cyrilzakka/clinical-trials huggingface dataset:
RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections

The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.

This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), \& Day 28 (+/-7 days) to assess therapeutic cure and safety.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe acute vulvovaginal candidiasis (severity score \>7)
* positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
* vaginal pH \<4.5 for subjects with positive potassium hydroxide wet preparation
* able to give written informed consent

Exclusion Criteria:

* receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
* known or suspected infectious causes of vulvovaginitis other than candidiasis
* history of genital herpes
* planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
* need for non-protocol systemic or vaginal antifungal therapy
* history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients
* pregnant females
* females who are breast feeding
* women intending to become pregnant during the study period
* recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening
* subjects who use or anticipate use of intravaginal products
* have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study
STrategies for Catheter Ablation of PeRsistent Atrial Fibrlllation

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF:

1. PV antral isolation alone (PVAI)
2. PV antral isolation plus ablation of drivers (PVAI+drivers)
3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older
2. Patients undergoing first-time ablation procedure for AF
3. Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
4. Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms or any combination of the above
5. Patients whose AF has been refractory to at least one antiarrhythmic drug
6. At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment
7. Patients must be able and willing to provide written informed consent to participate in the study

Exclusion Criteria:

1. Patients with paroxysmal AF (no episodes lasting \> 7 days)
2. Patients with early persistent AF, sustained episode ≤ 3 months
3. Patients with very long lasting persistent AF (episodes lasting \> 3 years)
4. Patients with CHA2DS2-VASc score of 0.
5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
6. Patients with AF felt to be secondary to an obvious reversible cause
7. Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin
8. Patients with left atrial diameter \> 60 mm in the parasternal long axis view
9. Patients who are pregnant
Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients

This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the amount of co-contractions of this last with the hamstrings during a maximal isometric flexion movement in hemiparetic stroke patients.

The effect of such a protocol on gait parameters and spasticity of the quadriceps will be evaluated also.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80y
* Hemiparesis after a first-ever stroke \> 3 months
* Spasticity of the quadriceps muscle
* Quadriceps strength at least at 3/5 (MRC testing)
* Subject able to walk at least 2min without rest
* Informed consent
* Social security affiliation

Exclusion Criteria:

* Severe comprehension troubles (language, cognitive or psychiatric disorders)
* History of previous stroke, locomotor or other neurological disorders
* Locomotor troubles affecting the paretic arm
* Contraindication to efforts : cardiac insufficiency, severe aortic valvular stenosis, recent heart failure, non treated high blood pressure, severe peripheral arterial disease
* Pregnancy or breastfeeding
* Adult subject to guardianship
Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy

The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.

Patients undergoing warmed, humidified carbon dioxide (CO2) insufflation for laparoscopic cholecystectomy will have less postoperative pain than patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation. The study design is a double-blind, prospective, randomized study comparing patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation vs those receiving warmed, humidified CO2. Main variables included postoperative pain (rated with a visual analog scales) and analgesic requirements.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cholecystolithiasis

Exclusion Criteria:

* Clinical diagnosis of cholecystolithiasis with cholecystitis
Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

The aim of this study is to examine the prevalence of lower urinary tract symptoms (LUTS) in children with Duchenne Muscular Dystrophy (DMD) and the relationship between functional level, posture, muscle strength, pelvic floor muscle control, participation in activities of daily living, and quality of life that may be associated with these symptoms.

Forty-five children with DMD between the ages of 5-18 (Age: 9.00±3.32 years, Weight: 31,10±12,59 kg, Height: 125,87±18,46 cm) and their families were included in the study. LUTS was assessed with Dysfunctional Voiding And Incontinence Scoring System, functional level with Brooke Upper Extremity Functional Classification and Vignos Scale, posture with the New York Posture Assessment Questionnaire, Baseline Bubble Inclinometer (10602, Fabrication Enterprises Inc. New York, USA) and Baseline Digital Inclinometer (12-1057, Fabrication Enterprises Inc, New York, USA), participation in activities of daily living was assessed with the Barthel Index and quality of life was assessed with the Pediatric Quality of Life Inventory 3.0 Neuromuscular Module. Also, using the Hoggan microFET2 (Hoggan Scientific, LLC, Salt Lake City UT, USA) device, hip flexors, quadriceps femoris muscles, shoulder flexors, elbow extensors, elbow flexors, trunk extensors and flexors were evaluated in terms of muscle strength. Evaluations were made once, and the associated factors were compared in the group with and without LUTS, and the relationship between the factors and the severity of LUTS was examined.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with DMD by a specialist physician as a result of gene analysis and/or muscle biopsy,
* Being between the ages of 5-18,
* Volunteering by parents to participate in the study and reading and signing the informed consent form.

Exclusion Criteria:

* Having a diagnosed neuromuscular disease other than DMD and/or with DMD,
* Having a diagnosed psychiatric and/or metabolic disease,
* Having a diagnosis of autism spectrum disorders,
* Presence of congenital and/or acquired anomalies that may affect communication,
* The family and/or the child has a problem of cooperation in completing the assessments for any reason,
* Using a catheter and/or a diaper all day,
* Having difficulty in understanding and speaking the Turkish language.
Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study

This study evaluates how often women with throat (oropharyngeal) cancer or who have a partner with oropharyngeal cancer get anogenital infections with high risk, potentially cancer-causing types of human papilloma virus (HPV).

PRIMARY OBJECTIVES:

I. Prospectively determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.

II. To determine the risk of requiring additional procedures or treatments secondary to these diagnoses.

III. To determine the sexual health and well-being among patients and partners with HPV(+)OPSCC.

IV. To develop standardized patient education and recommendations for referral and screening for this patient population.

V. Measure patient satisfaction with study education and anogenital pathology screening process via internal questionnaire.

OUTLINE: This is an observational study.

Participants complete surveys, watch an educational video on HPV vaccination and undergo collection of blood and saliva samples on study. Patients also undergo cervical screening per standard of care and may receive a referral to gynecology if not up to date on anogenital screening.

Eligibility Criteria:
Inclusion Criteria:

* \* Female patients with diagnosed HPV(+)OPSCC seen at the Mayo Clinic, Rochester

  * Age ≥ 18
  * Female partners of Mayo Clinic patients with diagnosed HPV(+)OPSCC
  * Patient has given permission to give his/her blood/saliva sample for research testing
  * Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

* \* HPV(-) OPSCC

  * Unable to provide informed consent
  * Unwilling to attend screening visit at Mayo Clinic site, if indicated
  * Unwilling/unable to complete surveys electronically
Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)

Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility problems. However, despite ART treatment options have evolved over time, the implantation rate remains rather low.

A possible role for inherited and acquired thrombophilias has been invoked, especially in women with previous implantation failures. However, several factors could play a role in these conditions.

A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes, independently of the presence of thrombophilia, has been recently suggested.

This register is designed in order to better define all possible variables influencing ART outcome and improve clinical management of women with previous implantation failures. During this study the investigators will collect and evaluate clinical data regarding the first cycle in women with previous ART failures.


Eligibility Criteria:
Inclusion Criteria:

* 2 or more implantation failures/losses of clinical pregnancies after ART
* ART cycle at enrolment
* Informed consent

Exclusion Criteria:

* Ovarian hypofunction
* Uterine pathology
* Hydrosalpinges
* Previous inclusion in the study
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation

The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of emergency department arrival).


Eligibility Criteria:
Inclusion Criteria:

* The patient is judged to be an adult (according to local practice, e.g. 16 years or older in UK) and has sustained severe traumatic injury. In the event the age is unknown, estimated body weight ≥50 kg.
* The patient is deemed by the attending clinician to have on-going active hemorrhage AND REQUIRES Activation of the local major hemorrhage protocol for management of severe blood loss AND HAS STARTED or HAS RECEIVED at least one unit of any blood component

Exclusion Criteria:

* The patient has been transferred from another hospital
* The trauma team leader deems the injuries incompatible with life
* More than 3 hours have elapsed from the time of injury
* Prisoner (as defined as someone admitted from a correctional facility)
* Known "Do Not Resuscitate" orders
* Enrolled in a concurrent ongoing interventional, randomized clinical trial
* Patients who wear "opt out" bracelet for study
* Obvious pregnancy
* Severely burned
Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique in Primary Dysmenorrhea

A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants. Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently. Group A will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while Group B will only receive the breathing technique. Assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales. Data will be analyzed using SPSS version 27.

This study will be a randomized clinical trial. Riphah International University QIE Campus in Lahore will serve as the site of data collecting and intervention services. Non-probability convenience sampling will be the method of sampling. The study's sample size will be 28 participants. Inclusion criteria for this study will be: women between ages 14-26 years, nulliparous women, with a score greater than 4 in WALIDD primary dysmenorrhea intensity scales, history of normal menstrual cycles that lasts 3-7 days and ranged from 21- 35 days, ability to perform exercises independently. Group A will be given kegel exercises as well as 4-7-8 breathing techniques for a total of 8 weeks with 4 sessions per week. Whereas, group B will be given the 4-7-8 breathing technique only. Initial assessment will be taken on the 3rd day of menstrual period. Follow-up assessment will be taken after week 4 post interventions and final assessment will be done after week 8 post intervention. WaLIDD primary dysmenorrhea intensity scale, Pain Self-Efficacy Questionnaire (PESQ), and Numeric Pain Rating Scale (NPRS) will be the data collecting instruments.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Women with a score greater than 4 on WALIDD primary dysmenorrhea intensity scale
* Women having a history of normal menstrual cycles that lasts 3-7 days and range from 21- 35 days.
* Ability to perform exercises independently

Exclusion Criteria:

* Women with very mild primary dysmenorrhea
* Women treated for ovarian cysts or other gynecological issues
* Women currently taking medication for dysmenorrhea
* History of any systemic illness
* A history of psychological conditions that could influence the perception of pain and functional activity.
Persons With Dementia and Their Extended Family Caregivers

Immediate family members shoulder the majority of care responsibilities for persons living with dementia. However, due to various societal changes, elder care responsibilities have expanded to extended family members, including grandchildren, siblings, nieces/nephews, siblings, and step-kin.

The main objective of this study is to understand the caregiving journeys of various extended family members involved in dementia care. We aim to learn about caregivers' care management strategies; their use of home and community-based services and informal support; and barriers to service usage. We will use the results from the study to help enhance service delivery, alleviate care-related stress, and improve the quality of life of dementia patients and their caregivers.

We will use a mixed-methods design to explore the challenges faced by caregivers as well as their service usage for the person living with dementia. Our methodology involves an initial telephone interview (approx. 70 minutes) that includes open-ended questions, standard items, and structured measures, followed by an 8-day semi-structured daily diary interview about daily care responsibilities and experiences with services (15-20 minutes each evening). This study will be conducted with 240 extended family members serving as one of the main caregivers for a person living with dementia in a community setting.


Eligibility Criteria:
Inclusion Criteria:

* Speaks/reads English
* Resident of Virginia, North Carolina, Maryland, West Virginia, Tennessee, Kentucky or Washington, D.C.
* Age 18+
* Is either the grandchild, sibling, niece/nephew, step-kin, adult child or spouse of the person living with dementia
* Is providing hands-on care and/or overall management of care for a person living with dementia in the community
* Caregiver co-resides with the person with dementia or has face-to-face contact with the person with dementia at least 3 days/week
* Has no difficulty talking/hearing on the telephone

Exclusion Criteria:

* Caregiver of persons with mild cognitive impairment
* Person with dementia lives in service-enriched housing such as a continuing care community, or residential facilities, such as assisted living facilities or nursing homes
Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1032 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1032.

PM1032 is a Bispecific Antibody Targeting CLDN18.2 and 4-1BB.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily;
* Male or female aged 18 to 75 years;
* Subjects with malignant tumor confirmed by histology or cytology, subjects with advanced malignant solid tumors who have no standard treatment, have failed standard treatment or are not eligible for standard treatment:

  1. Phase I dose escalation stage: gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, etc.;
  2. Phase I dose expansion stage, phase IIa dose expansion stage: gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, other tumors; CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay in central laboratory.
* Adequate organ function;
* ECOG score was 0-1;
* Expected survival≥12 weeks;

Exclusion Criteria:

* History of severe allergic, severe allergy to drugs or known allergy to any component of the drug in this study;
* Previous exposure to immune co-stimulatory molecule agonists such as 4-1BB mono/bispecific antibodies, etc;
* Patients who received CLDN18.2-targeted mono/bispecific antibodies or cell therapy;
* Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms were deemed unsuitable for this study by the investigator;
* Current definite interstitial lung disease or non-infectious pneumonitis, except for local radiotherapy;
* Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
* Adverse reactions to previous anti-tumor therapy have not recovered to NCI-CTCAE V5.0 rating≤1;
* Patients ever received the following treatments or drugs prior to the study treatment:

  1. Major organ surgery within 28 days prior to initiation of trial treatment or requiring elective surgery during the trial period;
  2. Received live attenuated vaccine within 28 days prior to the study treatment;
  3. Received chemotherapy, radical/extensive radiation, biotherapy, endocrine therapy and other anti-tumor drug therapy within 4 weeks of the first administration;
  4. Received systemic glucocorticoid or other immunosuppressive therapy within 2 weeks before the trial treatment;
* Active bleeding within 3 months of the first administration;
* History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
* Pregnant or lactating women;
* Other conditions considered unsuitable for this study by the investigator.
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.

The registry measured the times to, and studied the determinants of, first appropriate (FAT) and inappropriate (FIT) therapy delivered by single, dual and triple chamber (CRT-D) ICD implanted for primary and secondary prevention indications.

Eligibility Criteria:
Inclusion Criteria:

* Indication for an ICD according to current guidelines, incl. prophylactic indication

Exclusion Criteria:

* pregnant or at birth bearing age without contraception, participation in another clinical trial, short life expectancy, geographically unstable for a follow-up at the investigational center
Clinical Validation of the Norbert Health Device for Pulse Rate Measurement

The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

The study design is to validate the pulse rate accuracy. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years or older
* Ability to comprehend written consent and provide informed consent
* Ability to commit to and complete study related paperwork and activities (i.e. subject forms, have de-identified pictures taken, comply with periods of no movement, etc.)

Exclusion Criteria:

* Pregnant women
* Diagnosis of essential tremor or any medical condition causing tremors of the head or hands
* Facial tattoos, scars, large moles, beards/hair growth, birthmarks, vitiligo, skin conditions, facial discoloration, or heavy makeup within the areas of interest
* Inability for subject to avoid extreme movement during measurement reading windows
* Inability for subject to raise their hand during measurement reading windows
* No heart arrythmias
* Discretion of the Principal investigator or clinical study staff