cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties

Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. Revision risk factors reported when considering the main surgical approaches. Studied from the Dutch arthroplasty registry found a revision rate in hemiarthroplasty (HA) of 1.6% at 1 year and 2.5% at 5 years postoperatively. For total hip replacement (THA), the rate was 2.4% at 1 and 4.3% at 5 years postoperatively. Analyze shows that the risk factors for hemiarthroplasty were male sex, age under 80 (regardless of gender), posterolateral approach and uncemented fixation. The risk factors for HAT were exactly the same, but they found that smoking also played a role. It should be noted that age as a risk factor for revision is not a risk during the first year after the fracture, but becomes one in the years that follow.

In order to maintain compliance with the directive on medical devices (93/42 / EEC \[M5\]) and the future regulation (EU) (2017/745) relating to medical devices, SERF has set up post-market clinical follow-ups ( PMCF). This PMCF study aims to improve knowledge related to the performance, safety and benefit / risk ratio of the Sagitta EVL-R stem and to monitor patient care strategy through this clinical evaluation. Significant clinical results as well as safety must be confirmed with this patient cohort. It is important to note that this cohort reflects the specific care strategy of the University Hospital of Poitiers. Therefore, the strategy could be different between hospitals and countries.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Patients that were treated with the sagitta EVL-R stem for an indication of arthroplasty and according to the Instruction For Use (IFU).
* Primary or secondary arthrosis,
* Advanced joint destruction resulting from rheumatoid arthritis or traumatic arthritis,
* A fracture or an avascular necrosis,
* Following a previous surgical operation, on condition that the new device does not interfere with the material in place.
* indicated in the case of primary or secondary arthrosis, displaced sub-capital or transcervical fracture as well as stages I and IIB bone loss according to the PAPROWSKI classification.
* The SAGITTA EVOLUTION for REVISION implant is recommended for indications according to the bone loss classifications of SOFCOT stages I to VI, PAPROSKY types I to VI and the AAOS types Ia to Ic.
* Dysplasia

Exclusion Criteria:

* Patient presenting a contraindication indicated in the IFU.
Anatomical Variation in Rouvière's Sulcus

Rouvière's sulcus is a 2-5 cm fissure lying on the lower face of the liver, between the right lobe and caudate process. Due to its extrabiliary location, Rouvière's Sulcus could be used as an anatomical landmark for safe laparoscopic cholecystectomy. In literature there's an high variability about Rouvière Sulcus prevalence and its anatomical variants.

The goal of this observational study is to evaluate the presence of Rouvière Sulcus in patients underwent laparoscopic cholecystectomy. The main questions it aims to answer are the prevalence and the anatomical variations of Rouvière's Sulcus and the variants of Rouvière's Sulcus which are catheghorized according to Singh and Prasad criteria.

The following were considered secondary outcome: operative time expressed in minutes, biliary tract injuries according to Stewart's classification and Vascular injuries.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing videolaparoscopic cholecystectomy

Exclusion Criteria:

* If the lower face of the right hepatic lobe and the main elements of the biliary tract cannot be clearly analyzed patients will be excluded.
the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation

The aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation.


Eligibility Criteria:
Inclusion criteria

* age 18-60 years old,
* ASA grade Ⅰ-Ⅱ,
* 18\<BMI\<24.

Exclusion criteria

* the intubation time was less than 5 hours,
* oral and facial skin damage,
* allergic to adhensive tapes,
* nasotracheal intubation,
* patients were edentulous.
Treatment of Androgenic Alopecia in Males

The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.

Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.

Safety analysis will be assessed based on the reports of adverse events during study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of androgenetic alopecia
* Fitzpatrick Skin Types I-IV
* Norwood-Hamilton IIa to V
* Active hair loss within last 12 months

Exclusion Criteria:

* Photosensitivity to laser light
* Malignancy in the target area
Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

The purpose of this study is to determine if the drug, baricitinib, is safe and effective in reducing high levels of albumin in the urine (albuminuria) in African American/Blacks with APOL1- associated focal segmental glomerulosclerosis (FSGS) and non-diabetic APOL1-associated chronic kidney disease due to hypertension (HTN-CKD).


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-70 years
* High Risk APOL1 genotype (i.e., G1G1, G2G2, or G1G2)
* FSGS diagnosed by kidney biopsy or clinically diagnosed HTN-CKD
* UACR ≥300 mg/dL
* Estimated glomerular filtration rate (eGFR) ≥26 ml/min/1.73 m2 at screening
* Stable antihypertensive regimen for ≥ 1 month prior to enrolment
* Able to provide written informed consent

Exclusion Criteria:

* Diabetes
* HIV
* Sickle cell disease.
* Tip variant of FSGS.
* Systolic BP \>180 mmHg or diastolic BP \>90 mmHg based on average of 3 measurements.
* Active serious viral, bacterial, fungal or parasitic infection.
* Symptomatic herpes zoster infection within 12 weeks prior to study entry.
* Positive hepatitis B surface antigen during screening (could enroll after treatment).
* Previous kidney transplant.
* History of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
* Hemoglobin \<10 g/dL.
* Absolute lymphocyte count (ALC)\<500cells/mm3 or absolute neutrophil count (ANC) \< 1000 cells/mm3.
* Pregnant or nursing at time of enrollment
* Prior or current treatment with JAK inhibitor.
* Current use of potent immunosuppressants such as abatacept, adalimumab, anakinra, azathioprine, certolizumab, etanercept, golimumab, infliximab, probenecid, rituximab, ruxolitinib, sarilumab, tofacitinib, or tocilizumab.
* High dose corticosteroids (\>10 mg per day of prednisone or equivalent) or an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.
Ultrasound Guided Femoral Nerve Block Catheter Analgesia Compared With Epidural Analgesia for Patients With Knee OA (Osteoarthritis) Who Underwent Unilateral Total Knee Replacement

Post-operative pain following total knee replacement can be disabling and sometimes lead to the need for prolonged hospital stay. Therefore development of improved post-operative modalities for total knee replacement surgery pain control is important. High-resolution ultrasound (US) allows accurate visualization of nerves and surrounding structures and can lead to higher success rates of nerve block. The investigators aim at comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia for patients with knee OA who underwent unilateral total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Male / female, Bilateral or unilateral knee OA (Osteoarthritis), and ASA (American Society of Anesthesiologist classification) 1 and 2.

Exclusion Criteria:

* Bilateral total knee replacement, Revision total knee replacement, previous knee surgery, Rheumatoid Arthritis, Avascular necrosis (AVN) knee, Post traumatic or post infectious OA, ASA3 and 4.
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.

The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.

The study will enroll participants with advanced endometrial cancer who previously received treatment with platinum-based chemotherapy and an anti-programmed cell death protein-1 (PD-1)/programmed death ligand 1 (PD-L1) agent in a recurrent or advanced setting, either sequentially or in combination.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed.
2. Participants who have received the following previous therapy:

   * Up to 3 lines of systemic therapy with no more than 1 line of chemotherapy for recurrent, metastatic, or primary unresectable disease. Prior hormonal therapy is allowed and do not count as prior lines of therapy.
   * Participants have progressed on or after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Platinum-based chemotherapy and anti-PD-1/PD-L1 therapy may have been given together or in separate lines of therapy.
   * Participants must have documented radiographic disease progression during or after the last line of therapy.
3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and estimated life expectancy of \>6 months.
4. Participants having at least one resectable lesion and at least one measurable lesion, following resection of the lesion for TIL generation.
5. Participants who have adequate organ function, including adequate cardiopulmonary function.
6. Participants of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after the last dose of study intervention.
7. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

Exclusion Criteria:

1. Participants who have symptomatic untreated brain metastases.
2. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
3. Participants who require systemic steroid therapy \> 10 mg/day prednisone or another steroid equivalent dose.
4. Participants who have any form of primary immunodeficiency.
5. Participants who have another primary malignancy within the previous 3 years.
6. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMALD.
Effect of a Maintenance Protocol After Surgical Treatment of Peri-implantitis

This study was designed as a 12-month, two arms, randomized clinical trial to evaluate the efficacy of a supportive treatment protocol (SPIT). Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Study design:

This study was designed as a 12-month, two arms, RCT to evaluate the efficacy of a SPIC protocol. Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Interventions:

At the 6-month evaluation after the surgery, the baseline data for the present study were obtained and patients were randomised using a computerized block randomization protocol to one of the following SPIC protocols. In the test group, implant surfaces were treated with glycine powder air-polishing after ultrasonic instrumentation; the specific nozzle was activated subgingivally and circumferentially around the implant for 1 minute. In the control group, implants were cleaned with a rubber cup and polishing paste after ultrasonic instrumentation. This SPIC visits were carried out at 6 (baseline visit), 9, 12, 15 and 18 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one implant with peri-implantitis, defined as: radiographic evidence of bone loss \>2 mm, inflammation of the peri-implant mucosa as defined by positive BoP and/or suppuration, and at least one site with PD ≥ 5 mm.
* Based on the radiographic examination, the affected implant should not have a vertical peri-implant defect. Positive selection was based on the presence of pe-ri-implant lesions wider than 4 mm, with an angle greater than 35 º.
* In patients with a history of periodontitis, periodontal therapy should have been provided at least 6 months prior to the initiation of the study.

Exclusion Criteria:

* Presence of relevant medical conditions and/or systemic medications that would contraindicate the surgical procedure or modify the tissue response after therapy.
* Patients requiring antibiotic prophylaxis.
* Heavy smokers (\> 10 cigarettes/day).
* Pregnant or lactating women
Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy

Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

. As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1)

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi , septea) 2. Reproductive age 20 - 40yrs

Exclusion Criteria:

* 1. Menopausal and amenorrhic patients 2. Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy
Efficacy of Daylight as Adjunctive Treatment in Patients With Depression

The aim of this study is to improve the treatment effect for outpatients with depression by adding regular daily morning daylight exposure to their treatment with antidepressants. Patients will wear a personal light tracker to keep them motivated. Our hypothesis is that patients daily exposed to morning daylight, as a supplement to standard treatment for depression, will achieve significantly higher antidepressant effect that patients receiving standard treatment alone. Furthermore, we hypothesize that they will experience improved well-being and sleep.

Due to inadequate efficiency of existing medical and psychotherapeutic treatments for depression there is a need for investigating the efficacy of adjunctive treatments. Light therapy has proven efficient as an add-on treatment for depression, but some patients might prefer being outdoors rather than sitting in front of a light therapy screen. However, no high-quality studies, have so far investigated the antidepressant and other potential positive effects of regular exposure to morning daylight for patients with unipolar depression.

The aim of this study is to examine the efficacy of morning daylight as add-on to treatment as usual in patients with depression. Efficacy is measured as reduction of depressive symptoms, improvement of sleep quality, and improvement of well-being.

Methods and material: A randomized controlled trial comprising 150 patients diagnosed with unipolar depression aged 18-50 years will be conducted. Patients are included after giving informed consent and the study period is 6 weeks. A wearable Personal Light Tracker, measuring the amount off light received, will be provided for all participants. Participants will be randomized into the following groups:

Group 1: Daylight (outdoor daylight exposed stay for minimum 30 minutes per day before 1 pm). To motivate patients to go outside they will receive psychoeducation on the connection between exposure to morning daylight and a possible antidepressant effect, and they are introduced to potential options for outdoor activities. A detailed instruction to the personal light tracker and the matching app, for monitoring the amount of light received throughout the day, is provided.

Group 2: Control group receiving treatment as usual. Patients will wear a personal light tracker but they are not introduced to the light-monitoring-app.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling criteria for an ICD-10 diagnosis of unipolar depression (F. 32.0, F.32.1, F.32.2, F32.3, F. 32.8. F.33.0, F.33.1, F.33.2, F. 33.3)
* Hamilton Depression Score (HAM-D17) ≥ 12
* In treatment with the same antidepressant medication 14 days prior to inclusion
* The participant must have access to a smart phone

Exclusion Criteria:

* Actual treatment with Electro Convulsive Therapy (ECT)
* Seasonal Affective Disorder (SAD)
* Known sleep disturbances (sleep-apnoea, narcolepsy, or "restless legs syndrome")
* On lithium, agomelatine, melatonin and/or mirtazapine
* Known eye disorders
* Current alcohol- or drug abuse
* Current user of Light therapy
Fresh Carts for Mom's to Improve Food Security and Glucose Management

This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery prescription with delivery through Instacart at the start of the study or after 12 weeks or frozen medically tailored meals delivered from Door Dash. Researchers will compare the grocery prescription program, MTM (medically tailored meals), relative to standard of care to see if the impact on these food as medicine programs can improve glucose control over 12-weeks as compared to standard of care.

Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who report food insecurity using the Hunger Vital Signs Screener will be recruited to participate in a comparative study across two urban communities. One arm will receive a grocery prescription program from Instacart Health to be spent on eligible healthy food items based on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered to their door each week. The meals are based on diabetes guidelines and are culturally appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville, Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be recruited initially from a registered nurse who works at the clinic sites. The study team will then enroll participants after eligibility screening and conduct further onboarding into the food as medicine package based on locations.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of gestational diabetes or type 2 diabetes
* answer affirmative to one of two questions on the Hunger Vital Signs
* viable pregnancy
* lives in a service area of Instacart delivery
* has a phone or computer which allows ordering food for delivery

Exclusion Criteria:

* Does not speak English
* Does not have a phone, tablet, or computer to order groceries for Instacart
* Plans to move within the next 3 months
Project Health: Enhancing Effectiveness of an Obesity Prevention Program

This 2-site effectiveness trial will test whether a brief dissonance-based obesity prevention program delivered in single sex groups combined with food response and attention training will produce significantly larger weight gain prevention effects than an educational video control condition. An effectiveness trial is important to test whether this program reduces risk for unhealthy weight gain when delivered by real world clinicians under ecologically valid conditions, which is an important step toward broad implementation. A secondary aim focuses on eating disorder symptom prevention effects. A sample of 17-20 year olds with weight concerns (N = 120) will be randomized to single sex Project Health groups with food response and attention training or an educational video control condition. Participants will complete assessments at baseline, posttest, and 6- and 12-month follow ups.

In the previous Project Health trial, the investigators found Project Health is most effective when implemented in single sex groups paired with food specific response and attention training. This project will evaluate the effectiveness of this version of the Project Health intervention compared to a video control condition and is an important step toward dissemination. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality. The program may also have an important secondary benefit of preventing the onset of future eating symptoms and disorders. The study has 2 aims: (1) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger weight gain and overweight/obesity onset prevention effects than an educational video control condition (primary outcome). (2) Test the hypothesis that Project Health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger eating disorder symptom prevention effects than an educational video control condition (secondary outcome).

Eligibility Criteria:
Inclusion Criteria:

* Current at least moderate weight concerns (defined as a response of 4 or above on an 8 point scale ranging from none (0) to extreme (8))
* Self-reported room for improvement in diet and exercise habits (response of yes to "Do you believe there is room for improvement in your diet and exercise habits?" in the pre-screening questionnaire)
* BMI greater than or equal to 20 and less than or equal to 30
* Age between 17 and 20 years old

Exclusion Criteria:

* Current diagnosis of anorexia nervosa, bulimia nervosa or binge eating disorder
* Previous participation in a Project Health study