cyrilzakka/clinical-trials huggingface dataset:
Mutation Analysis of 17α-Hydroxylase

To elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase deficiency.

17α-hydroxylase is a rare form of congenital adrenal hyperplasia. Patients with complete 17α-hydroxylase deficiency may come to attention to the doctor at their early adulthood due to hypertension or disordered puberty. 17α-hydroxylase is a form of cytochrome P450 enzyme in the adrenal cortex for the production of cortisol, while 17,20-lyase is required in both adrenal glands and the gonads for the production of androgen precursors of sex hormones. Therefore, patients with 17α-hydroxylase will presented with elevated deoxycorticosterone (DOC) level and decreased aldosterone and cortisol level. Because DOC is the second most important naturally occurring mineralocorticoid hormone, hypertension and hypokalemic alkalosis will be noted in these patients. Besides, deficiency of 17,20-lyase activity will lead to impairment of virilization in 46 XY patients and deficient estrogen production in 46 XX patients.

The P450c17 has both 17α-hydroxylase and 17,20-lyase activity and are encoded by the CYP17 gene. The sequence of CYP17 gene was established in 1987 and more than 40 mutations were identified till now. The purpose of this study is to elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 17α-hydroxylase deficiency and their family

Exclusion Criteria:

-
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.


Eligibility Criteria:
Inclusion Criteria:

1. Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
4. Minimum life expectancy of ≥ 12 weeks;
5. Adequate organ function confirmed at screening period;
6. Histologically or cytologically confirmed unresectable,metastatic or Extensive-Stage small cell lung cancer (SCLC).

Exclusion Criteria

1. Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
2. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator's discretion) prior to the first dose of the study drug;
3. Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
4. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.;
5. Women who are pregnant, have positive results in pregnancy test or are lactating;
6. Not eligible to participate in this study at the discretion of the investigator.
Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.

The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in patients with chronic hepatitis C after liver transplantation. The only approved drugs for treatment of hepatitis C are pegylated interferon and ribavirin.

Hepatitis C recurrence after liver transplantation remains the main cause of graft loss after liver transplantation. Several strategies can be used to prevent or treat hepatitis C in the setting of liver transplantation. There are no controlled studies evaluating the efficacy and safety of antiviral treatment (using pegylated interferon and ribavirin) in liver transplant recipients. The main endpoint of this study was: 1) histological outcomes (effect of antiviral treatment on disease progression, i.e. liver fibrosis). The secondary endpoint were 1) Sustained virological response (persistent HCV-RNA clearance) and 2) Safety of pegylated interferon and ribavirin

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C defined by liver biopsy and presence of HCV-RNA
* More than 6 months from liver transplantation
* Written inform consent

Exclusion Criteria:

* Severe hepatitis C recurrence (F3-F4 fibrosis stage, cholestatic hepatitis)
* Double liver-kidney transplantation
* Leucopenia (2000) or thrombocytopenia (40.000)
* Anemia (Hemoglobin lower than 10 g/dL)
* Renal failure (creatinine \> 2 mg/dL)
* Autoimmune disease
* All contraindications for interferon and ribavirin therapy
Continuous Infusion and Bolus Doses of Rocuronium During Lumbal Discectomy, Muscle Strength and Patient Recovery

The continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.

Rocuronium is a non-depolarising neuromuscular blocking agent that can be administered in bolus doses or via continuous infusion during general anesthesia. Due to the specificity of the knee-chest position in a lumbar discectomy, many complications during anesthesia and surgery are possible. Therefore an effective and balanced intraoperative neuromuscular block is needed.

Studies so far have not included a comparison on muscle strength and quality of patient recovery of the effect of continuous infusion and bolus doses of rocuronium during anesthesia for lumbar discectomy.

The hypothesis of this research was that the continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.

The aim was to compare the influence of the continuous infusion and bolus doses of rocuronium on patient recovery. Therefore the investigators assessed how continuous infusion and bolus doses of rocuronium affect the recovery of muscle strength as measured by a hand-grip dynamometer. The quality of patient recovery was assessed by standardised questionnaire (Qor-40 - Quality of recovery questionnaire).

The aim was also to evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* ASA ( American Society of Anesthesiologists) grading status I-III
* scheduled for lumbal discectomy under general anesthesia
* signed informed consent for participating in the research

Exclusion Criteria:

* neuromuscular disease
* poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease
* allergic reaction to any of the medications in protocol
* pregnancy
* refusal to participate in the research
SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia

The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate.

Exclusion Criteria:

* Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.
Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.


Eligibility Criteria:
Inclusion Criteria selected:

* Histologically verified diagnosis if MALT lymphoma of any localization
* Measurable disease upon diagnosis or first or greater relapse after local therapy, prior chemotherapy orHP-eradication. In addition, also in patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successfulHP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection may be enrolled immediately
* Ann Arbor Stage I-IV
* In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
* ECOG performance status of 0,1 or 2
* Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin

Exclusion Criteria selected:

* Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component
* Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
* History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
* Major surgery, other than diagnostic surgery, within the last 4 weeks
* Evidence of CNS involvement
* A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
* Severe peripheral polyneuropathy
* Clinically significant cardiac disease or myocardial infarction within the last 6 months
* Known hypersensitivity to thalidomide or lenalidomide or rituximab
Raising Healthy Children: A Hybrid Trial of the Family Check-Up 4 Health in Primary Care

This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and randomized to receive the FCU4Health or Treatment as Usual.

The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents and children complete a comprehensive assessment, including questionnaire and observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to create a tailored plan to address family needs. This plan may include referrals to community resources or parenting modules that focus on family management.

Eligibility Criteria:
Inclusion Criteria:

* BMI at or above 85% tile for age and gender

Exclusion Criteria:

-
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children

To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside antiretroviral drugs (part 2), in HIV-infected infants and children.

This Phase I/II study will be conducted in 2 parts each lasting at least 24 weeks. Pharmacokinetics and safety data for part 1, a treatment regimen containing saquinavir and nucleoside antiretrovirals, will be collected for 8 weeks before proceeding to part 2. During the first 8 weeks, pharmacokinetic data will be analyzed to allow dose adjustments for individual patients and to confirm the starting dose estimates for part 2. In addition, safety data will be reviewed to ensure that saquinavir is well tolerated with nucleoside antiretrovirals before it is combined with a second protease inhibitor. In part 2, saquinavir will be combined with nelfinavir, a protease inhibitor recently approved for use in children. The pharmacokinetics and safety profile of these drugs in combination will be determined.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection according to standard definitions employed by the Pediatric AIDS Clinical Trials Group.
* Laboratory evidence of immunosuppression (Centers for Disease Control and Prevention \[CDC\] categories 2 and 3), or symptomatic HIV disease (CDC categories A, B, and C).
* At least 4 patients (2 in each parts 1 and 2) will be enrolled in each of three age strata:
* 6 months to 2 years; greater than 2 years to 6 years; and greater than 6 years to 13 years. NOTE:
* For the purposes of analysis only, patients will be stratified by age.

  1. Patients must be protease inhibitor therapy naive.
* Antiretroviral agents other than those prescribed by the investigator.
* Biologic response modifiers (other than erythropoietin, G-CSF, short course \[\<14 days\] corticosteroids, or intravenous immune globulin).
* Other investigational drugs.
* Drugs known to significantly interact with saquinavir and/or nelfinavir. Patients must be protease inhibitor therapy naive.
Effect on Primary Dysmenorrhea

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of \>/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
* Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
* Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
* Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
* Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.

Exclusion Criteria:

* Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
* Obesity: body mass index (BMI) \> 32 kg/m2
* Hypersensitivity to any of the study drug ingredients
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
* Abuse of alcohol, drugs, or medicines (e.g. laxatives)
* Other contraceptive methods:

  * Sterilization
  * Oral, vaginal or transdermal hormonal contraception during treatment
  * Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
* Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
* Major surgery scheduled for the study period
Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty

Polypharmacy is a major and growing public health problem occuring within all health care settings worldwide. The systematic review of Mansoon et al,2017 identified 138 different definitions for polypharmacy from which the most commonly used numerical definition is being this of five or more medicines. However, numerical definitions do not take into account factors such as comorbidity thus there is a need for a a shift towards the terms "appropriate" ,and "inappropriate polypharmacy" and potentially inappropriate prescribing (PIP). The prevalence of polypharmacy varies between 10% to as high as around 90% depending on the definition used and the population that is studied.There is worldwide literature regarding the epidemiology of polypharmacy in the elderly , health outcomes and cost. The is an abundance of guidelines and tools regarding deprescribing, the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing polypharmacy , minimizing inappropriate medication and improving outcomes. In Greece , as pointed out by the SIMPATHY project, there is no formal polypharmacy initiative and relative greek literature is scarce.There is no research in Greece regarding the prevalence of PIP among community-dwelling elderly patients as well as there are no studies evaluating the feasibility or effectiveness of deprescribing interventions in the elderly or older patients with frailty.

The aim of this thesis is to record, in the primary care setting in Crete, the underlying barriers and enablers of deprescribing among health care professionals and also to evaluate ,the clinical outcomes of deprescribing interventions in primary care. Additionally, the beliefs and attitudes of the patients and/or their caregivers towards deprescribing will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* community-dwelling patients
* Age ≥ 65 years
* Receive at least 5 medication ( polypharmacy )

Exclusion Criteria:

* hospitalized or patients living in nursing home
* Incapable of giving written consent
Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer

This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life.

PRIMARY OBJECTIVES:

I. To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer.

OUTLINE:

Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities
* Taxane-based chemotherapy for early stage breast cancer
* Diagnosis of early stage breast cancer

Exclusion Criteria:

* Individuals with late stage breast cancer
The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes

This clinical study aims to explore the effects of 3 dietary supplements on metabolic parameters, liver fat content, and body composition in individuals with prediabetes. Prediabetes refers to a condition where blood sugar levels are higher than normal but not high enough for a diabetes diagnosis. The study will last for three months, during which participants will either take a dietary supplement or a placebo. Five groups will be studied, including placebo groups. Blood tests will assess glucose and lipid metabolism parameters, adipokines, and liver and kidney function. Liver stiffness and fat content will also be measured using elastography. Additionally, body composition will be assessed, and participants' psychological state, quality of life, eating habits and sports habits will be evaluated using questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* willingness and ability to provide written informed consent and comply with all study requirements,
* age between 40 and 80 years
* prediabetes with a HbA1c level between 5,7-6,4%
* no antidiabetic treatment prior to the inclusion in the study
* BMI between 25 and 35 kg/m2
* fasting glucose of 100-125mg/dl
* in the case of women of childbearing potential, providing a negative pregnancy test at inclusion and once a month until the end of the study

Exclusion Criteria:

* failure to provide written informed consent and/or failure to comply with the study requirements
* age \<40 years
* HbA1c outside of the set range
* significant impairments of hepatic and/or renal function
* clinically significant abnormalities in medical history, routine laboratory screening, or in physical examination
* allergies against any of the components of the dietary supplements or the placebo
* type 1 diabetes mellitus, latent autoimmune diabetes in adults, maturity-onset diabetes of the young, gestational diabetes
* pregnancy, lactation
* concurrent treatment with any antidiabetic drug
* concurrent treatment with drugs/dietary supplements that have proven interactions with dietary supplements included in our study
Obstetric and Proctology Support of Patients With Perineums Suits

Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). If a number of risk factors are well described, the support arrangements at the time of delivery and the characteristics of the review Proctological remote delivery and its relationship to the clinical status of patients is little known and rarely studied.

In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.

The same support on both sites allows to consider the creation of a relatively homogeneous cohort in terms of support and consider an important recruitment. Moreover, the geographical proximity of the inclusions sites (maternity) with proctology service is likely to limit the risk of lost sight of.

Main objective / secondary:

Describe exactly the operational management of severe perineal tear (grade III and IV), their context and the factors associated with them occurring, the results of clinical and paraclinical proctology examination carried away from the birth, and study their relationship with the clinical status of patients at 6 months, 1, 2 and 3 years of confinement.

Methodology :

Type prospective, multicentre, non-interventional Study duration: 6 years

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years
* Affiliated to the national system of social security,
* Giving birth during the period of inclusion of the St. Joseph site or Port Royal for whom the diagnosis of severe perineal tear was done.

Exclusion Criteria:

* None