cyrilzakka/clinical-trials huggingface dataset:
Oral Health and Severe COPD

This case-control study aims to investigate the association of severe COPD with oral health.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 40 years and ≤ 85 years;
* Test group: patients with COPD GOLD 3 and 4 with available pulmonary function test values (FEV1, FVC) within the last two weeks;
* Control group: patients without diagnosed or self-suspected pulmonary disease matched for age, sex, smoking and number of systemic diseases to the test group;
* Understanding of measures performed in the study;
* Written informed consent.

Exclusion Criteria:

- Pregnancy.
The Genetic Basis of the Influence of Dairy Product Intake on Body Measures in Children

The objective of this study is to explore the genetic basis of the influence of dairy product intake on body measures in children. The investigators assume that the effect of dairy products intake on children body measures is affected by genetic polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Sick children
* Chronic diseases
Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL

This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).


Eligibility Criteria:
Key Inclusion Criteria:

1. Aged ≥18,≤80 years, both male and female.
2. Pathologically confirmed DLBCL
3. No prior treatment for DLBCL.
4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
6. Expected survival ≥3 months.
7. International Prognostic Index (IPI) ≤ 2
8. Sufficient bone marrow, liver, and kidney function.

Key Exclusion Criteria:

1. Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others.
2. Transformed DLBCL.
3. Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
4. The patients had previously received antitumor therapy.
5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
6. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
7. Mentally ill persons or persons unable to obtain informed consent.
8. The investigators think that the patient is not suitable for the study.
A New Treatment Option for Mastalgia

The main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus.

The main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus. This randomized controlled clinical trial was completed with 20 women suffering from mastalgia. Patients were randomly assigned to the TENS treatment and sham application groups. Pain intensity, pain patterns and quality of life were evaluated with Breast Pain and SF-36 questionnaires before and 10 days after treatment in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mastalgia between 18 and 70 yrs old

Exclusion Criteria:

* Previous or new diagnosis of diseases that may cause extramammary mastalgia (history of previous breast surgery; inflammatory and/or tumoral breast or chest disorders such as mastitis, fibrocystic breasts, breast cancer or chest malignancies etc.)
* Having with conditions that might prevent TENS application (pacemaker, metal prosthesis, epilepsy, etc.)
* Being unable or insufficient to fill the questionnaires.
Prevention of Retained Items iN Childbirth Environment and Surgical Sites

To evaluate the user confidence in the confirmation of correct counts using a novel device and to assess clinical usability of the device during surgery.

Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Retained surgical items have 70% re-interventions, reaching 80% morbidity and 35% mortality. (Birolini et al, 2016) 1

Swabs or sponges are like small towels that soak up blood and body fluids so that the surgeon can visualise the operating area effectively. Swabs are used in all areas of surgery which include operations on the tummy, chest, limbs. They are also used in the vagina during childbirth, to assess for tears and to minimise blood oozing from the vagina.

The common risk factors for this error are out of hours surgical or childbirth procedures, multiple handovers in the care of the patient, raised BMI (Body Mass Index) and unplanned change to the operative intervention. (Gawande et al, 2003)2 As the name suggests, a 'never event' should never happen. Unfortunately, incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice.

Never-events involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?

Patient safety is a well-known priority for the European commission, WHO and the NHS. Some of the National/International reports highlighting this problem:

* CQC-Opening the door to change (2018)
* US Joint Commission report: Preventing unintended retained foreign objects (2019)
* The Australian Commission on Safety and Quality in Health Care and The New Zealand Health Quality and Safety Commission (2015)
* Healthcare Safety Investigation Branch (HSIB,UK) investigation I2018/025 (2019)

Eligibility Criteria:
Inclusion Criteria:

1. Patients due to undergo surgery at the chosen NHS Trust.
2. Patients 18 years or older and consented to participation after an informed choice.

Exclusion Criteria:

1. Under 18 years of age
2. Emergency surgery
Safety and Efficacy of a Dietary Supplement in Females With Cellulite

To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.

The study will be conducted as a single centre, randomized, double-blind, controlled, parallel group study with healthy female volunteers, aged 18-45 years of age, with skin phototypes I to VI and a clinical diagnosis of cellulite on buttocks (at least score 6 at Cellulite Severity Scale (CSS)).

The study will take 24 weeks (6 months) per subject. There will be one previsit during the screening phase and 8 visits per subject during the treatment phase.

Safety and efficacy variables will be performed monthly.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* Age between 18 and 45 years at Day 01 of the study
* Body mass index (BMI) from 18.5 -24.9
* All Fitzpatrick skin types
* CSS score of at least 6
* Normal eating habits (no vegetarians or vegans)
* Written informed consent

Exclusion Criteria:

* Menopause and pre-menopause
* Smoking
* Pregnant women or women intending to become pregnant during study
* Lactation period
* Any kind of dermatological conditions
* Vegetarians or vegans
* Any kind of hepatitis, including any alteration in transaminases
* Use of illicit drugs
* Other surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (\>160/95 mm Hg at repeated measurements)
* Existence of scars and/or pigmentation in measurement areas (thighs and buttocks), which can influence study measurements
* Participation in any other clinical trial including blood sampling and/or administration or substances up to 30 days before Day 01 of this study
* Any prior aesthetic surgery (Liposuction, Subcision®), 3 months before the study, that may interfere with results
* Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study
* Participation in any other non-invasive clinical trial up to 30 days before Day 01 of this study, including blood sampling
* Recent blood or plasmapherese donation (less than 1 month prior to Day 01 of the study)
* Under medical treatment for a skin disease in the past and/or present with a therapy, which may influence the results of the study (systemic steroids or antibiotics, local steroids or topical immunomodulators during the last 3 months
* Use of sun beds or self-tanning products or sun exposure for one month before and during study
* Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
* Subjects intending to initiate any intensive sports
* Every other condition that the investigator might consider to involve a risk for the study subject.
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture

Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women 18 years and older
* Presenting to clinic with symptoms of UTI or cystitis
* Patients with Medicare and Medicaid insurance

Exclusion Criteria:

* Urinary diversion of any type
* Chronic indwelling urinary catheter
* Diagnosed UTI within the previous 21 days
* Antibiotic therapy within the previous 21 days
* Use of phenazopyridine within the previous 21 days
* Commercial insurance
* Non-English speaking
* Pregnant patients
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy

The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercises and stretching program in patients with chronic lateral epicondyle tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercises program realized of isolated form.

Experimental study randomized with double blind, whose purpose is to compare three protocols in those who apply different protocols of physical therapy to themselves in three groups of intervention with patients with chronic lateral epicondyle tendinopathy.

There take part in this study people of both sexes, with ages between 18 and 65 years, all of them present chronic lateral epicondyle tendinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Patients diagnosed of chronic lateral epicondyle tendinopathy with a minimum of 3 months of evolution.
* Pain when palpating the lateral epicondyle area.
* Positive test in at least 1 of the following 3 clinical tests: Cozen, Thomson or Mill's
* Have the capacity to perform all clinical tests, understand the study process, and obtain informed consent.

Exclusion Criteria:

* Previous history of direct trauma, fractures, joint instability, surgery or rheumatic alterations of the lateral epicondyle area.
* Full elbow extension limited.
* Alterations at cervical level such as: cervical radiculopathy (C4-C7), degenerative pathology in the cervical spine, exacerbated pain increase with neck movements or cervical compression.
* Symptoms compatible with entrapment of the posterior interosseous nerve.
* NSAID intake the week before the intervention;
* Have received treatment with infiltration in the last year;
* Have received physiotherapy treatment during the last month.
Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female subjects 65 years of age or older
* Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
* Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
* Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.

Exclusion Criteria:

* Subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis.
* Subjects with gross obesity, \>45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
* Subjects with active infections.
* Subjects with malignancy in the area of the involved hip joint.
* Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
* Subjects with a diagnosis of Fibromyalgia
* Female subjects who are pregnant or may be pregnant.
* Subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.
* Subjects who have a known sensitivity to device materials.
The Research About Acute Compartment Syndrome

Acute compartment syndrome (ACS) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. Threre is the controversy in diagnosing, treating ACS. It was found that there was no criterion about the ACS, and result unnecessary osteotomy. The presence of clinical assessment (5P) always means the necrosis of muscles and was the most serious or irreversible stage of ACS. Besides pressure methods, the threshold of pressure identifying ACS was also controversial.


Eligibility Criteria:
Inclusion Criteria:

* Fracture patients with Schatzker V and VI,
* Who were older than eighteen years.

Exclusion Criteria:

* The exclusion criteria were pathologic, extra-articular proximal tibial fracture,
* Patients who was eighteen years or younger.
* Patients treated with other implant,
* underwent conservative management were also excluded.
Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor


Eligibility Criteria:
Inclusion Criteria:

1. 12 ≤age≤70 years of age.
2. Hemophilia A or B patients.
3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
4. Establish proper venous access.
5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
6. Agree to use adequate contraception to avoid pregnancy.
7. Provide signed informed consent.

Exclusion Criteria:

1. Have any coagulation disorder other than hemophilia.
2. Plan to receive prophylactic treatment of coagulation factor during the trail.
3. Patients plan to receive Emicizumab during the trial.
4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
5. Have a history of arterial and/or venous thrombotic events.
6. Platelet \<100×109/L.
7. Hemoglobin\<90g/L.
8. Severe liver or kidney disease.
9. Severe bleeding event occurred within 4 weeks before the first administration.
10. Accepted major operation or blood transfusion within 4 weeks before the first administration.
11. Have a known allergy to STSP-0601.
12. Pregnant, lactating, or blood pregnancy test positive female subjects
13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
15. Patients not suitable for the trail according to the judgment of the investigators.
Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years

Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in adults. The erosive damage influences the functional prognosis in patients with RA. At present, there are no sufficiently sensitive and specific predictive markers of erosive damage.


Eligibility Criteria:
Inclusion Criteria:

* Patients consulting in the Department of Rheumatology at Amiens University Hospital
* Age ≥ 18
* RA meeting the 2010 ACR/EULAR criteria
* Less than 2 years of RA progression
* Effusion in at least 1 joint

Exclusion Criteria:

* Inability to give informed consent
* Ongoing pregnancy
* Previous treatment with an anti-osteoporosis medication
* Intra-articular corticoid or hyaluronic acid injection in the previous 6 months
* Coagulation disorders preventing arthrocentesis
* Incarceration or legal guardianship
Urinary Artificial Sphincter in Children

Retrospective monocentric study of the outcomes of patients with neurogenic bladder, who had a urinary artificial sphincter before the age of 18 years old.

Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient.

The management of patients with neurogenic bladder is complex. Several patients have been operated multiple times. Surgical procedures such as Mitrofanoff's, bladder neck surgery, bladder augmentation and urinary artificial sphincter, are common.

The investigators want to analyse the participants data, that led to indication of an urinary artificial sphincter, and its outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were younger than 18 years old when they had an urinary artificial sphincter

Exclusion Criteria:

* Patients who were 18 years old or older when they had an urinary artificial sphincter
First Clinical Live-Donor Uterus Transplantation Trial In Egypt

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) \[uterus absence (congenital and surgical), or an abnormality (anatomic and functional)\].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) \[uterus absence (congenital and surgical), or an abnormality (anatomic and functional)\].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

The study protocol includes live-donor UTx (mother, relative, friend) into women with AUFI. The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted after 8-12 months have passed from transplantation. Two official approvals must be obtained before starting recruitment process; from both (Higher Committee of Human Organ Transplantation of Egyptian Ministry of Health and Population, and Al-Azhar University Council).

Eligibility Criteria:
Inclusion Criteria:

* Less than 45 years old
* Good general health

Exclusion Criteria:

* Older than 45 years old
* Poor ovarian reserve
* Systematic or psychiatric disease
TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

The objective of this RCT is to compare the postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

Theoritically, the advantge of TAMIS surgery over traditional trans-abdominal IPAA surgery incudes shorter operation time due to simulatous surgery transanlly and transabdominally, reduced operative difficulty in narrow male pelvis, less retained rectal cuff and less "dog-ear" formation. However, its adgange has not been proven in prospecitve randomized trials. The aim of current study is to compare the short and long-term postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

* Clincially and pathologically proven ulcerative colitis
* Aged 18-75 years
* Patients who will undergo proctectomy and IPAA surgery, incuding the first stage of two-stage surgery, or the second stage of three-stage or modified two-stage surgery
* Elective surgery
* Informed constent obtained.

Exclusion Criteria:

* A contraindication for minimally invasive surgery or TAMIS surgery
* Ileus or peritonitis
* Previous surgery in rectum
* Pregnancy
* Carcinogenesis of rectum, dysplasia or stricture of ATZ, or planned mucosectomy
* Patients with planned permnant ileostomy