cyrilzakka/clinical-trials huggingface dataset:
A Second-generation AI Based Therapeutic Regimen in Patients With Gaucher Disease Treated With Enzyme Replacement Therapy.

An open-labeled, prospective, single-center proof-of-concept study. Patients with Gaucher Disease aged 18-75 who received intravenous Enzyme Replacement Therapy once every two weeks were enrolled. The study utilized the Altus Care™ cellular phone-based application, which integrated an algorithm-based approach to provide random dosing regimens within a pre-defined range determined by the physician. The app allowed personalized therapeutic regimens with variations in dosages and administration times.

Patients diagnosed with GD and intravenously treated at home with a regular dose of Enzyme Replacement Therapy once every two weeks for 6 months (30- 60 U/kg per mouth) were included in the study.

We installed Altus Care™- this is a cellular phone-based application that allows easy digitization of treatment plans or research protocols and remote implementation. In coordination with the patient's treating physician and the home treating nurse, an individualized treatment plan was prepared for each patient within a pre-defined range of minimal and maximal once in two weeks ERT dosages and timing frames for its administration. Per protocol, the patient's monthly dose was not changed, but each dose and the timing of administration was changed randomly using the app.

During the follow-up period, the research coordinator made a regular weekly checkup by phone, questioning the patient's clinical well-being and adherence to the treatment plan. A physical examination, CBC, and Lyso-GB1 assessed response to therapy were done approximately every two months (twice during the study and once again at the end of the follow-up). The patients filled out SF-36 questionnaires at the beginning and the end of the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years old
* Non-pregnant
* Diagnosed with Gaucher disease
* Treated with ERT for a minimum of 3 years
* An unchanged dose in the past 6/12 months

Exclusion Criteria:

* Pregnant
* Patients with evidence of severe infectious, malignant, autoimmune, or other disabling systemic diseases
* Patients unable to provide written informed consent
* Patients that do not possess a smartphone
* Patients who cant adhere to the visit schedule and protocol.
Analgesia in the Second Stage of Labour

This study investigates efficacy, safety and childbirth experience in women receiving pudendal block during the final stage of delivery. It is an observational study and half of included primarous women recieve a pudendal block.

Pudendal block is used when there is a need to alleviate pain in the final stage of labour:

* From fully dilated cervix to delivery of the child.
* Associated with pain as the foetus rotates and descends through the pelvis.
* End of second stage: the perineum dilates as the child is being born.

Pudendal block is provided by inserting a needle close to the pudendal nerve that runs through the pelvis and innervates the perineal area.Pudendal block is an old and relatively simple method, but not well studied. The main aim is to study pudendal nerve block as pain relief in final stage of labour for primiparous women delivering vaginally.

The investigators aim to investigate whether possible adverse effects may outweigh the positive analgesic effect in the final stage of labour, or the opposite. The ASL (Analgesia in the Second stage of Labour) study may fill knowledge gaps and add important knowledge regarding pain relief during the final stage of childbirth.

Eligibility Criteria:
Inclusion Criteria:

* Norwegian-speaking/reading
* Primiparity
* Single pregnancy
* Vaginal birth
* Cephalic presentation
* ≥37+0
* Age ≥18 years

Exclusion Criteria:

* Transferre from midwifery-led birth unit
* Allergy to local anaesthesia
* Not valid data on pudendal block
Incidence & Clinical Significance of Osteolysis Following PEEK Suture Anchor Use in Hand & Wrist Surgery

This prospective observational study evaluates the incidence \& clinical significance of osteolysis following polyetheretherketone (PEEK) suture anchor use in hand \& wrist surgery. Building on a pilot study, it focuses on patients undergoing hand \& wrist surgeries with suture anchor implantation over the past 10 years. Patients are grouped by anchor composition: PEEK, metallic, or bioabsorbable. We hypothesize that PEEK anchors will show significantly greater osteolysis than metallic or bioabsorbable anchors. Furthermore, among all patients with osteolysis, we expect no statistically significant differences in patient-reported outcomes (PROs), post-op complications, or revision surgery rates, regardless of anchor type. Lastly, for patients with ulnar collateral ligament (UCL) thumb injuries, we hypothesize that osteolysis presence will not correlate with increased UCL laxity upon valgus stress testing compared to the nonoperative thumb.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 - 99 years-old
* History of hand and/or wrist surgery with suture anchor fixation over the 10-year period between January 1, 2014 and January 1, 2024.
* Possess an en face and/or tangential radiograph of the suture anchor tunnels from either the intra-operative or immediately post-operative (within 14 days) period.

Exclusion Criteria:

* Systematic inflammatory / autoimmune disease or immune-modulatory drug use.
* History of revision surgery of the body part of interest.
Using Self-Motivating Messages to Encourage People to Exercise More

The investigators are interested in using personalized, self-motivating messages to motivate people to exercise more.

The investigators are interested in using personalized, self-motivating messages to motivate people to exercise more. Through a partnership with a university, the investigators are running a large-scale, randomized field controlled trial aimed at increasing exercise frequencies during a 100-day challenge. The primary purpose of this study is to test whether sending people motivating messages they wrote to themselves in the past can keep them engaged in the challenge and motivate them to exercise more frequently. One week into the challenge, employees who have signed up for the challenge will receive an email inviting them to participate in a short activity. Employees who click on the link will be directed to a survey. Once they finish reading the first introductory page and click "next", they will be randomly assigned to one of two groups. In the control group, employees will be encouraged to write down what they think will motivate them to walk more after 20, 50, and 90 days into the Challenge. These employees will receive standard reminders on the 20th, 50th, and 90th day of the challenge. In the treatment group, employees will be encouraged to write down motivating messages that they will receive on the 20th, 50th, and 90th day of the Challenge.

All employees who are exposed to either the control or the treatment condition will be included in the analysis.

The investigators plan to explore moderators based on (a) employees' demographics (age, gender, ethnicity, position), (b) employees' participation in previous challenges, and (c) employees' health condition and fitness level prior to the challenge (such as how actively they have been participating in other wellness activities, their health statistics).

Eligibility Criteria:
Inclusion Criteria:

* Employees who click on the link inviting them to participate in an activity and are assigned to either the treatment or control condition
Application of L-PRF in Periodontal Surgery

The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.

Randomization to one of two standard of care procedures:

1. Test group: After gingival flap reflection and debridement of bone and root surfaces L-PRF will be applied to the alveolar bone, tooth roots, and gingival flap prior to suturing.
2. Control group (Standard of care): Gingival flap reflection and debridement of bone and root surfaces, followed by suturing of the gingival flaps.

The study is a split-mouth design, randomized, prospective clinical trial. The protocol will randomize gingival quadrants in subjects to one of two standard of care procedures OFD or OFD + L-PRF. Patients needing periodontal surgery to correct periodontal disease will be enrolled. There will be two subject groups in this study. Each subject will be randomized to one of the treatments for the first quadrant and the contralateral quadrant will receive the other treatment. No risk is expected from being assigned to either group as both procedures are standard of care, with possible benefit of enhanced wound healing and bone regeneration in the test group.

Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Eligibility Criteria:
Inclusion Criteria:

* Patients between age 18 and 89
* Patients needing open flap debridement procedures for periodontal disease in one or more teeth in the same arch bilaterally (split mouth)
* Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report
* Female patients to include non- pregnant women of child-bearing potential.

Exclusion Criteria:

* Patients who disclose that they will not be able to cooperate with the follow-up schedule.
* Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
* Pregnant women or women intending to become pregnant during the study period
* Smokers who smoke \> 10 cigarettes per day
Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit

The purpose of this study is to determine if there is any difference between two ways of controlling blood sugar with insulin. In patients admitted to the intensive care unit, blood sugar levels often rise due to the stress of illness or surgery. Studies have shown that patients do better if their blood sugar is kept normal. In order to maintain normal blood sugar levels, the investigators often give insulin (a substance made by the body), and they decide how much to give based on how high the blood sugar is. This study will compare two different ways of deciding how much insulin to give and compare how well each method keeps the blood sugar in a normal range. Both ways of controlling blood sugar are institutionally-approved protocols and part of routine care.

Improved outcomes have been demonstrated with tight control of blood glucose in critically ill patients. A number of look-up algorithms based on hourly glucose measurements and titrated intravenous insulin have been developed for the intensive care unit (ICU). Despite the numerous published algorithms, no study has investigated which algorithm results in optimal glycemic control in critically ill patients. The purpose of this trial is to compare two institutionally approved intravenous insulin administration algorithms and describe subsequent glycemic control. We hypothesize that the protocol that allows for variable insulin administration for a given blood glucose (multiple algorithms) will be associated with more optimal glycemic control. Optimal glycemic control will be defined by time spent within a predetermined blood glucose range. In addition, the number of hypoglycemic episodes and mean and maximum blood glucose concentrations will also be measured. This trial will determine which insulin infusion algorithm is most effective in terms of glycemic control, and allow for standardization of glucose management in accordance with best practice.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the 7MB D/E ICU will be eligible for this study
Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.


Eligibility Criteria:
Inclusion Criteria:

* paroxysmal AF undergoing catheter ablation
* CHA2DS2-VASc score \<= 1
* informed consent

Exclusion Criteria:

* persistent AF
* CHA2DS2-VASc score \> 2
* prior CVA
* prior atnicoagulant
* severe HF
* abnormal liver or renal function
* history of severe bleeding
Obstructive Sleep Apnoea and Adipose Tissue Dysfunction

Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.

Assessment includes a adipose tissue biopsy and measurement of oxygenation and blood flow by a Clarke type electrodes and non-invasive Doppler techniques.

Eligibility Criteria:
Inclusion Criteria:

* men with or without obstructive sleep apnoea

Exclusion Criteria:

* weight loss interventions
* steroid use
* active smoking
Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.

* Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months.
* Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day.
* Participants may remain on study drug until there is evidence of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). In the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on bone scan.
* Progressive HRPC defined as a PSA increase over baseline of \>25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required.
* PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
* Prior chemotherapy is permitted if discontinued \> 4 weeks prior to starting therapy
* Prior therapy with estrogens is permitted but must have been discontinued \> 4 weeks prior to registration
* ECOG Performance Status 0-2
* Adequate renal function, hepatic function, and bone marrow function as outlined in protocol
* ECG showing a normal QT interval

Exclusion Criteria:

* Prior therapy with ketoconazole or corticosteroids for HRPC
* Major surgery or radiation therapy within 4 weeks
* Strontium-89 or samarium-153 therapy within 4 weeks
* Thromboembolism in past 6 months
* Patients who are taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes.
* Concomitant use of drugs known to be narrow therapeutic index CTP3A4
* Drugs that are sensitive CYP3A4 substrates
* Alcohol or drug dependence currently or in the last 6 months
QT Changes as Detected From LINQ ECG During and After Antiarrhythmic Loading (LINQ QT)

The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.

The purpose of this study is to determine if QT interval changes are detected during and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ ECG.

The QT intervals before and after antiarrhythmic loading will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with LINQ/LINQII prior to the study enrollment (no more than 50% patients implanted with LINQII), but no greater than 2.5 years for LINQ or 3.5 years for LINQII, or patients who are indicated to receive a LINQ/LINQII implant at least 7 days prior to antiarrhythmic drug loading
* Patients who are scheduled to receive antiarrhythmic drug loading
* Age 18-80
* Patient is willing and able to comply with the protocol, including follow-up visits, and performing Holter recordings and patient activation transmissions

Exclusion Criteria:

* Patients who have a contraindication to long-term antiarrhythmic therapy
* Patients not suitable for long-term antiarrhythmic therapy
* Patients with a previous, existing cardiac implantation (i.e., cardiac pacemaker or cardiac resynchronization requiring \> 40% pacing, implantable cardioverter defibrillator (ICDs))
* Patients with permanent and persistent AF
* Co-enrollment in another study or planning to participate in a concurrent device study during the course of this clinical study that could confound the results
An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors

This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.


Eligibility Criteria:
Inclusion Criteria

1. Histologically confirmed solid tumor refractory to standard therapy or for which there is no standard therapy
2. Age: more than 19 years
3. ECOG performance status: less than 2
4. Life expectancy of longer than 3 months
5. Adequate vital organ function as follows:

   * Bone marrow function

     * neutrophils: more than 1,500 per microliter
     * platelets: more than 75,000 per microliter
     * hemoglobin: more than 10.0g per deciliter
   * Hepatic function

     * AST and ALT: less than 2.5 x institutional upper limit normal
     * serum total bilirubin: less than 2.5 x institutional ULN
   * Renal function

     * Serum creatinine: less than 1.5 x institutional ULN
6. Capable of swallowing OPB-31121 tablets
7. Ability to understand and willingness to sign written informed consent document for participation in the trial and for analysis of genotypes CYP2C9 and NAT2
8. No chemotherapy, radiotherapy, surgery, or immunotherapy within 4 weeks prior to study entry and recovered from any prior toxicity

Exclusion criteria:

1. Symptomatic CNS metastasis
2. Uncontrolled concurrent illness, including active infection, heart failure, angina pectoris, and cardiac arrhythmia
3. Psychiatric illness that would limit compliance with study requirements
4. Pregnant or breast-feeding women and women of childbearing potential who cannot or will not use effective contraceptive measures
5. Administration of another investigational agent within 6 months prior to study entry
6. Use of CYP3A4 and CYP2C9 inducers, inhibitors, or substrates, and CYP2B6, CYP2C8 and CYP2D6 substrates
7. Hyperlipidemia:

   Total cholesterol:more than 300 milligram per deciliter or Triglycerides:

   more than 2.5 x institutional ULN
8. Abnormal thyroid function: Hypothyroidism or hyperthyroidism of grade 2 or higher (graded according to the NCI-CTCAE)
Determinants of Sleep Quality in Spanish Population (SSQD Study)

Introduction: Sleep disorders are a growing concern for public health, being related, among others, to an increased risk of cardiovascular diseases or poorer cognitive functioning. In addition, these might have a possible impact on aspects related to personal motivation and quality of life. However, few studies have analyzed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these.

Objective: To evaluate the determinants of sleep quality in a representative sample of the general adult population aged 25 to 65 years old and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities and biological markers.

Methodology:

Design: This is a descriptive observational, cross-sectional study that will include a representative sample of 500 people aged 25 to 65 years old from the city of Salamanca (Spain) selected by random sampling stratified by age and sex.

Study variables: A visit lasting approximately 90 minutes will be carried out. The determinants of sleep quality will be assessed using both objective and self-reported methods. Variables related to life styles will be assessed: physical activity, diet and toxic habits including tobacco smoking or alcohol use. Morbidity data will also be collected, and psychological factors such as anxiety will also be assessed. Serum melatonin levels will be determined as a biological marker related to sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Age 25-65 years old
* Sign the informed consent

Exclusion Criteria:

* Patients with terminal disease
* Any clinical condition that would interfere with study procedures
A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain

The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour
* CSF flow abnormalities must be excluded
* Males or females ≥ 18 years of age
* Karnofsky Performance Status \> 50%
* Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)

Exclusion Criteria:

* Unresected parenchymal brain metastases with a diameter \> 3 cm
* Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
* Prior intrathecal chemotherapy
* Prior treatment with systemic cytarabine or nitrosureas
* The patient ist pregnant or breast feeding
* Severe, active co-morbidities