MHPs working in the same center will receive one of the three types of training.

Outcomes include mental health providers' changes in demonstrated skills in providing LGBTQ-affirmative CBT from baseline to 4-, 8-, 12-, and 24-months post-baseline. This study will also investigate determinants of successful implementation of LGBTQ-affirmative CBT and examine the impact of the implementation strategies on client mental health.

Eligibility Criteria:
Inclusion Criteria: Providers

Eligible providers will meet the following criteria:

* 18 years of age or older
* working as a psychologist, psychiatrist, social worker, mental health counselor, nurse practitioner, or peer support provider
* affiliated with a US LGBTQ community center
* providing mental health services to at least one sexual or gender minority (SGM) client

Exclusion Criteria: Providers

Providers will be deemed ineligible due to:

- possessing substantive experience with LGBTQ-affirmative CBT (e.g., having read most the LGBTQ-affirmative CBT treatment manual, attended LGBTQ-affirmative CBT training, or been supervised by someone who has previously attended the LGBTQ-affirmative CBT training)

Inclusion Criteria: Clients

Eligible clients will meet the following criteria:

* of age to consent to mental health treatment in the state in which they live
* receiving ongoing mental health services at one of the 15 LGBTQ centers selected for the client evaluation aim of the present study
* self-identifying as LGBTQ

Exclusion Criteria: Clients

There are no exclusion criteria for clients