cyrilzakka/clinical-trials huggingface dataset:
Impact of the COVID-19 Pandemic on Central Precocious Puberty: a Retrospective Cohort Study from Turkey

Objective: This study investigates the clinical and demographic characteristics of girls diagnosed with central precocious puberty (CPP) in the pre-pandemic and pandemic periods to assess potential changes during the COVID-19 pandemic.

Methods: A retrospective cohort study was conducted on patients admitted to the Pediatric Endocrinology Departments of two centers in Turkey. Girls treated with GnRH analogs between March 2018 and 2022 were categorized into two groups: the pre-pandemic group (2018-2020) and the pandemic group (2020-2022). Clinical, anthropometric, and hormonal data were analyzed. Patients with organic lesions, genetic conditions, or medications affecting puberty were excluded.

Eligibility Criteria:
Inclusion Criteria (Who Can Participate?)

Girls: Tanner stage ≥2 before age 8 peak LH \> on gnrh analog test, basal Lh \>0,3

Patients with organic lesions (e.g., hypothalamo-pituitary tumors), congenital malformations, oncological diseases, neurosurgical or genetic disorders, or medications affecting puberty were excluded from the study
Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial

This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). Our hypothesis is that intra-gastric injection of Botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone.


Eligibility Criteria:
Inclusion Criteria:

1. Age 21 to 65yrs old
2. BMI \>32.5 (Class II obesity)

Exclusion Criteria:

1. Pregnancy or lactation
2. Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
3. Patients with known liver cirrhosis or known esophageal/gastric varices
4. Known eating disorders
5. Known major cardiovascular or pulmonary conditions
6. Previous gastric/bariatric surgery
7. Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
8. Known alcohol or drug abuse
9. Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product
Levels of Endocan in Umbilical Cord Blood Samples of Pregnant Females With Intrauterine Growth Retardation

As a proteoglycan secreted from endothelial cells, expression, and secretion of endocan increases in the endothelium of several tissues secondary to inflammation. It can be regarded as an indicator of endothelial damage. Besides, it is both a target and a modulator of the vascular endothelial growth factor (VEGF) signaling pathway. Considering its action mechanisms, it can provide information about angiogenesis, inflammation, and vascular permeability.

It is known that intrauterine growth retardation mainly occurs as a result of endothelial dysfunction and abnormal angiogenesis in the placenta. In previous studies, maternal serum endocan levels have also been shown to be increased in cases of preeclampsia, which is mainly characterized by placental dysfunction.So, we hypothesize that there may be an association between endocan levels and intrauterine growth retardation.

Endocan is a proteoglycan that is closely associated with inflammation. Its levels increase in association with the severity of endothelial damage. Endothelial dysfunction and abnormal angiogenesis in the placental tissues are the main pathophysiological mechanisms leading to intrauterine growth retardation.

It has been known that there was a significant association between maternal serum levels of endocan and preeclampsia. In cases with preeclampsia, increased serum levels of endocan in maternal blood samples has been reported.

Intrauterine growth retardation is a situation in which endothelial dysfunction and abnormal angiogenesis are the leading disturbances. In fetuses with intrauterine growth retardation, a hypoxic environment secondary to uteroplacental insufficiency. In previous studies, increased levels of endocan in maternal blood samples have been shown. Although maternal blood can be a good reflector of situations both in fetuses and their mothers, measurement of endocan in umbilical cord blood samples may better represent the pathology in fetuses.

Eligibility Criteria:
Inclusion Criteria:

For "intrauterine growth retardation" group:

* consent to participate study
* detection of intrauterine growth retardation during follow up of pregnancy

For "healthy fetuses" group:

* consent to participate study
* absence of intrauterine growth retardation during follow up of pregnancy

Exclusion Criteria:

* multiple pregnancy
* presence of major developmental anomalies of fetuses
* detection of chromosomal anomalies
* malnourished mothers
* vegetarian diet of mothers
* use of cigarette and alcohol during pregnancy
* previous history of stillbirths
A Study of JNJ-89402638 for Metastatic Colorectal Cancer

The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) of JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting
* Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1

  1. Part 1: Must have either measurable or evaluable disease
  2. Part 2: Must have at least 1 measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (\>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula

Exclusion Criteria:

* Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
* Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (\<=)1 (except alopecia, vitiligo, Grade \<= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)
* Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
* Received glucocorticoids (doses \>10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
* Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
Evaluation of Patient Analgesia After Bloc Serratus

Thorax traumas are very common in severe traumatology, including road accidents, representing the second most frequent site (after head injury, according to the FIRST study). These thoracic lesions are the cause of many complications (pneumothorax, hemothorax, lung infections, atelectasis).

The national recommendations recommend the use of multi-modal analgesia with the use of regional loco anaesthesia for pain management and prevention of respiratory complications, including infectious complications. The loco-regional anaesthesia of choice is thoracic epidural or paravertebral block, but these techniques are not without risks, and are contraindicated in many situations (severe head trauma, patient under curative anticoagulation, pelvic trauma...).

The anterior Serratus block appears to be a quality localoregional anaesthesia in thoracic surgery, and a few cases in the literature have shown an interest in severe traumatology.

The investigators perform this anterior Serratus block almost systematically in patients with thoracic trauma in the Hautepierre surgical intensive care unit.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Gender (Male and Female)
* Patient hospitalised in surgical intensive care or continuous trauma care with thorax trauma who received anterior Serratus block analgesia from January 1, 2018 to February 28, 2019
* Patient who has given his consent to the reuse of his data for the purposes of this research

Criteria for non-inclusion:

* Patient who has expressed opposition to participating in the study
* Impossibility of giving the subject informed information (difficulties in understanding the subject,...)
* Subject under the protection of justice
* Subject under guardianship or curatorship
Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight

Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults.

The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.

Furthermore, from april 2020 onwards, a prospective sub study will be conducted. This sub study aims to investigate the changes in lifestyle behaviour of children with overweight or obesity and their families during the COVID-19 pandemic, including the (governmental) measures taken for this, and the effect of obesity and different weight-related risk factors on the host response of these children.

The goal of this sub study is to collect data to enable analyses for future research questions regarding the influence of the COVID-19 on the lifestyle of a child with overweight and their family. Endpoints are for example physical activity, eating behavior, BMI-z score, remote lifestyle coaching, quality of life and parental practices regarding nutrition and physical activity behavior. We will also measure symptoms associated with COVID-19 and the host response that target COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the COACH program
* Aged till 18 years old (at time of inclusion)
* Overweight or obesity according to International Obesity Task Force (IOTF) criteria

Exclusion Criteria:

• None
Study to Evaluate DNL747 in Subjects With Alzheimer's Disease

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Alzheimer's disease when administered for 29 days in a cross-over design

This is a Phase 1b randomized, placebo-controlled, double-blind, crossover study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL747 in subjects with Alzheimer's disease (AD)

Eligibility Criteria:
Key Inclusion Criteria:

* Women of non-childbearing potential and men, aged 55-85 years
* AD diagnosis based on the 2011 National Institute on Aging-Alzheimer's Association Guidelines
* Supportive evidence for diagnosis of AD based upon positive CSF Aβ42 test, or documented history of positive amyloid-specific PET scan
* Screening MMSE score of 16-26 points
* Screening CDR Global Score of 0.5-1.0
* Availability of a person ("caregiver") who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits that require input for scale completion, assists the participant with compliance for at-home study treatment administration, and signs the necessary consent form (note: the caregiver is not required to stay in the unit)
* Approved AD treatments (acetylcholinesterase inhibitors ± memantine) and other prescription medications must be stable for ≥1 month prior to screening and anticipated to be stable over the duration of the study

Key Exclusion Criteria:

* Clinical history within 2 years of the screening visit or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with transient or sustained alterations in cognition
* Magnetic resonance imaging (MRI) at screening (or within 1 year of screening visit) consistent with any neurological or neurodegenerative disorder other than AD that is associated with transient or sustained alterations in cognition
Drug Eluting Balloon for Treatment of Unstable Angina

This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.

Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18, \< 80 years old, with unstable angina
* Single-vessel or double-vessel disease
* Length of target lesion \< 25mm
* Diameter of target vessel \>2.5mm, \< 3.5mm

Exclusion Criteria:

* Left main disease
* Chronic total occlusion
* Severe Tortuosity
* Heavy calcification
* Severe liver failure, moderate or severe kidney failure
* Malignant disease
* Active infectious disease
* Pregnancy or breastfeeding
Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis

the aim of the study is to compare between two non-surgical methods of treatment of peri-implantitis by using debridement and placing an healing abutment with electomagnetic field (MED-Magdent Miniaturized Device) in the test group and Sham healing abutment in the control group ( Sham MED).

Dental Implants are common alternative for replacement at the time of tooth loss. The two common methods for treatment implant with inflammation include surgical and global non-surgical treatment.

The non-surgical treatment includes soft tissue debridement with various tools which including manual, ultrasonic rotators, lasers and delayed release devices.

Using an electromagnetic field to induce bony healing in fractures and around implants is being investigated for studies and was found to be effective and safe. The electric field lowers osteoclasts activity, speeds up osteoid construction and stimulates creation blood vessels development. Forty patients who will attend to the department of periodontology at Rambam health care campus, at the School ofpostgraduate Dentistry, which will meet the research criteria, will be recruited. All patients will exhibit a moderate-onset gum infection around one of the implants.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Patients of 20 - 85 years.
* pocket depth of 5-8 mm and bone loss of 3-5mm Patients with fixed prosthodontics Implant with standart width

Exclusion Criteria:

* Heavy smokers (more than 10 cigarettes per day).
* Pregnant women
* active periodontal disease
* Consumption of Non Steroidal Anti Inflammatory drugs
Ivermectin in Treatment of COVID-19

confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt


Eligibility Criteria:
Inclusion Criteria:

COVID-19 patients during period of the study more than 18 years old

Exclusion Criteria:

refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any drug with interaction with ivermectin
Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty

The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques. The secondary objective is to assess the effect of implant position using GPS vs. conventional techniques on ROM and patient reported outcomes. Long-term follow-up to 10 years with minimum 2 year follow-up for patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 21 years of age at the time of surgery
* Patient is indicated for reverse shoulder arthroplasty
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing to participate for the entire length of the prescribed follow-up (minimum 2 years)
* Patient is willing and able to review and sign a study informed consent form
* Preop CT scan is within 3 months of the date of surgery

Exclusion Criteria:

* Revision shoulder arthroplasty
* Reverse shoulder arthroplasty for fracture
* Need for structural glenoid bone graft
* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Neuromuscular disorders that do not allow control of the joint
* Significant injury to the brachial plexus
* Non-functional deltoid muscles
* The patient is unwilling or unable to comply with the post-operative care instructions
* Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4 that affect follow-up care or treatment outcomes.
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversaly affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims
Autologous Bone Marrow Concentration for Rotator Cuff Tear

This study aims to evaluate the effect of bone marrow concentration on healing of rotator cuff tear by comparing clinical and imaging outcomes between patients receiving arthroscopic repair with intraoperative bone marrow concentration and those receiving arthroscopic repair only.

Rotator cuff tear is a common cause of pain and disability among adults. Most tears are largely caused by the normal wear and tear that goes along with aging. Although nonsurgical treatment relieves pain and improves function in the shoulder, surgical repair for a torn rotator cuff is indicated if symptoms persisted or deteriorated after 3 months nonsurgical treatments, Recently, arthroscopic repair has become the mainstream of surgical repair for rotator cuff tear. However, the healing of a repaired tendon is not always predictable. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve the healing of tendon grafts in a bone tunnel. Therefore, the goal of this study was to evaluate the effect of bone marrow concentration on healing of rotator cuff.

Eligibility Criteria:
Inclusion Criteria:

* With diagnosis of rotator cuff tear
* Age between 40 and 70 years

Exclusion Criteria:

* With prior history of shoulder surgery
* With current or prior history of trauma or infection at shoulder
* With current diagnosis of coagulopathy
* With current or prior history of cancer
* With current or prior history of hematological disease
* Pregnancy
* Patients who will not cooperate with one-year followup
CKD-828 (40/5mg) Pharmacokinetic Study

The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828 (Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.


Eligibility Criteria:
Inclusion Criteria:

* A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
* Have not any congenital or chronic diseases and medical symptom.
* Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).
* Able to participate in the entire trial.
* Signed the informed consent form prior to the study participation.

Exclusion Criteria:

* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.
* The evidence of acute disease within 28 days prior to the first IP administraion.
* Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
* Hypersensitivity Telmisartan or Amlodipine.
* SBP\<90mmHg or DBP\<50mmHg.
* Abnormal laboratory result(s): AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit.
* A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
* Diet(Especially, grapefruit juice-within 7 days prior to the first IP administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Donated whole blood within 60 days prior to the first IP administraion.
* Participated in the other clinical trials within 90days prior to the first IP administraion.
* Medicine within 10 days prior to the first IP administraion? Does the medication affect this trial.
* Appropriate for the trial judging from principal investigator.
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.

The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation.

Eligibility Criteria:
Inclusion Criteria:

* Body weight greater than or equal to 30 kilograms
* Pulmonary regurgitation ≥moderate pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient \>35mmHg by echocardiography
* pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm
* Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

* Pre-existing mechanical heart valve in any position
* Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart)
* Coronary artery compression
* A known hypersensitivity to Aspirin or Heparin
* Immunosuppressive disease
* Active infectious disease (e.g. endocarditis, meningitis)
* Estimated survival less than 6 months
* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.