cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial)

Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.

The aim of this study is to determine whether the number of oocytes obtained in women oocyte donors may be different with the use of rFSH or uFSH based on receptor N680S FSHR gene polymorphism.

This is an exploratory, prospective, randomized, comparative, open trial with control group treated according to the usual therapeutic approach in our institution for ovarian stimulation for oocyte donors prospective exploratory study control group .

Three groups will be set based on follicle-stimulating hormone receptor (FSHR) genotype for the polymorphism N680: Group SS (Ser/Ser), group SN (Ser/Asn) and group NN (Asn/Asn). Donor members of each group will be randomly assigned to receive daily 225 IU of recombinant or urinary FSH for controlled ovarian stimulation protocol with antagonists. To avoid unintentional bias, allocation to treatment group will take place at the time in which ovarian stimulation according begins with a list of random allocation of treatments for each of the groups (SS , SN and NN) that will be associated the code of the patient and are prepared and will be available before the start of the study. The code assignment and treatment of the patient will consecutively in the order of the list and must be recorded in the medical history of the patient. The next scheduled patient will be assigned to the code and the next immediate treatment in this list.

The protocol for controlled ovarian stimulation in oocyte donors, will be performed always according to the usual protocol in the Instituto Bernabeu.

Eligibility Criteria:
Inclusion Criteria:

* Be considered eligible to get into the oocyte donation program of Instituto Bernabeu
* Age between 18 and 30 years
* Body Mass Index over 18 and under 28
* Antral follicle count greater than 9 and less than 25 (adding both ovaries)
* Patients starting ovarian stimulation with 225 IU of FSH
* Presence of both ovaries
* Ability to participate and comply with the study protocol
* Signing the written consent form
* Not having received treatment with ovulation stimulators in the 3 months prior to stimulation

Exclusion Criteria:

* Not suitable for inclusion in the oocyte donation program of Institute Bernabeu
* Concurrent participation in another study
Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast

Hypothesis The study aims to demonstrate at least equivalence, or non-significant difference between TS and US in women with dense breast screened negative at 2D Mammography.

If the equivalence between TS and US will be demonstrated, US may be substituted by TS with great benefits for the patients and for the healthcare resources.

Aims

1. Assess if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
2. If TS detects new cancers in dense breast similarly to US (approximate rate or marginally lower rate), evaluate the the true positive/false positive ratio.
3. Cost-analysis. In case of less false positives detected by TS, the true-positive / false positive trade-off might be strongly in favour of TS with a great potential of costs reduction.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects \<50 years of age presenting for mammography, with the exception of those that, on previous mammograms are found to have breast density 1-2 according to the Breast Imaging Reporting and Data System (BIRADS D1-2). - Asymptomatic subjects ≥ 50 years of age who request mammography and have breast density BIRADS 3-4.
* No history of breast cancer - Written informed consent

Exclusion Criteria:

* Pregnant and breast feeding women
* Unable to tolerate breast compression
* Breast implants
* Unable to understand or execute written informed consent
* Unable or unwilling to agree to follow-up during observation period
Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq

Negative mental health effects of war exposure and displacement are pervasive, but many displaced persons and refugees in low-and-middle income countries lack access to evidence-based treatments. Community lay-therapists are a promising solution for the global mental health field. However, in spite of results from randomized-control trials, no research to-date has examined the external validity of community-led lay-therapist effectiveness. In this exploratory study, longitudinal data at three time points were collected from 28 Arabic-speaking displaced persons (nineteen women and nine men, ages 18-57) seeking mental health services from the Jiyan Foundation: a non-profit founded and based in Kurdish Iraq. Lay therapists trained in evidence-based treatments upon being hired operated largely independently of supervision from foreign clinicians. Participants in weekly psychotherapy completed the Posttraumatic Stress Checklist (PCL-5) and the Psychological Health Questionnaire (PHQ-9) at baseline, one month, and three months, as well as a modified measure assessing traumatic exposure, purpose-in-life, and a modified Afghan Daily Stressors Scale at baseline to assess for moderators of change over time.


Eligibility Criteria:
Inclusion Criteria:

* Must speak Arabic fluently; must be seeking mental health services at the Jiyan Foundation

Exclusion Criteria:

* No Arabic proficiency; under 18 years
Effects of Resistive Diaphragmatic Training on Chronic Stroke

To determine the effects of resistive diaphragmatic training on pulmonary function of chronic stroke patients. And also assessing their compromised respiratory functions

This study is to examine the effects of Diaphragmatic breathing exercises with resistance and Digital spirometer training for improving pulmonary functions in chronic stroke patients. Diaphragmatic Resistance training is based on the same principal as for the any other Skeletal Muscle training. The selection of 20 subjects divided equally and placed into an experimental group and a control group and the interventions would applied three times per week for 4 weeks. In each session, both groups receive Digital spirometer training for 15 minutes. In addition, experimental group receive diaphragm breathing exercises with resistance for 30 minutes. Resistance is Applied through Different thera bands and then performing the Breathing Exercises. First of all resistance applied through yellow band(1-6 pounds of resistance) and then red, Green and black which give (4-18 Pounds of resistance) The patient is asked to breath in deeply and slowly while not to move upper chest .Weight increased weekly as per patient's tolerance. Further Digital spirometer training Perform to determine the Pulmonary Functions FVC,FEV1,FVC/FEV1,PEF,VC. in both Control and Experimental Groups

Eligibility Criteria:
Inclusion Criteria:

* Age limit 40-50yrs both genders.
* Stroke patients with compromised pulmonary functions.
* Chronic stroke patients with impaired Breathing

Exclusion Criteria:

* Patients having any systemic illness
* Patients who have a damage accompanying orthopedic disease such as thoracic deformation or rib fracture.
* Patients with stroke (less than 6 months duration)
MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY

The MAGIC-HF STUDY project (MAgna GraecIa evaluation of Comorbidities in patients with Heart Failure STUDY), is an observational prevalence and incidence study focusing on the role that risk factors, various comorbidities, and their treatment may have on CV and non-CV outcomes in patients with all forms of HF. It also aim to assess whether comorbidities and their treatment may be predictors of response to pharmacological and non-drug treatment of HF.

Adult subjects with all forms of HF (HFrEF, HFmrEf, HEpEF) with at least one comorbidity who are referred to the Heart Failure Outpatient Clinic of the AOU "Mater Domini" Geriatrics Unit in Catanzaro will be recruited.

Initially, patients will be evaluated at baseline and followed-up for a minimum of six-month.

All patients will be subjected to clinical, instrumental and laboratory examinations, including medical history data collection and complete anthropometric assessment . Plasma and serum samples will be collected at recruitment and at the six-months follow-up visit. Stool samples will also be obtained and stored at -80C for the omics studies.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent obtained before performing any procedure
* Age\>18 years old
* Confirmed diagnosis of HFrEF, HFmrEF, HFpEF with clinical stability for at least 4 weeks
* Presence of at least one of the following comorbidities:
* Atrial fibrillation
* Peripheral arteriopathy
* Hypertension
* Chronic ischemic heart disease
* Diabetes mellitus type 2 or insulin resistance
* Hepatopathy
* Obesity
* Cancer
* Sleep apnea syndrome
* Chronic kidney disease
* Iron deficiency
* Cognitive Decline or Depression
* Sarcopenia
* Dysthyroidisms
* Hypovitaminosis D
* Hyperuricemia

Exclusion Criteria:

* Liver cirrhosis Child-Pugh C
* Severe chronic renal failure defined by an estimated glomerular filtration rate (eGFR) value \< 15 ml/min/1.73 m2 according to CKD-EPI
* Suspected alcohol or drug abuse
* Pregnancy or breast feeding
Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda

This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.


Eligibility Criteria:
Inclusion Criteria:

* Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF \> 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count
* Residence in the study area
* Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)

Exclusion Criteria:

* Pregnancy or clinical history suggestive thereof
* Weight \< 10 Kg
* History of any HAT treatment within the previous 24 months
* Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge
* Severe anemia (Hb\< 5g/dl)
* Active tuberculosis (sputum positive)
* HIV positive (if patient has been tested and results are known)
* Severe renal or hepatic failure
* Bacterial or cryptococcal meningitis
* Other severe underlying diseases upon admission
* Refugee status
Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

In this study a new technique for ablation in atrioventricular nodal reentrant tachycardia using cryo-energy will be studied in cases where the standard approach has higher risk.

Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common cause of fast heartbeats in young people. People with AVNRT have two pathways within the heart, the fast pathway (FP) and slow pathway (SP). A treatment for AVNRT is ablation (burning or freezing) of the SP. This can be done with either radiofrequency or cryo-energy. A complication which occurs in 1% of cases is AV block (AVB), meaning the person needs a pacemaker.

Slow pathway ablation is a problem in people when the electrocardiogram (ECG) shows a long PR interval, with greater rates of AVB. This accounts for 5% of AVNRT cases. A possible solution is to treat the FP with cryo-energy and leave the SP intact. This pilot study aims to show this is safe and effective.

Eligibility Criteria:
Inclusion Criteria:

* Documented supraventricular tachycardia (SVT)
* Planned to undergo electrophysiology (EP) study and ablation
* PR interval on ECG \<220ms (Group 1) or \>220ms (Group 2)

Exclusion Criteria:

* Pregnancy
* Age \<18 years
* Inability to provide consent
* High likelihood of tachycardia mechanism other than AVNRT (e.g. Pre-excitation on surface ECG, atrial tachycardia)
COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS

The study is designed as randomized clinical trial performed at the Department of Pediatric Dentistry , Pakistan Institute of Medical Sciences (PIMS) , Islamabad on primary molars requiring indirect pulp treatment in patients aged 5 to 9 years. Two groups , I and II of 40 teeth each will be selected according to inclusion criteria . In Group I , indirect pulp capping will be done with Calcium hydroxide while in Group II , it will be done with MTA . Both the groups will be evaluated clinically and radiographically at 0, 3 and 6 months . Results were compiled and analyzed using standard statistical techniques.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Criteria :

  * Primary molars with deep carious lesions
  * No H/O spontaneous pain
  * No associated swelling
  * No tenderness to percussion
  * Absence of pathological mobility
  * No sinus tract
  * Restorable

Radiographic Criteria :

* No periapical radiolucency
* No loss of lamina dura
* No physiological root resorption
* Teeth with radiographic evidence of more than 0.25mm remaining dentin thickness
* No furcal radiolucency

Exclusion Criteria:

* Non restorable teeth

  * Teeth with pathological mobility
  * Teeth with extensive external/internal root resorption.
  * Teeth with pulp canal calcifications
  * Subjects inability to tolerate any of the dental products being used
  * Systemic disease or severe medical complications ; Lack of compliance
Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in Subjects Suffering From Osteoarthritis Grade I or II

The aim of the present investigation is to evaluate the efficacy of Mangoselect®, a mangosteen extract, and of a formulation containing Mangoselect®, in subjects suffering from activity/exercise-induced knee joint pain/discomfort, during a 12-week supplementation period. Subjective discomfort improvement will be assessed with both WOMAC questionnaire and pain Visual Analogic Scale (VAS); functional joints features, quality of life, and inflammatory markers, will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after the end of the supplementation period. The design of the study is double-blind, randomized, multi-arm, parallel and placebo controlled.


Eligibility Criteria:
Inclusion Criteria:

* Physically active volunteers
* BMI 22-29.9 kg/m2
* Declaring knee joint pain during and/or after activity/exercise
* Joint knee pain rated of at least 4 cm on a 10 cm VAS following activity/exercise
* Diagnosed osteoarthritis grade I or II according to Kellgren-Lawrence classification

Exclusion Criteria:

* Diagnosed inflammatory joint disorder or osteoarthritis grade III or more according to Kellgren-Lawrence classification
* Currentlu chronically taking pain killer drugs or dietary supplement or intra-articular treatment 3 months before selection
* Anemia
* Subjects with knee/joint surgery/replacement in the past 10 years
* Significant injury of the studied knee joint 12 months before selection
* Unable to carry out functional tests and/or questionnaires
* Currently participating or having participated in another clinical trial in the 3 previous months
* Pregnant women and women positive at Beta-HCG serology test
* Any condition that the investigator believes would interfere with the ability to provide inform consent, or comply with study instructions, or confound the interpretations of the study results, or put the volunteer at undue risk
* Allergy to one of the component of the supplements
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic schedule three times a week: on Monday, Wednesday and Friday.

The purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema. \[Metronomic chemotherapy refers to the close, regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no drug-free breaks, over prolonged periods\]. Patients with recurrent or metastatic solid tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or 50 mg). Treatment is administered three times a week (Monday, Wednesday and Friday) continuously until disease progression or unacceptable toxicity or to a maximum of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Ages 16 - 75 years
* Genders: both
* Performance status 0-2 according to the World Health Organization (WHO) scale
* Life expectancy of at least 16 weeks
* Adequate bone marrow, hepatic and renal functions
* Absence of brain metastasis
* Metastatic/locally advanced refractory prostate, breast or non-small cell lung cancer previously treated with no more than two chemotherapeutic regimens
* White blood cells \>= 3500/mm\^3
* Absolute neutrophil count \>= 1500/mm\^3
* Platelets \>= 100,000/mm\^3
* Total serum bilirubin less than 1.5 mg/dl
* Serum transaminases less than 2.0 x upper normal limit (UNL) unless attributed to liver metastases
* Serum creatinine within normal range

Exclusion Criteria:

* Major active infection
* More than two prior chemotherapy regimens for metastatic disease
* Any of the following within the 12 months prior to starting the study treatment:

  * myocardial infarction,
  * severe/unstable angina,
  * coronary/peripheral artery bypass graft,
  * congestive heart failure,
  * cerebrovascular accident or transient ischemic attack, or pulmonary embolism,
  * cardiac dysrhythmias of grade \>/= 2,
  * atrial fibrillation of any grade, or
  * heart rate corrected interval (QTc) \> 450 msec for males or \> 470 msec for females.
* Hypertension that cannot be controlled with medications (\> 150/100 mmHg despite optimal medical therapy)
* Ongoing anti-coagulation therapy
* Pregnancy or breastfeeding
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration; or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.

The aim of the study is to investigate the use of Hemopatch to prevent biliary fistula in patients submitted to surgery for malignancy.

Background: Biliary fistula (BF) is one of the most common sources of post hepatectomy morbidity. International Study Group of Liver Surgery (ISGLS) define BF as increased bilirubin concentration in the drain at least 3 times greater than the serum bilirubin concentration on or after postoperative day (POD) 3. BF is graded into grade A, B and C, based on the clinical impact on the postoperative course. Considering ISGLS definition, the incidence of BF ranges from 4,4% to 27,2%. The definition developed in Humanitas Research Hospital (HRH), defines BF as bilirubin concentration in the drain fluid greater than 10 mg/dL on or after POD 3. In this case, the incidence is around 8%. Various topical haemostatic agents have been developed for liver resection area management their usefulness in preventing BF by using a sealing product on the resection surface still remains unclear and needs to be assessed.

Objective: this study aimed to assess the clinical validation of Hemopatch to prevent post-operative biliary fistula. Secondarily, it is aimed to evaluate the clinical validity of the two proposed definition of biliary fistula.

Methods: According to the incidence of BF in our previous series (considering ISGLS definition), we designed a randomized controlled study on 220 patients, who underwent hepatic resection from 2018 to 2020. Patients were randomized to treatment group A (Hemopatch) and standard group B (Tisseal and Tabotamp). Both ISGLS and HRH definitions of BF were considered. All patients were systematically drained. Drains were maintained at least 5 days, and bilirubin was measured on PODs 3, 5, and 7. Drains were removed if the bilirubin concentration in the drain fluid was less than 10 mg/dL on POD 7. A statistical analysis to compare perioperative variables between two groups was performed. Then, a multivariate analysis was performed to identify potential risk factors for BF.

Eligibility Criteria:
Inclusion Criteria:

* all patients submitted to liver surgery for malignancies.
* \>18 years of age.

Exclusion Criteria:

* biliary reconstruction
* other associated visceral resections
Study for Validation of In-vitro Turbidometric Platelet Aggregation Assay Using Human Blood in Healthy Volunteers

This study is designed for validation of in-vitro platelet aggregation assay using human blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for platelet aggregation assay, was collected from ten subjects, respectively.

Preparation of Platelet Rich Plasma (PRP):

1. Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate vacutainer vials.
2. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP from multiple vacutainer tubes (if required) into a 15 mL conical tube.
3. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15 minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL conical tube.
4. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets in PRP using PPP.

Aggregation Measurement:

Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP is used as a reference to establish 100% optical transmission.


Eligibility Criteria:
Inclusion Criteria:

* 20-50years old
* must be able to consent voluntarily
* consent to keep the study terms of obedience

Exclusion Criteria:

* blood coagulation disorder or bleeding disorder
* blood donation within 60 days or blood transfusion within 30 days before screening
* smoker or who stopped smoking within 1month before screening
* administration of drugs such as anticoagulants or antiplatelets or alcohol within 14 days before screening
* eligibility failure under investigator's judgements
Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement

This study is designed as a multicenter, randomized, assessor- blinded clinical trial.The primary aim of this trial is to assess whether retrograde inferior venal caval perfusion combined selective antegrade cerebral perfusion(ACP)under mild hypothermia, compared with moderate hypothermia combined with selective ACP alone, improves the outcome for the patients undergoing total aortic arch replacement.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 yr-65yr
2. Patient underwent total aortic arch replacement

Exclusion Criteria:

1. Inability to understand/give informed consent,
2. Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial.
3. Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion