cyrilzakka/clinical-trials huggingface dataset:
Effects of Estradiol on Menopausal Breast

The purpose of this study is to evaluate the effects on breast in postmenopausal women randomized to either oestradiol in combination with DRSP or E2 in combination with NETA during six months.


Eligibility Criteria:
Inclusion Criteria:

* Naturally postmenopausal, symptomatic, apparently healthy women, with the need for hormone therapy aged 50 - 70 years with a BMI \>18 and ≤30 kg/m2 and without any previous history of breast disease will be recruited for the study.
* They should be amenorrheic for at least 12 months or less than 12 months with S- FSH values \>40 IU/L.
* They should be free of any sex hormone treatment for at least three months before inclusion.

Exclusion Criteria:

* General contraindications for HT according to Swedish product label. Age \>60 years. BMI ≤18 or ≥30 kg/m2.
* Any previous history of cancer.
* Any previous history of breast disease or abnormal mammogram.
* In addition: hypertension (systolic BP \>160 mm Hg or diastolic \>100 mm Hg), hyperlipidemia (total cholesterol \>8.0 mmol/L or triglycerides \>3.0 mmol/L), diabetes mellitus, history of thromboembolic disease, heart failure, liver disease or porphyria, undiagnosed vaginal bleeding. No sex hormone treatment for at least three months before inclusion.
* No concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain

Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site.

Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site.

In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Hypertension
* Using subcutaneous treprostinil
* Already participating as a subject in our prospective study of infusion site pain
* Has documented debilitating pain (6/10 or greater) in the study after a site change

Exclusion Criteria:

* Uncontrolled hypertension
* Recent stroke or myocardial infarction
Prehospital Minutes Count During a Stroke.

The ultimate objective is to improve the efficacy of prehospital procedures for patients suffering an acute stroke. Increased precision in prehospital selection and a more efficient transport chain will lead to an even more rapid start of treatment and thus benefit patients. The research project has two parts: one part collecting data from medical reports and one study with qualitative in-depth interviews. The project will gather data from various parts of Norway and from a University hospital in Switzerland for comparison between regions and countries. Data will be retrieved through intrahospital and prehospital medical records from various parts of Norway (Nordland Hospital, Akershus University Hospital and Helgeland Hospital) and from Basel University hospital in Switzerland. Knowledge of factors associated with delays will be compared for regions in the north and south of Norway, as well as abroad. The information obtained will be analysed to identify components in the chain that may be improved as concerns time saving.


Eligibility Criteria:
Inclusion Criteria:

• Final diagnosis of stroke at discharge from hospital

Exclusion Criteria:

• Hospital admission later than one week from stroke onset
Telehealth Behavioral Migraine Management

This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral MIgraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx NY. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of migraine
* Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine
* Self-reported between 4 and 20 headache days/month
* Aged 18-65
* Can read English
* Capacity to consent

Exclusion Criteria:

* Psychiatric illness that would interfere with study participation
* Meeting criteria for probable medication overuse headache
Comparing Hepatic Intra-arterial Injection of Yttrium-90 Microspheres Versus Fluorouracil (5FU) in Colorectal Cancer Metastatic to the Liver Only

This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90 microspheres (selective internal radiation \[SIR\] spheres) versus infusional intravenous (IV) 5FU in colorectal cancer metastatic to the liver only and refractory to standard IV chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma, metastatic to the liver only.
* Failure of prior chemotherapy for advanced colorectal cancer.
* Adequate laboratory values of hematologic, renal and liver function
* World Health Organization (WHO) performance status (PS) \<= 2
* Written consent

Exclusion Criteria:

* Pregnant or lactating patients
* Other tumor type than adenocarcinoma (leiomyosarcoma; lymphoma).
* Patients with cirrhosis or other chronic liver disease
* Thrombosis of the hepatic main artery of the portal vein
* Lung shunting \> 20% as determined by nuclear medicine breakthrough scan
* Patients with serum bilirubin \> 1.0 x upper limit of normal (ULN) or with AST and/or ALT and/or alkaline phosphatase \> 5 x ULN
* Patients with concurrent or within 4 week period administration of any other experimental drugs.
* Other serious illness or medical conditions.
Calcium Electroporation for Treatment of Cutaneous Metastases

The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.

Double-blinded phase II clinical study. We will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. Separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. It is a once only treatment and the patients will be followed up for 6 months.

It is a non-inferiority study and we accept a difference in response on 15%.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Histological confirmed cutaneous metastases of any histology.
* At least 1. cutaneous metastases between 0,5 to 3cm, available to electroporation.
* Patient should have been offered standard treatment.
* At least 2 weeks since chemotherapy or radiotherapy.
* Performance status \>2 (ECOG).
* Life expectancy \>3 months.
* platelet count \> 50 mia/l.
* International Normalized Ratio (INR) \<1,2.
* Men and women of reproductive age must use effective contraception during the study.
* Patient should be able to understand participants information.
* Signed, informed consent.

Exclusion Criteria:

* Previously treatment with bleomycin \> 200.000 Units/m2.
* Allergy to bleomycin.
* Clinically significant coagulopathy.
* Pregnancy or lactation.
* Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
A Primary Care Intervention for Weight Management

The study will test whether adding brief counseling visits with an ancillary health care provider (a nurse or nursing assistant) will induce additional weight loss, as compared with quarterly physician visits alone. All visits will take place at the site of usual patient care (i.e., the primary care clinic).


Eligibility Criteria:
Inclusion Criteria:

Body mass index (BMI) of 27 to 50 kg/m2 Capacity to provide informed consent Ability to find transportation to and from counseling sessions Willingness to be randomized to either program Commitment to attend all sessions and to complete study-related assessments, including blood tests and questionnaires

Exclusion Criteria:

Type I diabetes Myocardial infarction or stroke within the previous 6 months Clinically significant renal or hepatic disease (as judged by a study physician) History of cancer in the past 5 years Congestive heart failure requiring diuretics Previous weight loss surgery Endocrine conditions that may cause weight gain, including unstable thyroid disease or hypercortisolism Initiation of therapy with or dose change to any of the following medications within 6 weeks of starting the study: insulin; metformin; sulfonylurea; thiazolidinedione; HMG-CoA reductase inhibitor ("statin"); or SSRI for depression Long-term use of any of the following medications: oral or high-dose inhaled steroid; atypical antipsychotic; tricyclic antidepressant; antiepileptic; any prescription or over-the-counter drug for weight loss Systolic blood pressure \> 160 or diastolic blood pressure \> 100 Hemoglobin A1c ≥ 10 Pregnancy or lactation Clinically significant psychiatric disease, including major depression, eating disorders, or substance abuse
Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.

The purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms
* Refractory to medical treatment for at least 6 months
* Qmax (maximum urinary flow) less than 10 mL/second

Exclusion Criteria:

* Patients not candidates for transurethral resection of the prostate (TURP)
* Advanced atherosclerosis and tortuosity of the iliac arteries
* No visualization of the prostatic artery CT angiography study
* Urethral stenosis, detrusor failure or neurogenic bladder
* Glomerular filtration \< 30 mL/min
* Presence of malignant tumor
* History of allergy to iodinated contrast
* Patients with any other medical or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

-cataract

Exclusion Criteria:

* preexisting corneal pathology
* small pupil
* glaucoma
* zonular dehiscence
* a history of ocular trauma or surgery
* uveitis
* intraoperative complications
Impact of Gonadotoxic Therapies on Fertility

The goal of this observational study is to learn how gonadotoxic treatments (chemotherapies, radiotherapies or immunotherapies) affect the fertility status of participants with cancer.

The main questions it aims to answer are:

* in females, if cancer therapies reduce the Anti-Müllerian hormone (AMH) concentration (ovarian reserve);
* in males, if cancer therapies reduce sperm concentration (sperm quality).

This is an international multicenter prospective exploratory study of fertility related data generated mostly routinely in fertility centers in Switzerland belonging to the Swiss network "FertiSAVE" as well as in fertility centers in Germany and Austria belonging to the German-Swiss-Austrian network "FertiPROTEKT" and further international centers who are interested to participate. Both networks include in total around 200 centers.

The data, which are mainly part of the routine clinical care, will be collected by the physicians and added to the REDcap study registry. Patients will be coded by the center to be able to follow them up. Each center will only have access to its own registry data set. Access to the total data set is only permitted for the principal investigator and the specific sub-investigators.

Data collection before the start of gonadotoxic treatment will be performed for 5 years.

Data collection after the end of gonadotoxic treatment will be performed for 10 years (time points: at 12-15 months, at 5 years and at 10 years).

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer or with benign reasons undergoing chemotherapy and/or radiotherapy of the pelvis (females) and the testicles (males) and/or immune therapy;
* Willing to participate;
* Austria: 14-50 years old (adolescents and adults), Germany: 18-50 years old, Switzerland: 14-50 years old (adolescents and adults);
* Serum hormone analysis before gonadotoxic therapy (females) or serum hormone analysis and sperm analysis before gonadotoxic therapy (males).

Exclusion Criteria:

* Missing consent;
* Language barrier.
The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy

This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.

All participants will receive cognitive behavioral therapy for insomnia, either through an online program or through visit with a therapist specializing in behavioral sleep medicine, and is some cases both. Participants will be randomized with equal probability to an ONLINE ONLY treatment arm or to a STEPPED CARE arm, whereby they will be assigned to on line or therapist-led treatment, based on their clinical presentation; but those assigned to this arm who start treatment with an online program and do not have sufficient response after 2 months will be switched over to a therapist-led treatment.

Eligibility Criteria:
Inclusion Criteria:

* insomnia disorder

Exclusion Criteria:

* Unable to be consented in English without an interpreter
* In poor physical or mental that limits capacity to participate in study treatment (e.g., Mini-Mental State Examination score \< 25)
* Unable to use the internet
* Study physician determines participation is not medically advised for any reason
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis

This is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to compare the efficacy of these currently used capsules with the efficacy of the same treatment provided in a cholic acid capsule that is made by a company that will be marketed after FDA approval.

At baseline, patients receive established doses of cholic acid capsules prepared at the Cincinnati Children's Hospital Medical Center Pharmacy. During the study, patients receive the same treatment provided in the to-be-marketed (TBM) cholic acid capsule. Hence, patients serve as their own controls, with baseline values presenting the reference value (CCHMC cholic acid capsule) and values after 30 days treatment presenting the value for the investigational treatment (TBM cholic acid capsule).

Bile acids are end products of cholesterol metabolism. Individuals with inborn errors of bile acid synthesis lack the enzymes needed to synthesize the primary bile acids cholic acid and chenodeoxycholic acid (CDCA). These conditions are serious and account for approximately 1% of cases presenting as idiopathic cholestatic liver disease. The liver disease associated with these inborn errors in bile acid synthesis is progressive and, if untreated, may lead to death from cirrhosis and liver failure.

Monotherapy with cholic acid is considered the most appropriate therapeutic strategy to treat inborn errors in bile acid synthesis because it provides a stimulus for bile flow and inhibits endogenous production and accumulation of potentially hepatotoxic and cholestatic bile acid precursors, while additionally facilitating the absorption of fats and fat-soluble vitamins. At therapeutic doses, adverse effects are not generally observed and as such, cholic acid has become the treatment of choice at the Cincinnati Children's Hospital since 1994.

This study will bridge data on the effectiveness of a standardized manufactured preparation to data obtained from patients originally treated with the currently used cholic acid capsules formulated in the CCHMC Pharmacy before being switched to the manufactured preparation.

Eligibility Criteria:
Inclusion Criteria:

* must have stable transaminase levels within 2 times the upper limits of the normal range.
* must have a diagnosis of an inborn error of bile acid synthesis.
* must have signed the written informed consent/assent document before study start.
* must be currently receiving currently used cholic acid therapy under IND 45,470.
* must be willing and able to comply with all study assessments and procedures.
* must be able to make two visits (Visit 1 and Visit 2) to the study site.

Exclusion Criteria:

* is not currently receiving cholic acid therapy for inborn errors of bile acid synthesis under IND 45,470.
* is unable or unwilling to comply with study requirements.
Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon

Urethral strictures are often initially treated endoscopically with dilatation or direct visual internal urethrotomy (DVIU), a procedure where the stricture is incised through the vision of a cystoscope. These methods are easy to perform, they are often well tolerated under local anesthesia and they have a low risk of complications. One disadvantage is the relatively low success rate which is 20-60% when used as a first intervention and considerably lower after several interventions. Instead of repeated endoscopic procedures, it is advisable to perform open urethroplasty. Urethroplasty has a success rate of 65-91% but a higher risk of complications and requires general anesthesia. Therefore, there is a need for a treatment option for recurrent urethral strictures after DVIU or dilatation, before the urethroplasty is performed.

Optilume is a CE-marked paclitaxel-coated dilatation balloon used for treatment of urethral strictures. The industry-sponsored randomised ROBUST III trial from 2022 showed a 75% success rate with Optilume but it is not sure if the results can be generalised to patients who would otherwise be candidates for open urethroplasty and whether the drug coating per se increases the efficacy of balloon dilatation. The aim of this study is to investigate whether the addition of paclitaxel-coating can increase the success rate and decrease the need for additional interventions and open urethroplasty for individuals who has a recurrent urethral stricture following at least one previous endoscopic intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Urethral stricture recurrence after at least one internal urethrotomy or dilatation
* Penile or bulbar stricture
* Length of stricture ≤ 2 cm
* Eligible for open urethroplasty
* Able to give informed consent

Exclusion Criteria:

* Stricture of the meatus
* Sclerosis of the bladder neck
* Multiple strictures \< 16 Ch
* Complete stricture without any lumen
* Previous dilatation with paclitaxel-coated balloon
* Previous radiation therapy of the pelvis (e.g. for prostate cancer)
* Previous pelvic fracture
* Urethral malignancy
* Presence of urethral fistula
* Presence of urethral condyloma
* Previous open urethroplasty
* Chronic urinary retention secondary to detrusor inactivity
Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults

This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.

The Primary objectives are:

1. To assess viral efficacy of the reductions of BETAF regimen dose at 12 weeks (on-treatment and intent-to-treat populations).
2. To asess viral efficacy of the reduction of BETAF regimen dose at 48 weeks (on-treatment and intent-to-treat populations).

Eligibility Criteria:
Inclusion Criteria:

* Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months.
* Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months.
* CD4 cell counts greater than 350 cells/mL at the time of consideration for the study.
* Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods.
* Patients agreed to participate.

Exclusion Criteria:

* Prior virological failure to any antiretroviral regimen or documented.
* Any diagnosis of psychiatric illness.
* Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment).
* Patients co-infected with HIV and active hepatitis B or C virus.
* Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.