cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period

The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children from 6 to less than 18 years of age suffering from narcolepsy with or without cataplexy - ICSD-3 criteria (narcolepsy type 1 and 2).
* PDSS
* Patients should be free of non-authorized medication, in particular psychostimulant treatments as from the screening visit onwards.
* Parents - and patients old enough to understand who have expressed a willingness to participate in the study, who have signed and dated the informed consent form prior to beginning protocol required procedures.
* In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests).

Exclusion Criteria:

* Any other conditions that can be considered the primary causes of EDS.
* Cataplectic patients treated by anticataplectics which are not under a stable treatment at the time of inclusion.
* Patients treated for cataplexy or any other pathology, by tricyclic antidepressants.
* Any significant abnormality of the electrocardiogram and particularly Fridericia's QTc interval.
* Patients with significant abnormality or clinical laboratory results.
* Psychiatric and neurological disorders in the investigator's opinion, would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms.
* Active clinically significant illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, haematological, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study objectives.
Evaluating Chronic Pain Management Program

This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.


Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology
* Self referred or referred willing to give informed consent

Exclusion Criteria:

* Autoimmune disorder
* Malignancies
* Cognitively impairment
Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals

Low current electrical stimulation test, also called the Tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. The results of this study will show whether or not doing a Tsui test can predict inadequate epidural analgesia early in the course of placing the epidural, so that the appropriate measures could be applied immediately upon gathering unfavorable results.

Despite its very high success rate, the epidural technique remains a rather blind technique, and failures continue to occur. The incidence and reasons for failure are not well understood. The Tsui test is not routinely performed with each epidural catheter insertion, but rather it is used when there is suspicion about the catheter location.

In this study, the Tsui test will be performed twice during the epidural procedure, and bupivacaine consumption will be recorded for the first 2 hours.

Information gained from this study could have great impact in clinical practice, since the incidence of inadequate labor analgesia is still relatively high (10-20%), leading to maternal distress and disappointing labor experience.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age requesting an epidural for labor and delivery
* Cervix dilated 0-5 cm and pain VAS\>6
* Able to communicate in English
* Informed consent

Exclusion Criteria:

* Refusal to provide written informed consent
* Patients unable to communicate in English
* Contraindication to regional anesthesia
* Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
* Sedatives or opioids received prior to insertion of epidural catheter
* Abnormal vertebral anatomy, such as previous spine surgery and scoliosis
* Coexisting neurological disorders
* Patients with implanted electronic devices
Hypoproteic Diet in Acromegaly

Since protein and AAs are master regulator of GH and IGF-I secretion, we hypothesized that a low protein diet could reduce GH and IGF-I levels in acromegalic patients in addition to conventional therapy. Furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of GH hypersecretion during conventional therapy and after a low protein diet

Nutrients are crucial modifiers of the GH/IGF-I axis. In particular, a close cross-talk between proteins and amino acids (AAs) and GH/IGF-I secretion exists.

Both AAs and proteins affect GH secretion. AAs stimulate GH secretion upon oral administration, with different potency among studies, being the combination of arginine and lysine the most powerful. Soy proteins also stimulate GH secretion when ingested either as hydrolysed proteins or free AAs. Furthermore, the acute GH response to AAs ingestion may be influenced by the daily amount of dietary protein/AAs consumption: diets high in proteins apparently increase basal GH levels.

AAs and proteins have a positive effect on IGF-I secretion as well. In general, high levels of proteins, especially animal and dairy proteins, and consumption of branched chain amino acids (BCAAs) increase serum IGF-I levels.

Considering pathological GH conditions, metabolomic analysis of acromegalic patients suggests that the main metabolic fingerprint of GH hypersecretion is a reduction in BCAAs, related to the disease activity. Moreover, there is evidence that GH, rather than IGF-I, is the main mediator of such metabolic fingerprint, which may be related to increased uptake of BCAAs by the muscles, increased gluconeogenesis, and raised consumption of BCAAs.

Thus, in acromegaly, a tailored diet is a further strategy that may contribute to blunt GH/IGF-I secretion. Indeed, some authors recently suggested that "personalized" or "precision" nutrition in some conditions and diseases could have an impact on their phenotype, combining dietary recommendations with individual's genetic makeup, metabolic and microbiome characteristics, and environment. However, studies on precision nutrition in acromegaly are still in a neonatal era.

Eligibility Criteria:
Inclusion Criteria:

* Age 18/65
* Diagnosis of Acromegaly
* In therapy with somatostatin analogues

Exclusion Criteria:

* pregnancy or lactation
* alchool or drugs abuse
* cancer
* Hematological diseases
Laval University Rouge et or Post ACL Surgery Program Effectiveness

The main objective is to compare the effectiveness of two readaptation programs post anterior cruciate ligament surgery. Laval University Rouge et or program is to be compared with the intervention guide from the CHU. Amateur athletes are recruited 3 months post ACL surgery. The level of confidence, symptoms, functional recovery level and muscle strength are assessed and compared between the two groups at 3, 4, 5, 6 and 9-month post surgery.

It is experimental research with pre-post repeated measure with a control group. The subjects are randomised either in the intervention group (Gr PRORO-UL) or the control group (Gr CHU-CP). The assessor is blinded to the randomisation. Both groups receive their program at the first assessment at three months post-ACL-surgery. They are strongly encouraged to continue their follow-up in physiotherapy to ensure the program is suitable to their individual progression. The participants are assessed again at 4, 5, 6 and 9 months post surgery to measure their progression. A weekly journal sent by e-mail is to be filled to ensure the subjects train according to their program attribution. It is a randomised control trial with a blinded assessor.

Eligibility Criteria:
Inclusion Criteria:

* Amateur athlete aged from 18 to 35 years old doing sports at least 3 times a week
* Having suffered from an Anterior Cruciate Ligament rupture
* Having undergone Anterior Cruciate Ligament surgery either with an anterior approach (with the patellar tendon) or a posterior approach (with the semitendinosus tendon)
* Having a functional deficit (score 85% or under at Knee Outcome Survey - Activity of Daily Living Scale questionnaire and/or score 80% or under at International Knee Documentation Committee questionnaire)
* Being available for follow up and actively follow the programme attributed.

Exclusion Criteria:

* Having suffered from multiple surgery for other ligaments in the same knee.
* Having undergone total meniscus removal
* Having suffered form Posterior Cruciate Ligament rupture.
* Having other injuries that could affect the functional performance and prevent from training.
Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis

In this study we will assess the presence of prolactin hormone in the gingival crevicular fluid , and synovial fluid of patient with rheumatoid arthritis and periodontitis


Eligibility Criteria:
Inclusion Criteria:

* for first group patients with active rheumatoid arthritis with periodontitis.
* second group , patients with periodontitis and otherwise systemically healthy
* third group, systemically and periodontallly healthy subjects

Exclusion Criteria:

* smokers,
* pregnant or lactating females
* patients taking medications the affects levels of prolactin hormone.
* no periodontal treatment in the past six months
A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects

The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:

* To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
* To characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
* To assess the food effect on the PK of a single oral dose of INX-08189


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and post-menopausal (absence of periods for more than 2 years) surgically sterile, or non-pregnant, non-lactating women using a reliable form of contraception (see Inclusion Criteria 9)
2. Age 18 to 65 years, inclusive
3. Normal (no clinically significant abnormalities) laboratory tests (chemistry, hematology and urinalysis)
4. No clinically significant abnormalities on ECG (QTcB interval must be \< 450 ms)
5. Weight ≥ 50kg and Body Mass Index (BMI) of 19 to 30, inclusive
6. Negative urine drug screen at screening and on Study Day -1
7. Negative serum βHCG pregnancy test at screening and on Study Day -1 (for all women)
8. Hepatitis B surface antigen, hepatitis C antibody, and HIV antibody negative
9. Agreement to practice a barrier method of birth control plus the use of a spermicide throughout the study period by both male and female subjects (oral contraceptives are not permitted)
10. Able to complete all study visits
11. Signed informed consent form (ICF)

Exclusion Criteria:

1. Any active medical problem for which the subject is being evaluated and/or treated
2. Calculated creatinine clearance (calculated using the IDMS traceable equation for the MDRD value) \< 50 mL/min/1.73 m2
3. Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing
4. Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)
5. Current lactation or breastfeeding
6. Major surgery within 30 days prior to dosing
7. Receipt of an investigational drug within 30 days prior to dosing
8. Donation of blood or plasma within 30 days prior to dosing
9. Any other problem, that in the opinion of the Investigator, will affect the safety of the subject or outcome of the study
A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

This study was a 2-arm randomized control trial (RCT) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. The RCT compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis
* 18 years or older
* An inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry
* Willing and able to provide informed consent

Exclusion Criteria:

* Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening)
* 6th grade reading level (determined by Wide Range Achievement Test- 4th Edition)
Antibiotic Therapy in Infections of the Diabetic Foot Syndrome

This retrospective study examines the surgical and antibiotic treatment of diabetic foot syndrome infections treated at the University Hospital Basel since 2019.

It analyses the implementation of the hospital in-house guidelines published in 2019 with regard to antibiotic therapy in diabetic foot infections, taking into account clinical, microbiological and histopathological criteria. The defined endpoints are (i) fully compliant with internal policies, (ii) partially compliant with internal policies, and (iii) not compliant with internal policies. The recording of these proportions is descriptive.

This retrospective study examines the surgical and antibiotic treatment of diabetic foot syndrome infections treated at the University Hospital Basel since 2019. (In 2019 the departments of infectiology and orthopedics at the University Hospital Basel published recommendations with regard to the duration of antibiotic therapy in infections of the diabetic foot syndrome. This depends on whether a surgical intervention was performed and takes into account both the microbiological and the histopathological samples). Data that are routinely collected in everyday clinical practice and stored in the hospitals' medical records will be evaluated. The aim of this research project is to check the implementation of these recommendations.

Inadequate use of antibiotics should thus be recognized. The study has the aspect of quality control.

Eligibility Criteria:
Inclusion Criteria:

* soft tissue infection or bone infection (incl. osteomyelitis) in diabetic foot syndrome
* inpatient stay at the University Hospital Basel between January 1st, 2019 and December 31st, 2021
* surgical intervention (amputation and/or debridement)
* signed general consent

Exclusion Criteria:

* datasets without a diagnosis of the diabetic foot
* no surgical intervention performed (amputation and/or debridement)
* surgical interventions performed by disciplines other than orthopaedics/traumatology (e.g. vascular surgery)
* infections in osteosynthesis material (implant or fracture-associated infections)
Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer

RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.

PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.

Eligibility Criteria:
INCLUSION CRITERIA:

DISEASE CHARACTERISTICS

* Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive
* Cumulative dose of radioiodine \< 800 mCi
* No radioiodine uptake on whole body scan within 18 months of enrollment
* Inoperable extensive locoregional tumor mass and/or metastatic spread
* Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation
* Elevated thyroglobulin level (\>2ng/ml on thyroid hormone, \>10ng/ml off thyroid hormone)or Tg-antibody positive

PATIENT CHARACTERISTICS

-18 years or older

Entry lab results:

* Hemoglobin \> 8.0 gm/dl
* Absolute Neutrophil Count \> 750 cells/mm3
* Platelet count \> 75000/mm3
* BUN \< 1.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* Total protein \> 6.4
* Total bilirubin should be \< 1.5 times ULN.
* AST (SGOT), ALT (SGPT), ALKP and amylase \< 1.5 times ULN
* Amylase \< 1.5 times ULN
* Albumin \> 2.5
* Ammonia \< 1.5 times ULN

EXCLUSION CRITERIA:

* Not pregnant
* No nursing within the past 3 months
* No allergy to valproic acid
* No coexisting malignancy other than basal cell carcinoma
* No hepatic disease or significant dysfunction
* Karnofsky score \> 80
* No pancreatitis
* No kidney dysfunction
* Fertile patients must use effective contraception
Tissue Donation for Myoblast Culture

Analyze human skeletal muscle and learn more about the ability of adult muscle to produce myoblasts (young muscle cells).

Study the ability of healthy human skeletal muscle to produce myoblasts, and to determine how many cells would be needed to regenerate a certain section of injured muscle. As part of this research, we hope to gain a better understanding of the effect of age on muscle and how normal skeletal muscle can regenerate itself by producing myoblasts. The information gathered from this study will be specifically used in future research for treating Anal Incontinence.

Eligibility Criteria:
Inclusion Criteria:

- Age: 18 years of age or older Female Patients who are already electing to undergo obstetric or gynecologic surgery (either vaginal or abdominal) for a preexisting condition.

Exclusion Criteria:

- Active systemic or pelvic infections including HIV HBV HCV, STD, PID Patients with tumors, metastatic disease or treated with cytostatics Patients undergoing emergency surgical procedures Unconscious or mentally incapable to consent
Comparison Between Classic Leg-press Training and Complex Leg-press Training on a Dynamic Leg-press

A complex training on a dynamic leg-press with visual feed-back will improve coordinative capacity, power, sensorimotor and cognitive aspects more than a classic training on the same leg-press but without visual feed-back.

The project evaluates two different resistance training programs on a leg press. One group will perform a standard resistance training with the aim of muscle hypertrophia, the other group will perform a complex resistance training combining rate of force development training, power training, speed endurance as well as sensorimotor aspects (i.e. following visual feedback to reproduce given forces or joint angles).

Hypotheses: Participants in the complex training group will change the relation between counter movement jump and squat jump, i.e. they will more improve in the counter movement jump because of improved sensorimotor capacity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult (\>18yrs) participants
* Able to do resistance training

Exclusion Criteria:

* Recent injuries preventing resistance training
Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH

The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.

Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5α reductase inhibitors (5-ARI) is the first-line treatment of BPH-related LUTS for the reduction of the size of the prostate and LUTS improvement. Combination therapy is tolerated well by most men; however, the incidence of adverse events is higher than with either therapy alone. In patients with improved LUTS following combination therapy, the aim of this study is based on the hypothesis that the withdrawal of either therapy will not increase the risk of LUTS aggravation while improving the quality of life.

The investigators plan a prospective, randomized, open-label, parallel trial, comparing alpha-blocker withdrawal and 5-ARI withdrawal to continued combination therapy. Treatments will be allocated in a 1:1:1 ratio, based on IPSS score (≤30% decrease from baseline) and prostate volume (≤35% decrease from baseline).

Eligibility Criteria:
Inclusion Criteria:

* Men aged ≥50 or \<80 years AND
* On combination therapy (alpha-blocker and 5-ARI) ≥12 months AND
* IPSS score (≤30% decrease from baseline) AND
* Prostate volume (≤35% decrease from baseline)

Exclusion Criteria:

* Suspected prostate cancer (PSA density \>0.15 ng/ml/cc) requiring specific management
* On-going prostatitis or urinary retention
* Acontractile detrusor
* Neurogenic lower urinary tract dysfunction
* Urethral stenosis
* Patient unable or unwilling to provide written informed consent
Automated Real-time Feedback on CPR Study

The purpose of this study is to evaluate whether or not real-time feedback on CPR process variables will increase rates of restoration of spontaneous circulation during prehospital resuscitation and upon arrival at the receiving emergency room as well as increase rates of survival to hospital discharge.

A subset of emergency medical services (EMS) agencies that are participating in the Resuscitation Outcomes Consortium (ROC) are adopting new monitor/defibrillators that are capable of monitoring CPR process during attempted resuscitation of patients in cardiac arrest, as well as providing automated real-time feedback about this process to EMS providers so as to improve compliance with recommended guidelines for CPR. Monitoring of CPR process during attempted resuscitation is an important step towards reducing the potential for poorly-performed CPR to modify the effect of the study interventions upon outcome. Clusters formed of rigs, an individual agency or groups of agencies were randomized to turn feedback on or off. After a fixed period of time, each cluster crossed over to the other arm. An unequal number of subjects were enrolled during each period.

Eligibility Criteria:
Inclusion Criteria:

* all individuals who experience cardiac arrest outside the hospital,
* are evaluated by organized EMS personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel) or receive chest compressions by organized EMS personnel.

Exclusion Criteria:

* Use of a mechanical CPR device