cyrilzakka/clinical-trials huggingface dataset:
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin


Eligibility Criteria:
Inclusion:

* Male or female, age 18 years or older at consent.
* The subject must have ongoing chronic pruritus
* The subject's pruritus is assessed by the investigator to be of unknown origin at baseline.
* Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to Baseline visit indicating an appropriate pruritus level for the study.
* The pruritus must have been unresponsive to prior treatment with emollients.
* The subject's pruritus must be present on multiple segments of the body
* Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study
* All females who are of childbearing potential must be willing to practice highly effective contraception and not be pregnant or nursing
* Willing to comply with study visits and study related requirements including providing written informed consent.
* Adequate cognitive and physical ability, in the investigator's opinion, to comply with study visits and study related requirements including providing written informed consent

Exclusion

* Prior treatment with any NK1-receptor antagonists
* Known dermatologic or systemic condition(s), other than dry skin, that is considered by the investigator to be the primary cause of current pruritus.
* Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy.
* Use of an excluded therapy within 3 weeks prior to randomization
* Treatment with any investigational therapy within 3 weeks prior to randomization.
* Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase \> 2.5 times the upper limit of normal during screening.
* History of malignancy within 3 years prior to randomization, with the (actinic keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of skin).
* Any known major psychiatric diagnosis that would impact the subject's ability to complete the study
* Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt.
* Known use of recreational drugs.
* Documented history of parasitic infection, including skin parasites such as scabies, within 12 weeks prior to randomization.
* Presence of clinically significant dementia, intellectual impairment, or any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
* History of hypersensitivity to serlopitant or any of its components.
* Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject's participation in the study.
Comparison of Fissurectomy to Fissurectomy With Anoplasty

Surgery is sometimes necessary to relieve patients with chronic anal fissure. It consists of resecting the edges of the fissure to make a wound larger than the initial fissure, in order to obtain healing. Thus, the edges of the wound do not stick together and the healing is done from the bottom of the wound. This procedure is widely performed in France with results that seem satisfactory. In addition to resection of the fissure, a partial closure of the wound can be associated with a small flap of rectal mucosa which is sutured with a few absorbable stitches: this is anoplasty.

There is some debate as to whether to perform a fissurectomy alone or to complement it with an anoplasty to accelerate healing. The choice of technique performed depends on the training and habits of the operators but the results of fissurectomy alone and fissurectomy with anoplasty have never been compared. In the medical-surgical proctology department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), both procedures are performed. The investigators therefore decided to compare the after-effects of fissurectomies alone with those of fissurectomies with anoplasty that were performed in the department in 2019. The choice between the 2 procedures is left exclusively to the discretion of the operator. The criteria for choice between the two patient populations are not different.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient managed in the proctology department of Groupe hospitalier Paris Saint-Joseph for single posterior idiopathic fissures (anoplasty possible only in the context of non-infected posterior fissure) between January 1 and December 31, 2019 by fissurectomy alone or fissurectomy with anoplasty

Exclusion Criteria:

* anterior or bipolar fissure
* infected fissure
* history of proctological surgery
* Crohn's disease
* HIV infection
* tubercular lesion validated by anatomopathology
* history of pelvic-perineal radiotherapy
* Tumor cells on histology
* fissurectomy +/- anoplasty associated with another proctological surgical procedure
* patient under guardianship or curatorship
* patient deprived of liberty
* patient under court protection
* Patient opposing the use of his data for this research
Impact of Tadalafil 5 mg on Post-micturition Dribble in Young-age Men With no/Mild Lower Urinary Tract Symptoms

The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of tadalafil 5 mg on post-micturition dribble (PMD) in young age men (18-50 years) with no/mild lower urinary tract symptoms (LUTS).

Post-micturition dribble (PMD), a post-voiding symptom, is defined as involuntary loss of urine immediately after urination. It is more common in males. Many population/practice-based studies have shown that PMD is one of the most common bothersome urinary symptoms in adult males ranging from 5.5 % to 29 %. (1, 2) In young age men (less than 50 years) with absence of prostate-associated lower urinary tract symptoms (LUTS), PMD is considered the most devastating urinary complaint with worsened physical and mental health-related quality of life (HRQoL). (3) Pathophysiology of PMD is usually attributed to residual urine in the bulbar urethra whatever the cause. Many theories, including weakness or failure of the pelvic floor muscles, incompetency of the external urethral sphincter or bladder neck obstruction, were suggested for this urine residue. (4) However, in patients with PMD with no/mild LUTS, pelvic floor muscle weakness especially the bulbocavernosus and ischiocavernosus muscles is usually the main putative mechanism. (5) Bulbar urethral massage and pelvic floor muscle exercise have been proposed as useful options for patients with PMD (6); yet, pharmacological treatment has not been standardized for those patients.

In this perspective, recent studies have shown that corpus cavernosum structural changes may be related to PMD. (7) It is well known that phosphodiesterase-5 (PDE-5) isoenzymes are highly expressed in the urethra as well as the corpus cavernosum, bladder and prostate. (8) In addition, once-daily 5 mg tadalafil, a PDE-5 inhibitor, has previously been used to treat voiding and storage LUTS. In addition, tadalafil once daily showed reduced PMD symptom severity and PMD volume in men with PMD and other LUTS. (9) Notably, this study included old age men (mean age 62 years) with moderate or severe LUTS.

The aim of the present study was to compare the effects of taking tadalafil 5 mg once daily on PMD in young men (18-50 years) with minimal/mild LUTS.

Eligibility Criteria:
Inclusion Criteria:

* 1- Adult patients (aged 19-50 years) 2- Complaining from PMD with no or mild LUTS (IPSS\<8).

Exclusion Criteria:

* 1- Patients with penile or urethral malformations 2- Patients recently received PDE5Is in the last 4 weeks prior to study start. 3- Systemic illness 4- Contraindications to PDE5Is. 5- History of pelvic surgery or irradiation 6- History of bladder or prostate surgery 7- Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL
Understanding Symptom Recognition and Treatment Decision-making in Hispanic/Latino Lung Cancer Patients

The purpose of the study is to understand why Hispanic/Latino patients with lung cancer are diagnosed later than other groups.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified Hispanic/Latino patients with biopsy-proven primary lung cancer treated at MSKCC, including stages of disease I-IV
* 18 years of age or older
* Fluent in English or Spanish
* Patients must reside in the U.S

Exclusion Criteria:

* Spanish-surnamed patients who do not self identify as Hispanic/Latino (e.g., Philippines-born individuals)
The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.

The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

Endometriosis is a common disease, aﬀecting 5-10% of women of reproductive age . It is an estrogen-dependent and estrogen-driven disease and so hormonal manipulation and suppression of estrogen production form the basis of the majority of medical treatment. The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

Phase I/II

1. premenopausal females, aged 18-45
2. History of regular menstrual cycles
3. Endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography.
4. Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
5. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray Phase I (only) Participant has mild or moderate pelvic pain associated with endometriosis at Screening.

Phase II(only) Participant has moderate or severe pelvic pain associated with endometriosis at Screening.

Exclusion Criteria:

Phase I/II

1. Subjects with severe trauma or surgery within 6 months prior to the screening；
2. Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
3. Pregnant or Serum β-human chorionic gonadotropin (hCG)\> 5 Million International Units(mIU)/mL at screening or baseline
4. Pregnant or breast feeding ;
5. Have pelvic pain that is not caused by endometriosis
6. Abnormal uterine bleeding
7. Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist or danazol or have received any of these agents within 6 months of the start of screening.
8. Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
9. Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 2 months of the start of screening.

Phase I (only) one month prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening; Phase II (only) Screening dual-energy x-ray absorptiometry (DXA) scan results of the lumbar spine, femoral neck, or total hip bone mineral density corresponding to 1.5 or more standard deviations below normal (T-score at or below -1.5)
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers

About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4 weeks of sedentary life style, randomization decides whether they start with exercise or with being "couch potatoes". All participants are also randomized to also consume 150 g of blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a week during the 4 week period. The exercise period and the "couch" period are started and ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk factors are measured before and after this run, ie 8 times in total.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* significant disease and disabilities that hinder running
A Novel Objective Diagnostic Test for Otitis Media With Effusion

Otitis media with effusion (OME) cases refer to a clinically silent condition. Otoscopic findings are subjective and not always reliable. As an objective test tympanometric evaluation is imperfect for diagnosis of OME. The objective of our study was to investigate, in OME cases, the correlation of tympanic membrane color changes with the presence and viscosity of effusion in the middle ear. The study aimed to provide objective diagnostic and therapeutic criteria for patients scheduled for surgery by 2 means: measuring the viscosity of the fluid and evaluating color changes objectively with red-green-blue (RGB) measurements.

Endoscopic images of the tympanic membranes of 52 patients (Group 1) and 52 healthy controls (Group 2) were taken during their otologic examinations. All patients in Group 1 had hearing loss and were diagnosed with OME after audiological evaluation. Specific points were designated at certain areas on each tympanic membrane, and RGB values of those specific points were measured on the tympanic membrane images of both groups. Additionally, in Group 1 viscosity of each effusion taken by paracentesis during surgery was also measured intraoperatively with a viscometer. Patients with viscosity values lower than 450 cP (centipoise) were subdivided into Group 1a, and those with values higher than 450 cP into Group 1b.

Eligibility Criteria:
Inclusion Criteria:

* Patients with OME, that had endoscopic-otoscopic examination findings and type-B tympanograms.
* They were all scheduled for ventilation tube insertion.

Exclusion Criteria:

* Patients presenting with acute otitis media, tympanosclerotic plaques, mental retardation, and children who were difficult to cooperate with.
Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy

This study aims at describing survival rates over time (Kaplan-Meier estimator) in patients suffering from AIDS-related primary central nervous system lymphoma who were diagnosed from 1996 to 2014 and treated with infusions of high-dose methotrexate and combined antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* AIDS-related primary central nervous system lymphoma
* treated with at least one infusion of methotrexate and combine antiretroviral therapy

Exclusion Criteria:

* prior non-Hodgkin lymphoma
Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia

A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of treatment as an usual. Sessions of BBAT lasted 90 minutes each and took place twice a week for 5 weeks. The primary end point is a change in the Visual Analog Scale score and Body Awareness Rating Scale and the secondary end points include Hospital Anxiety Depression, State Trait Anxiety Inventory, Beck Depression Inventory and Short Form 36. All assessments will be repeated at post treatment, 12 weeks and 24 weeks

This work is a clinical trial of randomised and controlled groups. The hypothesis of study is that Basic Body Awareness Therapy applied in patients with fibromyalgia improves, more than usual treatment, the pain, normalization of postural pattern and movement, improve in psychologic state and improve of quality life.

The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in area of primary health center, the patients will be divided in 2 groups, control group and treatment group. The groups will be examined at the begin, at 1 month of the begin of treatment, in 3 months, 6 months and one year to evaluated the outcomes in long time.

The dependence measurements will be Visual Analog Scale, Basic Body Awareness Rating Scale (BARS), SF-36, STAI A/R, BDI-II. The independence measurements will be demographic items: sex, age, country, level of studies, social status,..

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed of fibromyalgia according the American college of Rheumatology with 6 months at least
* the patients have to stay in different position as lying, sitting and standing

Exclusion Criteria:

* pregnancy
* suffering from another diseases that increase the pain or another specific diagnosis as rheumatic, heart disease and infectious disease
Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients

This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous \[IV\]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years old with documented diagnosis of stage V chronic kidney disease, on hemodialysis at study baseline
* Subjects who have been previously treated with vitamin D or its metabolites or naïve to paricalcitol
* Subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in Venezuela
* Subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study
* Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment

Exclusion Criteria:

* Subjects with severe hyperparathyroidism (parathyroid hormone \[PTH\] \> 3000 pg/mL)
* Subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (Ca x P) ≥ 70
* Known hypersensitivity and/or toxicity of vitamin D, its metabolites and/or other components of Zemplar® IV (paricalcitol)
* Subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product
* Subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum
* Subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin D and/or unwilling to complete the study visits
Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight.

This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms.

Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.

During the study participants will have talks with the study staff about healthy lifestyle and physical activity.

The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor.

* At 6 of the visits participants will have blood samples taken.
* At 5 of the visits participants will be asked to fill in a questionnaire
* At 4 of the visits participants will have to do a 6-minute walking test
* At 3 of the visits participants will have a test to check the heart.
* participants will have their eyes checked before or at the start of the study and at the end of the study

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Body mass index (BMI) greater than or equal to 30.0 kg/m\^2
* New York Heart Association (NYHA) Class II-IV
* Left ventricular ejection fraction (LVEF) greater than or equal to 45% at screening
* Diagnosed with T2D greater than or equal to 90 days prior to the day of screening
* HbA1c of below or equal to 10.0% as measured at the screening visit

Exclusion Criteria:

* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.