cyrilzakka/clinical-trials huggingface dataset:
TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen

Recently, there has been a rising trend of delaying childbearing and hence more women are diagnosed with breast cancer before completing their families. Given the continuous decline in recurrences and death secondary to breast cancer and the reassuring data on the safety of pregnancy following breast cancer more women are inquiring into the possibility of preserving fertility following chemotherapy. The challenge remains in using a regimen that is devoid of cyclophosphamide, but is as effective as the standard regimens that incorporate cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP) followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with convincing results regarding its effectiveness in the early setting, and could be potentially associated with less ovarian toxicity being devoid of cyclophosphamide.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≤ 40 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
3. Non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
4. Negative estrogen (ER) and progesterone receptor (PgR) status.
5. Baseline left ventricular ejection fraction (LVEF) ≥50% measured by an echocardiogram or MUGA.
6. Interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
7. Known HER2/neu status.
8. Negative pregnancy test within 14 days prior to starting chemotherapy.
9. Adequate hematologic, hepatic and renal function.
10. Signed informed consent.

Exclusion Criteria:

1. History of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
2. Previous history of amenorrhea \> 3 months within the last 2 years (excluding pregnancy).
3. Ovarian insufficiency defined as serum FSH \> 20 IU/L at the local laboratory, anytime during the menstrual cycle.
4. Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
5. Pregnant or breastfeeding patients.
6. Inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. Effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm - also in conjugation with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
7. Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.
8. Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
9. Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
10. Known sensitivity to any of the study medications.
Phase 1/2 Study of AOC 1020 in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)

A Randomized, Double-blind, Placebo-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of AOC 1020 Administered Intravenously to Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

AOC 1020-CS1 is a first-in-human, 3-part, multi-center, Phase 1/2, randomized, double-blind, placebo-controlled study designed to evaluate safety, tolerability, pharmacokinetics and to explore pharmacodynamics and efficacy of single and multiple-doses of AOC 1020 administered intravenously in participants with FSHD Type 1 (FSHD1) and FSHD Type 2 (FSHD2).

Cohort A comprises a placebo-controlled dose titration cohort (Cohort A1) which includes a nested single and multiple dose schedule. Cohort B comprises a placebo-controlled, nested single ascending dose (SAD)/multiple ascending dose (MAD) cohort (Cohort B1). Cohort C comprises a randomized, placebo-controlled, expansion cohort (Cohort C1). For each of Cohorts A, B, and C the study duration is 12 months as the active treatment period is approximately 9 months for Cohorts A \& B and approximately 10 months for Cohort C followed by a 12-week follow-up period for Cohorts A \& B and a 7-week follow-up period for Cohort C. Once participants have completed active treatment with follow-up through 12 months, they may have the option to participate in a planned open-label extension. If patients do not enroll in the open-label extension, they will be followed for 12-weeks after their last dose of study medication.

Eligibility Criteria:
Inclusion Criteria:

* FSHD1 or FSHD2 diagnosis confirmed by documented genetic testing (testing provided by Sponsor)
* Ambulatory and able to walk 10 meters (with or without assistive devices such as one cane, walking stick or braces)
* At least 1 muscle region suitable for biopsy (testing provided by Sponsor)
* Muscle weakness in both upper and lower body, as determined by Investigator

Exclusion Criteria:

* Pregnant or intends to become pregnant while on study, or active breastfeeding
* Unwilling or unable to continue to comply with contraceptive requirements
* Body mass index (BMI) \>35.0 kg/m2 at Screening
* History of muscle biopsy within 30 days of the screening biopsy or planning to undergo any nonstudy muscle biopsies over the duration of the study
* History of bleeding disorders, significant keloid, or other skin or muscle conditions (e.g., severe muscle wasting) that, in the opinion of the Investigator, makes the participant unsuitable for serial muscle biopsy
* Anticipated survival less than 2 years
* Blood or plasma donation within 16 weeks of Study Day 1
* Any contraindication to MRI
* Any abnormal lab values, conditions or diseases that, in the opinion of the investigator or Sponsor, would make the participant unsuitable for the study or could interfere with participation or completion of the study
* Treatment with any investigative medication within 1 month (or 5 half-lives of the drug, whichever is longer) of Screening
In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA)

In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. This is the location from which all participants will be recruited and where fluoroscopy data collection will occur. Participants will undergo fluoroscopic surveillance of their implanted knee using a C-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.

Enrollment will be increased to 24 subjects to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee. The kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will have a Klassic knee system.
2. Subjects must be at least six months post-operative.
3. Participants must be judged clinically successful with their most recent (new) Knee Society "Knee Score" equal to or greater than 80.
4. Participants must be able to perform a deep knee bend.
5. Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
6. Must speak English.

Exclusion Criteria:

1. Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
2. Subjects without the required type of knee implant.
3. Bilateral subjects (i.e., patients with both knees implanted)
4. Subjects who are unable to perform a deep knee bend.
5. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
6. Subjects who do not speak English
Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

A double-blind, randomized, controlled trial was conducted with the main objective of evaluating if patients with clinical assessment and VExUS reach decongestion faster within a maximum period of 7 days during the hospital stay. Likewise, the study will describe those patients who experience a decrease in serum creatinine (CrS), NT-proBNP at discharge, greater diuretic adjustment, rate of intrahospital readmission, and 30-day mortality.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Type 1 cardiorenal syndrome in emergency room at Instituto Nacional de Cardiologia Ignacio Chávez

Exclusion Criteria:

* Patients who denied to participate
* Liver disease (cirrohsis)
* Complex congenital heart disease
* Kidney transplant
* Heart transplant
* Severe valvular disease
* Chronic kidney disease KDIGO G5 and G5d
* INTERMACS Score 2
Nitric Oxide Production in MELAS Syndrome

Introduction

Baylor College of Medicine and Texas Children's Hospital are recruiting individuals with MELAS syndrome for a clinical study. MELAS syndrome is a mitochondrial disease; patients with this disease have muscle weakness and often develop brain strokes, where blood does not flow normally to different parts of the brain. It is believed that these strokes could be due to decreased production of nitric oxide, a naturally occurring compound important for normal blood vessel function. Nitric oxide is made from arginine and citrulline that are normally found in our bodies.

What is the purpose of this study? The purpose of this study is to measure nitric oxide in individuals with MELAS and see if giving arginine or citrulline will increase the formation of nitric oxide. Nitric oxide is thought to be helpful in preventing strokes. Therefore, if arginine and/or citrulline are shown to increase the formation of nitric oxide, they could be used to prevent or treat the strokes in patients with MELAS syndrome.

What does the study involve? Individuals with MELAS syndrome will be admitted twice to the General Clinical Research Center (GCRC) at Texas Children's Hospital. Each time they will stay for five days, during which a special diet will be provided. Nitric oxide production will be measured by stable isotopes infusion technique that involves placing small tubes in veins (IV catheter), blood sampling, and injecting a harmless stable isotope. Stable isotopes are forms of normal compounds that can be measured accurately. They are not radioactive and there are no known risks to giving them; they are already part of your body in small amounts.

During the first admission nitric oxide levels will be measured, then arginine supplementation will be provided for 48 hours, after which nitric oxide levels will be re-measured to determine the effect of arginine supplementation. During the second admission, the effect of citrulline supplementation will be measured.

Who can participate in the study? Adults or children affected with MELAS syndrome and carrying the DNA change that causes the condition (3243 A\>G mutation) can participate. Adults without MELAS disease will be recruited to participate as control subjects.

How to get more information? Subjects interested in participation or getting more information can contact Dr. Ayman El-Hattab at email: elhattab@bcm.edu, office phone: 832-822-4289, cell phone: 646-660-5666, or pager: 832-824-7243 (5523).

Eligibility Criteria:
Inclusion Criteria:

1. Age from 3 - 65 years
2. Clinical diagnosis of MELAS syndrome
3. Carrying the m.3243A\>G mutation

Exclusion Criteria:

1. Having acute or chronic disease or physical disability that will interfere with the ability to undergo the study procedures
2. Being pregnant
Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

The investigators propose to study intensively the bacteriology of feces in C. difficile associated diarrheal disease, using a variety of conventional and very up-to-date techniques.

Clostridium difficile associated colitis is an increasing problem in hospitals throughout the developed world; the number of cases has increased, and the failure to respond to conventional therapy has become far more common. The investigators have recently documented in the medical literature (Clin Infect Dis, June, 2005; Lancet Infect Dis, August, 2005). Possible reasons for failure of treatment include persistence of C. difficile and/or imbalance of other bacterial flora in the colon. The bacteriology of fecal flora in C. difficile associated diarrhea has not been studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin
* Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin
* Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy
* Hospitalized patients who have received \>2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort

Exclusion Criteria:

* none
Dual Task in Female Patients With Fibromyalgia

The aim of our study is to examine the relationship between dual task and physical and psychosocial factors in female patients with fibromyalgia.

We will perform Dual Task Test, 6 min Walking Test, the Baecke Habitual Physical Activity Questionnaire, Multidimensional Fatigue Inventory-20, Tracking Test, General Self-Efficacy Scale the Toronto Alexithymia Scale, the Revised FM Impact Questionnaire, the Social Support Scale.

Dual-tasking is a procedure that requires an individual to perform two tasks simultaneously to compare performance with single-task conditions, and the characteristics associated with dual-task performance in patients with fibromyalgia are unclear. Therefore, in our study, we focused on examining the relationship between dual task and physical and psychosocial factors.

Patients with a diagnosis of fibromyalgia will be included in our study.

Dual-task assessment of women with FM is with the "Dual Task Test", aerobic capacity with the "6 min Walking Test", physical activity level with the "Baecke Habitual Physical Activity Questionnaire", fatigue levels with the "Multidimensional Fatigue Inventory-20", cognitive levels With the "Tracking Test", self-efficacy levels with the "General Self-Efficacy Scale", alexithymia levels with the "Toronto Alexithymia Scale", quality of life with the "Revised FM Impact Questionnaire", motivation levels with the "Social Support Scale" will be evaluated .

Eligibility Criteria:
Inclusion Criteria:

* Women aged 30-75 years
* Patients diagnosed with fibromyalgia by a rheumatologist according to criteria set by the American College of Rheumatology
* Patients who can communicate effectively with study staff.
* Patients who have read, understood and signed the informed consent form

Exclusion Criteria:

* Those who are pregnant
* Participants who could not sit and stand in a chair even once, or climb stairs unaided
* Other rheumatic diseases and other severe somatic or psychiatric disorders such as cancer, severe coronary disease, or other serious somatic or psychiatric disorders such as schizophrenia
A Comparison of CPAP With and Without Humidification: A Pilot Study

To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The therapy cost and the successfulness of the treatment will be measured. A humidifier is a water chamber that is currently added to CPAP only if the patients needs it.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* Diagnosed with OSA (obstructive sleep apnea) and eligible for CPAP treatment under local requirements (NICE guidelines: AHI (apnea hypopnea index) ≥ 15, or AHI \> 5 with significant daytime sleepiness)
* Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years.
* Fluent in spoken and written English

Exclusion Criteria:

* Significant uncontrolled cardiac disease, as per the principal investigator's discretion
* Co-existing lung disease, as per the principal investigator's discretion
* Co-existing sleep disorder, such a predominant central sleep apnoea
* Pregnancy
* Participants that are unable or unwilling to give informed consent.
Tele-dermatology Non-presential (TeleDermaSA)

The purpose of the study is to evaluate the implementation of the Non-Face-to-Face Interconsultation of dermatology since it began to be used in August 2020 until August 2022 in the province of Salamanca (Spain)

Design: cross-sectional descriptive study. Subjects: The unit of analysis will be the NPIs performed in dermatology since its implementation in August 2020 until the present time in the health area of Salamanca. To analyze the face-to-face consultations to analyze the differences. A random sample of 500 PNCIs and 500 face-to-face consultations will be extracted.

Measurements: To analyze the ICNP and face-to-face IC to dermatology registered in the computerized clinical history made in PC from Medora and registered in Jimena. To record the number of consultations, type of pathology referred, dermatology response time, discharges after assessment, face-to-face consultations required, delay time, treatment required, follow-up required or not, diagnostic coincidence, quality of the photographic image sent.

A differentiated analysis will be made according to the use or not of the dermatoscope, type of center (urban, semi-urban and rural), gender of the patients and age groups.

Eligibility Criteria:
Inclusion Criteria:

* The unit of analysis will be the PNCIs performed in dermatology from Primary Care, registered in Medora software, with its corresponding photographic file, and its response in Jimena software of the dermatology service, from June 2021 to June 2022, one year.

Exclusion Criteria:

-
3D Depth Camera-Based Assessment of Adolescent Idiopathic ScoliosisUsing a Depth Camera

Adolescent Idiopathic Scoliosis (AIS) is a common spinal deformity affecting adolescent health, and early diagnosis and accurate assessment are crucial for preventing disease progression. Traditional assessment indicators, such as the trunk rotation angle (ATR) and Cobb angle, rely on clinical examinations and X-ray imaging, which have certain limitations, including radiation exposure and insufficient sensitivity. The Back Height Difference (BHD), as a quantitative measure of the back surface morphology, may reflect the degree of trunk deformity caused by scoliosis.

The use of the Kinect v2 depth camera to capture three-dimensional point cloud data of the back provides a high-precision, radiation-free assessment method.


Eligibility Criteria:
Inclusion Criteria:

(1) Adolescents aged 10-18 years, diagnosed with adolescent idiopathic scoliosis (AIS) with a Cobb angle ≥10°; (2) No history of spinal surgery or other corrective treatments; (3) Able to undergo short-term inpatient treatment (5 days) and comply with study procedures.

Exclusion Criteria:

(1) Patients with congenital, neuromuscular, or other secondary scoliosis; (2) Presence of major comorbidities affecting spinal structure or muscle tone (e.g., spinal cord injury, muscular dystrophy); (3) Patients unable to complete standardized assessment procedures.
Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy

The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Clinical diagnosis of painful diabetic neuropathy.
* non-fertile females

Exclusion Criteria:

* Other pain that may confound assessment of neuropathic pain.
* Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
* History of psychotic disorders among first degree relatives.
Ocular Blood Flow Imaging for Glaucoma Assessment

The goal of this clinical trial is to investigate the use of an FDA-cleared retinal blood flow imaging instrument called the XyCAM RI and XyCAM FC (Vasoptic Medical, Inc., Columbia, MD) in glaucoma management.

The main question it aims to answer are:

* Can the investigators use blood flow to discriminate between eyes with early-stage glaucoma and variable-matched controls?
* Can the investigators validate that the XyCAM FC simultaneously captures both stereo fundus photography and ocular blood flow monitoring?

Participants will be

* measured for their blood pressure, heart rate, height, and weight
* dilated with tropicamide
* imaged using the XyCAM RI, fundus photography, optical coherence tomography, and standard automated perimetry
* imaged using the XyCAM RI while inhaling 100% oxygen through a mask

The investigators will capture images of the participant's retina using the XyCAM RI or XyCAM FC ("test data") and by color fundus photography, optical coherence tomography (OCT), and standard automated perimetry (SAP) - the "standard clinical data". The investigators will perform five tests. The first two tests will be conducted using the XyCAM RI or XyCAM FC to obtain "test data". The final two tests will be conducted using routine clinical instruments to obtain "standard clinical data". The investigators will administer eye drops (Tropicamide) to dilate the participant's pupils prior to the first test. Tropicamide is a chemical that causes pupil dilation and is commonly used by doctors to examine the participant's eyes. The entire set of test data sessions should last less than eighty (80) minutes with an additional 60 minutes for carrying out the necessary procedures and imaging using the standard clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older with binocular vision
* Able to provide informed consent
* Patient is a healthy control OR is recommended for glaucoma assessment OR diagnosed with moderate to severe glaucoma in at least one eye as determined by Hodapp Anderson Criteria

Exclusion Criteria:

* The subject has significant media opacity (e.g., a visually significant cataract or significant corneal scar)
* The subject has previous ocular surgery other than uncomplicated cataract extraction, laser trabeculoplasty (ALT or SLT), or YAG capsulotomy
* The subject has prior ocular disease other than glaucoma
* The subject has anatomically narrow angles or a prior adverse reaction to administration of Tropicamide or fluorescein dye
* The subject has more than 15 diopters of refractive error
* The subject is a female who is pregnant or nursing
* The subject has diabetes mellitus