cyrilzakka/clinical-trials huggingface dataset:
Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Eligibility Criteria:
Inclusion Criteria:

* Women pregnant in dichorionic twins.
* Transvaginal sonographic cervical length is \<25 mm at 16-20 weeks gestational age.
* No symptoms, signs or other risk factors for preterm labor

Exclusion Criteria:

* Age \< 18 years or \> 45 years.
* Known allergy or contraindication (relative or absolute) to progesterone therapy.
* Monochorionic twins.
* Known major fetal structural or chromosomal abnormality.
* Intrauterine death of one fetus or death of both fetuses.
* Fetal reduction in the current pregnancy.
* Medical conditions that may lead to preterm delivery.
* Rupture of membranes.
* Vaginal bleeding
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder
* All visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy
* Confirmed recurrence of non-muscle invasive bladder cancer (NMIBC) after prior therapy that meet either one: a. Recurrence of high-risk NMIBC (high-grade Ta or any-grade T1) within 12 months after adequate Bacillus Calmette-Guerin (BCG), or any-grade T1 within 3 months after 1st induction course, refusing or ineligible for radical cystectomy (RC). b. Recurrence of intermediate- or high-risk NMIBC (any-grade Ta/T1) after prior BCG regardless of the timing of recurrence, refusing or ineligible for RC and considering no other effective treatment options. c. Recurrence of intermediate-risk NMIBC (low grade Ta) after intravesical chemotherapy including maintenance therapy following a single dose after operation, no other effective intravesical chemotherapy is available and refusing BCG treatment
* At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine sample collected prior to trans urethral resection of bladder tumour (TURBT)
* Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (\<=) 2

Exclusion Criteria:

* Histologically confirmed muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder.
* Prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor
* Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of erdafitinib intravesical delivery system
* Participants with active bladder stones or history of bladder stones less than \[\< 6\] months prior to the start of study treatment
* Participants have concurrent or second malignancy other than the disease which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s); -Bladder post-void residual volume (PVR) \>350 mL after second voided urine, -Current central serous retinopathy or retinal pigment epithelial detachment of any-grade
Effect of Quercetin Supplementation on Endometriosis Outcomes

Quercetin is a polyphenol compound that possesses anti-inflammatory properties and can be found in various food sources like apples, berries, cabbage, and onions. In Park et al.'s study, it was discovered that quercetin led to a significant decrease in the proliferation of endometriosis cells. Furthermore, quercetin also triggered apoptosis in endometriosis cells in vitro and reduced the size of endometriosis lesions in vivo. Nevertheless, as of now, there have been no studies conducted in Iran or worldwide that explore the effects of quercetin supplementation on individuals with endometriosis. Hence, the aim of this study is to investigate the impact of quercetin supplementation on factors such as glycemic status, lipid profile, oxidative stress, inflammation, growth factors, adiponectin, sex hormones, and anthropometric indicators in women suffering from endometriosis.

The participants in the study were randomly assigned to two groups: the intervention group and the control group. The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks. On the other hand, the control group will be given a placebo. Blood samples will be collected before and after the intervention to measure changes in blood lipid profile, fasting blood sugar, sex hormones (testosterone, estrogen, progesterone), TNFα, IL-6, adiponectin, IGF1, HbA1C, SHBG, FSH, LH, and plasma total antioxidant capacity.

Eligibility Criteria:
Inclusion Criteria:

* Willing to cooperate and complete the informed consent form.
* Diagnosed endometriosis using laparoscopy and histopathological tests.
* In the age group of 18 to 40 years.
* Having a regular menstrual cycle.
* Having a body mass index between 18.5 and 30.

Exclusion Criteria:

* Using hormonal medications or intrauterine treatments for a minimum of three months prior to collecting a sample.
* Having immune system disorders, persistent infections, diabetes, or any conditions like polyps and fibroids within the uterine cavity.
A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet

This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method.
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Use of tobacco and nicotine products, defined as any of the below:

  * Smoking more than 5 cigarettes or the equivalent per day
  * Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods
* Blood donation, plasma donation or blood draw, defined as any of the below:

  * In excess of 400 mL within the past 90 days prior to the day of screening
  * In excess of 50 mL within the past 30 days prior to the day of screening
* History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3

The goal of this observational study is to learn the effects of the drug velmanase alfa (Lamzede®) in the bodies of children under the age of 3 with Alpha-Mannosidosis.

The main questions it aims to answer are:

* study the effect of velmanase alfa on a marker of the disease called GlcNAc(Man)2 after one year of therapy
* explore how the child's body reacts to velmanase alfa during the therapy The parents or legal guardians of participants will be asked to provide the results of analyses performed in the routine clinical setting related to the participant's general health and the administration of velmanase alfa.

Additional data will be extracted from other observational sponsored studies/registries, compassionate use programs, investigator-initiated studies (IIS), and published case reports (presented in the literature) if existing.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with the provision of informed consent from their legal guardians (LAR)
* Have a confirmed diagnosis of alpha mannosidosis
* Have initiated treatment with velmanase alfa between birth to at least six weeks before turning 3 years of age
* Have information on the disease marker GlcNAc(Man)2 obtained:

before velmanase treatment initiation (ideally max 6 month before), and at least one post-treatment sample, collected following at least six weeks of treatment.

- Participants treated with Lamzede, 1 mg/kg body weight, via weekly intravenous infusions.

Exclusion Criteria:

Participants who have undergone prior hematopoietic stem cell transplantation (HSCT) or other investigational therapies for treating alfa mannosidosis (supportive treatments acceptable).
68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery

This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or high risk prostate cancer before surgery. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.

PRIMARY OBJECTIVE:

I. To assess the sensitivity and specificity of gallium Ga 68 gozetotide (68Ga-PSMA-11) PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.

SECONDARY OBJECTIVES:

I. To assess the positive and negative predictive value of 68Ga-PSMA-11 PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.

II. To assess sensitivity, specificity, positive and negative predictive value of 68Ga- PSMA-11 PET for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 20-50 minutes on day 1.

After completion of study, patients are followed up at 2-4 days, then at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma
* Considered for prostatectomy with lymph node dissection
* Intermediate to high-risk disease (as determined by elevated prostate specific antigen \[PSA\] \[PSA \> 10\], tumor \[T\]-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
* Able to provide written consent
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent)

Exclusion Criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
* Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation \[HiFu\])
AEDV Registry of Primary Cutaneous Lymphoma

Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.

Registry of patients with Primary Cutaneous Lymphoma seen at participating centers in Spain. The registry will identify patients with this disease and includes information about stage, diagnostic and therapeutic interventions and willingness to participate in further studies.

Data is entered in the registry in each of the participating cutaneous lymphoma clinics. These data are updated at least yearly. Participants receive specific training before starting, and there is an online continuous monitoring system.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with primary cutaneous lymphoma

Exclusion Criteria:

* Not willing to participate
Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism

The purpose of this study is to determine the effect on the incidence of fat emboli when using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures

The current practice of reaming the medullary canal for the fixation of femur fractures is recommended, however, there is an associated increase in the level of embolic events which confers morbidity and, occasionally, mortality.

The RIA is a single device which is able to ream the medullary canal, irrigate the canal and subsequently aspirate the reamed medullary contents in order to get rid of medullary fat and other contents responsible for these adverse embolic events.

A novel Reamer-Irrigator-Aspirator (RIA) (Synthes, Inc) will be evaluated in a randomized study, to determine its effect on the incidence of fat emboli events during reamed IM nail fixation of consecutive femoral shaft fractures as measured by intra-operative transesophageal echocardiogram and pulmonary function.

Eligibility Criteria:
Inclusion Criteria:

* Participant aged 16 to 65 years of age
* Skeletally mature
* Isolated, closed femoral shaft fracture (participant may also have sustained a distal radius/wrist, distal tibia/ankle, hand, and/or foot fractures for eligible inclusion)
* Fracture amenable to an antegrade I.M. nail
* Fracture amenable to insertion of a 12 mm RIA
* Fracture ≤ 48 hrs post injury
* Participant has a 'Thorax' Abbreviated Injury Score (AIS) of \< 2
* Participant has a 'Head \& Neck' AIS score of \< 2
* Provision of informed consent

Exclusion Criteria:

* Fracture proximal to the lesser trochanter
* Open fracture
* Participant has a humeral, tibial, contralateral femoral, spinal,and/or pelvic fracture
* Pathological fracture
* Fractures \> 48 hrs post injury
* Limited life expectancy due to significant medical co-morbidities
* Previous history of esophageal/gastric surgery
* Previous history of esophageal/gastric tumor
* Previous history of esophageal varices
* Medical contraindication to surgery
Urinary Urinary Nerve Growth Factor (NGF) as a Biomarker for Mixed Urinary Incontinence

Female urinary incontinence (UI) can be caused by pure stress UI (SUI), pure urgency UI (UUI) and mixed SUI and UUI (MUI). Clinically it might not be that easy to separate MUI and SUI. Patients might perceive urgency when they have an incompetent urethra and a full bladder.

Urinary tract nerve growth factor (NGF)is produced by bladder urothelium and smooth muscle. Increased levels of NGF have been reported in the bladder tissue and urine of patients with overactive bladder (OAB).

If the urinary levels of NGF differ among women with pure SUI and MUI, then urinary NGF level might be a biomarker in the differential diagnosis of MUI in women.

Also, decreased urinary NGF level was reported in OAB patients of whom the symptoms were improved. So, we might expect that the remnant OAB symptom including urgency incontinence can be improved, if the urinary NGF levels decrease after midurethral slings for SUI in MUI patients.

We aimed to explore the value of the urinary NGF as a biomarker for differential diagnosis and as a prognostic marker for predicting the improvement of OAB symptom after midurethral slings.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 or over 18 years with MUI for 3 or over 3 months
* Proven SUI by urodynamic study (UDS)or stress test
* Abdominal leak point pressure (ALPP)of 120 or less than 120cmH2O in UDS
* Symptoms verified using 5 day bladder diary as below i) number of urgency incontinence; 3 or more than 3/5days ii) number of micturition; 8 or more than 8/24hrs iii) number of urgency; 2 or more than 2/24hrs
* Women who cannot be pregnant or do not have plan to be pregnant
* Ability and willingness to correctly complete the micturition diary and questionnaire
* Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

* The subject has WBC≧3, Albumin≧+1, Nit ≧+1 upon urinalysis
* On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
* Patient has a significant pelvic orgen prolapse (POP) of ICS Stage 3 or over 3.
* Patients with combined POP surgery.
* Patients with bladder outlet obstruction on UDS or physical exam
* Patients with detrusor underactivity
* Diagnosed or suspected interstitial cystitis or bladder cancer
* History of radiation therapy on pelvic cavity
* Patients with neurologic condition which can affect lower urinary tract function
* History of urogenical malignancy within recent 2 years
* Treatment within the 14 days preceding enrollment, or expected to initiate treatment during the study with:

  i)Any anticholinergic drugs and any drug treatment affecting lower urinary tract function Estrogen treatment started more than 2 months prior to inclusion is allowed. ii) electrostimulation, bladder training, electromagnetic treatment
* Patient is on anti-coagulation therapy.
* Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)

This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.

This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.

Patients diagnosed with PMR whose PMR symptoms do not vary in intensity or frequency to the degree that a clinically indicated increase in prednisolone prescription might be anticipated will be included in the trial.

Participants will continue to receive prednisolone and will receive SPI-62 from Days 3-16

Inflammatory biomarkers, symptom measures, biomarkers of prednisolone toxicity, PK of prednisolone and SPI-62, and biomarkers of SPI-62 pharmacological activity will be measured on Days 2, 3, and 16. ABPM will be monitored on days 1 and 15.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Diagnosis of PMR according to European League Against Rheumatism and American College of Rheumatology classification criteria confirmed by a rheumatologist
* Absence of PMR relapse based on symptoms and acute phase markers
* Daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to Day 1

Exclusion Criteria:

* Any contraindication for prednisolone administration
* A diagnosis or any clinical features of giant cell arteritis
* Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR
* Use of medications for treatment of PMR other than oral prednisolone within specified intervals prior to Day 1 and during the treatment period
* Use of other medications likely to interfere with trial assessments
* History or diagnosis of endogenous hypercortisolism
* Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results
Activity Based Locomotor Exercise PrOgram-Wait-list controllEd Research

At Courage Kenny Rehabilitation Institute, rehabilitation for individuals with spinal cord injury (SCI) is being led by the NIH funded NeuroRecovery Network (NRN) Community Fitness and Wellness Program through the Activity-Based Locomotor Exercise Program (ABLE). Any individual with a spinal cord injury who is eligible for the ABLE Program is eligible for participation in the NeuroRecovery Network Research Project (NRN). The purpose of the ABLE POWER Study is to evaluate the effectiveness of activity-based locomotor exercise programs in individuals with SCI through a wait-list controlled design. Individuals who have a spinal cord injury and are on the wait list for ABLE will be enrolled in this project for a year while they wait for an opening in the ABLE program. Changes that occur while participants are on the wait list will be compared to changes that occur after they are enrolled in ABLE. A difference in the rate of improvement after enrollment in the intervention would be attributed to the ABLE intervention. Individuals participating in the ABLE program will receive the ABLE intervention regardless of participation in the ABLE POWER research study. In this design, there will be two measures in the year prior to enrollment in ABLE, and two measures in the year after enrollment, and the two time periods would be compared to the data collected at enrollment into ABLE.


Eligibility Criteria:
Inclusion Criteria:

* The participant must be eligible for the Neurorecovery Network (NRN) Study. Eligibility criteria for the NRN study are as follows: The participant must have a spinal cord injury, at any spinal level or time since injury. Individuals with uncontrolled diabetes, uncontrolled seizures, uncontrolled autonomic dysreflexia, uncontrolled hypotension, unstable angina, history of heart attack, osteoporosis, or weight of more than 275 pounds (due to the weight limit of the partial weight supported treadmill system) are not eligible.
* The participant must be on the ABLE wait list.

Exclusion Criteria:

• The participant must NOT have previously participated in ABLE.