cyrilzakka/clinical-trials huggingface dataset:
Office Hysteroscopy Versus Cervical Probing for Cervical Stenosis

This study aims to estimate if performing a small caliber office hysteroscopic cervical negotiation would succeed to bypass tight markedly stenotic cervix in comparison to blind cervical probing done under general anesthesia. Moreover, the investigators test the impact of drawing a detailed diagram after this procedure on the success of ET in participants with failed mock or actual trials of embryo transfer (ET).

It comprises 122 nulliprous women with failed cervical sounding on vaginal examination in the office. Participants were divided into 2 groups. Group A comprised 64 cases subjected to small-caliber office hysteroscopic cervical negotiation while 58 cases were subjected to cervical probing under general anesthesia. Main outcome measures included success to bypass primary cervical stenosis and complication rate

Eligibility Criteria:
Inclusion Criteria:

* Nulliprous women.
* Failed cervical sounding on vaginal examination in the office.

Exclusion Criteria:

* Previous operation on the cervix.
* Use of any medication to prime the cervix (primary).
* Multiparity: weather delivered vaginally or by cesarean sectrion
P3 Long Term Safety Study of Once Daily SB204 in Acne

This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.

A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion Criteria:

* Terminated early from an SB204 Phase 3 pivotal study for any reason
* Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
* Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
Quality of Life and Personality Traits in Patients With Type 1 Diabetes

The aims of this study are to examine the differences in the quality of life among individuals with type 1 diabetes and individuals without chronic diseases, differences in the quality of life among men and women with type 1 diabetes and the differences in the quality of life among individuals with good and poor glycaemic control. The relationship between personality traits and the management of disease in patients with type 1 diabetes will also be examined.

Diabetes affects the daily life of patients, chronic diseases have a major impact on the quality of life of individuals. Chronic illness affects family life of an individual, his professional life, as well as leisure activities, chronic illness can also increase worries, fears, feelings of sadness and helplessness.

Past studies examining the quality of life construct in patients with type 1 diabetes (T1D) showed that patients achieved lower levels of life quality, compared to individuals without T1D. Studies show that women with T1D achieve lower scores on the quality of life scales than men with T1D and differences in gender are already present in adolescence.

Patients with poor glycaemic control achieve lower results on the quality of life scales, the effect of hemoglobin on the quality of life is direct, as well as indirect.

The studies in which they examined the attitudes of personality traits with diabetes management show that two personality traits are associated with the management of the disease, the successful management of the disease is primarily associated with the conscientiousness. Concerning the effect of neuroticism on the management of the disease, research results are contradictory.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35
* Diagnosed with Type 1 diabetes for at least one year (for the T1D group)
* Willing to participate in study

Exclusion Criteria:

-
Understanding the Impact of Drug Shortages on Oncology Care Delivery

This trial studies the impact of drug shortages on oncology care delivery. Gathering information about cancer drug shortages over time may help researchers improve access to drugs during times of shortages.

PRIMARY OBJECTIVES:

I. To prospectively estimate the proportion of National Cancer Institute (NCI) Community Oncology Research Program (NCORP) community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs.

SECONDARY OBJECTIVES:

I. To prospectively estimate the rate of cancer care delivery problems attributable to a drug shortage of infusional therapeutic oncology drugs for patient populations treated with: a) all cancer drugs, b) all cancer drugs in shortage, and c) each individual cancer drug in shortage.

II. To assess strategies practices used during drug shortages (e.g., manage costs, stockpile, hire staff).

TERTIARY OBJECTIVES:

I. To assess practice factors (e.g., case mix, size, practice type) associated with the likelihood that a practice reports cancer care delivery problems.

II. To describe how practice-level strategies in response to drug shortages vary by practice characteristics.

III. To describe the possible effects on clinical trials (e.g., unable to enroll a patient or changing to an alternative treatment).

IV. To characterize cancer care delivery problems attributable to a shortage of supportive care agents.

V. To characterize cancer care delivery problems attributable to a shortage of oral anti-cancer agents.

OUTLINE: Practice sites complete a Baseline Drug Shortage Survey, Drug Shortage Incident Reports in real time as cancer care delivery problems occur, and the Quarterly Follow-Up Survey every 3 months for one year (4 total).

Eligibility Criteria:
Inclusion Criteria:

* Be a primary affiliate or sub-affiliate of an NCORP community site or minority underserved (M/U) community site that is affiliated with the University of Rochester Cancer Center (URCC) NCORP Research Base

  * Practice sites must have a valid Cancer Therapy Evaluation Program (CTEP) identification number
  * Practice sites may or may not share a pharmacy
* Provide infusional chemotherapy treatment (either inpatient or outpatient)

Exclusion Criteria:

* Practices sites without valid CTEP identification (ID)
* Practice sites that do not provide infusional chemotherapy
Early Percutaneous Tracheostomy and Swallowing Dysfunction

The aim of the study is to determine if performing an early tracheostomy (within the first 4 days of endotracheal intubation) in critically ill patients on mechanical ventilation, reduces the incidence of swallowing dysfunction.

The development of initial resuscitation maneuvers, associated with a better knowledge of the physiopathology of critical illnesses and the technological development experienced by critical care medicine, allow us to give vital support to patients for long periods of time. In this scenario, a considerable proportion of critically ill patients may require translaryngeal intubation and invasive mechanical ventilation. Patients who require prolonged translaryngeal intubation have a high risk of developing swallowing dysfunction, a condition predisposing to secretions aspiration. Until now, there has been no demonstration of a causal association between the duration of translaryngeal intubation and development of swallowing dysfunction. However, all the studies about this topic have been performed on patients submitted to prolonged translaryngeal intubation. Clinical studies have documented the development of early laryngotracheal lesions after intubation, which might explain post extubation dysfunction of swallowing reflex, probably as consequence of alteration of mechanic and chemo-receptors of the pharyngeal and laryngeal mucosa. There are no studies evaluating the impact of an early percutaneous tracheostomy on the incidence of swallowing dysfunction in critical care patients. The investigators have documented a 38% of swallowing dysfunction in our critically ill patients submitted to prolonged mechanical ventilation. The hypothesis of the study is that performance of an early percutaneous tracheostomy, within the first 4 days of translaryngeal intubation, in critical care patients on mechanical ventilation, reduces the incidence of swallowing dysfunction. The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) by a trained otolaryngologist, 3 to 5 days after weaning of mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent has been obtained for the procedure
* Patients whose need of mechanical ventilation is estimated in ≥ 7 days and require a percutaneous tracheostomy

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with neurologic pathology
* Patients with dysphagia history
* Patients whose MV duration is estimated in \< 7 days
* Patients with airway obstruction requiring an emergency tracheostomy
* Patients already having a tracheostomy in situ
* Pregnancy
* Patients who have already been enrolled on another trial
* Patients with absolute contraindication to perform a percutaneous tracheostomy
* Patients with high risk of dying, life expectancy of \< 48 hours
* Patients in whom limitation of therapy has been decided
* Family rejection to participate in the study
Dapagliflozin Post Marketing Surveillance in HF and CKD

This is an observational, non-interventional, single-arm multicenter study. The objectives of this study are to assess safety and effectiveness of Forxiga in a real world setting in patients who are prescribed with the study drug according to the newly approved indications in the Republic of Korea

As part of a post-approval commitment, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (hereinafter "Korea") requests a study to characterize the safety in patients treated with dapagliflozin by physicians in normal clinical practice settings.

In principle, all patients treated with the product in accordance with the newly updated local prescribing information for HF and/or CKD are eligible for the enrolment in this study. Product prescription and patient enrollment will depend on physicians' medical decision as per routine clinical practice. Patient follow-up will be 12 weeks or about 24 weeks (for long-term surveillance) and patients will be recruited over a period of 4 years after the new HFrEF indication approval by the local health authorities. This is due to the requirements from the local health authorities.

The primary objective of this study is to assess the safety profile of the product in Korean adult patients with heart failure (HF) and/or chronic kidney disease (CKD) in a real world setting under the approved indication(s) in Korea.

The secondary objective of this study is to examine the effectiveness of the product in Korean patients with 1) HF and/or 2) CKD in a real world setting under the approved indication(s) in Korea.

The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with the safety and effectiveness of the product when prescribed under the newly approved indication(s) in Korean patients with 1) HF and/or 2) CKD during the 12 weeks or about 24 weeks of follow-up duration.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years old and older
* Patients eligible for the product treatment (i.e. on-label treatment) according to the newly approved HF and/or CKD label in Korea
* Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

* Participation in any interventional trial during the treatment with the product.
* Any off-label indications that are not in accordance with the newly approved label in Korea.
* Any contraindications for the use of the product (as described in the local prescribing information).
* Prior use of product, as per local MFDS guidance.
Clinical Outcomes of USCTR vs. mOCTR

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in the United States with over 90% of patients reporting clinical improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm incisions (ECTR), and ultrasound guided CTR via a single \< 1 cm wrist or palmar incision (USCTR or CTR-US). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. Investigators hypothesize that USCTR using the SX-One MicroKnife, also known as UltraGuideCTR, will safely and non-inferiorly improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, without greater less loss of military duty days. This study is a single-site randomized controlled trial.

Participants with CTS will be randomized to a study arm and receive treatment with USCTR vs. traditional mOCTR. All patients will be followed for a period of 24 months with respect to standard clinical data, military relevant data, and validated patient related outcome measures (PROMs). Data will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months, and 24 months post-CTR procedure, with the primary focus being on outcomes up to 1 year.

Clinical outcomes of up to 83 participants (updated target sample size) treated with USCTR vs. traditional mOCTR will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥18 years
* DEERS Eligible
* Fluent in speaking, reading, and understanding English
* Clinical diagnosis of Carpal Tunnel Syndrome (CTS)
* Candidate for surgical CTR based on severe and/or refractory symptoms
* Confirmatory electrodiagnostic test indicating median neuropathy at the wrist (abnormal findings)
* Ultrasound findings consistent with median nerve enlargement in the carpal tunnel

Exclusion Criteria:

* Previous carpal tunnel release or previous wrist surgery on the ipsilateral side
* Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure
* Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side
* History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.)
* Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox
* Unable to understand and provide written informed consent
* Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e. identification of anomalous anatomic structures such as transligamentous thenar motor branch or space occupying lesions within the carpal tunnel)
* Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings
A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants

The purpose of this clinical trial is to learn about the safety, effects, and tolerability of the study medicine (sisunatovir).

This study is looking for healthy adult participants who meet the following criteria:

1. Males age 18 to 55 years
2. All fertile participants must agree to the use of highly effective contraception
3. Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg.
4. Participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.

This study will enroll up to 10 participants. All study participants will receive 1 dose of sisunatovir by mouth. The study duration is expected to be about 9 weeks. This includes a 28-day screening period, 16-day inpatient stay, and 2 overnight follow-up visits, if needed.


Eligibility Criteria:
Inclusion Criteria (key):

* Males
* Age 18- 55 years
* Body mass index (BMI) 18.0 kg/m2 to 32.0 kg/m2
* Body weight 55.0 kg to 100.0 kg
* Considered to be in good health
* Nonsmoker
* Content of 14C in urine, whole blood, and/or plasma samples does not exceed the general environmental background level of 14C

Exclusion Criteria (key):

* Clinically significant abnormal medical history or any abnormal finding on physical examination, vital signs, ECG, laboratory tests
* History of cancer that has not been in full remission for \>5 years
* Acute illness within 14 days prior to Day 1
* History of significant drug allergies
* History or presence of alcohol or drug abuse
* Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
* Usual habit of \<1 or \>3 bowel movements per day
* Exposure to radiation for therapeutic, diagnostic, or occupational reasons within the 12 months prior to Day 1.
* Participation in another clinical study in which a \[14C\]-labeled drug was administered within 1 year prior to Check-in
* Administration of another investigational medication within 60 days (or 5 half-lives, whichever is longer) prior to Day 1
* Participation in an investigational-device study within 60 days prior to Day 1
* Any ECG abnormality considered to be clinically significant by the Investigator
* QTcF interval \>450 msec and QRS interval \>120 msec
* Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
* Documented congenital or acquired long QT syndrome
* Presence of clinically significant hypertension
* Presence of clinically significant hypotension
* Loss or donation of more than 500 mL blood within 60 days prior to the Screening
* Excessive consumption of alcohol
* Use of any live vaccinations within 30 days
* Use/consumption of food or drugs known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inducers or potent CYP3A4 inhibitors within 14 days or 5 half-lives, whichever is longer, prior to RV521 administration
Insulin Glargine in Type 2 Diabetic Patients

Primary:

* To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c \< 7%)

Secondary:

* To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)
* To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients with first OAD (Sulfonylurea \[SU\] or Metformin) failure
* Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
* Serum creatinine ≤ 1.5mg/dL
* BMI: 21-41 kg/m²
* 7.5%\< A1c \<11%
* Fasting plasma glucose \> 7.5mmol/L
* On diet and exercise therapy and stable OAD treatment (SU or metformin \> ½ maximal dose)for more than 1 month prior to enrolment
* Women not of childbearing potential (sterilization procedure done or menopausal \> 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
* Able and willing to monitor blood glucose
* Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
* Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin

Exclusion Criteria:

* Type 1 diabetes
* Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
* Pregnancy, breast-feeding
* People who work night shifts
* Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
* Need for use of medications prohibited by the protocol during the study for treatment purpose
* Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
* Drugs or alcohol abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine

The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.


Eligibility Criteria:
Inclusion Criteria:- Male and female subjects between 18 and 65 years of age.- Onset of cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at least moderate sore throat at baseline- Current complaint of at least moderate NC at baseline- History of other symptoms associated with URTI during the last 4 days before study participation.- Other findings of URTI, confirmed on the physical examination.- Agreement to comply with the study requirements.- Written informed consent prior to enrollment in the study Exclusion Criteria:- Pregnant or lactating females.- Uncontrolled chronic diseases.- History of hypersensitivity (allergic reaction) to ASA, any other nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.- Any disease which significantly compromises breathing or interferes with the subjects assessment of sore throat.- History of or active peptic ulcer.- Severe impaired hepatic function.- Severe impaired renal function.- Simultaneous intake of monoamine oxidase inhibitors.- Use of menthol containing tissues within 2 hours before first intake of study drug.- Intake of any menthol containing product within 4 hours before first intake of study drug.- Use of any local or systemic short acting cough and cold preparations within 6 hours before first intake of study drug.- Use of any local or systemic long acting cough and cold preparations within 12 hours before first intake of study drug.- Intake of any analgesic within 12 hours before first intake of study drug.- Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection.- Current or previous intake of anticoagulants, corticoids, NSAIDs, methotrexate, or lithium.- Participation in another clinical trial within the last 30 days.