cyrilzakka/clinical-trials huggingface dataset:
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup

The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.

The PURPOSE of this study is to demonstrate the performance and reliability of the Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. The primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. The secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed

Eligibility Criteria:
Inclusion Criteria:

* men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011,
* capable of attending the 2-year follow-up visit;
* capable of understanding the information about the study and agreeing to take part in it.

Exclusion Criteria:

* patients with tumoral pathology.
Short-Term Effects of Dynamic Taping in Patients With Lumbar Disc Herniation

Previous evidence has shown that kinesio tape application reduces pain levels and improves disability in patients with chronic low back pain due to lumbar disc herniation. However, it is not known, whether the dynamic taping can decrease back pain, improve endurance of paraspinal muscles, and improve functional capacity in patients with lumbar disk herniation. The aim of the current study is to examine the acute effects of dynamic taping on pain, pain threshold, endurance, balance, lumbar joint mobility and functionality in patients with lumbar disc herniation.

The study will include 34 volunteer adult patients who have been diagnosed with lumbar disc herniation according to the physical examination and magnetic resonance imaging and have referred to the physiotherapy and rehabilitation service by a specialist physician. The patients will be divided into 2 groups as dynamic tape (n=17) and sham tape (n=17). Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.

The outcomes of the study will be analyzed by appropriate statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnose of lumbar disc herniation,
* self-reported activity pain due to lumbar disc herniation for at least the last 3 months,
* with pain severity equal to or greater than 3 on a numerical rating scale,
* patients with no skin irritation, sensitivities or allergies

Exclusion Criteria:

* Patients with spinal pathology, lumbar surgery, motor weakness, urinary or fecal incontinence due to lumbar disc herniation, cauda equina syndrome, pregnancy, neurological or rheumatological condition, dermatitis or pre-existing skin lesion over the taping area, and having dynamic taping allergies
AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood

The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the "core questions", i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.


Eligibility Criteria:
Inclusion Criteria:

* Aforementioned sex and age criteria.

Exclusion Criteria:

* Respiratory infections in the previous 3 weeks;
* Immunological or metabolic systemic disease;
* Major malformations of the upper airways;
* Active smoker.
Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy

The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy.

Uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Despite the fact that laparoscopic myomectomy is becoming increasingly popular, laparoscopic myomectomy remains underutilized because of inherit limitations. The limitations include technical challenges such as dissection of the myoma from its bed using the correct plane or multilayer closure of the myoma bed and the concern about the strength of the suturing and the subsequent risk of uterine rupture. As a result, laparoscopic myomectomy is currently performed only by expert surgeons.

Hand-assisted laparoscopic surgery (HALS) is a unique surgical approach that may overcome the limitations of pure laparoscopic surgery. HALS is not only less invasive than open surgery but also causes less technical challenges than laparoscopic surgery based on its manual nature and ability to use retractors. In gynecologic field, HALS has also been employed in ovarian cancers and large ovarian tumors.

In theory, HALS seems appropriate procedure, similar to the open approach, for patients with multiple or huge myomas. To date, no report has evaluated the feasibility and usefulness of HALS compared with open surgery (OS).

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were as follows: women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility; women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks); and women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

Exclusion criteria included any other uterine or adnexal abnormalities (e.g., abnormal endometrial thickness, and suspected ovarian or uterine malignancy), any sign of genital infection, presence of submucosal or pedunculated myoma as a dominant myoma, treatment of gonadotropin-releasing hormone (GnRH) agonist 2 months before surgery, or an inability to understand and provide written informed consent.
Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis

Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age over 18 and under 60
* Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face
* Patients with consent to surgery
* Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination

Exclusion Criteria:

* History of previous maxillomandibular fracture
* Treatment with anticoagulant drugs
* Treatment with intravenous bisphosphonates
* Treatment with anticonvulsants
* Patient's inability to maintain home hygiene standards in accordance with the study requirements
* History of drug and/or alcohol abuse
* Chronic corticosteroid therapy
* Radiotherapy, chemotherapy and/or immunosuppressive treatment or radiotherapy in the last 5 years
* Psychosis
* Pregnant or breastfeeding
* Poor compliance
* Endocrinological disorders in poor pharmacological control
* Other uncontrolled systemic conditions that preclude performing surgical procedures
Inflammation in Type 2 Myocardial Infarction

Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in patients with critical illness and strongly associated with mortality, the pathophysiology remains poorly understood. Inflammation is central to the development of atherosclerosis, plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and myocardial necrosis has not been defined. The investigators aim to to delineate the mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical medical illness.


Eligibility Criteria:
Inclusion Criteria:

* ≥21 years of age
* admitted to the Medical Intensive or Coronary Care Units
* sepsis or respiratory failure
* clinically indicated troponin measurement within 24 hours of ICU admission

Exclusion Criteria:

* unstable angina or Type 1 MI
* percutaneous or surgical coronary revascularization within 7 days
* heart failure exacerbation
* primary valvular disorder
* aortic dissection
* infiltrative heart disease or hypertrophic cardiomyopathy
* myocarditis
* pulmonary embolism
* electrocardiogram with \>1mm ST segment elevation in two consecutive leads
* serum cardiac troponin \>99th percentile URL but no clear rise or fall pattern
* history of chronic inflammatory disease
* use of therapeutic-dose anticoagulants / antiplatelet agents other than aspirin
* pregnant or incarcerated
* enrolled in a competing study
Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin

The study aims to explore the potential of combination therapy with fractional radiofrequency and topical tretinoin for treatment and overall improvement of striae albae. We also aim to assess subject satisfaction, local skin responses and adverse effects/reactions in relation to the treatments, alone and in combination.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written informed consent
2. Subject is 18 years of age or older
3. Fitzpatrick skin type I-III
4. Striae albae (grade II-IV) ≥1 year of age and ≥ 4 lesions with a length of ≥ 2 cm each
5. Women of childbearing potential are not pregnant (confirmed by a negative u-HCG prior to study treatments) and use a safe contraceptive method prior to treatments.

Exclusion Criteria:

1. Severe concurrent conditions such as cardiac disorders or poorly regulated diabetes
2. History of skin disorders such as keloids, abnormal wound healing or very fragile skin
3. History of heat-stimulated disease such as herpes simplex in the treatment area
4. History of bleeding coagulopathies or use of anti-coagulants
5. Surgery in the treatment area past 6 months or before complete healing
6. Tattoo or permanent make-up in treatment area
7. Excessively tanned skin from sun, tanning bed or tanning creams last 2 weeks
8. Dermabrasion, resurfacing, soft tissue/fat injections or chemical peeling in treatment area the past 3 months
9. Abnormal skin (e.g. rash, infection, dermatitis) at the treatment area at the time of inclusion
10. Treatment with Isotretinoin within the past 6 months
11. Use of non-steroidal anti-inflammatory drugs 1 week prior to treatment
12. Known allergies to tretinoin or lidocaine/prilocaine
13. History of cancer including pre-malignant moles
14. Impaired immune system due to immunosuppressive disease or medication
15. Electronic device implant
16. Any implantable metal piece or permanent chemical substance in treatment area
17. If female; lactating, pregnant or planning on becoming pregnant during the study
18. Non-eligibility at the discretion of the investigator
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia

The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.


Eligibility Criteria:
Main Inclusion Criteria:

1. 18 years or older
2. Clinical diagnosis of XLH
3. TmP/GFR \< 2.0 mg/dL
4. GFR ≥60 mL/min
5. Corrected Ca \<10.8 mg/dL
6. A willingness to utilize adequate contraception and not become pregnant\[or to have their partner(s) become pregnant\] during the study
7. Additional inclusion criteria apply

Main Exclusion Criteria:

1. Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of Screening
2. History of known immunodeficiency
3. Pregnant or lactating females subjects or female planning to be become pregnant during the study
4. Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of Screening, and/or during the study
5. Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or dosing
6. Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days prior to Screening and/or dosing
7. Condition which could present a concern for either the subject's safety or difficulty with data interpretation
8. Additional exclusion criteria apply
Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma

This is an open-label, single-center Phase 1/2 study with a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).


Eligibility Criteria:
Inclusion Criteria:

Have a primary diagnosis of B cell non-Hodgkin lymphoma

- Histologically confirmed: Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B Cell Lymphoma (PMBCL), Transformation Follicular Lymphoma (TFL), High grade B-cell Lymphoma (HGBCL), Mantle cell Lymphoma (MANT), Burkitt Lymphoma (BURK), Lymphoblastic Lymphoma

* Chemotherapy-refractory disease, defined as one of more of the following No response to last line of therapy OR Refractory post-autologous stem cell transplant (ASCT)
* Individuals must have received adequate prior therapy including at a minimum:

anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and an anthracycline containing chemotherapy regimen for individual with transformed FL must have chemorefractory disease after transformation to DLBCL.

* No active infection of HIV, HTLV and Syphilis
* Adequate renal function
* Adequate hepatic function
* Adequate cardiac function
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* Received allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
* Body weight less than 30 kg
* Pregnant or lactating women.
* Uncontrolled active infection.
* History of hepatitis B or hepatitis C infection.
* Previously treatment with any gene therapy products or cell therapy product in past 28 days.
* HIV infection.
* Lymphoma with central nervous system (CNS) involvement
* Have autoimmune disorders
* Have active infection or inflammatory disorders
* Prescreening test results in expansion rate less than 5 folds
* An allergy to gentamycin and/or streptomycin
REMdesivir-HU Clinical Study and Severe Covid-19 Patients

This is a Phase 3, open-label, multi-center, interventional safety study of REM therapy in participants 12 years of age or older with COVID-19, pneumonia and oxygen supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 12yrs and older with body weight at least 40kg
* Hospitalized with COVID-19 confirmed by PCR and/or COVID-19 typical symptoms with pneumonia:

  ▪ In case of no confirmed PCR test result available at screening, typical symptoms can also apply
* requiring supplemental oxygen at screening

  ▪ at the discretion of the investigator, any form of O2 support can apply
* Do not have access to Veklury treatment

  ▪ Patient may be under other treatment against COVID-19 (except for chloroquine/hydroxychloroquine)
* Willing and able to provide valid written informed consent prior to performing study procedures (for those \<18yrs of age, parental consent and patient assent is required). For an unconscious or comatose patient written informed consent given by next of kin or a legal representative is also accepted. If none of the above consents are available the investigator can enroll the patient as described in 21 CFR 50.24 (involving emergency research).

Exclusion Criteria:

Known liver disease, hepatic impairment and/or Alanine Transaminase (ALT) or Aspartate Transaminase (AST) ≥ 5 times the upper limit of normal

* Known severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (eGFR) \< 30 ml/min.
* Pregnancy or breast feeding at the discretion of the investigator
* Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours
* Know allergy to any anti-viral medication
* Hypersensitivity to the active substance(s) or to any of the excipients
* Current (or 48 hours prior) treatment with chloroquine/hydroxychloroquine Other investigationsl treatment up to 2x the "emptying" time of treatment, or if this is not known for 60 days, except in the case of a favipiravir study. In case of the clinical trial of favipiravir the petinents can be enrolled in the study if afterthe end of study / early termination visit.
* Any medical condition that the examining physician deems unsuitable for the patient to participate in the study.
Post-chemotherapy Symptom Management SMART

Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms.

High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N=282) or 12-week SMSH Telephone Interpersonal Counseling (TIPC, N=93) added during weeks 1-8. After 4 weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N=30) or add TIPC (N=31).

Nearly 15.5 million Americans have survived cancer and virtually all have experienced symptoms from cancer treatment. Numerous symptom management interventions have been tested during active treatment, yet few have addressed the continuing fatigue, pain, depression, etc. that endure following the end of treatment.

Existing post-treatment symptom management research has targeted survivors months after the end of active treatment, overlooking the immediate post-treatment period. During this period, some survivors have their symptoms resolve naturally (low need for intervention), while others suffer from high symptom burden (high need for intervention), with 30% experiencing depression. Sample: Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years.

Design: The SMART design incorporates two interventions with proven efficacy and addresses heterogeneity of survivors' responses by following the clinical logic of starting with one intervention, assessing its success, and continuing it when effective. High need survivors will be initially randomized to receive 1) weekly symptom assessment with referral for elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a more intensive intervention adding Telephone Interpersonal Counselling (TIPC) to the SMSH. After 4 weeks, non-responders to SMSH alone on depression were re-randomized to continue SMSH for 8 more weeks to allow for symptom resolution, or TIPC added for the remaining 8 weeks.

The primary outcome was symptom severity index, secondary outcome was depressive symptoms. The hypotheses tests included comparisons of primary and secondary outcomes according tp first randomization and second randomization for non-responders.

Eligibility Criteria:
Inclusion Criteria:

* Survivors must have a new diagnosis or localized recurrence of solid tumor cancer
* Be finishing curative intent adjuvant chemotherapy or chemoradiation, and do not have any subsequent cancer treatments planned, except for radiation therapy, hormonal therapy or trastuzumab for breast cancer.
* 18 years of age or older
* Have access to a telephone
* Understand English or Spanish
* Are not currently receiving counseling and/or psychotherapy

Exclusion Criteria:

* Diagnosis of a psychotic disorder in medical record verified by the recruiter
* Nursing home resident
* Bedridden
* Currently receiving counseling and/or psychotherapy.
Impact of Active Heating on Maternal and Neonatal Well-being

This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being

This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being.

The study was conducted in a university hospital with a total of 105 women who gave birth by cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35 intervention 2 (both underbody heater and heated IV fluid group) and 35 control group. The research data were collected with the Individual Information Form, Patient Follow-up Form and Visual Analog Scale. APGAR score, body temperature, cortisol and glucose levels were evaluated in the infant and body temperature, intraoperative bleeding, shivering, postoperative pain, gas and urination were evaluated in the mother between the three groups.

Descriptive statistics, Chi-square, Shapiro Wilks, Friedman, Wilxocon, Kuruskal Wallis and Mann Whitney U test were used in the evaluation of the data and significance level p\<0.05 was accepted.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section with spinal anesthesia,
* 37 weeks of gestation and above,
* with ASA I and ASA II scores,
* Pregnant women with a healthy fetus,
* The preoperative fasting period is between 2 to 12 hours,
* Pregnant women who were normothermic (36 to 37.5°C) preoperatively

Exclusion Criteria:

* Those requiring emergency delivery or with comorbidities
* Multiple pregnancies,
* Anemic pregnant women with a hemoglobin value below 11 g/dl according to the World Health Organization (2001),
* Central body temperature above 37.5°C and below 36°C on the morning of surgery
* Pregnant women with a history of malnutrition, thyroid function and other endocrine disorders, Parkinson's disease, peripheral circulatory disorders, diabetes mellitus, heart disease and stroke,
* Pregnant women with chronic bowel problems and urinary system problems were not included in the study.