cyrilzakka/clinical-trials huggingface dataset:
Comparison of Vitrification Effect Before or After In Vitro Maturation

Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. However, this strategy cannot always be used, particularly for hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification should be performed after IVM, little is known about vitrification effects on actin and tubulin cytoskeleton and kinetic of maturation of human ovocytes.

To answer to this question, Investigator performed quantitive analyses comparing matured oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been analysed during maturation and in matured oocytes.

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system ("Vitrolife"). Kinetic of maturation were analyzed by Primovision ("Vitrolife") and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Eligibility Criteria:
Inclusion Criteria:

* - ICSI treatment
* Immature oocytes
* \< 37 years old

Exclusion Criteria:

* - Polyckistic Ovarian Syndrome
* Endometriosis
* Ovulatory disease
Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the PACE Setting: A Pilot Study

The aim of this pilot study is to determine the feasibility of implementing an antipsychotic deprescribing initiative that is driven by pharmacists working collaboratively with the Program of All-inclusive Care for the Elderly (PACE) interdisciplinary team.

No individual antipsychotic has been approved by the U.S. Food and Drug Administration (FDA) for treating insomnia or behavioral and psychological symptoms of dementia (BPSD). Despite these medications being associated with significant harms, a considerable portion of older adults are prescribed antipsychotics for treatment of insomnia or BPSD. The aim of this study is to determine the feasibility of a pharmacist-driven antipsychotic deprescribing initiative in a community-based practice setting known as Program of All-inclusive Care for the Elderly (PACE). Our primary objective is to assess and describe the implementation process, including barriers and enablers to implementation. Our secondary objectives are to quantify and describe changes in antipsychotic prescribing following implementation; evaluate and report on antipsychotic re-initiations or changes in dosing; and evaluate and report on adverse drug withdrawal events (ADWEs) following antipsychotic deprescribing.

Eligibility Criteria:
Inclusion Criteria:

* Participant enrolled in a PACE organization during the implementation time period;
* PACE organization contractually receiving pharmacy services from CareKinesis during the implementation time period; and,
* Participant's prescriber determines that the participant could potentially benefit from deprescribing the antipsychotic.

Exclusion Criteria:

* A diagnosis of bipolar disorder, schizophrenia, schizo-affective disorder, acute delirium, Tourette's syndrome, tic disorders, autism, intellectual disability, developmental delay, obsessive-compulsive disorder, alcoholism, cocaine abuse, Parkinson's disease psychosis, or major depressive disorder for which the antipsychotic is specifically prescribed as adjunctive treatment;
* Participant's prescriber determines that the participant would likely not benefit or could be harmed from deprescribing the antipsychotic; and,
* Participant, or healthcare decision-maker on behalf of the participant (e.g., caregiver) refuses to participate in the deprescribing initiative.
Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia

Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant.

The use of G-CSF is justified by a possible increase in ADCC.

All patients receive Alemtuzumab in 3 successive phases:

Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.

Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.

Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 15 years
* Refractory ALL
* ALL in relapse post chemotherapy or post transplant
* ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease.
* Signed informed consent
* Patients under social security coverage
* Anti conceptional tablets in pre menopausal women.

Exclusion Criteria:

* Children below 15 years of age or aged 15
* Blast cells not expressing CD52 antigen (at all evaluations)
* HIV positivity
* ECOG Score 3 and 4
* Hypersensitivity to Alemtuzumab.
* Pregnancy or breast feeding.
* Other malignant disease in addition to ALL.
Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia

This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification.The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of \[2,12\] and \[12,18）age groups.


Eligibility Criteria:
Inclusion Criteria:

1. 2 years old ≤age\<18 years old, regardless of gender;
2. General anesthesia is planned;
3. ASA score grade I \~ II; 4）Able to sign the informed consent.

Exclusion Criteria:

1. Children with general anesthesia contraindications;
2. With diseases that are not suitable for the study in the scheme;
3. Abnormal liver and kidney function in screening stage;
4. Abnormal coagulation function;
5. Serum electrolyte abnormality;
6. Subjects intolerant or allergic to the study drugs;
7. Recently received other narcotic drugs or other drugs that affect the metabolism of study drugs;
8. The child thought to be unsuitable for the study, as determined by the investigator.
Resin-Cement Type Influence on Cement Remnants in Implant-Supported Restorations

This study quantitatively compared cement residues of two resin cement types around implant-supported restorations (ISR) with a crown-abutment margin located at the gingival level. This prospective, single-blinded, cross-over clinical trial compared optically detectable cement remnants between Self-Adhesive Resin Cement (RC) and Resin-Modified Glass Ionomer Cement (RMGIC).

This prospective, two-arm, non-randomized, clinical trial compared detectable cement remnants on 30 patients and 60 ISR. Two cements were compared; self-adhesive resin (RC) and resin-modified glass ionomer (RMGIC). Comparisons were carried out on identical pairs of ISR tested within the same patients with a 1-week healing interval. The primary outcome variable was the ratio of cement-covered area to total crown area. Areas were analyzed ex-situ by standardized digital image analysis.

Eligibility Criteria:
Inclusion Criteria:

* physical and psychological ability to undergo implant therapy (ASA I or II)
* presence of a single mandibular molar indicated for extraction with adjacent healthy and present natural teeth or implant-supported restoration
* presence of ≥ 6 mm width and ≥ 10 mm height native bone ridge - presence of intact alveolar bone walls after tooth extraction and presence of interradicular bone \> 4 mm to achieve primary implant stability
* presence of ≥ 1.5 mm distance to adjacent teeth at the bone level
* overall healthy, non-inflamed keratinized soft tissues.

Exclusion Criteria:

Presence of general conditions contributory to dental implant treatment comprising but not limited to:

* presence of active periodontitis 25
* poor oral hygiene as determined by the Oral Health Index (OHI)
* pregnant or lactating
* presence of uncontrolled medical systemic conditions, e.g. diabetes;
* ongoing or past medical treatments affecting wound healing, terminated less than 3 months prior to the study-related intervention
Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia

The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed diagnosis of ALL.
* Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.
* Patients in relapse
* Patients refractory to initial remission induction therapy
* Patients ineligible for initial remission induction therapy
* Patients with an ECOG Performance Status Score from 0 to 2
* Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN)
* AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN
* Serum bilirubin level not more than 3 × ULN

Exclusion Criteria:

* Patients with findings indicative of leukemic involvement of the central nervous system
* Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder)
* Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
* Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.

Other protocol-defined inclusion/exclusion criteria may apply.
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)

This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
* Measurable nodal disease by computed tomography (CT)
* Adequate hepatic, and renal function
* Adequate hematologic function
* absolute neutrophil count \>750/µL
* platelet count \>30,000 /μL
* hemoglobin \>8.0 g/dL

Exclusion Criteria:

* Any prior therapy used for treatment of CLL/SLL
* Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)
Health2006 - an Observational Study of Cardiovascular Disease, Diabetes, Asthma and Allergy

The aim is to assess the population prevalence of risk factors for different chronic diseases such as cardiovascular disease, type 2 diabetes, osteoporosis, asthma, and allergy. Risk factors include genetic and serologic biomarkers, questionnaire data on health and lifestyle. There are many hypotheses under study for each research field.

A population-based random sample of persons living in Copenhagen is drawn from the Danish Civil Registration System and invited for a health examination including blood sample drawing, measurement of lung function, serologic and genetic biomarkers, questionnaires on lifestyle and health. The study will form the basis for research within many different areas such as cardiovascular disease, type 2 diabetes, asthma, and allergy.

Eligibility Criteria:
Inclusion Criteria:

* Persons living in 11 municipalities in Copenhagen

Exclusion Criteria:

* Pregnancy
* Non-Danish citizenship
Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety

The goal of this clinical trial is to determine if the Powerly app can help prevent postpartum depression and anxiety in healthy pregnant women.

The main questions it aims to answer are:

* Does the Powerly app reduce postpartum depression and anxiety?
* Does it improve emotion regulation and maternal bonding with a child?

Researchers will compare two groups: one using the Powerly app and the other receiving care as usual (CAU) to see if the app leads to better mental health outcomes.

Participants will:

* Use the Powerly app for four weeks (if in the intervention group).
* Complete mental health assessments before the study, after four weeks, and six weeks postpartum.

Pregnancy is a period of significant emotional and physical changes, with up to 30% of expecting mothers experiencing high stress. After birth, around 15-20% of new mothers suffer from postpartum depression, and 25-35% experience anxiety. Despite broad availability of mobile apps aimed at these challenges, none of them have been rigorously tested through clinical studies. To fill this gap, we developed Powerly, a science-based mobile app designed to help prevent postpartum depression and anxiety.

In this study, 140 healthy pregnant women will be randomly assigned to one of two groups: one will use the Powerly app for four weeks, while the other will receive care as usual (CAU). Powerly is grounded in cognitive behavioral therapy (CBT) and personalized to the individual's needs, with input from healthcare professionals and pregnant women. We will collect information on participants\&#39; mental health at three points: before they start using the app, after four weeks of app use / CAU, and six weeks after giving birth. The app's effectiveness will be evaluated by examining improvements in mental health outcomes, such as reduced rates of postpartum depression and anxiety, better emotion regulation, and stronger maternal bonding with a baby.

Eligibility Criteria:
Inclusion Criteria:

* being between 24 and 32 weeks pregnant,
* owning an iPhone,
* having sufficient fluency in German language

Exclusion Criteria:

* high-risk pregnancies,
* history of substance abuse and psychiatric disorders such as bipolar disorder, schizophrenia, or other psychotic disorders,
* current use of professional face-to-face psychotherapeutic support,
* participation in other clinical trials or interventions at the same time
The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism

The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent has been signed by the parents.
* The child is at least one year old and has not had his 4th birthday at the beginning of the study
* The child is healthy.
* The child attends child care center at least 5 days a week, \> 4 hours per day.

Exclusion Criteria:

* Was born preterm.
* Had a birth weight \<2,500 g.
* Has congenital anomalies.
* Has a structural abnormality of the digestive tract or previous significant gastrointestinal surgery.
* Has chronic disease or malignancy.
* Has a serious, unstable medical condition.
* Is Failure to Thrive (FTT) (\<5th percentile of ideal body weight).
* Has an allergy or atopic disease.
* Has an allergy or intolerance to milk/dairy products.
* Has an established diagnosis of lactase deficiency.
* Is predisposed to infection (i.e., compromised immune system, HIV-AIDS, active bacterial disease, under steroid treatment).
* Received antibiotic treatment or intentionally consumes probiotic products during the preceding 4 weeks. (If the subject was on antibiotics before the beginning of the study or probiotics, a washout period of 2 weeks is required.)
Eye Movement and Cognitive Dysfunction

There is association between eye movement disorder and cognitive dysfunction. Therefore, utilizing eye movement and screening for cognitive dysfunction is feasible. In the present study, we will develop an artificial intelligence platform to screening for cognitive dysfunction by inspecting the function of eye movement. Futher more, based on the screening results, the platform will offer referral suggestions.


Eligibility Criteria:
Inclusion Criteria:

* ①Subjects who are diagnosed as mild cognitive decline, Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, other dementia and normal by neurologist.
* ②Subjects who can cooperate with the inspection.
* ③Subjects who agree to participate in the study and sign the consent form

Exclusion Criteria:

* ①Subjects who cannot do the inspection.
* ②Subjects who suffer from diseases that compromise the inspection.
Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

The Study aims to determine the proposed positive influence of Sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary syndrome and subsequent infertility

Study Design : a Prospective Randomized Controlled Trial.

A Total of 80 infertile Adult Females aged between 18 and 45 years currently diagnosed with Polycystic ovary syndrome , Meeting the Diagnosis of Rotterdam criteria be diagnosed if any two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be included in the study.

The study will include two groups; each group consists of 40 patients:- Group A : Control Group Group B : Test Group ( will Receive Sitagliptin at a dose of 100 mg every 24 hours

Eligibility Criteria:
Inclusion Criteria:

polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3 criteria are present:

1. oligo- and/or anovulation
2. hyperandrogenism (HA) (clinical and/or biochemical)
3. polycystic ovary morphology (PCOM) on ultrasonography (either 12 or more follicles measuring 2-9 mm in diameter and/or an increased ovarian volume \>10 cm3).

Exclusion Criteria:

1. congenital adrenal hyperplasia
2. Brittle control of a thyroid disorder
3. Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance
4. chronic kidney disease
5. liver dysfunction
6. documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption
Safety and Efficacy Study of Dysport RU and Glabellar Lines

The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.


Eligibility Criteria:
Inclusion Criteria:

* Female between 30 - 60 years of age
* Moderate to severe vertical glabellar lines at maximum frown at baseline

Exclusion Criteria:

* Silicone injections into the upper face
* Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or photorejuvenation within the previous 12 months
* Any planned facial cosmetic surgery during the study period
* A history of ablative skin resurfacing of the area to be treated during the study.
Posterior Wall Sparing of Laparoscopic Cholecystectomy in Cirrhotic Patients

To assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients in Assuit university hospitals and El Rajhi hospital.

Cholelithiasis is found in about one third of patients with liver cirrhosis and about twice as much as in the overall population. Predisposing factors for that include functional gallbladder alterations (reduced motility and decreased emptying), reduction in bile acidity, increased unconjugated bilirubin secretion, increased levels of estrogen, and increased intravascular haemolysis due to hypersplenism. Symptomatic biliary stones in patients with liver cirrhosis are associated with higher morbidity and mortality rates than those in patients with a non-cirrhotic liver. laparoscopic cholecystectomy is the gold standard for the treatment of most of gallbladder problems because of its several advantages over open cholecystectomy including shorter convalescence period and hospital stay. Furthermore, considering its safety, it is the gold-standard procedure in selected patients with symptomatic cholelithiasis and hepatic cirrhosis, especially Child-Pugh score A and B patients. Separation of posterior wall of the gallbladder from the liver bed in cirrhotic individuals is difficult and risky during a laparoscopic cholecystectomy surgery because of high-risk gall bladder bed due to fibrosis and tortuous, dilated vessels there so the strategy is leaving the posterior wall intact with the liver and the remnant mucosa was removed either by mucosectomy in patients with acute cholecystitis or by electro fulguration in those with chronic cholecystitis.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 - 60 years old Child A and B cirrhotic patients with Cholelithiasis Patient fit for surgery

Exclusion Criteria:

* Patient with pervious abdominal surgery
Evaluation of a Predictive Score for the Onset of Moderate to Severe Alcohol Withdrawal Syndrome, the PAWSS, in a Population of Intensive Care Patients at Brest University Hospital

alcohol use disorder (AUD) is a very common condition in patients admitting in ICU's. Brutal stop of alcohol consumption may lead to a withdrawal syndrome, wich is associated with a worse outcome for ICU patients (longuer ICU and hospital stays, use of mechanical ventilation, traumas). The aim of this study is to valid a score (PAWSS : prediction of alcohol withdrawal syndrome (AWS) scale) to predict at admission mild to severe AWS in ICU patients population.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* able to answer to PAWSS in the first 48hours of ICU stay

Exclusion Criteria:

* No alcohol consumption in the last 30 days
* hospital stay of more than 5 days at ICU admission
* hospital stay less than 5 days in total
* expected sedation time of more than 48h
* patient not able to understand the PAWSS
* no consent