cyrilzakka/clinical-trials huggingface dataset:
Transitional Case Management for Patients Suffering From Substance Use Disorders

According to the World Health Organization the population suffering from addiction problems is increasing. This population is characterized by multiple needs at the medico-psychosocial level. However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs. They often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. They also show very low utilization of health care services, accompanied by social marginalization. This can be related to relapses and poor social functioning. A high number of relapses occur particularly at the end of hospitalization. Interventions in the field of addiction, such as Transitional Case Management (TCM) should increase the adherence of these patients to treatment by accompanying them in the sensitive period following hospitalization. One of the objectives of the study is to evaluate the impact of TCM on the number, duration and type of hospitalizations, as well as the number of emergency room visits. The investigators will also measure the duration until the possible future hospitalization, after the TCM. The secondary objectives of this study will be to see the effect of TCM on adherence to outpatient treatment. The investigators will focus on the impact of follow-up on the participant's medico-psycho-social network, substance use and other psychological variables. The investigators will also evaluate his or her psychiatric symptoms and global and social functioning. Life satisfaction and satisfaction with the care received will also be measured. The investigators will compare the population treated by the TCM with the other users of the addiction service who are hospitalized. The study will investigate this through questionnaires at the beginning of care, at one month, three months, six months and 12 months after the start of TCM management.


Eligibility Criteria:
Inclusion Criteria:

* Substance use disorder
* Hospitalisation at recruitment
* Substance Use Disorder according to the DSM-5 and one of the following criteria:
* No preexisting outpatient follow-up care or regular follow-up care
* More than three emergency room visits during the last 12 months
* More than three hospitalizations in psychiatric hospital during the last 12 months
* More than 40 hospitalization's days during the last 12 months
* First hospitalization for a SUD

Exclusion Criteria:

* Evidence of organic brain disease or learning disability based on the chart review.
MPAACS: Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery

The objective of our research is to determine whether treatment with magnesium will reduce the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small studies of magnesium have already been conducted, but these studies were small and the results conflicting. A large, well-conducted study of magnesium treatment is required to definitively determine whether magnesium is effective in preventing this common complication after surgery. In addition, our study will include patients undergoing valvular surgery, a group previously excluded from research despite the fact that they are at increased risk of atrial fibrillation.

All patients referred for non-emergent cardiac surgery for isolated CABG, isolated valvular heart surgery, or combined valvular and CABG surgery are eligible for the study. Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily. Atrial fibrillation (and other arrhythmias) will be detected by placing all subjects on continuous 24-hour ECG telemetry monitoring for postoperative days 0 through 4.

The study is powered to detect at least a 30% relative reduction in postoperative atrial fibrillation in the CABG group; n=756. Because of the higher incidence of atrial fibrillation in the Valve +/- CABG group a total of 500 patients will be required to detect at least a 30% difference between treatment groups. These sample sizes are based on an alpha of 0.05 and 80% power.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing coronary artery bypass surgery with or without valve procedure
* scheduled for on-pump or cardiopulmonary bypass protocol

Exclusion Criteria:

* existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications
* ventricular fibrillation
* sustained ventricular tachycardia
* 2nd or 3rd degree heart block
* paroxysmal supraventricular tachycardia
* major aortic repair planned during open-heart procedure
* permanent atrial/ventricular pacemaker implanted
* dialysis dependent or creatinine clearance \< 35 umoles/min or oliguric/anuric renal failure
* patient intolerant of beta blockers
* patient has reactive airways disease dependent on regular beta-adrenergic agents
* patient is scheduled to undergo off-pump surgical protocol
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns

A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP

To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.

Eligibility Criteria:
Inclusion Criteria:

* Infants born with gestational age ≥ 37
* Birth weight ≥ 2500g
* Age 1 - 14 days
* Will have a blood sample performed, either for clinically suspected jaundice or newborn screening sample

Exclusion Criteria:

* Infants showing signs of inborn disease
* Infants transferred to pediatric ward for treatment
* Infants that have received phototherapy
SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults

This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent asthma

A multicentre randomised, double-blind, parallel-group study to compare the salmeterol/fluticasone propionate combination (SERETIDETM DISKUSTM 50/100) 50/100µg one inhalation twice daily with fluticasone propionate (FLIXOTIDETM DISKUSTM 100) 100µg one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma

Eligibility Criteria:
Inclusion criteria:

* male or female ≥ 18
* documented history of asthma
* reversibility FEV1 or PEF ≥ 12% (post 400µg salbu)
* moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value)
* naive or ≥ 4weeks-free ICS (inhaled corticosteroids)

Exclusion criteria:

* respiratory disorder
* FEV1\<60% predicted
* exacerbation/respiratory infection ≤ 4 weeks
* oral/parenteral/depot corticosteroids ≤ 6 months
* LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks
* smoker or former smoker ≥ 5 packs year
Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial

Compared with adults, children have higher metabolic needs, and the airway is more likely to collapse. Before tracheal intubation after anesthesia induction, the patient 's spontaneous breathing completely disappears. At this critical stage, the residual oxygen of the lung is consumed, resulting in hypoxemia and atelectasis. Therefore, it is necessary to explore the best oxygenation strategy during intubation. In addition, ultrasound has become a common equipment in the operating room. It has the advantages of portability, repeatability, and no radiation, and can provide strong support for the diagnosis of gastric distension.

At present, hypoxia is still the main cause of complications and death during perioperative period. Compared with adults, children have lower functional residual volume and lower tolerance to hypoxia caused by apnea due to their special physiological and functional characteristics. During anesthesia induction and tracheal intubation, spontaneous breathing completely disappears. At this critical stage, hypoxemia is prone to occur, which in turn causes various serious complications. Mask ventilation may occur mask ventilation difficulties and flatulence ; since the introduction of nasal high-flow oxygen therapy ( HFNC ) into the operating room in 2015, its oxygenation method has been shown to be able to significantly improve blood oxygen when used alone in pre-oxygenation. When tracheal intubation is performed, HFNC can still maintain ventilation in the patient 's nose, so HFNC can combine the advantages of both masks to perform pre-oxygenation. There are few studies on the effect of HFNC on apnea oxygenation in children in the operating room.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-10 years old;
* American Society of Anesthesiologists (ASA) Level I or II;
* Children with healthy lungs and hearts;
* Clear headed and able to cooperate with anesthesiologists for treatment.

Exclusion Criteria:

* Contraindications for HFNC: (1) Complete obstruction of the upper respiratory tract; (2) Skull base fracture or nasal bone fracture; (3) Patients who refuse to use HFNC;
* The American Society of Anesthesiologists (ASA) rating is greater than Level II;
* Children with upper respiratory tract infections within 2 weeks;
* Pulmonary dysfunction, congenital heart disease in children;
A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4

This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-65 years of age
* Chronic hepatitis C, genotype 1 or 4
* Treatment-naive

Exclusion Criteria:

* No previous treatment with any interferon- or ribavirin-based therapy
* Other forms of liver disease
* HIV infection
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus. The study includes a 16-week Treatment Period.

This study will consist of a Screening Visit, a 7-day Run-in Period, a 16-week Treatment Period, and a Follow-up Visit (approximately 7-10 days after the last dose of study drug). Informed consent will be obtained prior to performing any study-specific procedures.

The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility.

Day 1 of the Treatment Period will be defined as the day of the administration of the first dose of study drug. If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1 ratio to receive either placebo or CR845 tablets at a dose of 1.0 mg orally BID for 16 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

* Confirmed diagnosis of PBC;
* If currently taking ursodeoxycholic acid (UDCA), should be on stable dose for \>12 weeks prior to screening and plan on continuing to take UDCA throughout the study;
* If previously taking UDCA, should have discontinued its use \>12 weeks prior to screening;
* Self-reports experiencing daily or near-daily pruritus during the month prior to screening;
* Prior to randomization has a mean baseline WI-NRS score indicative of moderate to severe pruritus.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

* Presence of Child-Pugh Class C decompensated cirrhosis at screening;
* Itching secondary to biliary obstruction;
* History or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein thrombosis;
* Current placement on liver transplantation list with anticipated liver transplant during the course of the study or current Model for End-stage Liver Disease (MELD) score ≥15;
* Alanine aminotransferase or aspartate aminotransferase \>5 × upper limit of normal at screening, or within 2 months prior to screening;
* Anticipates receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) from the start of screening through the end of the Treatment Period;
* New or change of treatment with antihistamines and corticosteroids (oral, intravenous, or topical), opioids, gabapentin, pregabalin, cholestyramine, rifampicin or fibrates within 14 days prior to screening.
Comparison Between Arthroscopic Simple Biceps Tenotomy & Anchor Technique Tenotomy with Clinical and Ultrasound Assessment

Comparison between arthroscopic simple biceps tenotomy \& anchor tenotomy technique regarding clinical outcomes \& ultrasound assessment

This research compares two surgical techniques for addressing pathologies of the long head of the biceps (LHB) tendon: arthroscopic simple biceps tenotomy and anchor tenotomy. The LHB tendon, originating from the supraglenoid tubercle, plays a critical role in forearm supination, elbow flexion, and shoulder abduction. Pathologies affecting this tendon often cause significant shoulder pain, with surgical options including tenotomy and tenodesis. While simple tenotomy is quick and avoids implant complications, it may result in cosmetic deformities like the "Popeye" sign and muscle cramps. Anchor tenotomy, a novel technique, aims to minimize these issues by preventing the Popeye deformity. This study employs a prospective randomized double-blinded controlled trial design at Assiut University Hospitals, involving 72 patients with LHB pathologies such as tendinitis, rotator cuff tears, and subacromial impingement. Exclusion criteria include prior tenodesis or neuromuscular diseases. Clinical outcomes will be assessed using functional scores (e.g., Oxford Shoulder Score), ultrasound evaluation of tendon positioning, and follow-up examinations at intervals up to one year post-surgery. The primary outcome focuses on the presence of the Popeye deformity, while secondary outcomes include postoperative shoulder function and tendon distalization measured via ultrasound. This research aims to provide evidence-based insights into the comparative effectiveness of these two techniques in improving clinical outcomes and minimizing complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with LHB pathologies such as :

Biceps tendinitis Rotator cuff tears Subacromial impengiment Instability \& traumatic causes

Exclusion Criteria:

* LHB Tenodesis Patients with neuromuscular disease
Autoantibodies on Spinal Cord Injury

The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.

Most patients experience variable degrees of functional recovery after spinal cord injury (SCI), predominantly in the first months after lesion. In SCI animal models, autoantibodies are pathogenic and their titers rise up at the time when spontaneous recovery stops. The aim of this study is to determine the autoantibody profiles after SCI and to infer their relation with functional recovery. To achieve this, autoantibody profiles, biochemical, hematological and immune-related parameters (cytokines, chemokines and growth factors) will be determined from a serum blood sample and functional recovery will be evaluated accordingly to standardized scales.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic or non-progressive vascular SCI
* Less than 45 days after lesion
* Any neurological level
* Complete and incomplete lesions
* If patient has been treated with glucocorticoids, it should have passed at least 7 days from the end of the treatment

Exclusion Criteria:

* Cauda equina syndrome
* Autoimmune disorder
* Tumor (even if benign)
* Neurodegenerative disease
Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

Objective:

Hyperprolactinemia(HPRL) which can result in a series of prolactin-related symptoms is a frequent adverse effect of antipsychotics. The investigators are interested to explicate the characteristics of serum prolactin level change after taking different antipsychotics and related factors.

Method:

1. Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.
2. The investigators collect their information, and then

   1. set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.
   2. Variables will range from antipsychotic kinds, dosage, treatment duration and blood concentration to demographic information, to disease history, to clinical treatment on hyperprolactinemia, to laboratory test results, such as blood routine examination, biochemistry, sex hormone levels and so on.
   3. After data cleaning and management, we will apply logistic regression, cox regression, Receiver Operating Characteristic curve (ROC) and machine learning to

      * analyze factors of prolactin level;
      * establish a model of prolactin change with time;
      * propose optimal monitoring time of prolactin according to prolactin change with time;
      * analyze correlation among antipsychotics, prolactin and clinical characters, for the purpose to supply objective evidence for antipsychotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders(DSM)-5;
* were taking or going to take antipsychotics;
* have the results of serum prolactin level.

Exclusion Criteria:

* other mental disorder;
* suffered endocrinic diseases of pituitary or thyroid gland;
* suffered other organic brain diseases;
* have the history of tobacco or alcohol abuse, or psychoactive drug substance abuse.
A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis


Eligibility Criteria:
Inclusion Criteria:

1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
2. Patients aged ≥18 to \<80 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)

Exclusion Criteria:

1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
2. Patients with serum phosphorus concentration ≥ 10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Antithrombin III in Infectious Disease Caused by COVID-19

The purpose of this research study is to see if participants who have SARS-CoV-2 and low levels of AT3 in the blood will benefit by being given AT3.


Eligibility Criteria:
INCLUSION CRITERIA:

1. \>18y of age,
2. Subject or proxy who can provide informed consent
3. Positive SARS-COV-2 by Polymerase Chain Reaction (PCR) or as determined by clinical team

EXCLUSION CRITERIA:

1. Adults or Proxy unable to consent
2. Individuals who are not yet adults (infants, children, teenagers)
3. Pregnant women
4. Prisoners
5. Patients expected to die within 24 hours or with a "do not resuscitate" order,
6. Multi-organ failure,
7. History of hypersensitivity or allergy to any component of the study drug,
8. Ongoing massive surgical or unexplained bleeding,
9. History of bleeding or clotting disorder,
10. Severe traumatic brain injury (Glasgow Coma Scale \<6),
11. Spinal or multiple-trauma,
12. Cancer (incurable/terminal phase) and/or patients receiving palliative care,
13. Enrollment in another concurrent clinical interventional study if considered interfering with this study objectives
14. Per study team discretion, any condition(s) that may prevent safe treatment, preclude adequate evaluation or adding further risk to their underlying illness.
BAROSTIM NEO System in the Treatment of Heart Failure

The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.

During long-term follow-up, all participants are required to have at least one annual visit.

Parameters assessed during long-term follow-up visits:

* Physical Assessment
* Subject Medications
* Serious adverse events

Eligibility Criteria:
Inclusion Criteria:

* Actively participating in the Neo Randomized Heart Failure Study.
* Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

* Treating physician decision that the subject should not continue with therapy.
Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors

Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer).

Main questions:

* What does the study drug do to human body (Pharmacodynamics \[='PD'\])
* What does the body do to study drug (how processed in body (Pharmacokinetics \[='PK'\]) - Safety

Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy 2. Evaluable or measurable disease by RECIST 1.1

Exclusion Criteria:

-