cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy

This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen or risdiplam or have a history of onasemnogene abeparvovec-xioi, compared to placebo.

Myostatin is a negative regulator of muscle growth. Blocking myostatin activity has been shown to increase muscle size and function. Taldefgrobep alfa directly blocks myostatin activity and was well tolerated in other clinical studies. In combination with medications that increase the amount of SMN protein in the body, taldefgrobep alfa has the potential to further improve motor function and clinical measures for people living with SMA.

Eligibility Criteria:
Key Inclusion Criteria:

* Spinal Muscular Atrophy confirmed by genetic diagnosis of 5q-autosomal recessive SMA as well as SMN2 copy number
* Ambulant or Non-Ambulant
* Treated with an SMA disease-modifying therapy and anticipated to remain on that same treatment regimen and dose throughout the trial including nusinersen, risdiplam, and/or a history of onasemnogene abeparvovec

Key Exclusion Criteria:

* Cannot have previously taken anti-myostatin therapies
* Must weigh at least 15kg
* Respiratory insufficiency, defined by the medical necessity for invasive or non-invasive ventilation for daytime treatment while awake (use overnight or during daytime naps is acceptable)
* History of Spinal Fusion within 6 months of Screening. MAGEC rod nonsurgical adjustments are allowed during the study
* Presence of an implanted shunt for the drainage of CSF or an implanted central nervous system (CNS) catheter
Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer

This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population

Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic breast adenocarcinoma
* No HER2 overexpression or gene amplification
* Absent or low ER or PR expression
* No previous therapy for metastatic breast cancer is allowed
* Age 18-75 years
* Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
* Performance status (WHO) 0-2
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases)
* adequate renal function (serum creatinine \<1.5 times the upper normal limit)
* bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
* No radiation of measurable disease (except brain metastases)
* No progressive brain metastases according to clinical or radiological criteria
* No brain metastases without prior radiation therapy
* Written informed consent

Exclusion Criteria:

* Active infection
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* History of stroke
* Anticoagulation therapy (except of low dose aspirin \<325mg)
* Other invasive malignancy except nonmelanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults

This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years.

The estimated duration is up to 21 days of screening period, followed by the treatment day with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total duration from screening to EOS will be 64 days maximum.

Duration per participant is up to 64 days

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, between 18 and 65 years of age, inclusive.
* Body weight between 65.0 and 95.0 kg, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

* Presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
* Blood donation, any volume, within 2 months before inclusion.
* Presence or history of drug or biologic hypersensitivity, or allergic disease diagnosed and treated by a physician (excluding seasonal allergy).
* History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
* Smoking regularly and unable to stop smoking during the inpatient portion of the study (occasional smoker can be enrolled).
* If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood test) or breastfeeding.
* Any biologics (antibody or its derivatives) given within 4 months before inclusion or within 5 half-lives (whichever takes longer).
* Participation in any previous clinical trial of dupilumab.
* Participation in any clinical research study evaluating another investigational drug or therapy in which the inclusion visit for the current study will be within 30 days of receiving the drug or 5 elimination half-lives (whichever is longer).
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women .

To evaluate the role of metformin in pregnant women with obesity (BMI above 30) , on maternal and infant outcome.

Obesity is defined as having an excessive amount of body fat based on the BMI, Obesity can be classified based on the BMI to obese class I ,Class II ,and extreme obesity (class III) , Obesity can harm the fertility by inhibiting normal ovulation. Even in women who regularly ovulate, the greater the BMI, the longer it appears to take to become pregnant. Obesity can also affect the outcome of in vitro fertilization (IVF). (1)

Being obese during pregnancy increases the risk of various pregnancy complications, including :

Miscarriage ,stillbirth ,GD , preeclampsia , obstructive sleep apnea , difficult vaginal delivery ,need for C-section ,and complication of C-section ,Fetal macrosomia , and increasing the risk for metabolic syndrome and childhood obesity , it also make It may be hard for the participants health care provider to diagnose birth defects during pregnancy even prenatal tests like ultrasound(2),(3) .

Normal weight gain during pregnancy for obese women having single pregnancy is between about (5-9) KG .

Normal weight gain during pregnancy for obese women having Multiple pregnancy is between about (11-19) KG (4).

For women who are extremely obese, gaining less than the recommended amount or losing weight during pregnancy might lower the risk of fetal and neonatal macrosomia .

The fetus is regarded as suspected appropriate or gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW \> 90th percentile (5) .

A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age (6,7,8) .

In this study the investigator will try to focus on diagnose undiagnosed diabetic using GTT (glucose tolerance test specially with women who has one or more risk factors A raised body mass index (BMI) over 30kg/m². A previous baby over 4kg or more ,Confirmed gestational diabetes in a previous pregnancy or have a first degree relative that has diabetes All pregnant women who have not already been diagnosed with diabetes should be screened for Diabetes with a fasting plasma glucose (FPG), an HbA1c, or an untimed random plasma glucose test at their first prenatal visit

* Women who by 24 weeks' gestation have not yet been diagnosed with overt or gestational diabetes should, at between 24 and 28 weeks' gestation, undergo a 2-hour, 75-g OGTT for gestational diabetes
* At 24-28 weeks' gestation, a result of 153-199 mg/dL for a 2-hour, 75-g OGTT indicates gestational diabetes, while a test result of 200 mg/dL or higher indicates overt diabetes(9),(10)

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with BMI ≥ 30 kg/m2, and normal glucose tolerance test.

Exclusion Criteria:

* pregnant women who are diabetic,
* had a history of previous GDM,
* previous small baby,
* PCO or
* previous early pre-eclampsia,
Prevention of Recurrence of Diverticulitis

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females =\>18yrs of age.
2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol
3. An episode of acute diverticulitis that resolved without colonic resection.
4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted

Exclusion Criteria:

1. Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
2. Active peptic ulcer disease
3. History of or current presence of inflammatory bowel disease (IBD)
4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
5. Allergy or hypersensitivity to aspirin or related compounds
6. Allergy to radiologic contrast agents
7. Use of another Investigational product within 30 days of Baseline
8. Use of antibiotic therapy within 4 weeks of Baseline
9. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor or anti-spasmodic agents
10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
12. History of alcohol or other substance abuse within the previous year
13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
14. Females who are lactating
A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip

This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic osteoarthritis pain of hip

Exclusion Criteria:

* Patients with current or prior conditions or treatment that would impede measurement of efficacy and safety
Turkish Version of Hand-Use-at-Home Questionnaire

To investigate the validity and reliability of the Turkish Version of parent-rated Hand-Use-at- Home questionnaire (HUH) in children with neonatal brachial plexus palsy or unilateral cerebral palsy.

Cerebral Palsy (CP) is defined as a permanent but non-progressive disorder group that affects the developing fetal or infantile brain, leading to impairment in movement and posture, thereby limiting physical activity and participation. The prevalence of CP in society is around 0.21%. In a study conducted in Turkey, this ratio of 4.4 / 1000 live births has been reported. Motor disorders in CP often are accompanied by sensory, perceptual, cognitive, communicative and behavioral problems and secondary musculoskeletal problems.

Obstetric brachial plexus (OBP) injury is a common peripheral nerve injury in children. Its incidence is reported between 0.42 and 5.1 per 1000 live births. As the primary mechanism of injury, it is accepted that traction or compression of all or part of the brachial plexus.

In these patients, weakness in the upper extremity, long-term contractures, and difficulties in the use of the extremities occurs due to the damage of nerves. In both diseases, patients have difficulty in bimanual activities.

Many treatment methods focus on increasing the use of upper extremities of patients and ensuring their independence in daily life activities. There are many methods for evaluating the hand use performance of patients and the effectiveness of different treatment methods. However, these clinical evaluation methods often do not reflect the patient's performance at home, at school, in their daily living environments.

The "Hand Use at Home (HUH)" questionnaire, which was created to be evaluated by parents, was developed in 2017 for measuring and evaluating the spontaneous use time of unilateral paretic children aged 3-10 in the affected hand and arm daily life activities.

The validity and reliability of the questionnaire were determined in children with obstetric brachial plexus paralysis and unilateral SP.

The purpose of this study; The translation of the HUH questionnaire into Turkish is to investigate its cultural adaptation, validity, and test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of unilateral cerebral palsy or obstetric brachial plexus palsy
* Age between 3 - 10
* Volunteer to study

Exclusion Criteria:

* Having a visual disorder
* History of botulinum toxin injection and surgery for upper extremity and hand in the last 6 months.
* Having robotic rehabilitation or intensive treatments such as constraint-induced movement therapy to increase upper extremity use in the last 6 months.
A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome

The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors.

Since 1978, we have been following a family of 105 descendants with Gardner Syndrome (GS). Mutation carriers were screened by endoscopy, and colorectal resection was performed upon pending malignancy. Resectable desmoid tumors were excised, whereas large tumors of the abdominal wall were treated by a combination of brachytherapy (BT) and radiotherapy (RT). Outcome was analyzed with respect to length of tumor-free survival, and morbidity from surgery or radiotherapy. Results: 37 of 105 family members have GS. Preventive colorectal resections were performed in 16 patients (15%), with one death due to subsequent gastric cancer. In 4 patients who denied screening endoscopy, invasive tumors of the colon (3 patients) and stomach (one patient each) developed. Of 33 desmoid tumors, 10 (30%) were located in the mesentery, 17 (52%) in the abdominal wall, and 6 (18%) in extra-abdominal sites. Excision of 12 desmoids was performed in 8 patients (36%), and 4 were treated by a combination of BT and RT. Following BT/RT, all patients showed full or partial remission.

Eligibility Criteria:
Inclusion Criteria:

* family with an identical adenomatous polyposis coli (APC-) germ line mutation

Exclusion Criteria:

* negative testing for adenomatous polyposis coli (APC-) germ line mutation
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer

This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Able to provide informed consent.
* Histologic diagnosis of prostate adenocarcinoma.
* ECOG performance status 0-1.
* High-risk localized disease by NCCN criteria (\>cT3, Grade group \>4, or PSA \>20 ng/mL) or clinical N1 disease.
* Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))

Exclusion Criteria:

* Prior pelvic radiotherapy.
* Contraindications to radiotherapy
A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction

A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
2. Subjects with a post operative BCDVA of 20/40 or better.
3. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations and willing and able to comply with the follow-up study visit.
4. Subjects implanted bilaterally with enVista Aspire EA IOLs, powers ranging from + 6 to + 34.0 D, prior to enrollment into the study on or after 1 November 2023.
5. All subjects with a visually significant PCO (BCDVA worse than 20/40) who undergo a YAG capsulotomy may be enrolled 30 days post YAG procedure and with a postoperative BCDVA 20/40 or better.

Exclusion Criteria:

1. Subjects with any serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, could confound the results of the study.
2. Subjects for whom a Toric IOL is indicated to achieve emmetropia.
3. Subjects for whom monovision treatment is planned.
Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

The goal of this project is to use health information technology and team-based care in novel ways to support the establishment of a Patient-Centered Medical Home model of care aimed at improving the diagnosis and management of hypertension. Compared with patients who receive usual care, patients who receive intervention will have a lower average systolic blood pressure 9 months after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women age 18-79
* At least 2 Blood Pressure readings from separate days on record
* Average of last 3 Blood Pressure readings (or last 2 if only 2 available) with (Systolic Blood Pressure ≥140 or Diastolic Blood Pressure ≥90) and (last Systolic Blood Pressure ≥135 or last Diastolic Blood Pressure ≥85), recorded by any University of Colorado Hospital clinic within the last 18 months
* No clinic visit in the past month
* At least one Primary Care Physician visit in the past 18 months
* First Primary Care Physician visit at least 6 months in the past

Exclusion Criteria:

* Serious comorbidities, including active cancer diagnosis, hospice care, nursing home residence
* Diagnosis of diabetes (these patients are enrolled in a separate study that also targets Blood Pressure control)
* End-stage renal disease / hemodialysis
* Primary Care Physician appointment pending
* Patient instructed to monitor Blood Pressure at home / documentation of white coat hypertension
* Blood Pressure managed by specialist or outside provider
Resistance Training in Children

The project is going to examine the effects of resistance exercise training in prepubescent youth on skeletal muscle strength and lipid content.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer males and females ages 8 - 10 years.

Exclusion Criteria:

* No history or ongoing neuromuscular diseases.
* No history or ongoing musculoskeletal injuries.
* No history or ongoing disease that effects metabolism.
AV Nodal Reentrant Tachycardia Study

The purpose of this study is to determine/identify what mechanisms/factors are involved with regard to AV nodal reentrant tachycardia.

HYPOTHESES:

1. The Tendon of Todaro forms a line of block during slow/fast AVNRT preventing the atrial impulse from entering the triangle of Koch (and perhaps providing sufficient time for activation to pass through the coronary sinus coat to activate the posterior extensions of the AV node as is critical to maintenance of tachycardia)
2. The coronary sinus myocardial coat participates in all of the forms of AVNRT. The reentrant circuit is thus not confined within the triangle of Koch and sites remote from the compact AV node could be targeted for ablation reducing the risk of AV conduction block.
3. A model of the reentrant circuit can be created for each patient's tachycardia, using the site of earliest retrograde activation to suggest the retrograde limb and the resetting response to suggest the anterograde limb.

DATA ANALYSIS/STATISTICS:

Resetting and Mapping of AV nodal reentrant tachycardia:

Pacing will be analyzed to see at which sites, the tachycardia can be reset by the latest extra-stimuli (i.e., with the least advancement in local activation). The coupling interval will be compared to the latest extra-stimulus capable of resetting (advancing) the tachycardia from the postero-septal tricuspid annulus.

Ablation Results:

The patients will act as their own reference, since the standard ablation technique in the postero-septal space is being performed first and tested for efficacy. The McNemar test will be applied to compare the efficacy of ablation at the postero-septal tricuspid annulus alone (standard ablation), with the efficacy of this ablation plus ablation within the coronary sinus. From our initial observations, It is anticipated that the additional ablation in the coronary sinus will increase the efficacy of the procedure from \<95% to \>98%, such that 100 cases should provide sufficient data to reach statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Ages 16-80
* At least one documented episode of AV nodal reentrant tachycardia
* Patient scheduled for electrophysiology study and catheter ablation for supraventricular tachycardia

Exclusion Criteria:

* Ages \< 16 or \> 80
* Medical condition significantly increasing risk of extending procedure time or X-ray exposure
* Pregnancy
* Prior ablation with radiation exposure \>2 hours
* Electrophysiology study performed without sedation or anesthesia
* Unavailable for follow-up