cyrilzakka/clinical-trials huggingface dataset:
The Pakistan Early Childhood Development Scale Up Trial

The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.

In Pakistan, the "National Program for Family Planning and Primary Healthcare" delivers maternal and child health and nutrition services in rural and remote areas of Pakistan through community-based Lady Health Workers. The strengths of the programme include provision of services at grassroots levels, reinforcement of health and basic nutrition messages and community acceptability. Given, the growing recognition that optimal early child development (ECD) also requires the integration of psychosocial care; the PEDS-Trial has been proposed to evaluate the benefits of the addition of 'stimulation and care for development' interventions and the feasibility of scaling up an ECD strategy within the community healthcare system of Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* All children born in the defined geographical area of study during the study enrollment period will be eligible for the study along with their primary care giver (mother). Infant must be 1d-2.5m of age at time of enrolment.

Exclusion Criteria:

* Children born with profound severe disabilities
Gingival Crevicular Fluid Vaspin and Omentin Levels in Obese Patients With Chronic Periodontitis

Our objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with chronic periodontitis in order to determine the usefulness of vaspin and omentin as a diagnostic and prognostic biomarker of periodontal disease.

All individuals underwent a full-mouth periodontal examination, which included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP). BMI and WHR were used for assessing obesity. In addition, HbA1c and fasting plasma glucose levels were used for elimination of diabetes mellitus. Based on the periodontal and anthropometric measurements, individuals (n=76) were divided into four groups: the periodontal-healthy group (n=19), chronic periodontitis group (n=19), periodontal-healthy with obesity group (n=19) and chronic periodontitis with obesity group (n=19). Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. Vaspin, omentin, and TNF-α levels were measured by enzyme-linked immunosorbent assay.

Eligibility Criteria:
Inclusion Criteria:

1-) 30-49 years of age 2-) had a minimum of 20 natural teeth, excluding third molars 3) glycosylated hemoglobi levels \<6% 4) fasting plasma glucose levels \<100 mg/dl. 5-) Criteria for the periodontal healthy group were GI = 0, PPD≤ 3 mm, and no signs of attachment and bone loss by clinical and radiographic examination.

6-) Criteria for the chronic periodontitis group were clinical signs of inflammation (red color and swelling of the gingival margin), GI ≥ 2, PPD and CAL ≥ 5 mm, and bone loss affecting \>30% of the existing teeth on clinical and radiographic examination.

7-) Criteria for obese groups were 30≤ BMI \<40 kg/m2, and concomitant WHR ≥0.85 for females and WHR ≥0.90 for males.

8-) Criteria for normal-weight groups were 20≤ BMI \<25 kg/m2, and WHR below that determined for obesity.

Exclusion Criteria:

1. Aggressive periodontitis,
2. Periapical pathologies
3. Excessive forces including mechanical forces from orthodontics and occlusion
4. Systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions)
5. Chronic high-dose steroid therapy, radiation or immunosuppressive therapy
6. Pregnancy, lactation,
7. Smoking within the past five years, or allergy or sensitivity to any drug.
8. Had no history of periodontal therapy or drug therapy (e.g., anti-inflammatories, antibiotics, or any other pharmacological treatment) for at least six months.
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, age greater than or equal to 18 years.
* Confirmed chronic HCV infection.
* Subjects will have cirrhosis status assessment; liver biopsy may be required.
* Genotype 2 subjects must have cirrhosis of the liver to be eligible.
* Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
* Infection with HCV genotype 2 or 3 as determined at Screening
* Body mass index (BMI) greater than or equal to 18 kg/m\^2
* Screening laboratory values within predefined thresholds.
* Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
* Subject must be of generally good health as determined by the Investigator.

Key Exclusion Criteria:

* Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
* Pregnant or nursing female or male with pregnant female partner
* History of any other clinically significant chronic liver disease.
* HIV or chronic hepatitis B virus (HBV) infection.
* Malignancy with the exception of certain resolved skin cancers.
* Chronic use of systemically administered immunosuppressive agents.
* Clinically-relevant drug or alcohol abuse.
* History of solid organ transplantation.
* Current or prior history of clinical hepatic decompensation.
* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
* Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
MagnezixKids Study

The overall objective of the study is to describe the outcomes of osteosyn-thesis with magnesium based screws in children with a primary or second-ary (within 7 days from trauma) dislocated fracture of the Epicondyles ul-naris or Condylus radialis, and to compare them with outcomes of conven-tional osteosynthesis using steel screws.

If our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.


Eligibility Criteria:
Inclusion Criteria:

* primary or secondary (within 7 days from trauma) dislocated fracture of the Epicondyles ulnaris or Condylus radialis (indication for operative treatment according to international standard: Dislocation of more than 2 mm in Condylus radials fractures and more than 5 mm in Epicondylus ulnas fractures )
* Age 3-15 years
* Informed Consent as documented by signature

Exclusion Criteria:

* - open fractures or complex multi fragment fractures that require dif-ferent osteosynthetic procedures than screw fixation
* severe local accompanying injury (injury to nerves/vessels)
* polytrauma patients
* fracture age \> 7 days
* preexisting ipsilateral elbow fracture
* relevant comorbidities, which have influence on fracture and wound healing
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or the legal representatives
* Previous enrolment into the current study
* Enrolment of the investigator's family members and other dependent persons
* Any of the following applicable absolute and relative contraindica-tions listed in the MAGNEZIX® CBS and CSc 4.8 mm instruction for use :

Absolute contraindications:

* insufficient or avascular bone mass for anchorage of the implant, ex-cept osteochondral fractures and dissecates
* confirmation or suspected septic infectious surgical site
* application in the area of the epiphyseal plates

Relative contraindications:

* acute sepsis
* alcohol, nicotine and/or drug abuse
* epilepsy
* poor skin/soft tissue conditions
* uncooperative patient or patient with restricted intellectual capacity
* no options for adequate postoperative treatment (e.g. temporary strain relief)
Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

Observational study about the incidence of relative adrenal insufficiency in patients with cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal bleeding and without liver disease; and in patients with severe acute pancreatitis.

This is a study using pharmaceutical specialties in the approved conditions of use.

Observational, prospective, open-label, in-patient study, that includes patients with upper gastrointestinal bleeding of variceal or peptic origin, and in patients with severe acute pancreatitis.

The adrenal function of every patient included will be evaluated in the first 24 hours of admission This assessment shall be performed using the corticotropin-stimulation short test (synacthen test), that includes serum and saliva determination of cortisol, in basal conditions and 30 and 60 minutes after the administration of 250 ug of corticotropin synthetic (Synacthen, Novartis Pharma AG, Basel, Switzerland).

The cortisol levels will be determined by competitive immunoassay using direct chemoluminescence technology (Bayer Corporation, Pittsburgh, PA, USA).

In patients with severe acute pancreatitis all of these determinations will be repeated at the third day of admission.

Several other clinical and biochemical features will be recorded.

Eligibility Criteria:
Inclusion Criteria (one of the following):

* Presence of acute upper gastrointestinal bleeding (variceal or peptic) + presence of hypovolemic shock (defined as a systolic blood pressure \<100 mmHg coupled with a heart rate\> 100 ppm), or Hb \< 80 g / L;
* Acute pancreatitis (diagnosed by clinical, radiological and biochemical features)with severity criteria (At least one of the following: index of Ranson \> 3, APACHE II \> 8 or CPR\> 120 mg/L, Balthazar CT grade E)

Exclusion Criteria:

* Age \<18 years and \>80 years.
* Pregnancy.
* Patient refusal to participate in the study.
* Prior corticosteroids treatment(oral or topical).
* Treatment during the 30 days prior to inclusion with any of the following drugs: contraception, etomidate, ketoconazole, rifampin or phenytoin.
* History of cranial trauma or surgery.
* Any malignancy in treatment or progression.
* HIV infection.
* Prior known adrenal pathology.
* Patients not eligible to any active treatment because the existence of any clinical condition considered terminal.
* Patients with associated traumatic blood loss, or any other extraintestinal source of active bleeding.
* Burns.
* Patients who have been previously included in this study.
Stingless Bee Honey Augmentation in Major Depressive Disorders: A Randomized Clinical Trial

The goal of this clinical trial is to learn if stingless bee honey can be an augmentation supplement in Major Depressive Disorder (MDD) in adults. It will also learn about the adverse effects of the honey. The main questions it aims to answer are:

1. Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD?
2. Are there any effects of SBH on BDNF between intervention and control groups in MDD?
3. Are there any effects of SBH on oxidative stress between intervention and control groups in MDD?
4. Are there any effects of SBH on verbal learning and memory between intervention and control groups in MDD?

There is no placebo.

Participants will:

Take stingless bee honey or nothing every day for 2 months Visit the clinic once every 4 weeks for checkups and tests Report adherence and adverse effects of stingless bee honey on a self-reported online questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Adults with ages 18 to 65 with Major Depressive Disorder Scores of Beck Depression Inventory Malay version equal or more than 11

Exclusion Criteria:

* Women in pregnancy or breast-feeding. Patients who with honey allergy or stingless bee honey allergy. Currently taking honey not limited to stingless bee honey or taken honey not limited to stingless bee honey in the past one month. Patients with Major Depressive Disorder comorbidity either with generalized anxiety disorder, panic disorder, social anxiety disorder, bipolar disorder, substance-use disorder, suicidal ideation or attempt, dementia, Alzheimer disease, diabetic, hypertension, chronic kidney disease
Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients

The purpose of this study is to determine whether addition of AS101 to the standard chemotherapy regimen is effective in the treatment of newly diagnosed elderly (≥60) AML patients and AML transformed myelodysplastic syndrome (MDS) patients.

AML patients frequently develop cytopenia, which can result in life-threatening bleeding and infections. Despite the administration of prophylactic platelet transfusions, these patients remain at risk of clinically significant hemorrhage. There is a growing need for new, innovative strategies, because the outcome for AML patients, particularly for the older ones, has not substantially changed in the last three decades. Thus, novel compounds to target the tumor cell's resistance to chemotherapeutic agents are essential for the improvement of patients' prognoses. AS101 is a non-toxic, organic, tellurium-based small compound with immunomodulating properties which have previously shown bone marrow sparing effect. In addition in preclinical studies AS101 has shown synergistic effect with several cytotoxic drugs. This study will investigate the safety and efficacy of AS101 formulation in combination with the standard therapy for newly diagnosed elderly AML and AML transformed MDS patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of primary AML or AML transformed myelodysplastic syndrome (MDS) with FAB classification other than M3 as proven by bone marrow aspiration.
* Age ≥60 years.
* ECOG performance status of 0-2 (Karnofsky \>60%).
* Adequate renal functions: Serum Creatinine \< 2 times the upper limit of normal (ULN).
* Adequate hepatic function: serum AST and ALT ≤ 3 x ULN.
* Patients with reproductive potential must use an effective contraceptive method through the study. Patients must receive contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.

Exclusion Criteria:

* Patients receiving any other investigational agents.
* Symptomatic CNS involvement.
* History of pancreatitis or active alcohol abuse.
* Histologic diagnosis of FAB M3 AML.
* Life expectancy of less than 1 month.
* Patient receives Myelotarg (ozogamicin gemtuzumab).
* Use of hematopoietic growth factors such as G-CSF within 1 week prior to treatment initiation.
* Pregnant or lactating females.
* Patient has known human immunodeficiency virus (HIV) infection or known HIV-related malignancy; Patient has active hepatitis A, B or C infection.
* Active, uncontrolled, systemic infection considered opportunistic, life threatening, or of clinical significance at the time of treatment, or any severe concurrent disease which, in the opinion of the investigator, would make the patient inappropriate for trial entry.
* The patient has had congestive heart failure - New York Heart Association (CHF-NYHA) grade II or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which, in the opinion of the Investigator, could put the patient at risk of clinically relevant arrhythmia.
Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

The purpose of the present study is to elucidate the spectrum of ocular flora and their antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.

A conjunctival and palpebral swab will executed at least 14 days before routine cataract surgery. Isolates will be identified using standard microbiological protocols. In vitro susceptibility will be determined using a breakpoint minimal inhibitory concentrations. In case of positivity, the swab will be repeated the day of surgery. Topical antibiotic may be used in case of positivity at the discretion of the surgeon. Descriptive statistics will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cataract surgery
* Age \> 18 years
* Any gender and race
* Willing to sign informed consent

Exclusion Criteria:

* Any antibiotics within 3 months
* Any ocular infection within 3 months
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)

This was a non-interventional, retrospective registry study, utilizing electronic health record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS). Real-world health care resource utilization (HCRU) of AML patients was characterized.

Adult patients (18 years or older) with the inclusion diagnosis, AML (ICD-10 C92.0), between 1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion diagnosis) until the end of follow-up (30.6.2020), or death. This study did not involve any contacts to patients.

The study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to 1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with acute myeloid leukemia (ICD-10 C92.0) during 1.1.2016-30.6.2020
* Adult (18 years or older) at the time of first diagnosis
* Health registry data is available and accessible
* Resident in the hospital district HUS at the time of index diagnosis

Exclusion Criteria:

- AML patients with no treatment information
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)

To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18-65 years and
* Diagnosed with GAD and
* No other psychiatric conditions, and are otherwise medically healthy.

Exclusion Criteria:

* Women who are pregnant or lactating.
Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.


Eligibility Criteria:
Summary of Inclusion Criteria:

* Able to voluntarily provide written informed consent to participate in the study.
* User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
* User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.
Analgesic Effects of Ultrasound Guided PEC Blocks on Analgesic Opioid Consumption of Cancer Surgery Patients

Examining the analgesic effect of ultrasound guided Pectoral Blocks on analgesic opioid consumption after surgical removal of breast tissue.

This study's uniqueness is in the quantification of the analgesic effect of regional anesthesia on its influence to reduce the use of opioid substances, and the variety of side effects associated with them, which has yet to been described in literature.

This is a prospective, observational,single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. Sixty women undergoing breast tissue resection under general anesthesia will be enrolled after filling out an informed consent form.

As standard protocol in our hospital all participants will include women undergoing the surgery under general anesthesia, and the an addition of regional PEC block anesthesia.

The use of opioid substances during surgery will be done under the discretion of the anesthesiologist, according to accepted professional criteria.

All participants will undergo the the PEC block before surgery under general anesthesia under aseptic conditions, which is the standard analgesia protocol in our department.

Ultrasound guided PECS Block will be performed by identifying the thoracic muscles. Following the identification, the investigator will inject the anesthetic solution which will contain the conventional 25 cc of Bupivacaine 0.25-0.5% .

The concentration is determined by the upper dose limit to 2 mg / kg 11.

At the end of the operation all participants will be transferred to the post anesthesia recovery supervision unit, as standard protocol. The women will receive analgesic treatment according to accepted recovery unit protocols of Beilinson Hospital, and according to the professional discretion of the anesthesiologist in charge of the recovery unit.

On postoperative day one all participants will be asked to fill out a questionnaire that measures the degree of their pain after surgery, and the extent of the expected side effects from exposure to opioids This questionnaire is based on a questionnaire measuring quality QoR recovery from general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

Women over 18 who undergo breast tissue resection under general anesthesia at Beilinson Hospital, and are able to comply with the study's protocol

Exclusion Criteria:

1. Lack of patient's consent or lack of patient's ability to provide consent.
2. Known hypersensitivity to local anesthetic or to opioid, which will affect the nature of the pain management therapy in these patients.
3. Existing evidence of infection or gangrene on the thorax which prevents implementation of regional anesthesia - .
4. Known coagulation disorder.
Management of Fragments During Ureteroscopy

The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.


Eligibility Criteria:
Inclusion Criteria:

* Patient with ureteral stones suitable for endoscopic treatment

Exclusion Criteria:

* presence of ipsilateral kidney stones
* known ureteral stricture
* previous placement of ureteral stent
* use of drugs with known activity on smooth ureteral muscle
* unwillingness or impossibility to return for follow-up