cyrilzakka/clinical-trials huggingface dataset:
Application of Linkage Analysis in the Identification of Novel Hereditary Factors in Familial Aneurysms

The aim of this study is to describe the effectiveness of the application of Linkage Analysis, compared to the standard procedures currently provided by the italian NHS, in the identification of thoracic aortic aneurysms and dissection (TAAD) transmission markers in individuals with familial TAAD.

According to current guidelines, it is important to screen first-degree relatives of patients with familial thoracic aortic aneurysm and dissection (FTAAD) using imaging techniques in order to detect any undiagnosed or asymptomatic cases. The current diagnostic methods for FTAAD involve clinical and instrumental diagnosis. In addition to these methods, genetic analysis through DNA testing, using a blood sample has become an essential tool. The use of massive parallel sequencing (NGS) of multiple genes or the entire exome (Whole Exome Sequencing - WES) is considered the gold standard for genetic diagnosis of FTAAD. However, it should be noted that linkage studies are not currently included in the diagnostic protocols of the Italian National Health System, although they may be helpful in complex familial cases where DNA sequencing has not provided conclusive evidence.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ascending thoracic aortic aneurysms in the absence of a mutation identified by WES
* Subjects with small and medium artery aneurysms in the absence of a mutation identified by WES
* Relatives of individuals with ascending thoracic aortic aneurysms in the absence of a mutation identified by WES
* Relatives of individuals with ascending thoracic aortic aneurysms in the absence of a mutation identified by WES
* Signed informed consent

Exclusion Criteria:

* Subjects wit syndromic FTAAD with WES identified gene mutation
* Subjects wit non-syndromic FTAAD with WES identified gene mutation
DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia

This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment

PRIMARY OBJECTIVE:

I. To validate significant associations between SNPs and treatment outcome and toxicity on Children's Cancer Group (CCG)-1891 on an independent sample set from a successor CCG study for standard risk acute lymphoblastic leukemia (ALL), CCG-1952.

II. To evaluate the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients on CCG-1952.

III. To evaluate interactions among genotypes and other risk factors for treatment response in a combined data set of CCG-1891 and CCG-1952 with recently developed analytic tools for high dimensional data.

IV. To develop predictive models utilizing genetic information obtained in Aim 1.1 and clinical data to predict treatment response and toxicity.

OUTLINE:

Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X\^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in clinical trial CCG-1891 or CCG-1952 with pediatric ALL
A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0\~29.9 kg/m2
* A subject who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator within 30 days before the first administration of the investigational drug
* A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
* A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.

Exclusion Criteria:

* A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
* A subject who has an acute illness within 30 days prior to the first dose of investigational drug
* A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
* A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
* A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
* A subject who is judged unsuitable to participate in this study by the principal investigator
Cardiovascular Consequences After COVID-19

The occurrence of cardiovascular complications in SARS-CoV-2 infections appears to be more frequent than in other viral respiratory infections, probably due to a singular pathophysiology of this coronavirus.

The lack of characterization of cardiovascular damages linked to Covid-19 could have medium and long-term consequences on the prognosis of patients. This problematic could lead to a second major public health problem linked to Covid-19 and it is therefore crucial to keep monitoring and screening patients at risk.

In this context of emerging infectious diseases, of poorly characterized cardiovascular damages during infection and of absence of data on the long-term evolution of the infection, the investigators propose to carry out a prospective and observational cohort study focused on the evaluation and the systematic cardiovascular follow up of patients who survived an episode of Covid-19, regardless of their cardiovascular profiles.


Eligibility Criteria:
Inclusion Criteria:

• All adults affiliated to social security attending the post-Covid follow-up consultation, having presented an episode of Covid-19 diagnosed by at least one positive nasopharyngeal RT-PCR test for SARS-Cov-2 and considered recovered.

Exclusion Criteria:

* Age \<18 years old
* Major under guardianship or curatorship
* Absence of non-opposition
A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)


Eligibility Criteria:
INCLUSION CRITERIA

Subjects will be eligible to begin study participation if they meet all of the following inclusion criteria:

* Subjects must give written informed consent
* Male or female subjects ≥18 to ≤75 years of age (at randomization in Study ELN100226-RA201)
* Subjects must have been randomized in Study ELN100226-RA201;
* Subjects who have completed the Month 6 visit of Study ELN100226-RA201 OR Subjects who have an inadequate therapeutic response (defined as a \< 20% reduction from baseline \[Month 0 in Study ELN100226-RA201\] for both painful/tender and swollen joint counts) after receiving at least 4 infusions of study drug and has not been rescued with other RA medications during the treatment phase of Study ELN100226-RA201;
* Subjects must be taking MTX at the same dose last used in Study ELN100226-RA201;
* Female subjects of childbearing potential agreed to use adequate, contraceptive methods (either intrauterine device \[IUD\], oral or depot contraceptive, or barrier plus spermicide). Female subjects of childbearing potential used adequate contraception for at least 2 months prior to study entry and continued contraception for at least 3 months after their last infusion of study drug;
* Subjects must be willing and able to complete all planned study procedures.

EXCLUSION CRITERIA

Subjects will be excluded from the study if they meet any of the following exclusion criteria:

* Females who are pregnant or breastfeeding or those planning to become pregnant in the next 14 months;
* Subjects who have experienced anaphylaxis, angioedema, urticaria, clinical syndrome diagnostic of serum sickness, or biopsy-proven vasculitis to a previous infusion of study drug;
* Subjects who received rescue intervention in Study ELN100226-RA201, defined as an increase in dose of an existing permitted concomitant treatment of RA or the introduction of a new treatment of RA;
* Subject who are expected to be unavailable for the duration of the trial, likely to be noncompliant with the Protocol, or who are felt to be unsuitable by the Investigator for any other reason;
* Subjects with a history of a malignancy (other than surgically excised basal or squamous cell carcinoma of the skin);
* Subjects with a history of clinically significant and/or persistent gastrointestinal, pulmonary, chronic infection, cardiovascular, renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers) or hematological illness, which in the opinion of the Investigator places the subject at unacceptable risk for participation in the study;
* Subjects who intend to donate blood or blood products during the period of the study or within one month following completion of the study.
Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement

The aim of this study was to evaluate the dimensional alveolar bone changes in immediate post extraction implant placement with loading compared to immediate post extraction implant placement without loading in the maxillary premolar area . The main question it aims to answer is : Can immediate post extraction implant placement in the maxillary premolar area with loading achieve better alveolar bone dimensions than without loading?


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who have at least one non restorable tooth in the maxillary premolar area that needs to be extracted.

  2. Patients with healthy systemic condition. 3. Patients aged from 20 to 45 years old. 4. Buccal bone thickness should be at least 1mm. (Morton et al., 2014) 5. Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014) 6. Good oral hygiene.(Wiesner et al., 2010) 7. Accepts one year follow-up period (cooperative patients) Patient provides an informed consent.

  8. Adequate Inter-arch space for implant placement. 9. Favorable occlusion (no traumatic occlusion)

Exclusion Criteria:

- 1. Patients with signs of acute infection related to the area of interest. 2. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).

3. Current and former smokers (Lambert, Morris and Ochi, 2000) 4. Pregnant females.
A Psychotherapy Development Study for Internet Gaming

The fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) introduces Internet Gaming disorder (IGD) as a Substance-Related and Addictive Disorder in Section 3, Conditions for Further Study. Although research is in the nascent stages, existing studies demonstrate that IGD is associated with psychosocial distress including suicidality, and adverse vocational and educational outcomes in youth. Internet gaming disorder also shares substantial overlap with substance use, and it primarily affects adolescents, who rarely seek treatment on their own. Parents more often express concerns about their child's game playing behaviors, and data suggest that parents can have strong influences on it. This psychotherapy development study will evaluate feasibility, acceptability, and effect sizes of a behavioral intervention designed to help parents reduce gaming problems in their children. Sixty concerned parents and their children will complete parental and self-report inventories and structured diagnostic interviews regarding the child's gaming behaviors, substance use and psychosocial functioning. Participants will be randomized to either a control condition consisting of referral for mental health issues and family support services or to the same plus a 6-week family-based behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors and encouraging and rewarding alternatives to game playing. Gaming and other problems will be assessed pre-treatment, mid-treatment, at the end of treatment, and at a 4-month follow-up. This study is unique in evaluating initial psychometric properties of a parental version of a measure that uses the DSM-5 criteria for IGD in a clinical sample, and it will also assess associations of IGD with substance use, psychological symptoms, and family functioning over time. Most importantly, this study will be the first randomized trial of an intervention designed to reduce gambling problems, and results are likely to guide future research and treatment efforts related to this condition.


Eligibility Criteria:
Inclusion Criteria:

* parent/guardian of a 10-19 year old residing in the same household \>8 months/year
* reports significant problems with game playing

Exclusion Criteria:

* have a condition that may hinder study participation
Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study

Hypercapnia is a frequent clinical situation defined as an elevation of the partial pressure of carbon dioxide (PaCO2) above 45 mmHg. Several physiopathological parameters such as respiratory minute volume, dead space volume or CO2 production influence the PaCO2. Therefore, hypercapnia can affect the time of various diseases.

Available epidemiological data regarding hypercapnia are from studies investigating the efficacy of non-invasive ventilation (NIV), with different population cohorts. However, their interpretation must be cautious given the heterogeneity in patient case-mix and results.

Then, whether hypercapnia is a common reason for intensive care unit (ICU) admission, epidemiological data is scarce and heterogeneous. The aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to ICU with hypercapnic respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* patients ≥18 years old presenting with at least of the following items :

  1. respiratory rate ≥ 25/min,
  2. paradoxical motion of the abdomen,
  3. intercostal retraction AND
* a PaCO2 \> 45 cm H20 before ICU admission or within the 12 hours following ICU admission.

Exclusion Criteria:

* Refusal to give informed consent,
* pregnancy,
* \< 18 years patient,
* dying patient
Effect of Covid-19 Vaccination on Male

we will assess the effect ofcovid19 vaccination on the reproductive and sexual function of the Male Egyptian

Coronaviruses are a group of RNA viruses that primarily affect the respiratory system and cause the common cold, fever, and coughs in mammals and birds. However, in some cases, coronaviruses are associated with more serious and lethal conditions, such as pneumonia, bronchitis, and severe acute respiratory syndrome .

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) originating from Wuhan, China, led to a global health crisis. SARS-CoV-2 had infected more than 450 million people, resulting in more than 6.6 million deaths. The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), the infectious disease caused by SARS-CoV-2, a pandemic, and many states enacted strict rules, such as border closures, transportation restrictions, and quarantine.

Quality and satisfying sexual life have a positive effect on the social and daily relationships as well as on the intimate life of many individuals. The WHO summarizes the definition of sexual health as the physical, emotional, mental, and social well-being of an individual. On the other hand, sexual dysfunction can be described as any condition preventing the individual from being satisfied by the sexual activity at any stage of the sexual relationship.

The renin-angiotensin system (RAS), also ACE 2 and TMPRSS2 play an important role in the cellular entry for SARS-CoV-2. Because the male genital system presents high ACE 2 expression, the importance of this pathway increases in COVID-19 cases. As the COVID-19 pandemic has affected the male genital system in direct or indirect ways and showed a negative impact on male reproduction Ozer Baran and Aykut Aykac et al reported that the fear of infection and transmission of the disease to the partner that occurs during the Covid-19 pandemic manifests itself in the form of a decrease in the frequency and quality of sexual intercourse.

A COVID 19 vaccine is a biotechnology product intended to provide acquired immunity against corona virus disease 2019 (COVID 19) As of 1st June 2020, there were 124 candidate vaccines that were being developed for the prophylaxis of COVID-19. Of these, 10 vaccine candidates had entered phase1, combined phase 1/2 or phase 2 human clinical trials in adults

Eligibility Criteria:
Inclusion Criteria:

* Male patients receive covid 19 vaccinations. Age from 20 to 55 years

Exclusion Criteria:

* Patients complaining of ED or any sexual dysfunction before Vaccination.

  * Patients with history of male infertility before Vaccination.
  * Patients who have pyschological disorders or any other systemicdiseases
Behavioral Self-Regulation

The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.


Eligibility Criteria:
Inclusion Criteria:

* body mass index between 27 and 40
* age between 21 and 35

Exclusion Criteria:

* report a history of eating disorder or a current eating disorder
* report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician
* report major psychiatric diseases or organic brain syndromes
* currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months
* pregnant, lactating, or less than 6 months post-partum
* intend to move out of city within the time frame of the investigation or will miss multiple meetings during the study time frame
The Effects of Sacroiliac Joint Manual Therapy on Autonomic Nervous System and Lower Abdominal Pain in Women in Their 20s With Primary Dysmenorrhea

Disorders of the autonomic nervous system are considered another possible cause of dysmenorrhea. spinal manual threapty is acting on the parasympathetic and sympathetic nerves.

The sacrum affects all vertebrae, which affects the position of this bone, is thought to have a lot to do with dysmenorrhea.

In this study, by applying spinal manual threapty threapty to the sacroiliac joint in women in their 20s with primary dysmenorrhea, we tried to present an effective treatment method by evaluating the function of the autonomic nervous system and confirming the occurrence of pain in the lower abdomen.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 20-29
* Regular menstrual cycle (24-32 days)
* Those who have had symptoms of primary dysmenorrhea for at least 1 year
* Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
* The body mass index is between 20-30
* Positive reaction to Gillet test

Exclusion Criteria:

* pelvic inflammatory disease
* uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
* Those who have used an intrauterine contraceptive device
* Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment
Study of Capsule Endoscopy to Determine the Accuracy for Detection of Esophageal Varices

Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this study was to determine whether esophageal capsule endoscopy is convenient and accurate as upper endoscopy for detection of esophageal varices and related lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years and less than 86 years at the time of consent.
* Clinically evident or biopsy proven cirrhosis.
* No previous documented UGI bleeding due to peptic ulcers, varices, portal hypertensive gastropathy, angiomas, or watermelon stomach.
* No previous endoscopic, radiological or surgical treatment for variceal bleeding or ascites.
* Probable life expectancy of at least 24 months without liver transplantation, as judged by the hepatologist and endoscopist-investigators, and have a Model for End-Stage Liver Disease (MELD) score ≤ 29.
* Signed a written informed consent.

Exclusion Criteria:

* Prior variceal bleeding- esophageal, gastric, or other site.
* Prior endoscopic (e.g. sclerotherapy, ligation, or combination therapy), radiological (e.g. transjugular intrahepatic portosystemic shunt-TIPS) or surgical (e.g. portocaval or splenorenal shunt) treatment of esophagogastric varices or ascites.
* Patient who was uncooperative or unable to give written consent.
* Severe co-morbid illness, e.g. end stage chronic renal disease (e.g. dialysis dependence, creatinine greater than 2 times normal) or respiratory failure (e.g. ventilator dependent, oxygen dependent, unstable asthma or chronic obstructive pulmonary disease- e.g. 2 or more hospitalizations for exacerbation in 1 year, asthma or obstructive pulmonary disease which required daily bronchodilators and/or oral/inhaled steroids), tense ascites requiring repeated therapeutic paracenteses, severe hepatic encephalopathy, peritonitis, or sepsis.
* Active cancer with less than a 24 month expected survival and/or cancer on active treatment with chemotherapy and/or radiation therapy.
* Esophageal motility disorder, esophageal stricture or esophageal diverticulum, causing dysphagia or requiring dilatation.
* GI obstruction or partial obstruction (by history or imaging), symptomatic GI stricture or pseudo-obstruction which may prevent passage of the capsule.
* Patients with potentially reversible portal hypertension such as alcoholic hepatitis, acute viral hepatitis, untreated autoimmune hepatitis, or chronic hepatitis B or C on viral therapy.