cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Cascade Screening for Elevated Lipoprotein(a)

The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives based on data from a clinical health care development project.

An elevated plasma level of lipoprotein(a) \[Lp(a)\] is an independent and causative risk factor for atherosclerotic cardiovascular disease. The Lp(a) plasma level is predominantly genetically determined via a complex hereditary pattern of the LPA gene, and remains relatively constant throughout an individual's entire life cycle. The relationship between plasma Lp(a) and the risk for a cardiovascular event has been shown to be linear.

Cascade screening, i.e. screening of biological relatives of the first detected patient (index) with a disease in a family, is an effective approach to identify and diagnose new patients with hereditary diseases. The method has been shown to be cost-effective for the most common genetically caused dyslipidemia, familial hypercholesterolemia, but the knowledge if cascade screening would be an effective method to screen for elevated plasma Lp(a) is not known.

The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives. The study will be based on results from a clinical health care development project in which patients who have had their plasma Lp(a) measured in the clinical routine will be asked to participate in the project. The participating patients invite their relatives to participate in the cascade screening and to measure their plasma Lp(a) levels. Six Swedish hospitals participate in the project and 750 patients with atherosclerotic coronary artery disease be included and divided into three strata according to their plasma Lp(a) level (low \<70 nmol/L; intermediate 70-169 nmol/L; high \>170 nmol/L). The indexes will in turn invite 1200 first- and second-degree relatives to have their plasma Lp(a) measured.

A scientific evaluation of the health care development project will be performed to study the penetrance of elevated plasma Lp(a) levels in indexes to their relatives.

Eligibility Criteria:
Inclusion Criteria

* participation in the clinical health care development project
* established atherosclerotic coronary artery disease

Exclusion Criteria:

* diagnosis of familial hypercholesterolemia
* chronic kidney disease stadium ≥4
Exercise After Lumbar Disc Herniation Surgery

Physical therapy and rehabilitation may improve low back pain and quality of life after lumbar disc herniation. But there is not any agreement of its optimal start time, and rehabilitative methods. This study evaluates the effects of early and late rehabilitation to the low back pain and quality of life following unilateral microdiscectomy.

Lumbar disc herniation (LDH) is a frequently encountered ailment in neurosurgery clinics and is prevalent among the general populace, with a reported incidence of about 2%. As it is primarily observed in the workforce, it adversely affects their quality of life. One common reason for referring a patient for surgery is radiculopathy and low back pain co-occurrence. LDH is typically observed in the adult population in active occupation. Most patients with LDH can be treated conservatively, but surgery may be necessary for around 13% of cases.

The decision to operate depends on the individual patient, but persistent radicular pain and neurological dysfunction unresponsive to conservative treatment are common indications. Minimally invasive surgical techniques are becoming more prevalent. Currently, microsurgery is the most common approach for lumbar disc herniation. In addition, endoscopic and minimally invasive surgeries have become more prevalent.

Lumbar microdiscectomy is a surgical procedure involving discectomy with paravertebral muscle dissection. Subsequently, patients may experience postoperative back pain, potentially impacting their quality of life. Physical rehabilitation is frequently suggested following surgery. Some studies have indicated that physical therapy and rehabilitation may not significantly improve low back pain and quality of life after lumbar disc herniation. There is yet to be an agreement on the effectiveness of physical therapy, its optimal start time, and rehabilitative methods.

This study evaluates the effects of early and late rehabilitation following unilateral microdiscectomy for lumbar disc herniation. It also examines the differences in low back pain and patients' quality of life due to exercise.

Eligibility Criteria:
Inclusion Criteria:

* radicular pain that persisted despite 4-6 weeks of conservative treatment,
* detection of single-level disc herniation in MRI lumbar microsurgery.
* Individuals who underwent single-level unilateral lumbar microsurgery. Those with a surgical incision \<3 cm.

Exclusion Criteria:

* Individuals with more than one level of muscle exposure at the time of surgery.
* those with a skin incision \>3 cm
Stepped Care for Patients to Optimize Whole Recovery

This is a prospective, randomized clinical trial of 204 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce pain interference (Aim 1) and decrease illicit opioid use, alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise \[Wii Fit, Tai Chi\] and stress reduction \[relaxation training, auricular acupuncture\] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response on pain interference illicit opioid use, alcohol use, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).

Participants who meet criteria for CP and OUD (N=204) will be initiated onto MOUD and randomized to 24 weeks of either treatment as usual (TAU) or 24 weeks of SC-POWR. SC-POWR patients will be "stepped up" according to a priori criteria. Patients randomized to SC-POWR will receive a behavioral intervention consisting of 12 Cognitive Behavioral Therapy (CBT) sessions over a 24-week period involving improvements in substance use and pain since baseline. Following 24 weeks of SC-POWR, patients are offered once monthly peer-support groups.

Eligibility Criteria:
Inclusion Criteria:

* Seeking treatment at APT Foundation
* Receiving medications for opioid use disorder (MOUD provided by APT)
* Have high impact chronic pain (\>= 3 months duration of pain occurring most days which limits life or work activities and/or leads to inability to work)
* Meet DSM-5 criteria for moderate to severe OUD
* In the past 2 months, has an opioid-positive urine test or self-reports opioid use
* Understand English
* Able to provide informed consent

Exclusion Criteria:

* Have pending surgery or invasive pain management procedure
* Acutely psychotic, suicidal, or homicidal
* Psychiatric instability (e.g., recent suicide attempt)
* Have a contraindication to exercise (e.g. complete heart block)
* Have a pending or planned relocation or pending incarceration
Balance Training in Chronic Obstructive Pulmonary Disease

The aim of the study will be to verify whether the addition of an exercise program aimed to improve balance can reduce the risk of falling in subjects with COPD over 80 years of age compared to the standard rehabilitation program. Patients will be randomly assigned in two groups (intervention and control). The pulmonary rehabilitation (PR) program is organized in accordance with current guidelines.

Chronic Obstructive Pulmonary Disease-COPD is the most prevalent pathology among chronic airway diseases. The average age of life has increased. Subjects over 80 years old have peculiar characteristics. Individuals with COPD have an increased risk of falling compared with healthy peers. A pulmonary rehabilitation program reduces the risk of falling as measured by gait speed. Balance training on the elderly has been shown to be effective in improving muscle strength, coordination, balance and in reducing the risk and number of falls and the fear of falling.

The enrolled subjects will complete an in-patient PR program according to enrollment.

Control: education, aerobic and strength training and callisthenic exercises. Intervention: education, aerobic and strength training as group Control and balance training. At baseline will be recorded: demographics and anthropometrics, comorbidities, drug therapy, flow/volume curve, arterial blood gases, serum hemoglobin, history of fall, exacerbations and risk of sarcopenia. Before and after the PR the following outcome measures will be assessed: balance performance, peripheral muscle strength, gait speed, health status, dyspnea, quality of life, exercise capacity, confidence with balance and perceived change. Sample size calculation was performed based on the primary endpoint of the study. We estimate a number of 50 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80 years old,
* Diagnosis of COPD according to GOLD Guidelines (Tiffenau Index \<70%) under optimized medical treatment,
* Able to perform and complete study procedures.

Exclusion Criteria:

* Anticholinergic Cognitive Burden score ≥3,
* Mini-Mental State Examination \<22,
* Acute or chronic impairment and/or medical diseases that are likely to preclude exercise testing and PR.
* Brain lesions,
* Inner ear disease
* Visual deficit,
* Lower limb surgery in the previous 6 months.
Efficiency of Tadalafil for Management of Female Sexual Dysfunction

comparative study between tadalafil versus placebo effect for the management of circumsized female

the group of patient will be randomly divided into 2 groups, half of the patients will receive tadalafil and the other half will receive placebo

Eligibility Criteria:
Inclusion Criteria:

* female with history of female genital mutilation female with history of sexual dysfunction

Exclusion Criteria:

* any medical disorder
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects

The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 45 people will be enrolled.15 will be asked to drink this blend twice a day for up to 4 days, and 15 will receive standard treatment in the hospital for the same time period. The other 15 subjects will be non-delirious control subjects who do not consume any study products.

This will be an interventional pilot study to determine the effectiveness of a specific amino acid supplement developed by the investigators versus standard treatment in mitigating delirium in geriatric patients hospitalized at UAMS for certain infections. Up to 30 delirious and 15 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (45 subjects maximum). Fifteen patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 15 patients with delirium will receive standard treatment in the hospital for the same time period. The other 15 subjects will be non-delirious control subjects who do not consume any study products. All subjects will undergo 2-5 blood draws and 3-7 cognitive assessments while they are admitted to the hospital, depending on study group assignment and discharge date.

Eligibility Criteria:
Inclusion Criteria: Delirious cohort

1. Aged 60 years and older.
2. Documented presence of either delirium, acute confusion, or altered mental status in medical record.
3. Currently hospitalized with a diagnosis of one of the following:

   1. sepsis/septicemia
   2. Pneumonia
   3. Urinary tract infection
   4. Clostridium-difficile infection
   5. Other bone or tissue infection
   6. Fever of unknown origin

Inclusion Criteria: NON-Delirious cohort

1. Aged 60 years and older.
2. Current diagnosis of one of the following:

   1. sepsis/septicemia
   2. Pneumonia
   3. Urinary tract infection
   4. Clostridium-difficile infection
   5. Other bone or tissue infection
   6. Fever of unknown origin

Exclusion Criteria: all subjects

1. Chronic kidney disease (eGFR \<30).
2. Admitted to the hospital for major psychiatric illness.
3. Major psychiatric illness not controlled by medication/treatment.
4. Delirium etiology of drug overdose or alcohol withdrawal.
5. Major surgery within the past five days.
6. Known or suspected Covid-19 positive.
7. Continuous feeding tube
Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors

* Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
* If MTV \> CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
* Alternatively, if CTV \> MTV, then the difference in volumes is related to higher treatment toxicity.

Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.

* If MTV \> CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
* Alternatively, if CTV \> MTV, then the difference in volumes is related to higher treatment toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed primary brain tumor.
* Patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors.
* Patients must be 18 years or older.
* Patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing MRI/MRS exam
* Patients who do not suffer from claustrophobia (fear of enclosed spaces)
* Karnofsky performance status ≥ 60.
* Patients whose size would allow them to fit into the bore of the MRI instrument.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients younger than 18 years.
* Inability to undergo MRI/MRS exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device. Claustrophobia (fear of enclosed spaces).
* Karnofsky performance status \< 60.
* Patients too large (\> 300 lbs.) to fit into the bore of the MRI instrument.
* Inability to understand the informed consent document.
Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to investigate the evidence that guaifenesin is an effective treatment for upper back/neck/shoulder muscle spasm/stiffness and pain.


Eligibility Criteria:
Inclusion Criteria:

* Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:

  1. is at least 30 days from previous episode.
  2. has an onset occurred within 48 hours of Visit 1.
  3. has symptoms consistent with a clinical diagnosis as per the physical examination at Visit 1.
  4. has a subject-rated muscle spasm score and a pain score of at least 40 out of 100 on a 100mm VAS.
* Paticipant has a normal neurological examination.

Exclusion Criteria:

* Medical history: a) Paticipant has a known or suspected intolerance or hypersensitivity to guaifenesin or methocarbamol (or closely related compounds) or any of their stated ingredients. b) Paticipant has history of upper back pain with active hypersensitive spots - trigger point in the muscles of upper back/neck/shoulder/maxillofacial regions. c) Paticipant has a current or recent history of liver and/or kidney disease, neck/back/shoulder injuries, spinal disc disease, myocardial infarction (\<12 months from Visit 1) and osteoporosis. d) Subjects have history of other chronic pain e.g. headache, osteoarthritis, arthritis, lower back pain etc.
* Medications: a) Paticipant has used a muscle relaxant or narcotic within 2 weeks of Visit 1. b) Paticipant has used monoamine oxidase inhibitors or selegiline within 2 weeks of Visit 1 c) Currently using tricyclic antidepressants, lithium, anticoagulants, or tramadol.
* Paticipant is involved in a workers compensation case.
* Paticipant is unlikely to refrain from using analgesics, NSAIDs, and other muscle relaxants for the duration of the study, with the exception of cardioprotective doses of aspirin (i.e., ≤ 325 mg/day).
* Paticipant is unlikely to refrain from physical therapy, massage therapy, acupuncture, heat treatment, spas, etc for the duration of the study.
Transcranial Pulse Stimulation for Depression

Transcranial pulse stimulation (TPS) is a newly developed brain stimulation therapy from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Major depressive disorder (MDD) is the world's leading cause of disability. Novel treatment approaches are urgently needed given that a significant fraction of patients does not sufficiently respond to standard antidepressant treatments. Our open-label pilot study using TPS in MDD indicates preliminary efficacy. However, experimental control is necessary to infer reliable scientific evidence for the efficacy of TPS. Here, we propose a randomized, double-blind, sham-controlled clinical trial to probe the utility of TPS as a modern antidepressant treatment.


Eligibility Criteria:
MDD group

Inclusion Criteria:

* Age 18 to 60;
* A clinical diagnosis of a MDD and a HAMD17 score ≥14;
* Treatment naivety or stable (≥4 weeks) psychopharmacological medication.

Exclusion Criteria:

* Severe internal diseases including blood clotting disorders;
* Neurological disorders including bleeding prone micro-pathologies or a history of severe head injuries;
* Current psychiatric comorbidities, including addiction;
* Pregnancy;
* Common NIBS exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation and intracranial metallic particles.
Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia

The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* 20 years to 65 years
* Schizophrenia patient with an acute exacerbation
* Understand the requirement of the study and voluntarily consent to participate in the study

Exclusion Criteria:

* Patients who have another psychiatric disorders
* Patients who have unstable medical conditions
* Patients who have clinically important abnormalities of liver function test (\>2.5 fold of upper normal limit), ECG and vital sign at screening visit
* Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
* Patients who have a history of an allergic reaction to olanzapine
* Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.
* Patient who take clozapine within 12 weeks before screening visit
Ruxolitinib Vs Allogeneic SCT for Patients with Myelofibrosis According to Donor Availability

The present study will be a multicenter, prospective phase II-study comparing efficacy of allogeneic SCT for patients with myelofibrosis who have a suitable stem cell donor after a 3 months Ruxolitinib induction therapy with patients who lack a suitable stem cell donor and will continue to receive Ruxolitinib.

This study is a multicenter, prospective phase II-study compares efficacy of allogeneic SCT for patients with myelofibrosis who have a suitable stem cell donor after a 3 months Ruxolitinib induction therapy with patients who lack a suitable stem cell donor and will continue to receive Ruxolitinib.

In this study will further assess and compare the safety and efficacy of study treatments/ induction therapy in both study arms on spleen reduction, improvement of constitutional symptoms, QOL, toxicity, fibrosis regression, development of GvHD as well as chimerism, engraftment, relapse incidence, disease related mortality, outcome and overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic primary myelofibrosis or myelofibrosis post polycythaemia vera or essential thrombocythemia stage intermediate 2- or high-risk according to IPSS or DIPSS \[46\] or intermediate 1-risk with high risk cytogenetics, other than normal karyotype, sole del 20q, del 13q, or sole+9, or transfusion-dependency
2. Patients age: 18 - 70 years at time of inclusion (female and male)
3. Patients understand and voluntarily sign an informed consent form
4. Platelet count ≥ 50 x 109/L
5. No prior Ruxolitinib treatment
6. ECOG ≤ 2

Exclusion Criteria:

1. Severe renal, hepatic, pulmonary or cardiac disease, such as:

   * Total bilirubin, SGPT or SGOT \> 3 times upper the normal level
   * Left ventricular ejection fraction \< 30 %
   * Creatinine clearance \< 30 ml/min
   * DLCO \< 35 % and/or receiving supplementary continuous oxygen
2. Positive serology for HIV
3. Pregnant or lactating women (positive serum pregnancy test)
4. Age \< 18 and ≥ 71 years.
5. Uncontrolled invasive fungal infection at time of screening (baseline)
6. Serious psychiatric or psychological disorders
7. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
8. Transformation to AML
Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss

This project aims to offer a quantitative and qualitative nutritional approach, along with educational nutritional guidelines for participants with Non-Communicable Chronic Diseases. The main goals are: 1- Regularization of eating habits and windows; 2- Modulation of biochemical, anthropometric, and cardiovascular parameters; 3- Increase in knowledge about healthy eating. In this way, participants will undergo a complete nutritional assessment, comprising anthropometry, biochemistry, clinical, and dietary evaluations.

The study will be conducted at the Endocrinology and Hypertension Clinic of the São José do Rio Preto Medical School from 2025 to 2027, aiming to collect data for a thorough analysis of the participants. The study participants will be randomly assigned to 2 groups (intervention 1 and intervention 2). Participants in the first group will follow a daytime eating window (7 am - 7 pm). Participants in the second group will follow a nighttime eating window (12 pm - 12 am). Nutritional consultations will be individual and will occur once every 3 months until the conclusion of the study, according to the clinic's scheduling availability. The average duration of each session will be approximately 1 hour per participant. All participants will be reminded of their appointments via phone/WhatsApp.

Eligibility Criteria:
Inclusion Criteria:

* Age: Adults \>18 years \< 80 years; Diagnosis of obesity, diabetes, and hypertension; Gender: Male and female; Availability to attend quarterly meetings over a period of 18 months; Sedentary.

Exclusion Criteria:

* Difficulties in responding to the requested instruments; Impediments to regular attendance in data collection; No diagnosis of Obesity, Diabetes, and Hypertension; Use of insulin therapy, Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors, and Glucagon-Like Peptide-1 (GLP-1) analogs; Chronic Kidney Disease patients; Normal weight or undernourished individuals; Physical exercise practitioners (\>150 minutes of exercise/week).