cyrilzakka/clinical-trials huggingface dataset:
Treatment of Pilonidal Cyst With Holmium Laser

Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records

From the medical records of a series of patients treated for pilonidal cysts with Holmium laser:

1. Primary objective: to assess the rate of healing at 1 month after Holmium laser treatment (healing being defined as no dressing)
2. Secondary objectives: to assess the following:

   * Healing rate at last follow-up (1 month after surgery)
   * Recurrence rate at last follow-up (1 month after surgery)
   * Consumption of \>1 level analgesics in the week and month following the procedure
   * Duration of nursing care

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older, who has been informed of the research;
* Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure.

Exclusion Criteria:

* Patient under legal protection, guardianship or curatorship;
* Patient who has indicated his opposition to the use of his data.
* Patient undergoing emergency surgery for an abscess
Exercise for Subacromial Pain Syndrome

This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in comparison with traditional supervised exercise as treatment for patients with subacromial shoulder pain. The purpose is to evaluate if HSR is feasible fir these patients, and compare its effect to traditional exercise at pain and function of the shoulder. One half will complete the heavy slow resistance exercise, the other will complete the conventional exercise.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain \> Three months
* Subacromial pain
* Dysfunction or pain during abduction
* Pain during isometric strength test of abduction or external rotation of the shoulder.
* Positive Hawkins test
* Normal passive range of movement in the glenohumeral joint

Exclusion Criteria:

* Surgery of the affected shoulder
* Patients that are not considered suitable to complete the treatment, or able to answer a Norwegian questionnaire
* Shoulder dislocation or shoulder instability
* Clinical sign of cervical nerve root affection
* Rheumatoid arthritis
* Clinical sign of full rupture of the rotator cuff.
* Pregnancy
* Cortisone injection past six weeks
An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.

The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age who understand and voluntarily sign an informed consent form.
* Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for \> 2 cycles and \< 6 cycles.
* Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment.

Exclusion Criteria:

* Refusal to participate in the study.
* Women who are pregnant or breast-feeding.
* Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
* Hypersensitivity to the active substance or to any of the excipients.
Study of Diroximel Fumarate in the Real-World Setting

The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs) and to explore the real-world safety profile of DRF (ie, gastrointestinal \[GI\] tolerability, lymphocyte dynamics, adverse events \[AEs\] leading to discontinuation, and serious adverse events \[SAEs\]).


Eligibility Criteria:
Key Inclusion Criteria:

* Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the USPI.
* DRF prescribed and planned to be initiated within 60 days after enrollment.

Key Exclusion Criteria:

* History of gastric bypass or required use of feeding tubes.
* Have received prior treatment with DRF.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 6 months before trial start
* Treatment with at least 1000 mg metformin per day for at least 3 months
* Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
* DPP-4 (dipeptidyl peptidase-4) inhibitor naive
* HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis
* BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2
* Able and willing to take one subcutaneous injection every day
* Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements

Exclusion Criteria:

* Known or suspected allergy or intolerance to any of the trial products or related products
* Severe hypertension
* Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
* Cardiac disease, within the last 12 months
* Impaired hepatic function
* Impaired renal function
* Proliferative retinopathy or macular oedema requiring acute treatment
* Female of childbearing potential
* Known or suspected abuse of alcohol, narcotics or illicit substances
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.

Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using the non-bordered foam dressing as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. The only included indication is Venous Leg Ulcers (VLU). A total of n=20 participants will be recruited at up to 6 centers within the US and Canada.

There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent to participate (including consent for digital imaging)
* Adult aged ≥18 years
* Diagnosed with a chronic, exuding VLU
* Exudate amount moderate to large
* Wound size from 3 cm2 to 30 cm2, as determined by the clinician
* ABPI (within 3 months) \> 0.7. If ABPI \> 1.4, then big toe pressure \> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
* Willing to be compliant with compression therapy

Exclusion Criteria:

* Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
* Circumferential wound
* Known allergy/hypersensitivity to the materials of the dressing
* Use of wound fillers
Treating Cocaine Abuse: A Behavioral Approach

This study is designed to advance our development of a treatment for cocaine dependence. The investigators hypothesize that clients with high-risk characteristics will benefit from enhanced levels of treatment.

Treatment development for cocaine dependence often proceeds without effort to adapt treatment parameters to patient characteristics. Such a one-size-fits-all approach is problematic because of the heterogeneity of the clinical population. Additionally, the approach is often subject to opposing biases either towards constraining costs or maximizing efficacy. This project includes two sequential clinical trails examining variations of the CRA + Vouchers treatment for cocaine dependence that are designed to explore matching treatment parameters to patient baseline characteristics known to moderate treatment response among cocaine-dependent outpatients. In Trial 1, all patients were randomly assigned to receive 24 weeks of CRA therapy but randomly assigned to one of three voucher-based incentive conditions: (a) 6 weeks of vouchers contingent on abstinence and incentive monetary value at usual level; (b) 6 weeks of vouchers contingent on abstinence but incentive value set at usual level for low-severity patients (intranasal cocaine users or married patients) and at twice the usual value for high severity patients (i.e., unmarried cocaine smokers/injectors), or to (c) a control condition where incentives were provided independent of recent cocaine use. In Trial 2, all patients receive 12 weeks of abstinence-contingent incentives, but randomly assigned to also receive (a) 24 weeks of CRA therapy or (b) 4 weeks of CRA therapy. The overarching goal of the two trials is to strike a balance between the aforementioned biases towards constraining costs or maximizing efficacy and thereby facilitate cost containment without compromising efficacy, especially among more severe patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Meets DSM IV criteria for cocaine dependence

Exclusion Criteria:

* Psychosis
* Pregnancy
* Leaving immediate geographic area sooner than 6 months
* An organic psychiatric disorder
* Medical illness such that participation is not feasible (e.g., on dialysis).
* Subjects in acute alcohol withdrawal
* Uncontrolled seizure disorder
* Significant depression or suicidal ideation (pending psychological evaluation)
Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery

This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.


Eligibility Criteria:
Inclusion Criteria:

Surgery will be scheduled as first case in the morning at 9 Am. On arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. Monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index.

Exclusion Criteria:

Diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.
Rifaximin for Functional Dyspepsia

Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people in the community. However, results of current pharmacological treatment on functional dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been used in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators test whether rifaximin is also effective in curing post-prandial distress symptoms related to dyspepsia.

The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.

Eligibility Criteria:
Inclusion Criteria:

* Non-ulcer dyspeptic patients who fulfill post-prandial distress syndrome according to the Rome III Criteria
* Active dyspeptic symptom
* Normal upper endoscopy
* Urea Breath Test -ve or Rapid urease test -ve
* Not typical gastroesophageal reflux or biliary colic symptoms, but presence of infrequent acid reflux is allowed

Exclusion Criteria:

* No active dyspeptic symptom
* Allergic to rifaximin
* Recent antibiotics use in the past 8 wk
* Recent PPI or H2RA in past 4 wk
* On anti-coagulants, anti-convulsant or oral contraceptives
* On NSAIDs, aspirin or Clopidogrel
* Pregnancy or breast feeding
* Previous gastric surgery
Subjective Evaluation of a Sound Processing Method for Hearing Aids on Auditory Distance Perception

Within the course of this study, a signal processing feature has been developed at Ecole Polytechnique Fédérale de Lausanne (EPFL), in collaboration with Sonova AG, in order to enhance the listening experience with remote microphone systems. In particular, the developed feature is supposed to improve the so-called audio-visual fusion, i.e. the fact to perceive the sound as coming from the physical location of the source. One of the main goals of the present study is to evaluate the extent to which this feature reaches that objective.


Eligibility Criteria:
Subjects fulfilling all of the following inclusion criteria are eligible for the study:

* Willing and able to give written informed consent as documented by signature,
* French-native adult speakers,
* (Preferably) younger than 60 y.o.

For all normal-hearing participants:

- Hearing thresholds lower or equal to 20 dB on both ears, as ensured by a pure-tone audiometry (125 Hz to 8 kHz) conducted at the beginning of the session.

For all hearing-impaired patients:

* Patients of Mr. Philippe Estoppey, private audiologist settled in Lausanne,
* User of bilateral BTE Phonak hearing aids, commercialized after July 2012, with fittings that did not change over the last three months,
* Presenting a severe-to-profound sensorineural hearing loss,
* Presenting a symmetrical hearing loss (no bilateral hearing threshold that differ by more than 20 dB at any audiometric frequency (125 Hz - 4 kHz)).

For HI patients experienced with remote microphone systems:

- Past or present users of FM and/or Roger devices for more than six months.

For other HI patients:

- No past or present experience with FM and/or Roger devices for more than one month.

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

* Collaborator of the laboratory (LTS2) or student attending the courses of audio and acoustics given by the laboratory staff (EE-348 Electroacoustics, EE-548 Audio Engineering),
* History of chronic or terminal illness, psychiatric disturbance, senile dementia, or cognitive impairment,
* History of strong tinnitus and/or hyperacusis,
* Strong visual impairment after correction with glasses or not,
* History of epilepsy or other reactions associated with the proximity to a screen,
* Motor disability that would disturb their presence at EPFL.
Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome

The study purpose is to determine the hypolipidemic effect of Alirocumab co-administered with atorvastatin on levels of triglyceride-rich lipoproteins and LDL compared to monotherapy with atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.

The trial is randomized (1:1 alirocumab to placebo), double-blinded, placebo-controlled with a cross-over design. The trial will last 10 months and includes a 10 week washout period between study phases.Twenty adult subjects with dyslipidemia secondary to nephrotic syndrome and treated with atorvastatin will be recruited. Alirocumab or placebo will be co-administered biweekly. Safety, efficacy chemistries, vital signs, anthropometry and monitoring for adverse events also will done at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Nephrotic Syndrome (NS) (FSGS, IMN or NS and type 2 DM)
* atorvastatin
* LDL C \>= 70 mg/dl or non-HDL C \>= 100 mg/dl
* Plasma trigycerides \< 800 mg/dl.
* Highly effective methods of contraception for pre-menopausal women
* Post-menopausal women must be amenorrheic for at least 12 months.

Exclusion Criteria:

* homozygous FH
* Fibrates within 6 weeks of screening visit
* Uncontrolled hypothyroidism
* Known history of hemorrhagic stroke
* Known history of loss of function of PCSK9
* use of systemic corticosteroids unless used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks of randomization
* Previous treatment with at least a single dose of alirocumab or any other anti-PCSK9 monoclonal antibody
* Other conditions or situations per protocol
* Laboratory findings or contraindications to background therapies
* Warnings/precautions of use (when appropriate) as displayed in the respective national product labeling
* Any currently known contra-indication to study drug, pregnancy or breastfeeding of infants.
Therapeutic Effect of an Herbal Medicine on Anxiety

Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.

The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.

The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).

Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of generalized anxiety disorder
* HAM-A scale \> 17 and \<30

Exclusion Criteria:

* HAM-A scale \> 30
* Psychotherapy
Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty

The investigators hypothesise that cementless one-stage exchange revision surgery can be performed in patients with chronically infected hip replacement with substantial benefits for the patients, in terms of fast rehabilitation, low re-revision rates and good long term results.


Eligibility Criteria:
Inclusion Criteria:

* Patient with clinical signs of infection for more than 4 weeks, arising from total hip arthroplasty (primary and revision), resurfacing hip arthroplasty or hemi-hip arthroplasty
* Informed oral and written consent given

Exclusion Criteria:

* Life expectancy under 2 years
* Cognitive dysfunction
* Pre-operative unwillingness to receive blood
* Intravenous drug abuse
* Alcoholism
* Immunocompromised patients
* Patients receiving immunosuppressive medication
* Ongoing systemic inflammatory disease
* Poorly regulated diabetes mellitus
* Renal failure (requiring dialysis)
* Acute systemic inflammatory response syndrome with proven infection (sepsis)
* Signs of coexisting active long-term local infection (i.e. endocarditis)
* Previous two-stage revision of hip arthroplasty due to ipsilateral chronic infection (regardless of symptom free interval) or contralateral chronic infection (within the last 2 years).
* \< 6 weeks since last surgery of the affected hip
* If definition of infection is not fulfilled: infection defined as Culture positive: ≥ 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) Culture negative: \< 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) + Chronic fistula with history of previous or existing secretion or Positive cultures in pre-operatively joint fluid aspiration with other clinical signs of infection or Visual pus or purulent fluid during exchange procedure with clinical signs of infection
Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.

The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline \& 6-months.

Eligibility Criteria:
Inclusion Criteria:

1. between 20-80 years of age
2. healthy with no conditions that could alter wound healing
3. requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
4. a tooth requiring extraction that is treatment planned for implant placement
5. willing to participate in the study and sign the informed consent
6. willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.

Exclusion Criteria:

1. systemic conditions which could alter wound healing
2. tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
3. severe local infection at extraction site
4. a tooth exhibiting severe resorption of buccal or lingual plates
5. absence of keratinized tissue buccal to the tooth to be extracted
6. severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.
Faslodex Post Marketing Surveillance

This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Patients who have failed 2 or more prior hormone therapies (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)
* Patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)

Exclusion Criteria:

* The patients who received Faslodex treatment before