cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study

Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Unfortunately, there are no successful interventions to address these impairments. Prospective memory impairment is a particularly functionally- and clinically-relevant problem in PD. The investigator's project will determine if a targeted intervention strategy improves PD participants' prospective memory. The investigator's goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.

Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Unfortunately, there are no successful interventions to address these impairments. Prospective memory impairment is a particularly functionally- and clinically-relevant problem in PD. The investigator's project will determine if a targeted intervention strategy improves PD participants' prospective memory. The investigator will use a randomized controlled design and a laboratory-based assessment of prospective memory to test the effect of the strategy in a controlled environment. The investigator will also see if PD participants, with support from an occupational therapist (OT), can generalize the strategy to their complex, real-world environments and tasks. Our goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn \& Yahr39 stage I-III (mild-moderate disease) and are treated with levodopa/carbidopa.

Exclusion Criteria:

* Possible dementia,
* treatment with certain medications that interfere with cognition (e.g., anticholinergics),
* change in medications over the study period, other neurological disorders, brain surgery (e.g., STN DBS),
* history of psychotic disorder or significant current psychiatric disorder, or any condition that would interfere with testing (e.g., vision problems).
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.


Eligibility Criteria:
Inclusion Criteria:

* Subacromial impingement syndrome
* MRI with intact rotator cuff
* Patients suitable for general anaesthesia

Exclusion Criteria:

* Known major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
* Abnormal ECG
* Prolonged QT syndrome
* Current or regular use of analgesic medication for other indication(s)
Diurnal Testosterone Concentration

In this case-controlled, observational study, 24 subjects will participate in a 12-hour blood collection with a single blood draw at +24 hours. 12 men will have low testosterone levels (hypogonadism) and 12 men will have normal testosterone levels. Blood samples will be drawn every 2 hours and later analyzed for total testosterone and calculated free testosterone. The primary objective of this study is to assess the degree of diurnal variation in men with testosterone deficiency.


Eligibility Criteria:
Inclusion Criteria:

Men with testosterone deficiency:

* Ability to read, write, and understand English
* Male sex at birth
* Age greater than or equal to 18
* Age less than 46
* Diagnosed with testosterone deficiency prior to visit 1
* Screening testosterone concentration of less than 350 ng/dL
* Willing and able to comply with the study protocol
* Willing to provide informed consent for this study
* No previous exposure to exogenous T unless off therapy for at least 4 weeks

Men without testosterone deficiency:

* Ability to read, write, and understand English
* Male sex at birth
* Age greater than or equal to 18
* Age less than 46
* Never diagnosed with testosterone deficiency
* Screening testosterone concentration of greater than 350 ng/dL
* Willing and able to comply with the study protocol
* Willing to provide informed consent for this study
* No previous exposure to exogenous T

Exclusion Criteria:

* Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 4 weeks
* Serious psychiatric disease or uncontrolled medical illness, as suspected from the history or clinical examination
* Used any sex hormones or steroidal anabolic drug supplements within 28 days before screening testosterone collection
* Incapable of giving informed consent or complying with the protocol
A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study

This is a long-term safety follow-up study of the Phase I/IIa multicenter study of SCM-AGH in subjects with moderate to severe acute pancreatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol SCM-APT2001 (ClinicalTrials.gov ID: NCT04189419) will be eligible for this long-term follow-up protocol.

Subjects who meet all eligibility criteria for Long Term Follow-Up(LTFU) study participation at the SCM-APT2001 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who provide written informed consent
* Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study

Exclusion Criteria:

* N/A
Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift

Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a relevant technique in patients with severe cardiac comorbidity. The technique is a safer alternative compared to general or spinal anesthesia in these fragile patients.

The most recognized technique with ultrasound guidance (Karmakars technique) is technically demanding and based on injection of local anesthetic relatively close to the exit of the spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal prompting a risk of low blood pressure. This may be fatal in high risk patients.

The investigators have developed a simple technique based on injection away from the spinal canal. The investigators expect minimal risk of spread of local anesthetic to the spinal canal with this technique.

This randomized, double blinded trial compares the new technique to the established technique of ultrasound guided blockade of the lumbar plexus.

The hypothesis is that the new technique has a higher success rate with reduced effect on blood pressure for ultrasound guided lumbar plexus block compared to the established technique.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* ASA I (American Society of Anesthesiologists physical status classification)

Exclusion Criteria:

* volunteers who are not able to cooperate
* volunteers who do not understand and speak danish
* daily use of analgesics
* allergy to local analgesics or contrast agents
* abuse of medicine or alcohol
* volunteers with technical impediments of the planned interventions
Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis

Primary objective:

To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.

To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.


Eligibility Criteria:
Key inclusion criteria:

* Japanese subject aged 18 years and above.
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
* History of AD for 1 year or more.
* A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
* AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
* Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Key exclusion criteria:

* Subjects for whom TCS are medically inadvisable e.g. due to important side effects or safety risks in the opinion of the investigator.
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
* Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
* Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
* Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation.
* Active skin infections within 1 week prior to randomisation.
* Clinically significant infection within 4 weeks prior to randomisation.
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
* Tuberculosis requiring treatment within the 12 months prior to screening.
* Known primary immunodeficiency disorder.
Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation

A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only \~50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Amitriptyline is one of the commonest agents used for migraine prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of analgesics according to pain inhibitory capacity has been shown effective by our group for painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition capacity gained more from a drug that augment pain inhibition as compared to those with efficient inhibitory capacity. The investigators now propose to assess migraineurs for their pain inhibition capacity, and examine whether, along similar reasoning, those with reduced inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs, who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized two arms parallel double blind design, and followed up for attacks reduction. The investigators expect to identify the best predictors for efficacy of migraine prevention by the study drug. This approach will promote individualization of migraine therapy.


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* premenopausal
* meeting the international headache society criteria for migraine
* having \>4 attacks or days of migraine/month

Exclusion Criteria:

* baseline month diary indicating lower frequency of migraine
* chronic migraine (\>15 days of headache per month)
* use of migraine preventive treatment during previous 3 month
* language barrier or cognitive dysfunction
Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure

The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context.


Eligibility Criteria:
Inclusion Criteria Obese Participants:

* Age 18-60 years
* Written informed consent
* Scheduled for routine liquor puncture
* BMI ≥ 30 kg/m2
* No proven diagnose of diabetes

Inclusion Criteria Lean Participants:

* Age 18-60 years
* Written informed consent
* Scheduled for routine liquor puncture
* BMI 18-25 kg/m2

Exclusion Criteria:

* Known allergy to the natural odour
* Acute upper respiratory tract infection, acute or chronic sinusitis
* Present or past surgical intervention of the nasal cavity, the paranasal sinus, the pituitary or the frontal brain
* Pregnancy/lactation
* Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease, severe renal impairment with an estimated glomerular filtration rate \<30 ml/min/m2)
* Inability to understand the study procedure and to sign the study consent
Relative Bioavailability of Ambroxol Hydrochloride of Soft Pastilles Compared to Ambroxol Hydrochloride Syrup in Healthy Male and Female Volunteers

Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
* No finding deviating from normal and of clinical relevance
* No evidence of a clinically relevant concomitant disease
* Age ≥18 and Age ≤55 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.

This project is designed to answer the question: Is there an acute IGFBP-3 response in normal children?

Our specific hypothesis states that under the influence of growth hormone secretagogues, intact IGFBP-3 molecule will undergo proteolysis and liberate IGFBP-3 fragments, along with other components of the ternary complex. This proteolysis will result in measurable rise in IGFBP-3, which will indicate the subject's growth hormone status. Short children with growth hormone deficiency will not show an IGFBP-3 response.

The diagnosis of growth hormone deficiency is problematic, given the shortcoming of the standard growth hormone stimulation test. This study is designed to investigate a new tool for the diagnosis of growth hormone deficiency.

Ten short, prepubertal children, who fulfill the inclusion criteria, will undergo a two-secretagogue standard growth hormone stimulation test, and an insulin like growth factor binding protein-3 (IGFBP-3) stimulation test simultaneously. During this test, components of the ternary complex moieties, viz, insulin-like growth factor-I (IGF-I), IGFBP-3 and acid labile subunit (ALS) will also be measured along with growth hormone.

The aim of this study is to detect an acute rise in IGFBP-3 of \>15% from baseline.

The importance of this study is that it inculcates the specificity and improved sensitivity of stimulated IGFBP-3 in the diagnosis of growth hormone deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Bone age \< 10 years female, \< 12 years male
* Pubertal status: Girls: Tanner I for breast development. Boys: testicular volume of ≤ 3 cc, as measured by the standardized orchidometer (Prader type). The onset of pubic hair development up to and including Tanner III is allowed in the study.
* Adequate nutrition: body mass index ≥ 25th percentile for gender.

Exclusion Criteria:

* Syndromic short stature
* Chronic illnesses.
* Other disorders, including osteo- or chondrodystrophies, and endocrine causes of short stature such as Cushing syndrome, and untreated hypothyroidism.
Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears

A massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. To our knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. Adding the first randomized controlled trial to will be a substantial contribution to the current body of evidence available in the subject of massive rotator cuff tears. Most studies found in the literature following patients with massive rotator cuff tears are retrospective, have small numbers of patients, offer no control group and do not adequately compare treatment methods.Moreover, there is no consensus from experts regarding which treatment is superior.

Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the treatment of massive rotator cuff tears. This study will include the use of comprehensive functional, motor and radiographic outcome assessments.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 40 to 65 years of age
* Massive rotator cuff tear, identified by MRI as being greater than 4cm in greatest diameter.
* Provision of informed consent

Exclusion Criteria:

* Absence of functioning latissimus dorsi muscle (assessed by "cough test"
* Absence of subscapularis muscle insertion (assessed by MRI)
* Glenohumeral arthritis of Grade 2 or higher, including evidence of acromio-humeral arthritis
* Acute tears (identifiable injury which precluded symptoms in past 6 months)
* Neurologic injury causing paralysis of affected shoulder girdle/arm
* Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
* Anticipated problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Peri-implant Disease and Prosthetic Cement: Cross-sectional Study

The main objective of the present clinical study project, of a cross-sectional observational nature, is to evaluate the presence of submucosal cement residues through endoscopic visualization in clinical situations with peri-implant disease.

The secondary objective is to investigate the potential correlation between the severity of the pathological condition and the spatial position of cement residues in relation to the implant-prosthetic unit.

For each subject, the following data were collected: gender, age, periodontal history, smoking habits, reasons for implant rehabilitation (trauma, caries, periodontitis, agenesis, other), the position of the implant in the oral cavity, elapsed time between prosthetic rehabilitation and pathological condition. If the deposit was recognized as cement residue, its presence was recorded, and the anatomical position of the cement residue (mesial, distal, lingual/palatal, vestibular) and the spatial position of cement residues in relation to the implant-prosthetic unit were collected.


Eligibility Criteria:
Inclusion Criteria:

* at least one single-implant with cemented restoration and clinical-radiographic signs of peri-implant disease
* patients with previous periodontitis had to have a healthy but reduced periodontium

Exclusion Criteria:

* neuromotor pathologies or morphological-dysfunctional alterations
Study on Boredom in High Potential Adolescents

The research focuses on "High Potential" (HP) in adolescence, in a link with the professional practice of the investigators.

Furthermore, supported by scientific literature and professional clinical practice, this research is interested in school boredom, regularly expressed by the consulting adolescents, in its relation with a depressive syndrome.

The objective of the research is to know if school boredom is a precursor of a depressive episode in high school students with HP compared to high school students without HP.

The investigators are questioning the meaning of school boredom experienced by adolescents with HP and its link with a depressive syndrome. The investigators will use clinical interviews, rating scales for a quantitative measure and projective tests for a psychodynamic study. The responses of adolescents with HP will be compared to those of adolescents without HP.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents coming for consultation in a medical-psychological center of Sponsor
* Adolescents aged 14 to 16 years and 11 months.
* Adolescents expressing a psychological malaise and/or an anxiety disorder at the time of the consultation request
* Adolescents who were informed about the study, received the information note about it and did not object to participating
* At least one parent or guardian who was informed of the study, received the study information sheet, and did not object to the child's participation
* Adolescents affiliated or entitled to a social security plan

Exclusion Criteria:

* Adolescents who do not understand the French language well enough to complete the questionnaires.
* Adolescents with a clear diagnosis of psychiatric pathology (e.g. schizophrenia)
* Adolescents with an IQ ≤ 80 because the level of intellectual efficiency would be too fragile and too far from the expectations of our research.