cyrilzakka/clinical-trials huggingface dataset:
Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide

The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.

Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent.
* Male or female subjects aged between 18 and 45 years, inclusive.
* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
* Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
* Non-smokers or ex-smokers for at least 3 months.
* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
* (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
* Clinically relevant surgical history.
* Any abnormality in the coagulation tests.
* Any abnormality in the liver function tests.
* A history of relevant atopy or drug hypersensitivity.
* History of alcoholism or drug abuse.
* Consumed more than 14 units of alcohol a week.
* Significant infection or known inflammatory process at screening or admission to each treatment period.
* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
* Had used medicines within 2 weeks of admission to first period that may have affected the safety or other study assessments, in the investigator's opinion.
* Had previously received BIA 9-1067.
* Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
* Had participated in more than 2 clinical trials within the 12 months prior to screening.
* Had donated or received any blood or blood products within the 3 months prior to screening.
* Vegetarians, vegans or had medical dietary restrictions.
* Cannot communicate reliably with the investigator.
* Unlikely to co-operate with the requirements of the study.
* Unwilling or unable to gave written informed consent.
* Employees at BIAL - Portela \& Cª, S.A.
* (If female) She was pregnant or breast-feeding.
* (If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
Study of a Vestibular Biomarker of Phase in Bipolar Disorder

Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania (maniac phase). Vestibular tests have been shown high sensibility and specificity as a biological marker for major depression. This exploratory investigation will measure and compare the vestibular activity of bipolar disorder patients during different phases ( 6 depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).


Eligibility Criteria:
Inclusion Criteria:

* Bipolar disorder I or II
* depressive phase of bipolar disorder
* maniac phase of bipolar disorder
* euthimic phase of bipolar disorder

Exclusion Criteria:

* drugs addiction
* alcohol addiction
* neurologic condition, disorder
Clinical Utility of Rapid CT/NG Testing in the ED

The purpose of this study is to:

1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the Emergency Department (ED) for a Sexually Transmitted Infection (STI).
2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic under and over treatment for TV in women evaluated in the ED for an STI
3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) and TV testing in the Emergency Department setting.

To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually Transmitted Infection diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* The study population includes women between the age of 18 and 50 who present to the ED and are going to receive CT/NG testing in the ED.

Exclusion Criteria:

* Patients will be excluded if they are unable to provide informed consent or are not English speaking.
Oral Health Education for Caregivers of Children With Disabilities

Considering the impact of caregivers' oral health knowledge, attitudes and practices on the oral health of their children; we introduced an educational program to the parents and caregivers of children with developmental disabilities about the oral healthcare of their developmentally disabled children to rise up with the oral health status of those children.

* Target Population; Parents of Children with DD enrolled in selected special education centers in Khartoum state, Khartoum, Sudan, and their developmentally disabled children.
* A convenient sample of two special education centers were selected randomly from a list of all the 105 special education centers registered at the State Ministry of Education, and allocated into intervention and control groups.
* One center was used as case who received the educational program and the other center was used as a control group.
* Eligibility Criteria: child aged 3-18, with a developmental disability, caregivers approval to participate (signed the informed consent).
* All the Children who met the eligibility criteria in both centers were examined and all their parents were interviewed, before and after the intervention.
* An interview questionnaire for the parents of Children with DD in both centers was used to evaluate their knowledge and attitude toward the oral health care of their children before and 3 months after the intervention.
* Oral examination was carried out to determine the baseline oral hygiene level and treatment needs of the Children with DD, before the educational session.
* A second examination was carried out after a period of 3 months after the educational session, to determine any change in oral hygiene and treatment needs of the children after their parents and or caregivers' attendance to the educational session.
* The baseline and follow up examination were carried out blindly by a calibrated dentist.
* The same examiner carried out the baseline and follow up examinations to avoid any inter-examiner variations.
* Oral examination was arranged according to oral health surveys basic methods recommended by WHO in 2013.
* The Simplified Oral Hygiene Index (measuring debris index and calculus index).
* Dentition Status and Treatment Needs chart provided in oral health assessment forms for children by the WHO 2013 was used to determine the amount of unmet dental needs and help in evaluating the caregivers' oral healthcare behaviours and the frequency of dental visits.

Eligibility Criteria:
Inclusion Criteria:

* has a developmental disability.
* enrolled in any of the randomly selected special education schools.
* caregivers signed the informed consent.

Exclusion Criteria:

* not a student in any of the randomly selected special education schools.
* caregivers refused to participate and sign the informed consent.
* age not in the range of 3 - 18 years old.
[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
* FIGO stage IA
* FIGO stage IB and II when LND is contraindicated
* No contraindications for surgery
* Signed informed consent

Exclusion Criteria:

* • Age \<18 years
* Presence of tumor spread outside the corpus uteri
* Absence of tumor invasion into the myometrium
* High-grade tumor (G3)
* Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
* Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy
* Prior pelvic or retroperitoneal LND
* History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization
* Allergy to iodine-containing drugs
* Contraindications to surgical treatment
* Lack of signed informed consent
Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants

The investigators hope to gain insights into the functional organization of the human cerebral cortex in response to upper limb amputation and surgical interventions including hand replantation and hand transplantation.


Eligibility Criteria:
Inclusion Criteria:

* between 18-70 yrs old
* undergone successful allogeneic transplantation of one or both hands OR undergone successful reattachment of one or both hands OR will have experienced surgical repair of one or more severed nerves (ulnar, medial, radial, digital in the upper limb
* must speak English

Exclusion Criteria:

* younger than 18 years or older than 70 years
* not undergone a replant or transplant
CT Window Setting to Select Double-lumen Tube Size

The purpose of this study is to investigate the appropriate window setting of chest computed tomography to select a correct size of double-lumen endobronchial tube.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* Abnoraml anatomy of tracheobronchail tree
* Intraluminal lesion in the left mainstem bronchus
* Anticipated difficult intubation
Double-Blind Placebo-Controlled CIN Trial

This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.

Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.

This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.

Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN criteria.

Secondary outcome measures will include AKI by other definitions (stage I AKI, traditional CI-AKI definition), hospital length of stay, 30-day readmission rate, number of additional percutaneous interventions within 30 days, number of additional CT examinations within 30 days, and 30-day mortality rate. All subjects will receive a minimum of 1 mL/kg/hr (max: 125 mL/hr) of volume expansion for at least three hours before and after the CT..

Eligibility Criteria:
Inclusion Criteria:

* Inpatients scheduled for CT scan of abdomen and/or pelvis
* Had surgery in the last 4 weeks
* Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of CT)
* Suspected infection or fluid collection in abdomen and/or pelvis

Exclusion Criteria:

* Pregnant
* Severe Allergy (anaphylaxis) to contrast
* Dialysis in last 7 days
* Received intravascular iodinated contrast in last 48 hours
* CT of abdomen and pelvis in last 7 days shows no fluid collection
* Prisoners
* CT ordered for an indication that requires (eg, CT angiogram) or contraindicates (eg, renal stone CT) the administration of intravascular contrast
PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide

The purpose of this study is to explore whether the GLP-1 receptor agonist exenatide, may prevent glucocorticoid-induced glucometabolic abnormalities and beta-cell dysfunction in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* 18 years ≤ age ≤ 35 years on the day of the first visit
* 22.0 ≤ BMI ≤ 28.0 kg/m2
* (History of) good physical and mental health as determined by history taking, physical and laboratory examinations and ECG.
* fasting glucose level of \< 5.6 mmol/L, in addition to a glucose level of \< 7.8 mmol/L at 2 hours after intake of 75 g glucose (OGTT).
* able to keep a normal day and night rhythm during the trial period (i.e. no shift work)

Exclusion Criteria:

* history or presence of a medical disorder
* use of drugs, except for incidental (non-opioid) analgesic agents
* first degree relative with T2DM
* performing intensive physical activity \> 1x/week
* an allergic or anaphylactic reaction to prednisolone treatment in the past
* clinically relevant history or presence of any medical disorder, which are mentioned in the Summary of Product Characteristics (SPC) as contraindication for the use of prednisolone
* glucocorticosteroid use during the last three months prior to the first dose
* participation in an investigational drug trial within 90 days prior to the first dose
* donation of blood (\> 100 mL) within 90 days prior to the first dose
* history of or current abuse of drugs or alcohol (\>14 U/week)
* smoking
* use of grapefruit products during the study period
* recent changes in weight and/or physical activity
* serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer

The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.

The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.

Eligibility Criteria:
Inclusion Criteria:

* Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV
* Indication for chemotherapy
* Age \> 18 years
* Life expectancy of at least 3 months

Exclusion Criteria:

* Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher)
* Performance Status (ECOG) \> or = 3.
* Previous chemotherapy
* Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
* Neutrophils \< 2000 x mm3, platelets \< 100000 x mm3
* Inadequate renal function (creatinine \> or = 1.25 x normal values) or liver function (ALT or AST \> or = 1.25 x normal values)
* Present or suspected hemorrhagic syndromes
* Inability to comply with protocol and follow-up
* Inability to access study site for clinical visits
* Refusal of informed consent
Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma

Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients \> 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients \<= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.

Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients \> 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients \<= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractary or relapsed multiple myeloma
* ECOG ≤ 3
* Life expectancy \> 3 months
* Neutrophils account ≥ 0.5 X 10\^9/L, platelets ≥ 30 X 10\^9/L.
* Transaminases \<3 times upper normal limit, bilirubin \< 2 times upper normal limit
* Age \> 18 years
* Time after last chemotherapy or radiotherapy \> 1 month or time after transplantation \> 2 months.
* No possible other actual treatment
* Written consent form

Exclusion Criteria:

* Candidate to second transplantation
* No following criteria
* Other neoplasties
* Peripheral neuropathy \> Grade 2.
* Previous ileus paralytic
* Hepatic failure
* No controlled infection
* No controlled high calcium levels
* Any organic insufficiency that no permit follow the correct treatment
* Pregnancy, breast feeding or fertility without anticonceptive method
* Any psychological, social and/or familiar event that no permit follow the correct treatment
* Diabetes mellitus not controled
Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules

The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Demonstrate evidence of recent injection drug use (injection stigmata),
* 18 years of age or older,
* Screened for and found susceptible to HBV
* Able to provide informed consent.

Exclusion Criteria:

* Evidence of intoxication that prevented provision of informed consent.
Gastropexy in the Repair of Patients with Paraesophageal Hernias

Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.

Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.

Control Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.

Interventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.

Follow-Up Assessments:

Imaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.

Patient-Reported Outcomes: The following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery:

SF-36: A global quality of life instrument. GSRS: The Gastrointestinal Symptoms Rating Scale. Reflux Frequency Questionnaire: A measure reflux disease-related symptoms. Dakkak's Dysphagia Score: An assessment of swallowing difficulties.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers

Exclusion Criteria:

* Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.
* Diagnosis of achalasia or any other significant esophageal motility disorder.
* Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.
* Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.
Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients

The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.

Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.

Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.

Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged above 18 years
* With septic shock
* Scheduled for general anesthesia

Exclusion Criteria:

* Patients under 18 years
* Burn patients