cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.


Eligibility Criteria:
Inclusion Criteria:

* HIV Infected subjects
* Subjects failing in current HIV treatment, or
* Subjects with a viral load \< 400 copies/mL and not tolerating their current HIV treatment.

Exclusion Criteria:

* Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
* Subject is pregnant
Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome

This study will investigate the effectiveness of repeated ozone therapy combined with splint therapy for carpal tunnel syndrome (CTS).CTS patients will be split into two groups: ozone plus splint and splint only. Both groups will use wrist splints for 3 weeks, with the ozone+splint group receiving weekly ozone injections for three weeks.


Eligibility Criteria:
Inclusion Criteria:

* being 18-65 years, with mil-modarete CTS, symptoms continued for at least 3 months

Exclusion Criteria:

* hand edema or prior injections, thenar atrophy, prior CTS surgery, severe EMG results, recent physical therapy, steroids, or platelet-rich plasma for CTS in the past year, and conditions causing secondary CTS (e.g., thyroid disorders, diabetes, pregnancy, rheumatoid arthritis, Dupuytren's contracture, inflammatory arthritis, connective tissue diseases). Also excluded: neck or arm pain conditions (e.g., cervical disc herniation, wrist fracture, proximal upper extremity entrapment neuropathy, polyneuropathy, peripheral nerve damage, fibromyalgia), history of G6PD deficiency, uncontrolled hyperthyroidism, thrombocytopenia, and contraindications to general ozone therapy (e.g., ACE inhibitors for severe cardiovascular instability).
Promoting Widowed Elders Lifestyle After Loss

This study is for adults 60 years and older who are grieving the recent loss of a spouse or partner. Bereavement is one of the most distressing transitions faced by older adults and triggers dramatic changes to older adults' daily routine which puts them at-risk for a mood disorder. The purpose of this study is to promote bereaved elders' mental health by focusing on healthy lifestyle practices. Study treatment involves using a tablet to record their daily physical activity, diet, and sleep behaviors, for 12 weeks. The investigators follow-up with people for up to one year.

Preventing mental health problems that develop following spousal bereavement is important because these conditions are highly prevalent and have lasting adverse consequences for the well-being of the bereaved survivor. The proposed research will evaluate the feasibility and acceptability of a healthy lifestyle intervention that uses a technology-based behavioral self-monitoring protocol to encourage engagement in physical activity, healthy eating, and good sleep practices following spousal bereavement. Data from 10 participants will be used for the development of a prevention intervention manual (Aim 1). A small pilot study will be conducted (Aim 2) in which 50 participants will be randomly assigned to 12 weeks of (1) behavioral self-monitoring using a smartphone (n=20), (2) behavioral self-monitoring using a smartphone + motivational interviewing-based lifestyle coaching (n=20), or (3) enhanced usual care (n=10). Blood samples will be collected to explore inflammatory cytokines as a potential mediator/moderator of mental health risk.

Eligibility Criteria:
Inclusion Criteria:

* 60 years and older
* experiencing the recent death (within 8 months) of a spouse or partner
* at-risk for developing mental health problems, based on high-risk markers defined as: subthreshold symptoms of depression (Hamilton Depression Rating Scale \[HAM-D\]101 of 9-14), anxiety (Generalized Anxiety Disorder Scale \[GAD-7\] ≥ 10, and/or complicated grief (Inventory of Complicated Grief \[ICG\] of 20-29), together with absence of current major depression, generalized anxiety, post-traumatic stress, or suicidiality; or high medical comorbidity (2 or more systems on the CIRS-G), low social support (Perceived Isolation Scale below zero), functional disability (limitation with at least 1 ADL/IADL),or

Exclusion Criteria:

* current DSM-V criteria for syndromal mood, psychosis, anxiety, eating disorder, or substance abuse dependence;
* dementia; 3MS\<80;
* patients taking psychotropic medications to stabilize mental health problems including antidepressants and benzodiazepines;
Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: single center non-randomized trial.

Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing (PAT or PEI) for the large and inoperable hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.

Eligibility Criteria:
Inclusion Criteria:

* Review and sign informed consent;
* Between 15 and 80 years of age at time of trial enrollment;
* Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
* Radiologically documented tumor size of \> 5 centimeters;
* Radiologically documented liver cirrhosis.

Exclusion Criteria:

* American Anesthesia Association (ASA) Class IV or V and/or any
* contraindications to general anesthesia;
* Uncontrollable ascites;
* Deep persistent jaundice;
* Hepatic encephalopathy;
* Coagulopathy;
* Severe thrombocytopenia;
* Unable or unwilling to attend follow up visits and examinations;
* Other associated surgical procedure;
The Effect of Potatoes on Markers of Cardiometabolic Health

A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and dietary intake.

A 2-period randomized cross-over study will be conducted. Free-living subjects will be provided with a potato based side dish (equivalent to one medium sized potato) or an isocaloric refined grain based side dish every day for 4 weeks, in random order. The treatment periods will be separated by a minimum two-week break. Endpoint testing will be conducted over two days at baseline and the end of each diet period.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* BMI \> 20 and \<40 kg/m2
* Male or female

Exclusion Criteria:

* Diagnosed diabetes or fasting glucose \>126 mg/dl
* Hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
* Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
* Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
* Pregnancy or lactation
* Weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
* Smoking or use of any tobacco products
A Comparison of the Effectiveness of Massage and Kinesio Taping in Neck Pain

This study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.

Neck pain is a common condition, affecting 30% to 50% of the general population, and is most prevalent in middle age.33 It is usually accompanied by a substantial effect on daily life, resulting in an extensive use of health care resources.

Several physical therapy applications such as massage therapy, kinesio taping, thermal and electrophysiological agents, hydrotherapy/spa therapy, and therapeutic exercises especially neck stabilization exercise are used to manage FM. Both massage therapy and kinesio taping have a favorable effect on clinical symptoms. However, it is not clear which method is more effective. Therefore, this study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age,
* having generalized neck pain for more than 3 months,
* being volunteer

Exclusion Criteria:

* pregnancy,
* inflammatory rheumatologic diseases,
* malignity,
* structural deformity,
* previous surgery related to the cervical spine,
* cervical spinal stenosis,
* being allergic to Kinesio tape
* severe psychological disorder,
* any intervention that included exercise or physical therapy in the last 3 months.
MySpine MC Versus MySpine Standard

This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique. Both techniques are performed by aid of MySpine patient-specific guide systems.

Adult subjects, among those whose clinical condition makes them eligible for a spinal stabilization and meeting the inclusion/exclusion criteria, will be invited to participate to the research project and ask to sign a consent in order to further use of personal and clinical data collected during standard practice visit.

The primary objective of the research project is to compare clinical outcomes, in terms of assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability), of spine surgery with cortical bone trajectory screw placement technique respect the traditional pedicle screw placement technique. Preoperative data and collected during visit as per standard routine at 6 weeks, 3, 6 and 12 months postop will be recoreded and assessed for the purpose of this research project.

Eligibility Criteria:
Inclusion Criteria:

1. patients affected by degenerative disc disease, osteochondrosis and grade I spondylolisthesis needing a one/two level surgical treatment with posterior approach and screw fixation
2. those who need a surgical procedure of lumbar spine stabilization from level L1 to level L5.
3. patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery
4. Healthy patients or patients with mild or severe systemic disease identified as patients with ASA score 1, 2 or 3.
5. Patients with BMI ≤ 35 kg/m2
6. non responsive or insufficient response to conservative treatment.

Exclusion Criteria:

1. Patients presenting contraindications as defined by Medacta instruction for use
2. Patients affected by lytic spondylolisthesis and degenerative spondylolisthesis with grade≥2 will be excluded
3. Patients \<18 years
4. Patients who are pregnant or intend to become pregnant during the study
5. Known substance or alcohol abuse
Lymphoma in the Orbit

Imaging techniques have considerably improved over the last decades and ocular adnexal lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and molecular diagnostics in histology have been achieved offering an accurate diagnosis, the investigators would like to introduce that surgical biopsy of an orbital lymphoma becomes crucial for the possibility of a correct diagnosis and proper treatment. As radiotherapy accomplished great preciseness as well and OALs respond excellently to radiation, this therapy should be the treatment of choice in local defined lymphomas instead of blind treatment with steroids. Radiation results in great local control rates of 85% to 100%

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria: - both genders

* \>17 years of age
* underwent biopsy of an ocular adnexal lymphoma between 01/2006 and 12/2010 at the University Hospital Zurich, Division of Ophthalmology
* diagnosis histologically proven

Exclusion criteria:

* less than 18 years of age
* patient underwent no MRI before surgery (biopsy)
Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis

Evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface after 6 months of treatment compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patient having given freely her/his informed, written consent.
* Patient having a good general health.
* Age: between 18 and 70 years.
* Patient with superficial onychomycosis or light to moderate distolateral onychomycosis (without matrix involvement and involvement from 10 to 60%) on at least one great toenail.
* Patient with positive KOH staining.
* Patient cooperative and aware of the device modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
* Patient being psychologically able to understand information and to give their/his/her consent.
* Patient who agrees to refrain from receiving pedicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.
* Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before screening visit and during all the study.

Exclusion Criteria:

* Pregnant, breastfeeding woman or woman planning a pregnancy during the study;
* Patient enrolled in another clinical trial or which exclusion period is not over.
* Patient having used any systemic antifungal treatment in the last 6 months before screening and/or any topical antifungal treatment in the last months before screening visit.
* Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk;
* Patient suffering from a severe or progressive disease (at investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, poor blood circulation HIV, psoriasis, lichen planus, immunosuppressive pathology, moderate and high risk obesity (BMI ≥30);
* Patient having a known allergy or hypersensitivity to one of the constituents of the investigational device.
* Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
Pulse Pressure Variation for Prediction of Fluid Responsiveness in Coronary Artery Disease Patients With Diastolic Dysfunction

The investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid responsiveness would be reduced in patients with coronary disease who have diastolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* scheduled for elective coronary artery bypass grafting
* normal diastolic function (E/E' \< 8) or diastolic dysfunction (E/E' \>15) according to preoperative Echocardiographic evaluation

Exclusion Criteria:

* arrythmia,
* reduced left ventricular function (ejection fraction \< 40%)
* valvular heart disease requiring concomitant surgical correction
* pulmonary hypertension (mean pulmonary arterial pressure ≥30 mm Hg)
* peripheral arterial occlusive disease, pulmonary disease (asthma, chronic obstructive pulmonary disease, and lung resection)
* end-stage renal disease
Plant-Based Meat vs Animal "Red" Meat Trial

To assess the changes in the circulating levels of TMAO after 1-week of beef or plant-based burger diet.

Single-center, randomized, single-blinded cross-over trial including healthy adult participants (N=40, omnivores, aged between 25 and 65 years, and with a body mass index (BMI) between 20 and 40 kg/m2 (see participation criteria below). Participants will be randomized to either red meat (cow burger) or plant "meat" (plant-based burger). The primary outcome will be the within-group change in the TMAO levels.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 25 years and ≤65 of age
* BMI ≥20 Kg/m2 and ≤40 Kg/m2
* No known kidney disease
* No antibiotics in the previous 30 days

Exclusion Criteria:

* Any person who does not meet the above criteria and/or who refuses to participate
* Food allergies (specific ingredients contained in the patties)
Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route.

The aim of the research is to analyze postoperative pain


Eligibility Criteria:
Inclusion criteria:

* Adult woman (≥18 years old)
* Woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
* Woman who did not express her opposition to the reuse of her data for the purposes of this research.

Exclusion criteria:

* Woman who expressed her opposition to participating in the study
* Surgical procedure associated with hysterectomy
The Finnish Faecal Microbiota Transplantation Study (FINFMT)

The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. The outcome and possible side effects of the FMT will be followed by blood and feces samples for one year and with questionaires up to ten years after the FMT.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years age
* receiving FMT for rCDI or any other madical condition
* written consent
* Not included in other FMT trials

Exclusion Criteria:

* Unable to provide written consent
* \< 18 years age
* Included in other FMT-trial
Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders

Gilles da la Tourette syndrome (TS)\* is a common chronic neuropsychiatric disorder characterized by motor and vocal tics. In most adult patients, quality of life is significantly impaired. TS, therefore, is a cost-intensive disease (in Germany: mean total costs=€3404/year). Despite significant adverse effects, dopamine receptor antagonists were recommended as first choice treatment for many years. Although efficacy could be demonstrated only recently, today, behavioral therapy with face-to-face Comprehensive Behavioral Intervention for Tics (CBIT) (including psychoeducation, habit reversal training, function-based assessment and intervention, and relaxation training) is recommended as first line treatment for tics. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated internet-delivered CBIT (iCBIT) program. In addition, internet-delivered CBIT will shorten waiting time, will reach additional groups of patients and will be - once developed and established - highly cost-effective (about € 100 vs. € 1450 for face-to-face CBIT). Investigators want to perform a multicenter, randomized, controlled, observer-blind trial including 160 adult patients in order to demonstrate that 8 sessions (10 weeks) of iCBIT are superior to internet-delivered psychoeducation/relaxation in adult patients with TS. Both immediate (1 week after end of treatment) and long-term effects (after 3 and 6 months) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Chronic tic disorder or Tourette syndrome according to DSM-5
* Age ≥18 years; Yale Global Tic Severity Scale (YGTSS) total tic score (TTS) \> 14 or \> 10 (for patients only with motor or vocal tics)
* Clinical Global Impression-Severity Score (CGI-S) \> 4
* Medication for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study
* Fluent German in speaking and writing
* Ability to give informed consent and signed informed consent

Exclusion Criteria:

* History of schizophrenia or pervasive developmental disorder
* Comorbid obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), depression, anxiety disorder when unstable and/or in need of an initial adjustment for a therapy
* History of behavioral treatment for tics
* Current illicit substance abuse or addiction (clinically diagnosed)
* Secondary tic disorder or other significant neurological and psychiatric disease
* No internet access or ability to use the internet
* Participation in a study with medicinal products or devices is not allowed within 6 weeks before inclusion or concurrent to this study
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study

This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. Due to the high risk of cancer, mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy. Doctors want to learn if a more personalized risk assessment impacts the patients' risk perceptions and comfort with decision-making around cancer prevention behaviors.

PRIMARY OBJECTIVES:

I. To deploy tools for delivering enhanced genetic risk predictions based on BRCA1/2 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on genetic knowledge, risk perceptions and decisional conflict regarding cancer prevention decision-making.

II. To perform long-term follow-up of individuals in the randomized controlled trial (RCT) to determine if there are differences in satisfaction, decision-making and outcomes in individuals who received standard versus enhanced genetic risk predictions over time.

OUTLINE: Patients undergo collection of blood or mouthwash samples. Patients are then randomized to 1 of 2 arms.

ARM I: Patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling.

ARM II: 4-8 weeks later, patients receive a standard follow-up phone call.

After completion of study intervention, patients are followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Have had genetic counseling and testing for mutations in BRCA1 and/or BRCA2 through a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
* Were found to have a known pathogenic mutation upon testing
* Are within 3 weeks of results disclosure
* Have available medical records for ascertainment of clinical information
* Are able to provide a source of deoxyribonucleic acid (DNA) (blood or mouthwash) for study
* Have access to a telephone and a computer or other internet-ready device
* Have not yet had a bilateral prophylactic mastectomy or bilateral Salpingo oophorectomy