cyrilzakka/clinical-trials huggingface dataset:
Urinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective Study

M1- evaluates the cases of lower urinary tract injuries during caesarean section with or without hysterectomy in cases with morbid placental adherence in the period between years 2018 and 2021. This study was carried out in assiut university women health hospital M 2- Clarification of the risk factors and outcome of urinary tract injuries.

Placenta accreta spectrum disorder (PAS), also called abnormally invasive placenta (AIP), describes a clinical situation where the placenta does not detach spontaneously after delivery and cannot be forcibly removed without causing massive and potentially life-threatening bleeding(1-2) The incidence of PAS is rising worldwide(3) PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality.(4) PAS may occur after any kind of procedure that causes damage to the endometrium, including curettage, manual removal of the placenta, uterine-artery embolization, or myomectomy(5-6) a full thickness surgical scar is associated with both the absence of endometrial re-epithelialization and vascular remodelling around the scar area, and this may lead to abnormally invasive placentation (increta/percreta).(7) Ultrasound is the first-line imaging tool for the screening and diagnosis of PAS. However, it is now well-established that magnetic resonance imaging (MRI) has a role in the diagnosis of PAS, with high sensitivity and specificity(8-9) Urinary bladder injury is one of the operative morbidities of cesarean section. It occurs in 0.08% - 0.94% of cesarean sections(10) Repeated cesarean section and type of morbidly adherent placenta (MAP) are considered the major risk factors for urinary tract injuries during cesarean delivery(11) Urinary bladder injury complicates about 11.7% of cesarean sections in women with placenta accreta spectrum (PAS)(12) The presence of tough adhesions between the bladder and the lower uterine segment carries the risk of urinary bladder injury. Trial of separation of the bladder in such circumstances may result in bladder injury. Filling of the bladder will delineate the contour of the bladder and clarify the proper plane of dissection (13)

Eligibility Criteria:
Inclusion Criteria:

* All cases in the 3rd trimester admitted to Asyut university women health hospital and diagnosed antenatally as having morbidly adherent placenta

  * Confirmed diagnosis of MAP.
  * Peri partum hysterectomy for MAP.
  * Complicated CS without hysterectomy
  * Maternal age between 18 and 45 yrs
  * No other medical diseases

Exclusion Criteria:

* associated other uterine pathology
* Refusal of the patient
* Emergency CS before confirming MAP diagnosis.
* Urinary tract injuries due to other causes than MAP
* Presence of major medical disorders e.g. DM, PE, Cardiac lesion, Coagulopathy, liver diseases or kidney diseases
* Postpartum depression.
Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM

Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G).

Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) to be defined in 3 categories:

* elderly FIT (ADL 6; IADL 8; 0 score= 3-4, \< 5 score=2)
* elderly UNIFIT (ADL 5; IADL 6-7; 0 score= 3-4, 5-8 score=2; ≥ 80 fit)
* elderly FRAIL (ADL ≤ 4; IADL ≤ 5; 1 score= 3-4, \> 8 score=2; ≥ 80 unfit)

Eligibility Criteria:
Inclusion Criteria:

* Patient with Large B-cell Lymphoma
* Age ≥ 65 years
* informed Consent

Exclusion Criteria:

* Violation of inclusion criteria
* Abscence of data considered essential for the study
* Withdrawal of Consent
An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B

This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 and \</= 70 years of age
* HBeAg-negative chronic hepatitis B
* HBsAg-positive for at least 6 months, anti- hepatitis B (HBs) negative
* Serum alanine transaminase (ALT) \> 2 ULN (upper limit of normal) but \</= 10 x Upper limit of normal (ULN)
* Hepatitis B virus (HBV) DNA \> 10'000 copies/ml (Roche Monitor or Taqman)
* No previous treatment with interferon (standard or pegylated) or with a nucleoside analogue
* Women of childbearing potential must agree to use reliable contraception during the study and for 3 months after treatment completion

Exclusion Criteria:

* Previous antiviral interferon-based therapy for chronic hepatitis B
* Pregnant and lactating women
* Evidence of decompensated liver disease
* Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
* History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
* Previous or current hepatocellular carcinoma
* History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease
* Inadequate hematologic or renal function
* Serum bilirubin level \> 2 times the upper limit of normal
* Severe psychiatric disease
* History of severe seizure disorder or current anticonvulsant use
* History of evidence of any disease or condition which would make the patient, in the opinion of the investigator, unsuitable for the study
* Evidence of drug abuse within one year of study entry
* Alcohol intake of more than 3 standard drinks per day for men and 2 standard drinks per day for women (1 standard drink contains 10 g of alcohol)
* Participation in another trial or receipt of an investigational drug within 12 weeks prior to screening
Positive Minds Strong Bodies Implementation

This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes.

The Positive Minds-Strong Bodies Enhanced intervention addresses the dual challenges of mental health and physical disability among minority elders. The core Positive Minds intervention includes 10 sessions offered by Community Health Workers over a maximum of 6 months, designed to identify and correct negative distortions or cognitions, promote behavioral activation and encourage supportive relationships. Strong Bodies is a 36-session physical intervention consisting of a series of exercises conducted while wearing a weighted vest in a group setting over 6 months; both interventions include a group maintenance component to maintain gains. The investigators will evaluate the acceptability, effectiveness and twelve-month sustainability of the Enhanced Positive Minds-Strong Bodies intervention (E-PMSB) offered by Community Health Workers (CHWs) and Exercise Trainers in community-based organizations (CBOs) and community clinics. The intervention is offered in English, Spanish, Mandarin or Cantonese.

Eligibility Criteria:
Inclusion Criteria:

* Latino, Asian, Black, or non-Latino White adults 60+ years of age
* With mild, moderate or severe depressive or anxiety symptoms.
* Participants receiving medications for mental health will have this recorded and used as a covariate.
* Community-dwelling participants who have some mobility limitations but are not home-bound.

Exclusion Criteria:

* Any specialty mental health care (therapy sessions with psychiatrist, psychologist or social worker) in the past 3 months or scheduled in the coming month.
* Evidence that patient lacks capacity to consent or is cognitively impaired
* Current suicidal risk (score of 4 or 5 on Paykel suicide questionnaire), whereby participant will be connected to an emergency services or specialty provider per the study emergency protocol.
* Physically instability, acute or exacerbation of a chronic disease, or a neuro-musculoskeletal impairment
* Severe substance abuse
* Self-reported psychosis or schizophrenia
* Inability to commit to 2 sessions per week
Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.

Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.

Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.

However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.

In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.

The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.


Eligibility Criteria:
Inclusion Criteria:

* Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Exclusion Criteria:

* Delayed prosthetic reconstruction
Oral Administration of Polyethylene Glycol (PEG) for 6 Months in Chronically Constipated Autistic Children

Many autistic children suffer from chronic constipation. Gut mobilization was obtained administering polyethylene glycol (PEG) at the dose of 6.9 g/d once a day for 6 months in an open trial involving 21 chronically constipated autistic children 2-8 years old, followed prospectively for 6 months. Children diagnosed with Autism Spectrum Disorder by DSM-5 and confirmed by ADOS-2 criteria, were evaluated before (T0), 1 month (T1), and 6 months (T2) after intestinal mobilization, recording Bristol stool scale scores, urinary p-cresol concentrations, and behavioral scores for social interaction deficits, stereotypic behaviors, anxiety, and hyperactivity.

Chronic constipation is common among children with ASD and is associated with more severe anxiety, hyperactivity, irritability and repetitive behaviors. Young autistic children with chronic constipation display higher urinary and foecal concentrations of p-cresol, an aromatic compound produced by gut bacteria, known to negatively affect brain function. Acute p-cresol administration to BTBR mice enhances anxiety, hyperactivity and stereotypic behaviors, while blunting social interaction. This study was undertaken to prospectively assess the behavioral effects of gut mobilization in young autistic children with chronic constipation, and to verify their correlation with urinary p-cresol. To this aim, 21 chronically constipated autistic children 2-8 years old were evaluated before (T0), 1 month (T1), and 6 months (T2) after intestinal mobilization, recording Bristol stool scale scores, urinary p-cresol concentrations, and behavioral scores for social interaction deficits, stereotypic behaviors, anxiety, and hyperactivity. Gut mobilization was obtained administering PEG (6.9 g/d once a day) for 6 months. A progressive, statistically significant decrease in all behavioral symptoms was recorded over the six-month study period. Urinary p-cresol levels displayed variable trends, mainly increasing at T1 and decreasing at T2. These results support gut mobilization as a simple strategy to at least partly ameliorate ASD symptoms, as well as comorbid anxiety and hyperactivity, in chronically constipated children. These beneficial effects likely involve multiple mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling DSM-5 diagnostic criteria for Autism Spectrum Disorder
* Chronic constipation, namely unsatisfactory defecation characterized by difficult and infrequent passage of lumpy and hard stools during at least the previous 3 months, as reported by parents based on the Bristol Stool Scale

Exclusion Criteria:

* ASD constipated children already treated with laxatives
Study to Compare a Fast Gama Camera for Nuclear Imaging to Conventional Camera

A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is referred to nuclear medicine department for a SPECT scan.
2. Written informed consent is obtained by a study investigator.

Exclusion Criteria:

1. Patient pregnancy (known or suspected).
2. Lack of written informed consent
3. Prisoner status
4. Patient under age 18 or over 80 years old.
Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue

Post-COVID recovery is associated with reduced functional fitness/capacity, low quality of life, and physical disabilities in those who survived after contracting the disease. The unpleasant symptoms of chronic post-viral/post-COVID syndrome (chronic fatigue perception, variant nonspecific myalgia, bad mood or depression, and insomnia or sleep disturbances) usually magnify the symptoms of already existing previously diagnosed concurrent untreatable chronic disorders , including the idiopathic chronic fatigue (ICF).(Leszczak et al., 2024)

Baduanjin exercise training (BET) is one of the Chinese traditional Health-Qigong exercises that not only integrate slow coordinating postures/positions, breathing techniques, musculoskeletal stretching movements/positions, and meditative mind but also plays a strong role concerning health benefits (e.g. musculoskeletal pain-reducing, sleep disturbance-enhancing effects, and fatigue-reducing effects) (Zou et al., 2018).

forty idiopathic chronic fatigue (ICF) patients will be randomly assigned into two equal groups (n=20)

1. Study group (20 patients) this group will be supervised daily, except Fridays, during the 60-minute session of 12-week BET) or waitlist group
2. Control group (20 patients)

Eligibility Criteria:
Inclusion Criteria:

* • 40 patients will be recruited in the study.

  * age ≥ 18 to ≤ 50 years old
  * achieved three diagnostic items/criteria of ICF will be included in this BET trial: Fatigue lasting over 6 months, which significantly limits daily activities, reducing the person's usual activity level by more than 50%, as confirmed by a doctor.

At least three of the following symptoms:

Generalized muscle weakness Difficulty sleeping Frequent headaches A painful throat Muscle tenderness throughout the body Migratory joint pain Swollen lymph nodes in the neck or armpits Fatigue lasting more than a day after typical activities

Exclusion Criteria:

* Patients with a history of medical or complementary treatments for ICF disorder in the 6 months before contracting COVID or after recovery.
* Individuals who have engaged in therapeutic exercise, pharmacological treatments, or complementary therapies for post-COVID symptoms within the last six months prior to enrollment.
* ICF patients regularly using antidepressants or antipsychotics were excluded.
* Those who take sleeping pills regularly were also excluded.
* Patients with autoimmune diseases, malignant conditions, anemia, endocrine disorders, systemic diseases, or osteoarthritis affecting the cervical spine, lumbar region, or limbs were excluded.
* Individuals with abnormal results in laboratory tests, including neurological, neurophysiological, cardiological, liver/kidney function tests, or urine/stool analyses (as determined by a physician) were excluded.
Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury

The aim of the study is to investigate whether dexmedetomidine could suppress catecholamine release into peripheral blood to prevent PSH attacks and to achieve neuroprotection.

Paroxysmal sympathetic hyperactivity (PSH) is a syndrome typically recognized in patients suffering from traumatic brain injury, characterized by paroxysmal increases in sympathetic activity such as elevated heart rate, increased blood pressure and respiratory rate, high temperature, excessive sweating and abnormal motor (posturing) activity.

This prospective study will include patients with traumatic brain injury,who will be divided into two groups, evaluated by the Paroxysmal Sympathetic Hyperactivity-Assessment Measure (PSH-AM). Patients will also be evaluated with head CT.

The aim of the study is to investigate whether dexmedetomidine could suppress catecholamine release into peripheral blood to prevent PSH attacks and to achieve neuroprotection.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years
2. Moderate or severe traumatic brain injury
3. GCS≤12
4. Diagnosed by CT
5. No catecholamines (such as dopamine, adrenaline, norepinephrine) have been used before admission
6. Have a clear history of head trauma
7. Non-open traumatic brain injury

Exclusion Criteria:

1. Severe liver dysfunction (Child-Pugh B or C)
2. Severe renal dysfunction (serum creatinine \> 445 mmol / L or blood urea nitrogen \> 20 mmol / L)
3. Hemodynamic instability when entering the ICU (heart rate \<50 beats / min or hypotension, SBP \<90mmHg or MAP \<65mmHg)
4. Deaths within 72 hours after entering the ICU
5. Severe multiple injuries (ISS≥25 points)
6. Have central nervous system diseases (such as hypoxic ischemic encephalopathy, stroke, brain tumors, etc.)
7. Allergic to dexmedetomidine or midazolam
8. Observed with the results of disease interference test (such as pheochromocytoma, etc.)
9. In pregnancy or lactation
10. Receiving hypothermia treatment
11. Are participating in other drug research or clinical trials
the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to:

Group A Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered.

While patients randomized to group B will undergo TLH with pre-sacral nerve block.

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to: Group A Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered , then the uterus will be removed, and the operation will be terminated

While patients randomized to group B will undergo TLH with pre-sacral nerve block as follows:

Uterosacral nerve block will be performed before the removal of uterus and the closure of vaginal cuff, and before the removal of trocars from abdominal cavity, insertion of 6-inch 22G needle 2 to 3 cm below the umbilicus, injection of the SHP area which situated anterior to L5-S1 vertebral bodies, Caudal to the bifurcation of the abdominal aorta with 30 ml 0.25% bupivacaine (Marcaine®0.25% , Astra Zeneca, Egypt) will be administered. Following the injection of local anesthetic, patient will be placed from Trendelenburg position to horizontal position. The we will remove the uterus and trocars , and the operation will be terminated.

Data will be recorded in a case report form (CRF) and statistical analysis will be done.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing elective total laparoscopic hysterectomy Body mass index less than 29 Kg/m2

Exclusion Criteria:

* Previous presacral neurectomy
* Concurrent surgical procedure other than salpingectomy and/or oophorectomy
* Chronic narcotic consumption Inability to provide consent
* Patients with contraindication to laparoscopic surgery (e.g. severe cardiopulmonary dysfunction).
* Bleeding tendency (e.g. patient on anticoagulants, platelets disorders)
* Intra-abdominal adhesions (due to previous abdominal surgery e.g. myomectomy)
The Implementation of MinimAlly Invasive Hysterectomy Trial

Removal of the uterus (hysterectomy) is the most commonly performed major gynaecological procedure in women. Obstetricians and gynaecologist (O\&G) surgeons conduct the majority of hysterectomies. Surgical approaches to removal of the uterus include laparoscopic hysterectomy, vaginal hysterectomy with or without laparoscopic assistance and open hysterectomy through an abdominal incision. It is widely accepted that laparoscopic hysterectomy and vaginal hysterectomy are less invasive procedures, cause fewer surgical complications, less postoperative pain, require a shorter hospital stay and are associated with quicker recovery than abdominal hysterectomy. In Australia and despite the evidence, Total Abdominal Hysterectomy (TAH) rates are unreasonably high (\~40%) and only 13% of all hysterectomies are done via Total Laparoscopic Hysterectomy (TLH) in Australia.

This study aims to implement and evaluate a training program in TLH for gynaecologists. The potential benefits to the community are:

* A reduction in the incidence of overall surgical adverse events in patients receiving a hysterectomy
* A reduction in the length of hospital stay for patients requiring a hysterectomy
* A reduction in the direct hospital costs for hysterectomy


Eligibility Criteria:
Surgical training program participants Inclusion criteria

1. RANZCOG accredited O\&G specialists who are proficient in RANZCOG laparoscopic skills level 3 or higher;
2. Surgical capabilities will be assessed using The Global Operative Assessment of Laparoscopic Skills (GOALS) Tool which is an adapted GOALS tool for hysterectomy. GOALS measures depth perception, bimanual dexterity, efficiency, tissue handling and surgeon autonomy each on a 5 point Likert scale. An experienced mentor will assess each surgeon using this scale and skills will be validated against objective outcomes (surgical adverse events recorded in the baseline period).
3. Will be able to attend each of the 10 training days.

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