cyrilzakka/clinical-trials huggingface dataset:
Telmisartan/Hydrochlorothiazide (HCTZ) Fixed Dose Combination Compared to Its Monocomponents in Healthy Subjects

Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
* Age ≥ 18 and ≤ 45 years
* Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
* History of orthostatic hypotension, fainting spells or blackouts
* Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
* Smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day)
* Inability to refrain from smoking on study days
* Known alcohol abuse
* Known drug abuse
* Blood donation (≤ 1 month prior to administration)
* Excessive physical activities (≤ 5 days prior to administration)
* For female subjects:

  * Pregnancy
  * Positive pregnancy test
  * No adequate contraception
  * Inability to maintain this adequate contraception during the whole study period
  * Lactation period
Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products.

Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.

Same as brief summary

Eligibility Criteria:
Inclusion Criteria:

* Postmenarchal
* Cancer diagnosis
* Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy
* A minimum of 1 year since completion of gonoadotoxic therapy
* Intact uterus
* At least one ovary

Exclusion Criteria:

* Estrogen receptor positive cancers
Effects of Concurrent HIIT and WB-EMS Exercise on the Cardiometabolic Risk Profile in Obese Individuals

The main purpose of this study is to compare the impact of concurrent high-intensity interval training (HIIT) and whole-body electromyostimulation exercise (WB-EMS) or low-volume conventional strength training (CST) on the cardiometabolic risk profile, overall physical fitness (cardiorespiratory fitness and muscular strength), body composition, inflammatory markers and subjective health outcomes after a 12-week intervention trial in overweight individuals at increased cardiometabolic risk. Furthermore, this study aims to investigate the influence of intra-session exercise order on all outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \>25
* presence of at least 2 cardiometabolic risk factors

Exclusion Criteria:

* Healthy persons or patients under age
* Overweight persons without any additional cardiometabolic risk factors
* Pregnancy, Lactation
* Psychological disorders, epilepsy, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* acute cardiovascular disease
* malignant disease
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction
Treatment of Metabolic Alkalosis With Acetazolamide. Effect on the Length of Mechanical Ventilation.

The purpose of this study is to analyze whether the treatment of metabolic alkalosis with acetazolamide in intubated patients with chronic obstructive pulmonary disease (COPD) or with obesity hypoventilation syndrome (OHS) reduces the length of mechanical ventilation (MV).

Metabolic alkalosis (MA) may reduce central respiratory drive, cardiac output and worsen oxygenation, leading to a delay in weaning from MV. Acetazolamide is a carbonic anhydrase inhibitor that is able to correct MA and to stimulate respiratory drive. There is a paucity of studies on the outcome of patients with MA under MV treated with acetazolamide.

The primary objective of our study is to analyze whether the treatment of MA with acetazolamide in intubated patients with COPD or with OHS reduces the length of MV, reduces the length of ICU stay or ICU mortality. Complications associated with acetazolamide treatment will be also analyzed.

Phase III double-blinded trial, with COPD or OHS patients under MV who have pH \> 7,35 and bicarbonate \> 28 mEq/L. Patients will be randomized to receive 500 mg of acetazolamide or placebo. According to arterial blood gas analysis (ABGA) values treatment administration will be evaluated daily until extubation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD or obesity hypoventilation syndrome on invasive mechanical ventilation during less than 72 h with metabolic alkalosis, defined as a pH \> 7.35 and actual bicarbonate \> 28 mmol/L, and with potassium plasmatic levels \>= 4 mEq/L.

Exclusion Criteria:

* Postoperative patients.
* Previous psychiatric disease.
* Epilepsy.
* Pregnancy.
* Hepatic cirrhosis.
* Sulfonamide or acetazolamide allergy.
* Plasmatic creatinine \> 2.5 mg/dL or creatinine clearance \< 20 mL/min or continuous renal replacement techniques.
* Intolerance to enteral feeding.
* Administration in the previous 72 h of bicarbonate or acetazolamide.
* Terminal disease.
Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation

The present study will evaluate the long term effects on scar formation for dermatome-induced skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment) alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to evaluate both time to complete wound closure and quality of the resulting scar when Collagenase Santyl® Ointment was used to treat the wound.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be considered qualified for enrollment if they participated in the Collagenase Santyl® Ointment Study 017 101-09-001 and provide written informed consent.
* The informed consent document must be read, signed, and dated by the suubject before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject. A photocopy of the signed informed consent document must be provided to the subject and the original signed document placed in the subject's chart.
* Subject participated in the 017-101-09-001 study and received at least one application of a test article, whether Collagenase Santyl® Ointment or White Petrolatum.

Exclusion Criteria:

* N/A
Variants of Paranasal Sinuses in Nepali Population

The variants of paranasal sinuses (PNS)and nasal cavity are of clinical importance since some variants are susceptible to recurrent infection. Moreover, during functional endoscopic sinus surgery, knowledge of anatomy is of utmost importance in order to prevent injury of vital structures like optic nerves, carotid arteries etc. However, there is lack of study enrolling adequate number of patients in our country. Critical variants are often underreported by radiologists. Thus, it is imperative to know true prevalence of different anatomical variants.

The nasal cavity and paranasal sinuses(PNS) together constitute single anatomical and functional unit. There are different anatomical variants of paranasal sinuses and nasal cavity. This is the anatomical structure with most variation and computed tomography(CT) is frequently done to evaluate anatomy of PNS and nasal cavity. Knowledge of anatomical variants is important for early diagnosis of pathology in the region and to prevent complications during functional endoscopic sinus surgery(FESS). Different anatomical variants frequently seen in CT of PNS and nasal cavity include deviated nasal septum, bony spur, concha bullosa, paradoxical nasal turbinate, agger nasi cells, bulla ethmoidalis, haller cells, onodi cells, different degree of pneumatization of sphenoid sinus etc. Anatomical variation of these structures differs in different ethnic groups. Some variants like onodi cells, complete sellar pneumatization of sphenoid sinus, anterior ethmoid artery traversing ethmoid air cells, dehiscent optic nerve and carotid artery pose structure around them into risk during surgery. If exact prevalence of these anatomical variations is known, it becomes easy for surgeons to approach lesions in the area easily. Some variants like haller cells, ager nasi cells, bulla ethmoidalis block osteomeatal complex and drainage pathway of frontal sinuses. Sinusitis may be refractory to medications due to these variants. We could find three studies done in our country and the sample size ranges from 76 to 218. We are aiming for larger study which could provide more accurate picture of prevalence of different anatomical variants. CT of PNS is done frequently in our hospital and we rarely collect data from the images for research purpose. There would be utilization of those data as well. Patient need not pay extra or receive extra radiation for the study. We think the study is very noble and would be a great help for surgeons and clinicians in the country.

Eligibility Criteria:
Inclusion Criteria:

* CT scan of PNS of patients \> 13 years referred for various reasons.
* CT scan of Head referred to our department for various reasons.

Exclusion Criteria:

* CT of PNS and head done for evaluation of trauma and tumors
* CT of Patients age less than 13 years .
Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients

The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.


Eligibility Criteria:
Inclusion Criteria:

* Requires catheterization \>24h hours following incontinence or pelvic reconstructive surgery

Exclusion Criteria:

* Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization
* Allergy to sulfonamides or trimethoprim
* Non-English speaking
* Pregnancy
* Breast feeding
* Severe renal impairment (creatinine clearance \<30)
* Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.
Electronic Study for Anastrozole Pharmacovigilance Evaluation

Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions.

Exclusion Criteria:

* Metastatic breast cancer patients, previous hormonal therapy, other malignancies.
Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis

This is an open label, prospective, test of superiority efficacy trial of Ipomea pes-caprae ointment as an add-on therapy in patient with jellyfish dermatitis. Each patient will receive standard medical treatment depend on the severity of the disease. The doctor will divide the dermatitis area of each patient into two parts. Ipomea pes-caprae ointment will be applied as an add-on therapy to the "test area", while the ointment will not be applied to the "control area". Patients will be asked to come for follow up 6 times in the 28-days study period. Primary objective is to compare the healing time of dermatitis in both areas.

The "Test area" and "Control area" are allocated in each participant. We use the Internal Control fashion. The healing time of each area will be collected as an outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of jellyfish dermatitis
* total lesion area is more than 4 square centimeter

Exclusion Criteria:

* expose to jellyfish more than 7 days
* severe systemic reaction to jellyfish
* allergy to Ipomea pes-caprae or the component of the ointments
Association Between Carotid Plaque Length and Cardiovascular Outcomes

This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 5000 consecutive patients without known CAD who underwent first coronary angiography for stable chest pain and carotid ultrasound was performed during hospitalization from January 2017 through December 2018.

Patients who had obstructive CAD (defined as ≥50% luminal stenosis) confirmed by coronary angiography and who underwent carotid scanning were included in the final analysis.Carotid ultrasonography was performed simultaneously, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.The incidence of major adverse cardiovascular events was recorded during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent coronary angiography for stable chest pain and carotid ultrasound simultaneously;
* Patients with obstructive CAD (≥50% coronary stenosis);

Exclusion Criteria:

* \<18 years of age;
* previous carotid surgery or significant carotid artery disease;
* prior stroke or transient ischemic attack;
* previously documented CAD (including history of myocardial infarction, acute coronary syndrome, or coronary revascularization);
A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy

This study will evaluate the pharmacokinetics (PK) and safety of risdiplam in participants with spinal muscular atrophy (SMA) under 20 days of age at first dose.


Eligibility Criteria:
Inclusion Criteria:

* Male or female newborn infant aged \<20 days at first dose
* Newborn infants with genetic diagnosis of 5q-autosomal recessive SMA or newborn infants identified as positive for SMA via newborn screening or via prenatal testing.
* Gestational age equal to or greater than 37 weeks
* Receiving adequate nutrition and hydration at the time of screening
* Adequately recovered from any acute illness at baseline and considered well enough to participate in the study
* Parent/caregiver is willing to consider nasogastric, nasojejunal, or gastrostomy tube placement during the study to maintain safe hydration, nutrition, and treatment delivery, if recommended by the investigator.

Exclusion Criteria:

* Presence of clinical symptoms or signs consistent with SMA Type 0
* In the opinion of the investigator, inadequate venous or capillary blood access for the study procedures
* Systolic blood pressure or diastolic blood pressure or heart rate abnormalities
* Presence of clinically relevant electrocardiogram (ECG) abnormalities
* The infant (or the person breastfeeding the infant) taking any of the following: any inhibitor of CYP3A4 taken within 2 weeks (or within 5 times the elimination half-life, whichever is longer) prior to dosing, any inducer of CYP3A4 taken within 4 weeks (or within 5 times the elimination half-life, whichever is longer prior to dosing, and/or use of any multidrug and toxin extrusion (MATE) substrates taken within 2 weeks (or within 5 times the elimination half-life, whichever is longer) prior to dosing
* Concurrent or previous administration of nusinersen or onasemnogene abeparvovec
* Clinically significant abnormalities in laboratory test
Randomized Trial of Follow-up to Mailed FIT Kits

This study aims to assess whether follow-up calls can increase the return rate of mailed FIT Kits. To assess this, a randomly selected half of eligible patients were randomized to receive a follow-up call reminding the patient to return the FIT Kit.

This study aims to assess whether follow-up calls can increase the return rate of mailed FIT Kits. Patients ages 45 to 59 due for colorectal cancer screening, who had not received a FIT Kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were sent a FIT Kit in October of 2024. Half of patients were randomized to receive a follow-up call reminding the patient to return the FIT Kit. This work analyzes the return rate of the mailed FIT Kit, with or without phone call follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-59
* Due for colorectal cancer screening
* Not sent a FIT Kit in the past 3-months
* Previously returned a FIT Kit.

Exclusion Criteria:

* Under age 45 or over age 59;
* incarcerated;
* not due for colorectal cancer screening
* sent a FIT Kit in the past 3-months
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of 6 through 47 months of age on the day of informed consent.
* Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
* Individuals who can comply with study procedures including follow-up
* Individual is in generally good health as per the Investigator's medical judgement

Exclusion Criteria:

* Acute (severe) febrile illness
* History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
* A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
* Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
* Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

Primary Objective:

* Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors

Secondary Objective:

* Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.

Eligibility Criteria:
Inclusion criteria:

* Permanent AF defined by the presence of all of the following criteria:

  * Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter;
  * Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization;
  * No evidence of sinus rhythm in the period between these two documentations of AF;
  * Decision of the patient and physician to allow AF to continue without further efforts to restore sinus rhythm.
* At least one of the following risk criteria:

  * Coronary artery disease;
  * Prior stroke or Transient Ischemic Attack \[TIA\];
  * Symptomatic heart failure;
  * Left ventricular ejection fraction \[LVEF\] less or equal to 0.40;
  * Peripheral arterial occlusive disease;
  * Aged 75 years or older with both hypertension and diabetes mellitus.

Exclusion criteria:

* Paroxysmal AF;
* Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm;
* Heart failure of New-York Heart Association \[NYHA\] class IV or recent unstable NYHA class III.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population

The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population


Eligibility Criteria:
INCLUSION CRITERIA:

* Healthy adult and elderly female and male
* Female must be of non-childbearing potential
* Body weight =50 kg

EXCLUSION CRITERIA:

* Abuse of alcohol or drugs
* Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV
* Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication
* Smoking history of = 10 cigarettes a day in the last three months
* History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases
* Participation in clinical trial during the previous 6 months