cyrilzakka/clinical-trials huggingface dataset:
Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility

Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is a common finding in male infertility. Often semen with a decreased sperm concentration may also show significant abnormalities in sperm morphology and motility that affect Male fertility. The purpose of this study is to assess the ability of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) cells to stimulate Sertoli and spermatogonia cells and affect male fertility.

This is an open-label study to evaluate efficiency of administration of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) in the testis in patients with oligospermia and azoospermia.

Forty men with several form oligozoospermia and azoospermia will be recruited for the study. 20 patients with same diagnosis served as a control with standard medications.Other patients -10 with oligospermia and 10 with azoospermia will receive standard medication and SVF injections.

The diagnosis of Azoospermia (Oligospermia) will be established on the basis of two and more semen analysis evaluations done at separate occasions and detailed history taking, physical examination and investigations (blood tests include hormon levels as testosteron. follicle stimulating hormone (FSH), luteinizing hormone (LH). karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated.

This study affect only Pretesticular and Testicular forms, without chromosomal aberration. SVF can produce a lot of cytokines ( as EGF, FGF, NGF, PDGF, VEGF, IGF, GMCSF, GCSF, TGF, Erythropoetin, TPO, BMP, HGF, GDF, Neurotrophins, MSF, SGF, GDF and growth factors) moreover the microvesicles and exosomes released by this cells can prevent cells from apoptosis and stimulate regenerative process of surrounding tissues and cells.

SVF will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after cell injection.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic oligozoospermia (spermatozoid number \<2x10\^6/mL) - 10 patients
* cryptozoospermia/azoospermia - 10 patients

Exclusion Criteria:

* age before 18 or after 60 years old
* heart insufficiency. stroke (during 1 year)
* anemia
* blood disease
* pelvis bone trauma
* chronic diseases in decompensation stage
* skin diseases
* tuberculosis
* hyperprolactinaemia
* hyper or hypothyreosis
* obstructive zoospermia
* sperm stimulating hormone therapy
* Men with previous surgery in testis
* Men with infectious genital diseases and anatomical abnormalities of the genital tract
* Those with major medical problems such as malignancy, hepatitis B . C, etc. HIV
* Chromosomal aberration (e.g. Y microdeletion, trisomy....)
A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques

The goal of this study is to look into the patterns of sensitization to figure out how allergic contact dermatitis (ACD), individual susceptibility, and patient characteristics are connected. The joint application of classic statistics and machine learning methods will reveal the relationship between contact dermatitis expressions and several clinical characteristics.


Eligibility Criteria:
Inclusion Criteria:

-

Eligible patients were adults diagnosed with dermatitis who had a positive patch test result on the chemical panel of Baseline Series of Allergens.

Exclusion Criteria:

-

Although there is no consensus for the definitive exclusion criteria from a patch testing, most studies agree that the chronic use of anti-inflammatory treatments, corticosteroids, and cyclosporine, high UV exposure and other chronic dermatoses are factors that might produce false- positive or false- negative results and thus should be avoided.
Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

Obesity has been associated with menstrual irregularities, chronic an-ovulation, infertility, and poor outcomes in women undergoing in vitro fertilization.

There is strong evidence that obesity is associated with a higher n vitro fertilization cycle cancellation rate (despite administration of higher doses of exogenous gonadotrophins), a lower mature oocyte yield and lower number of cryopreservation cycles.

Furthermore, obese women have been shown to have impaired response to ovarian stimulation and significantly lower live births after in vitro fertilization. Indeed, obesity affects many ovarian intra-follicular steroidogenic, metabolic and inflammatory pathways.This is particularly evident in women with abdominal (central obesity). Waist circumference measurement is used to identify individuals with abdominal obesity but it cannot differentiate between intra-abdominal fat and subcutaneous abdominal fat accumulation.

The reliable measurement of visceral fat and subcutaneous fat is not only important as a tool to predict cardiovascular and metabolic disease risk, but it is also essential to evaluate the effect of these fat compartments on female reproductive function. Intra-abdominal fat accumulation is related to insulin resistance in women with polycystic ovary syndrome and in these women the resulting hyperinsulinemia contributes to an-ovulation.

Obese anovulatory women with polycystic ovary syndrome who resume ovulation during a 6-month lifestyle program lose more visceral fat with no difference in the change of subcutaneous fat compared to the women who did not resume ovulation.

Another recent study that enrolled 140 non-polycystic ovary syndrome in vitro fertilization women demonstrated that women with increased waist circumference and higher follicular fluid leptin have less oocytes fertilized and failed in vitro fertilization outcomes. Increased intra-abdominal fat during early pregnancy is associated with insulin resistance and increased diastolic blood pressure and it can predict glucose intolerance in later pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age of women 18 - 35 yrs old.
* Women with Body mass index I 18 - 35 kg/m2.
* Infertile women with an indication for In vitro fertilization
* Anticipated normal responders.
* Normal uterine cavity by trans-vaginal ultrasound.

Exclusion Criteria:

* Poly cystic ovarian syndrome
* Diabetic patients.
* Known Poor ovarian response
* Patients with abnormal uterine cavity.
* Refusal to participate in the study.
Plasma Exchange for Renal Vasculitis

The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.

Primary systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (ANCA), is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure at presentation often progresses to end stage renal disease despite immunosuppressive therapy. We investigated whether the addition of plasma exchange was more effective than intravenous (IV) methyl prednisolone in the achievement of renal recovery for ANCA associated systemic vasculitis presenting with a serum creatinine above 500umol/l (5.8mg/dl).

137 patients with a new diagnosis of ANCA associated systemic vasculitis, serum creatinine above 500umol/l (5.8mg/dl) and a renal biopsy demonstrating a focal, necrotizing glomerulonephritis were randomized to receive seven plasma exchanges or IV methyl prednisolone 1000mg/day for three days. Both groups were treated with cyclophosphamide and oral prednisolone. The primary end-point was dialysis independence with a serum creatinine below 500umol/l (5.8mg/dl) at three months. Secondary end-points included renal and patient survival at 12 months and severe adverse event rates.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Wegener's granulomatosis or microscopic polyangiitis, using criteria adapted by EUVAS from the disease definitions of the Chapel Hill consensus conference
* Biopsy proven, pauci-immune, necrotising and/or crescentic glomerulonephritis, in the absence of other defined glomerulopathy
* Severe renal impairment defined by: (i) oliguria (\<400ml/24hr), or (ii) intention to commence dialysis within 48 hours of admission, and (iii) creatinine \>500umol/l (5.8mg/dl).

Exclusion Criteria:

* Age under 18 or over 80 years
* Inadequate contraception in women of child-bearing age
* Pregnancy
* Previous malignancy
* Hepatitis B antigenaemia, anti-hepatitis C virus or anti-human immunodeficiency virus antibody
* Diagnosis of Churg-Strauss syndrome, Henoch-Schönlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia or systemic lupus erythematosus
* Circulating anti-GBM antibodies or linear IgG staining of the GBM on renal biopsy
* Life-threatening non-renal manifestations of vasculitis, including alveolar hemorrhage requiring mechanical ventilation within 24 hours of admission
* On dialysis for \> two weeks prior to entry
* Creatinine \> 200umol/l (2.3mg/dl) one year or more before entry
* A second clearly defined cause of renal failure
* Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis
* \> two weeks treatment with cyclophosphamide or azathioprine
* \> 500mg IV methyl prednisolone
* Plasma exchange within the preceding year
* \> three months treatment with oral prednisolone
* Allergy to study medications.
Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort

This study aims to evaluate the diagnosis performance of several item used for the classification, the diagnosis and the prognostic of pSS (primary Sjogren syndrome)


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected pSS underwent a standardised evaluation

Exclusion Criteria:

* Opposition of patient
Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units

The aim of this study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome of hospitalized newborn in intensive care units

Hospitalized newborn in intensive care units can receive opioids to manage pain or sedation. Neonatal opioid abstinence syndrome can occur when newborn receive opioid treatment for a long time.

Many scoring systems, like Lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. The majority of items in these scores are motor skills items.

Actigraphy allows to measure objectively the newborn motricity. This study will analyse the correlation between actigraphy and Lipsitz scoring system.

Eligibility Criteria:
Inclusion Criteria:

* Newborn \> 22 gestation weeks
* Hospitalization in neonatal intensive care unit at CHU de Caen.
* Opioids treatment \> 48 hours.

Exclusion Criteria :

* ante or post-natal brain injury diagnosis
* upper arm motor deficit
* palliative care
Influence of Preoperative Enema Application on Return of Gastrointestinal Function After Elective Cesarean Section: A Randomized Controlled Study

The researchers investigate that use of preoperative enema to the effect postoperative bowel gas passage.


Eligibility Criteria:
Inclusion Criteria:

1. elective cesarean
2. no history of previous abdominal operation(except cs)

Exclusion Criteria:

1. Emergency cesarean delivery
2. Refusal to participate.
Evaluation of the Effectiveness of a Web-based Treatment Program for Depression for the Reduction of Depressive Symptoms

200 persons with depression are recruited via internet depression forums devoted to depression and are randomly assigned either to the online program deprexis or to a wait-list control condition. All participants receive free-of-charge online access to deprexis either immediately or with an eight week delay.

Prior to intervention and eight weeks later, both groups are assessed via an anonymous online survey which was implemented using the software package OPST®. The survey consists of different questionnaires. The Beck Depression Inventory (BDI) represents the primary outcome. It is assumed that the severity of depressive symptoms will improve to a significantly greater extent in the deprexis than in the wait-list control condition in the course of eight weeks.

Deprexis is a web-based intervention that can be obtained online (www.deprexis.com). Deprexis encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented) or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and emotion-focus interventions. The ten modules are framed by one introductory and one summary module. Communication is carried out online via simulated dialogues. Patients have to respond to narrative text messages from the virtual therapists in multiple-choice response fashion, enabling them to express doubt, to affirm a particular message or to request more information. Text messages are aided with drawings, photographs and animations. The program is adaptive and selects exercises and contents on the basis of the subject's response. The modules are sequential and each module refers and builds upon previous one. Modules can (and should be) repeated within the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* registration in a moderated online forum exclusively for affective disorders
* (externally) confirmed diagnosis of a unipolar depression
* informed consent (provided online in line with regulations by the Hamburg Department of Data Security)

Exclusion Criteria:

* unable to provide informed consent
* diagnosis of bipolar or schizophrenia spectrum disorders
* substantial neurological impairment (e.g. dementia)
* acute suicidal tendencies as assessed with the Suicide Behaviors Questionnaire-Revised (SBQ-R). Subjects excluded for this reason are provided various emergency contacts and phone numbers.
POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.

Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years.

Stratification: Institution, Age (\<50, ≥50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no).

Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).

Sample Size: 1900 participants

Follow-up: Participants will be followed up for 5 years.

Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
* At sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit \>2.0mm in largest dimension or defined as macrometastasis on molecular assay)
* Fit for axillary treatment and adjuvant therapy
* Have given written informed consent

Exclusion Criteria:

* bilateral invasive breast cancer
* more than 2 nodes with macrometastases
* neoadjuvant therapy for breast cancer except:

  * if sentinel node biopsy performed prior to neoadjuvant chemotherapy in women with early breast cancer
  * short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months)
* previous axillary surgery on the same body side as the scheduled sentinel node biopsy
* not receiving adjuvant systemic therapy
* previous cancer less than 5 years previously or concomitant malignancy except:

  * basal or squamous cell carcinoma of the skin
  * in situ carcinoma of the cervix
  * in situ melanoma
  * contra- or ipsilateral in situ breast cancer
Validation of the Spanish Version of the Neck Disability Index

The primary purpose of this study is to adapt the Neck Disability Index (NDI)and the Cervical Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the correlation between intensity of cervical pain, degree of disability, and quality of life; to determine the correlation between the NDI, CCS6 and the Northwick Park Neck Pain Questionnaire; and to determine factors that predict the chronification of disability.


Eligibility Criteria:
Inclusion Criteria:

* patients who visit physician for cervicalgia
* with or without referred pain
* must be able to read and write

Exclusion Criteria:

* disease of central nervous system, with or without treatment
* migraine
* indications for surgery
* suspicion of systemic disease
Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

Endologix Infrarenal Bifurcated Stent Graft Study


Eligibility Criteria:
Inclusion Criteria:

* All surviving patients from the original study cohort who received the Powerlink device
* All surviving patients from the original study cohort who were assigned to the open surgical control arm
Characteristics of Patients With Type 2 Diabetes Mellitus (CVD-RNDR)

This observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes Registry data.


Eligibility Criteria:
Inclusion criteria are:

* New user receiving or dispensed prescription of SGLT-2 inhibitor medication or other GLD treatments oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups;
* T2DM diagnosis on or prior to the index year;
* ≥ 18 years old at index year.

Exclusion criteria are:

* Patients with a T1DM diagnosis on or prior to index year and only insulin use in the year prior to index;
* Patients with a gestational diabetes in the index year or 1 year prior to index.
Epidural Oxycodone for Pain Management for Lower Limb Amputation

The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation.

Phantom limb pain (PLP) is often described as tingling, throbbing, sharp, pins/needles in the limb that is no longer there. It occurs more commonly in upper extremity amputations than lower extremities and tends to be intermittent in frequency. Pain severity varies, and onset can be immediate or years afterward.

The preventive strategies for the PLP pain are difficult to manage and if not addressed adequately may lead to chronic pain. The perioperative role of the anesthesiologist and the acute pain physician is important in the management of somatic and sometimes neuropathic postoperative pain.

Oxycodone is a semi-synthetic narcotic analgesic and historically has been a popular drug of abuse among the narcotic abusing population. Oxycodone is used orally or intravenously.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status II or III.
* Undergoing lower limb amputation.
* Under epidural anesthesia.

Exclusion Criteria:

* Hypersensitivity to opioids.
* Cardiac arrhythmias.
* Acute asthma or other obstructive airways disease.
* Severe renal impairment.
* Pregnancy.
Obstetric Anesthesia Experiences in COVID-19 Positive Patients

At the end of 2019, a new coronavirus named COVID-19 (SARS-CoV-2), one of the lower respiratory tract samples was detected in China. The World Health Organization (WHO) declared it a global epidemic on March 11, 2020, due to the emergence of COVID-19 cases in 113 countries other than China, where the first epidemic occurred, and the spread and severity of the virus. Pregnancy increases susceptibility to respiratory complications of viral diseases.

This study aimed to retrospectively evaluate the demographic data of COVID-19 patients undergoing cesarean section, our anesthesia practices, complications, and condition of neonates, and to summarize up-to-date information on COVID-19 in obstetric anesthesia.

Our study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information about anesthesia were analyzed retrospectively from the patient files.

All patients were operated in negative pressure operating theatres reserved for them. The whole team was equipped with Level 3 personal protective equipment (PPE) (liquid-proof apron, N-95 mask, goggles, visor, overshoes). Anesthesia was administered by 2 healthcare professionals from the anesthesia team, including an experienced anesthesiologist and an assistant anesthesia technician. A third person was kept ready outside to help in case of need.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent cesarean section
* Patients who had positive PCR nasopharyngeal swabs for COVID-19

Exclusion Criteria:

* Patients who tested negative and were clinically suspicious
Bone Toxicity Following Pelvic Radiotherapy

A randomised controlled clinical feasibility trial to determine the feasibility and acceptability of a "musculoskeletal health package (MHP)" intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and inform power calculations for a definitive trial.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* histologically confirmed uterine or cervix cancer
* patients undergoing potentially curative/adjuvant radiotherapy
* ability to give informed consent to participate

Exclusion Criteria:

* age less than 18 years or greater than 85 years
* patients with pre-existing bone conditions such as: osteoporosis treated with bisphosphonates in the previous 5 years/fibrous dysplasia/osteogenesis imperfecta or other metabolic bone condition
* inability to give informed consent to participate
* home address outside Greater Manchester
* contraindication or intolerance of Magnetic Resonance scanning