cyrilzakka/clinical-trials huggingface dataset:
Embryo Aneuploidies and Ovarian Stimulation

There is a considerable concern about the effects of controlled ovarian hyperstimulation (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos.

The main question remaining is if COH may increase the aneuploidies rate in young and healthy women. Therefore, the primary endpoint of the present study is to analyse the incidence of chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the male factor influence, donated sperm will be used.


Eligibility Criteria:
Donor Inclusion Criteria:

* 18 to 35 years old.
* BMI: 18-25Kg/m2
* Regular menstrual cycles
* Normal kariotype
* No previous controlled ovarian hyperstimulation (COH) treatments.

Donor Exclusion Criteria:

* Endometriosis
* Policystic ovarian syndrome
* Recurrent miscarriages.

Recipient Inclusion Criteria

* Aged until 45 years old
* No systemic diseases
* Following egg and sperm donation treatment.

Recipient exclusion criteria:

* Uterine disease (polyps, myomas, mullerian defects)
* Recurrent miscarriages.
A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma

First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

Study Design: This is an open-label, dose exploration study evaluating AMG 232 in subjects with advanced p53WT solid tumors or multiple myeloma. The study will be conducted in 2 parts: Part 1 - Dose Exploration (parts 1a, 1b and 1c) and Part 2 - Dose Expansion. Part 1a is aimed at evaluating the safety, tolerability, PK and PD of AMG 232 and determining the MTD of a 7-day once daily (QD) dosing schedule in subjects with advanced solid tumors using a practical continuous reassessment method (CRM). Part 1b will evaluate the safety and tolerability of 3-day QD dosing schedule (or alternate dosing schedule based upon emerging data) with a particular emphasis on evaluating the tolerability of daily doses equal to or higher than the part 1a MTD in subjects with solid tumors or multiple myeloma. Part 1c will evaluate the safety and tolerability of 7-day twice daily (BID) dosing schedule with daily cumulative doses equal to or higher than the part 1a MTD in subjects with solid tumors. The dose expansion part of the study (Part 2) can open once the MTD has been determined in Part 1a. Part 2, part 1b and part 1c can be explored in parallel. The dose expansion part will consist of up to 85 additional subjects with specific tumors harboring MDM2 amplification (liposarcoma \[LPS\], gliobastoma \[ GBM \] and all other solid tumors) or potentially harboring MDM2 overexpression (ER+ metastatic breast cancer) and a group of subjects with multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Men or women \> 18 years old
* Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma
* Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.
* Ability to take oral medications and willing to record daily adherance to investigational product
* Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

* Active brain metastases
* For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years
* Active infection requiring intravenous (IV) antibiotics
* Anti-tumor therapy
* Therapeutic or palliative radiation therapy within 30 days of starting treatment
* Currently enrolled in another investigational device or drug study
Survival With Patients Treated With Salivary Gland Cancer

Salivary gland malignancies is very heterogenous group of tumors regarding tumor histology and localization. The aim of this study is to assess main clinical and pathological parameters related to patients survival

The retrospective study enrolled medical charts of the patients treated due to salivaly gland cancers in the Clinic for maxillofacial surgery at Clinical center of Vojvodina in the period of 1. January 1996. to 31. December 2021. Patients demographics, type of the tumor, localization, TNM status and patohystological parameters were evaluated for patients survival and disease free periods

Eligibility Criteria:
Inclusion Criteria:

Patients with salivary gland malignancies treted in the Clinic for maxillofacial surgery

Exclusion Criteria:

Incomplete medical data Patients with metastatic tumord of salivary gland Patients with recurrent malignancies of salivary glands sent from other clinics
A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass

Study hypothesis: High protein diets have been shown to make people full and and help to retent of muscle mass. This study was designed to determine effects of a protein- enriched meal replacement (MR) on weight loss and muscle mass retention by comparison to an equal calorie carbohydrate-enriched MR.

Methods: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100 obese men and women comparing two equal calorie meal plans.,1) 2.2 g protein/kg of LBM per day \[high protein diet (HP)\] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). Body weight, body composition, and lipid profiles were measured at baseline and 12 weeks.

Background: While high protein diets have been shown to improve satiety and retention of lean body mass (LBM), this study was designed to determine effects of a protein- enriched meal replacement (MR) on weight loss and LBM retention by comparison to an isocaloric carbohydrate-enriched MR within customized diet plans utilizing MR to achieve high protein or standard protein intakes.

Methods: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100 obese men and women comparing two isocaloric meal plans utilizing a standard MR to which was added supplementary protein or carbohydrate powder. MR were used twice daily (one meal, one snack). One additional meal was included in the meal plan designed to achieve individualized protein intakes of either 1) 2.2 g protein/kg of LBM per day \[high protein diet (HP)\] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). LBM was determined using bioelectrical impedance analysis (BIA). Body weight, body composition, and lipid profiles were measured at baseline and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) between 27 to 40 kg/m2
* in good health by history, physical examination, and basic laboratory screening (complete blood count, serum chemistries, liver panel, and lipid panel)

Exclusion Criteria:

* type 2 diabetes or glucose intolerance
* regularly drank more than one alcoholic beverage daily
* unable to provide consent
Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?

The purpose of this study is to find out whether it is necessary to prophylactically treat patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is that it is not necessary to pretreat patients with antibiotics if the operation is minimally invasive with a mesh placed at the defect.

The investigators plan to follow up at least 100 patients who did not receive antibiotics prior to their inguinal hernia repair and compare their outcome to 100 patients who did receive prophylaxis. The investigators mainly will be analyzing the incidence of surgical site infections as evidenced by swelling, redness, pain, warmth or other signs deemed by the surgeon.

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic inguinal hernia repair, unilateral or bilateral

Exclusion Criteria:

* Those requiring antibiotics for the surgery;
* Those patients who have experienced surgical site infections from previous surgeries
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic subjects
* Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
* HbA1c at least 12%
* Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

* History of drug or alcohol dependence
* Receipt of any investigational drug within the last month prior to this trial
* Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
* Severe uncontrolled hypertension
* Recurrent severe hypoglycemia as judged by investigator
* Any disease or condition, which the Investigator feels, would interfere with the trial
Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases

Multicentric randomised trial. The goal of this clinical research study is to evaluate the efficacy and safety of serplulimab combined with FOLFIRI+bevacizumab in the treatment of pMMR/Ras/BRAF wild-type unresectable peritoneal metastasis of colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS and RAS/BRAF wild-type. Imaging showed peritoneal metastasis.
* 2. Peritoneal metastatic carcinoma that could not reach CC0/1 was detected surgically.
* 3. Patients with the following general characteristics:

  1. Age between 18 and 75 years
  2. Performance Status (ECOG) 0, 1 or 2, life expectancy \> 12 weeks
  3. Adequate renal, and bone marrow function: a. Leukocytes \>/= 3,000/microL; b. Absolute neutrophil count \>/= 1,500/microL; c. Platelets \>/= 100,000/Ul; d. Serum creatinine \</= 1.5 mg/dL
* 4. Hepatic function: AST (SGOT)/ALT (SGPT) \</= 5 X institutional (Upper Limit of Normal) ULN.
* 5. Able to tolerate immunotherapy, chemotherapy and surgery.
* 6. Patients will be informed and a signed consent before initiating any procedure specific to the trial.

Exclusion Criteria:

* 1. Age \>75years or age\<18years.
* 2. Cancers of non colonic origin.
* 3. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years.
* 4. Known HIV, Hepatitis B or Hepatitis C positive.
* 5. Pregnant women or likely to be pregnant.
* 6. Persons under guardianship.
* 7. Subjects deemed unable to comply with study and/or follow-up procedures.
* 8. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol

Introduction: Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite being preventable. Moderate wine consumption has been associated with one of the preventative approaches due to its benefits on cardiovascular health, including endothelial protection and antioxidant effects, attributed to its chemical composition, such as flavonoids.

Objective: To assess endothelial function through flow-mediated dilation after the consumption of red wine compared to non-alcoholic wine.

Methodology: A parallel, randomized, placebo-controlled clinical trial with a blinded evaluator will be conducted with 20 healthy participants, evaluated at two distinct time points. Participants will be selected to receive either red wine or non-alcoholic wine and will be crossed over after 7 days to receive the opposite beverage from the initial one. The primary outcome will be the change in flow-mediated dilation of the brachial artery pre- and post-intervention in both groups. The secondary outcomes will include the flow-mediated dilation values, brachial artery diameter after the intervention, and measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP).


Eligibility Criteria:
Inclusion Criteria:

* consume alcohol sporadically

Exclusion Criteria:

* continuous medication, including anti-inflammatories
* pregnant women
Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions

EUS-guided tissue acquisition is an established modality to diagnose malignancies of the pancreas and extrahepatic bile ducts. In the recent years fine needle biopsy (FNB) needles have largely replaced fine needle aspiration (FNA) for EUS-guided tissue acquisition. The Acquire FNB needle is a Franseen needle which has three symmetric cutting edges to obtain core tissue specimens. The Trident FNB needle has been recently introduced to the market for EUS-guided tissue acquisition. It has a multi-blade three-prong tip which one of the tips is longer than the other two.

The aim of this study is to prospectively compare these two types of needle in term of diagnostic accuracy, and safety profile.

Patients with solid mass lesions in the pancreas or extrahepatic biliary system will be randomly assigned to one of two types of FNB needle. Four passes of FNB will be acquired from the mass lesion in each patient. The primary aim is to compare sensitivity of two types of FNB needle to diagnose malignancy. Also, each pass of FNB needle will be assessed separately by two expert pathologists to determine per-pass sensitivity of two types of FNB needles.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients and outpatients 18 years of age or older with solid mass lesions in the pancreas or extrahepatic biliary system

Exclusion Criteria:

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Decline to participate in the study and sign the informed consent form
* Cystic lesions.
Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?

Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.


Eligibility Criteria:
Inclusion Criteria:

* ASA rating of I-II Mask induction of General Anesthesia

Exclusion Criteria:

* Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines
Study on the Effect of Fish Oil and Appetite

20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they were given a standard breakfast and asked to report their appetite on visual analogue scales (VAS) immediately before and after the meal. The results were analyzed in accordance with the paired design under consideration of both supplement sequence and gender.

In a randomized cross-over design, 20 normal-weight healthy subjects (10 males, 10 females) were given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they were given a standard breakfast and asked to report their appetite on visual analogue scales (VAS) immediately before and after the meal. The results were analyzed in accordance with the paired design under consideration of both supplement sequence and gender.

Eligibility Criteria:
Inclusion Criteria:

* Normal weight (18.5\<BMI\<25 kg/m2).
* Healthy.

Exclusion Criteria:

* Subjects taking medication that could influence appetite.
* Subjects with special nutritional needs e.g. pregnant and lactating, seriously ill or old people.
* Subjects that had had fish oil-supplements for four weeks prior to the intervention period.
Evaluation of Some Prognostic Factors in Acute Aluminum Phosphide Intoxicated Cases

study of some laboratory and clinical findings which may show the severity of aluminium phosphide toxicity and the need of the cases to be admitted to ICU

aluminium phosphide poisoning is a major cause of death in intoxicated and suicidal cases since there is no antidote and there is no specific investigation for it so there is a need for further study to identify the cause of death and the most specific investigation in the case of AlP toxicity

Eligibility Criteria:
Inclusion Criteria:

1. History of exposure or intake of Aluminum phosphide.
2. Clinical picture of Acute Aluminum phosphide poisoning including severe vomiting, hypotension, abdominal pain, cardio-pulmonary distress.
3. Cases of the age of 15 to 45 years old

Exclusion Criteria:

- 1. Cases with an unclear history. 2. History of co-morbidities or systemic diseases because of the possibility of misleading laboratory results.

3. History of co-ingestion of drugs or another poison.
Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients

This is an open-label, postmarketing, observational study to document health outcomes, in Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa (levodopa/carbidopa intestinal gel).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with advanced Parkinson's Disease
* Prescribed Duodopa by his/her treating physician.

Exclusion Criteria:

* Patients who were previously treated with Duodopa.
* Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of advanced PD.
Relationship of Patient-Specific Functional Scale With Shoulder Functions: A Prospective Study

The aim of the study is to examine the relationship between the Patient- Specific Functional Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems.


Eligibility Criteria:
Inclusion Criteria:

* having a shoulder pathology
* being volunteer
* having shoulder pain at least 3 months
* being literate

Exclusion Criteria:

* having more than one upper extremity pathology
* having an upper extremity pathology involving the neck and trunk
* having a neurological finding
Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease

It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 90. Liver biopsy proved NAFLD patients will be recruited in this study for 2 years follow-up. Patients will be assessed at baseline, at every six months for blood count, liver function test, fasting blood-glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness.

No.

Eligibility Criteria:
Inclusion Criteria:

* 1. 18-70 years of age, 2. liver biopsy proven non alcoholic fatty liver disease. 3. Agree to be followed up regularly; 4. Signature of written informed consent.

Exclusion Criteria:

* 1. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.

  2. Patients undergone bariatric surgery. 3. HIV infected patients. 4. Pregnant women. 5. Patients with severe diseases with expected survival less than 2 years. 6. Patients had followings before liver biopsy:
  1. Hepatocellular carcinoma or suspected liver cancer,
  2. Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
  3. Other malignancy,
  4. Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock

Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock

Objectives: Comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock.

Intervention:

1. Microcirculation-oriented resuscitation group: When the system hemodynamics meets the standard of EDGT, the microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV \> 68%).
2. Control group: The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.

Primary outcome:

(1)change in SOFA score at 72h (2)30-day mortality

Eligibility Criteria:
Inclusion Criteria:

* patients fulfilled the diagnostic criteria of septic shock.

Exclusion Criteria:

* declined to participate
* pregnant
* patients who were younger than 18 years old
* active bleeding
* septic shock is diagnosed for more than 4 hours
* patients are expected to be die within 24hours