cyrilzakka/clinical-trials huggingface dataset:
Impact of the Operator Performing Oocyte Retrieval on the Cumulative Live Birth Rate

This is a monocentric retrospective observational study. The study investigates the impact of the operator performing the oocyte retrieval on the cumulative live birth rate (CLBR).

The objectives of the study are as follows:

* To evaluate whether the operator performing the oocyte retrieval influences the probability of pregnancy, expressed as the cumulative live birth rate (CLBR).
* To assess whether operator performance improves with increased experience.

To address the study objectives, data will be collected using a specific internal web-based database. All oocyte retrieval procedures performed at the Humanitas Fertility Center from January 2013 to December 2022 will be included in the evaluation. Outcomes will be expressed in terms of CLBR.


Eligibility Criteria:
Inclusion Criteria:

The study database will include patients who underwent oocyte retrieval procedures with the intention of achieving pregnancy at the Humanitas Fertility Center between January 2013 and December 2022, including repeated ART cycles.

Operator experience will be assessed based on the number of previously performed oocyte retrieval procedures. All operators who performed at least 50 procedures, either at IRCCS - Humanitas Research Hospital or at another institution, will be included in the study.

Exclusion Criteria:

Patients who underwent preimplantation genetic testing (PGT) cycles, as well as those who underwent cryopreservation for oncological or elective purposes, will be excluded from the study.

Operators who performed fewer than 50 oocyte retrievals, either at IRCCS - Humanitas Research Hospital or at another institution, will be excluded. Additionally, the first 50 procedures performed by each operator will not be included in the dataset.
High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth

This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach birth weight.

Neonates with \<32 weeks gestation age or \<1500 gram birth weight gets early intravena lipid start with 2 gram per body weight and 1 gram per body weigh then observed the time to reach birth weight

Eligibility Criteria:
Inclusion Criteria:

* birth weight below 1500 gram or gestational age below 32 weeks

Exclusion Criteria:

* mayor congenital abnormalities
Fenofibrate in Ulcerative Colitis

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment of hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent.

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however the exact underlying mechanisms of UC remain poorly understood. UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.

PPARα has been proposed as a key lipid metabolism modulator and regulator of inflammation. There are three isotypes of PPAR (α, β and ȣ) which have distinct but overlapping functions.

Fibrates, which are specific pharmacological agonists of PPARα, have been widely used in the treatment for hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator- activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both males and females will be included
* Negative pregnancy test and effective contraception.
* Mild and moderate UC patients diagnosed and confirmed by an endoscope

Exclusion Criteria:

* Breastfeeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Other inflammatory bowel diseases (CD).
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies
* Addiction to alcohol and/or drugs
* Known allergy to the Fenofibrate
Prophylactic Norepinephrine Infusion Combined With Colloid Coloading for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility Criteria:
Criteria: Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥ 37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Coagulation or renal function disorders
* Known allergy to hydroxyethyl starch
* Fetal distress, or known fetal developmental anomaly
Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET

To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged 18-70 years.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. HR+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry.
4. HER2 status was determined by immunohistochemistry or fluorescence in situ hybridization.
5. Palbociclib treatment of metastatic breast cancer for at least one cycle.
6. Available medical history.

Exclusion Criteria:

1.Incomplete medical history.
Vitamin B12 Status and Its Impact on Chronic Haemodialysis Patient

To evaluate vitamin B12 level in haemodialysis patients and its impact on hematological and neurological manifestations

Vitamin B12 (cobalamin) is a water-soluble vitamin involved in several normal cellular functions (1). Vitamin B12 is required for the development, myelination, and function of the central nervous system; healthy red blood cell formation; and DNA synthesis (2- 4). Low levels of vitamin B12 have been associated with high concentrations of homocysteine (Hcy) and can lead to health complications (5). Hyperhomocysteinemia is an important risk factor for cardiovascular disease (6). Vitamin B12 and other B vitamins are involved in homocysteine metabolism, and researchers have hypothesized that supplementation with these micronutrients can reduce the risk of cardiovascular disease by lowering homocysteine levels (7, 8). Vitamin B12 deficiency is one of the causes of Macrocytic anaemia with increased mean corpuscular volume (MCV), defined as more than 100 fL, which is the hallmark of megaloblastic anaemia

Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease on haemodialysis pts.
* Parients more than 18 years .
* CKD patients controled group stage 3and stage 4.

Exclusion Criteria:

* Recent renal transplantation patients.
* Patients on sulpha drugs.
* Patients on methotrexate.
* Patients on anticonvulsant.
* Patients on chemotherap agent.
* Patients on colchicine.
* Patients on bile acid sequestrant.
* Patients on h2blockers.
* Patients on metformin.
* Patients on proton pump inhibitors .
* Diabetic patients.
* Parients with history of intestinal surgery.
* Patients diagnosed with malabsorption syndrome.
* Patient on vitamin b12 intake.
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury

The purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury.

The investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.

Major depression is a significant chronic problem for people with traumatic brain injury (TBI), and its treatment is difficult. A promising approach to treat depression is mindfulness-based cognitive therapy (MBCT), a relatively new therapeutic approach rooted in mindfulness-based stress-reduction (MBSR) and cognitive behavioural therapy (CBT). This multi-site, randomized, controlled trial of a MBCT intervention will examine the value of this intervention in improving quality of life and decreasing depression in people with TBI. MBCT may represent a time-limited, cost-effective group intervention through which clinicians would have an opportunity to address some of the most debilitating aspects of TBI.

Eligibility Criteria:
Inclusion Criteria:

* traumatic brain injury suffered more than one year ago but less than five
* Evidence of depression post-traumatic brain injury (Beck Depression Inventory-II score of 16 or greater)
* Ability to speak and read English
* Age 18 or more

Exclusion Criteria:

* Inability to benefit from the intervention based a consensus process amongst study clinical psychologist and physicians, and from scores on memory and auditory attention (California Verbal Learning Test, Digit Span subsection of Wechsler Adult Intelligence Scale); verbal fluency and executive functioning (Controlled Oral Word Association Test); verbal abstract reasoning (Similarities subsection of Wechsler Adult Intelligence Scale); and executive functioning (Trail Making Test).
* Evidence of unusual psychological processes such as psychosis, suicidal ideation, substance abuse, or major concurrent mental illness (Beck Depression Inventory-II and Symptom Checklist-90-R will supplement the decision-making process of study clinicians).
A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma

This study is a multicenter, single-arm, open-label phase II study to assess the efficacy and safety of YH003 in combination with pembrolizumab and nab-paclitaxel in the first-line treatment of patients with unresectable/metastatic mucosal melanoma.


Eligibility Criteria:
Inclusion Criteria:

* 1.Subjects must have the ability to understand and willingness to sign a written informed consent document.
* 2. Subjects must have histologically advanced or cytologically confirmed metastatic or unresectable mucosal melanoma;
* 3.Subjects have not received standard systemic therapy; patients have disease progression 6 months or more after the end of neoadjuvant or adjuvant therapy (except nab-paclitaxel), and can be enrolled in the clinical study;
* 4. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1;
* 5. Subjects must be age 18 years or older;
* 6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 7. Life expectancy ≥3 months based on investigator's judgement；
* 8. Subjects must have adequate organ function;
* 9. Women of childbearing potential need to have a negative pregnancy test and need to take contraceptive/contraceptive measures including their partners.

Exclusion Criteria:

* 1.Subjects have another active invasive malignancy within 5 years；
* 2.The subject has received anti-tumor therapy or other investigational drug therapy or traditional Chinese medicine (herbal medicine) with anti-tumor indications prior to the first dose;
* 3.Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy.
* 4.History of clinically significant sensitivity or allergy ；
* 5.Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.；
* 6.History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease；
* 7.Subjects have active pulmonary embolism with hemodynamic changes 12 weeks before the first dose;
* 8. Subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment;
* 9. Subjects have clinically uncontrolled diseases;
* 10. Subjects have severe cardiovascular disease;
* 11. Subjects have evidence of active infection;
* 12. Subjects must not have a known or suspected history of an autoimmune disorder；
* 13.Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose.
* 14. Any condition that the investigator assesses as inappropriate for participation in the study.
A Study of Familial and Genetic Aspects of Adult T-Cell: Leukemia/Lymphoma , Tropical Spastic Paraparesis, and Infective Dermatitis

Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.

Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.

Eligibility Criteria:
* INCLUSION CRITERIA:

All cases of ATL and TSP which satisfy the case definitions above. Cases will be selected regardless of HTLV-1 sero-status.

EXCLUSION CRITERIA:

Cases who have none of the first three priority family members available i.e. parents, offspring and siblings, will be excluded from this study however summary data will be maintained.
Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Magnetically controlled capsule endoscopy (MCCE) is an outstanding opportunity for the painless endoscopic screening of the esophagus and stomach before small bowel examiantion. Further improvement in patients positioning might increase the esophageal transit time of the capsule endoscope and could improve the sensitivity and specificity of the esophageal MCCE investigation. Our present study aimed to compare the visualization of the esophagus (especially the Z-line) with different capsule swallowing protocols.

Magnetic controlled capsule endoscope (MCCE) systems have been developed over the last 10-15 years to examine the upper GI tract, particularly the stomach. The new Navicam MACE system consists of a magnetic capsule endoscope, an external control magnet, a data recording kit and a computer workstation. With the appropriate software, allows real-time tracking and monitoring of the capsule inside the body. This method may in the near future be an optimal non-invasive method for screening gastric cancer and Barrett's oesophagus in high-risk populations.

Esophagogastroduodenoscopy (EGD) is the gold standard diagnostic test, however it is very inconvenient for patients without sedation.

The aim of our present study was a feasibility study to evaluate the safety and efficacy of Ankon MCCE for the investigation of esophageal abnormalities in patients referred for small bowel capsule endoscopy in our endoscopy department, to develop and test a method to use MCCE for esophageal examination, and to analyze the visualization of esophageal mucosa with our newly developed capsule swallowing protocol and manual capsule maneuvering.

Eligibility Criteria:
Inclusion Criteria:

- patients referred for small bowel capsule endoscopy in any indication

Exclusion Criteria:

* known or suspected stricture in the GI tract
* previous surgery with bowel anastomosis
* swallowing complaints
* dementia
* implanted cardioverter defibrillator
* inability to sign the informed consent
Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis

The study investigates different criteria for remission based on MRI and circulating biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates factors that affect disease activity, function and participation by use of different questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Axial spondyloarthritis according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axial spondyloarthritis
* Sacroiliitis on conventional X-rays or Magnetic Resonance Imaging (MRI).
* Disease activity assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>40 mm despite treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAID).
* Clinical indication for tumor necrosis factor (TNF) inhibitor treatment by the treating physician.

Exclusion Criteria:

* No contraindications for TNF inhibitor
* No contraindications for MRI
* No contraindications in participation in a study
Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation

The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-mucinous colon adenocarcinoma.
* Primary tumor as pT1-3, pN0 or pN1 (metastases in \< 4 regional lymph nodes), confirmed R0 resection.
* RAS and BRAF wild-type \& MSS molecular status as per local testing.
* Liver metastases not eligible for curative liver resection
* Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (CR+PR+SD) during second-line treatment for at least 4 months.
* A maximum of two prior chemotherapy treatment lines.
* Performance status, ECOG 0.
* Satisfactory blood tests Hb \>10g/dl, neutrophils \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<2 x upper normal level, AST, ALT\<5 x upper normal level, creatinine \<1.25 x upper normal level.
* CEA\<50 ng/ml

Exclusion Criteria:

* Hereditary CRC syndromes including FAP and Lynch syndrome.
* Prior extra hepatic metastatic disease or primary tumor local relapse.
* Extra-peritoneal cancers (rectum).
* Other malignancies in the previous 5 years
* Active intra-venous or alcohol abusers
* HIV infection
The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients

The aim of this study is to examine the possible clinical effects associated with vitamin K supplementation on the glycemic control, insulin sensitivity and lipid profile of type II diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 21-65 years old diagnosed with Type II diabetes.
* Fasting blood glucose concentration ≥ 126 mg/dL .
* Normal liver Function tests defined as ALT levels up to 33 U/L for males and up to 25 U/L for females, Albumin levels ≥ 3.5 g/dL, Bilirubin up to 1.1 mg/dL .
* Normal clotting function defined as defined by INR.
* Normal kidney function defined as serum creatinine values up to 1.3 mg/dL.

Exclusion Criteria:

* Type I diabetic patients.
* Use of supplements with potential effect on vitamin K level namely supplements containing vitamin K, co-enzyme Q10 or vitamin E \> 400 IU .
* Patients requiring anti-coagulant therapy including patients with prosthetic valves, mitral tissues, DVT, PE, atrial fibrillation and valvular heart disease.
* Patient with history of coagulation, MI, stroke and embolization.
* Pregnant or breast feeding women.
* Being on hormonal therapy or receiving contraceptive pills.
* Patients treated with glucocorticoids, thiazide diuretics, and atypical antipsychotics.
* Patients on cholestyramine, antibiotics and coumarins.
* Patients on lipid lowering agents.
* Known intestinal malabsorption syndrome, cholestasis or steatorrhea.
* Smokers.