cyrilzakka/clinical-trials huggingface dataset:
A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment

Dyspareunia is defined as a complaint of persistent or recurring pain or discomfort associated with attempted or complete vaginal penetration

e purpose of this study is to determine the effectiveness of low intensity shockwave treatment for patients with dyspareunia and their ability to tolerate sexual activity, (i.e., penetration of vagina, self or partnered pleasure).

Participants will:

* Be given a preliminary physical therapy examination and evaluation.
* Be asked to attend weekly low intensity shockwave treatment visits.
* Be asked to complete 3 Month follow up questionnaires

This study seeks to determine the effectiveness of low intensity shockwave (LiSWT) for patients with dyspareunia, with the primary objective being the ability to tolerate penetration of the vagina and sexual activity, (self or partnered pleasure). A secondary objective of the study is an improved quality of life.

This is a single blind, randomized controlled trial, with randomized placebo phase design.

A total of 60 participants enrolled at 4 clinical sites will be blinded to the group they are assigned to, (treatment or sham). Clinical investigators cannot be blinded to treatment or sham in order to deliver the treatment.

There are two arms of the study: the Intervention arm where subjects receive active low intensity shockwave treatment plus typical physical therapy. Intervention is the delivery of shockwaves to the pelvic floor region using Softwave Tissue RegenerationTechnologies OrthoGold 100 MTS OP155 unfocused parabolic probe electrohydraulic device.

The Control arm subjects receive sham shockwave treatment plus typical physical therapy.

Each clinical site will have an envelope with pre-determined even and odd numbers determining randomization. Upon enrollment a random number from the envelope will be drawn and assigned to the participant.

At 4-6 weeks participants in the control arm will be given the option of moving to the shockwave (intervention) arm. Participants will spend 4 to 4 1/2 months in the study receiving treatment once per week, 4-6 weeks duration for both treatment arms. Subjects will then be contacted for a 3-month follow-up by phone completing their study participation.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration)
* Cisgender female or have natal vaginal tissu
* Has not started hormonal therapy within the past 2 weeks
* Has not received pelvic floor physical therapy within the past 2 weeks
* Is able to electronically access informed consent and outcomes measures forms

Exclusion Criteria:

* Have a diagnosis of lichen sclerosis
* Have an active infection (e.g. herpes)
* Are earlier than 12 weeks post-surgery
* Are earlier than 6 weeks postpartum
* Have a history of gynecological cancer
* Have a history of pelvic radiation
* Are actively undergoing cancer treatments
* Are currently pregnant
* Currently using lidocaine or cortisone
Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.

The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children and adolescents from 6 to \< 18 years of age
* Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013)
* Newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
* At least 1 PVAS major item, at least 3 PVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
* eGFR \> 15 mL/min/1.73 m2 (using modified Schwartz equation per central lab guidelines)
* Participants must have a bodyweight of ≥ 15 kg at day 1.

Exclusion Criteria:

* Any other known multisystem autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus , IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis
* Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study
* Any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids that may cause confoundment with study assessments and study conclusions.
A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)

30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)
* Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
* Patients must have received primary treatment for their disease and had no progression

Exclusion Criteria:

* Diagnosed with NSCLC longer than 6 months ago
* Treatment with other bisphosphonates in past 12 months
* Presence of metastases

Other protocol-defined inclusion and exclusion criteria may apply.
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of hematological malignancies
* Acute leukemias
* Acute Myeloid Leukemia (AML) and related precursor neoplasms
* Favorable risk AML is defined as having one of the following:
* Acute lymphoblastic leukemia (ALL)/lymphoma
* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.
* Age 60 years of age or younger at the time of consent
* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.
* Adequate organ function

Exclusion Criteria:

* Pregnant or breastfeeding.
* Active uncontrolled infection within 1 week of starting preparative therapy
* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.
* Any prior autologous or allogeneic transplant
* CML blast crisis
* Active central nervous system malignancy
Chronic Intermittent Cold Exposure on Weight Loss

1. To test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss.
2. To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle and circulating markers) of treatment with chronic intermittent cold exposure and conventional treatment
3. To measure tissue specific changes of weight loss and the treatment with chronic intermittent cold exposure in glucose uptake rate in adipose organ (white and brown adipose tissue), liver, myocardium, skeletal muscle and brain
4. To measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle.
5. To compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 (inclusive)
* Body weight less than 120 kg
* Weight stability for 3 months
* Plasma triglyceride concentration less than 3.0 mmol/l
* Plasma HDL-cholesterol more than 0.9 mmol/l in males and more than 1.0 mmol/l in females
* Blood pressure less than 140/90 mmHg (inclusive)
* Normal glucose tolerance or impaired glucose tolerance but not diabetes (fasting glucose \< 7.0 mmol/l or 2 h glucose in the oral glucose tolerance test \< 11.1 mmol/l)

Exclusion Criteria:

* Smoking
* Frequent weight loss attempts
* Pregnancy or lactation
* Diabetes mellitus
* Hypo/hyperthyreosis
* Cardiovascular disease, stroke or neurological disorder
* Medication (antihypertensive and antidiabetic drugs, lipid lowering drugs, antidepressants, corticosteroids)
* Claustrophobia
* Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results.
* Presence of any ferromagnetic objects that would make MRI imaging contraindicated
The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study

Direct comparison study between previous LASIK or non-LASIK cataract eyes, the performance between non-LASIK and LASIK patients were (i) Ophthalmic examinations: UDVA, CDVA and uncorrected near visual acuity (UNVA) (40cm) and (ii) Refractive prediction error: defined as difference between postoperative sphere and target refraction.


Eligibility Criteria:
Inclusion Criteria:

* presence of cataract in both eyes
* corrected distance visual acuity under 20/40
* Phacoemulsification cataract surgery was arranged for both eyes

Exclusion Criteria:

* complicated cataract
* corneal opacities or irregularities
* corneal astigmatism \> 1.50 diopter
* amblyopia, anisometropia
* surgical complications such as posterior capsular bag rupture or vitreous loss, IOL tilt or decentration
* coexisting ocular pathologies, glaucoma, non-dilating pupil, history of intraocular surgery, or retinopathy
* optic nerve or macular diseases
* refusal or unable to maintain follow-up.
Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome

Phase II, randomized controlled, unblinded clinical trial. Will evaluate whether the administration of oral cyclosporine started on day 0 of transplantation is effective in reducing the incidence of cytokine release syndrome (CRS) in patients who receive an outpatient haploidentical transplant.

CRS is usually limited after the administration of post-transplant cyclosporine (PT-CsA) administered on days +3 and +4, however, there is no standard prevention or treatment regimen for CRS after haplo-TCPH and therapeutic behavior has usually been adopted.

Sample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center. In the control group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day +5 of the transplant, mycophenolic acid 1 gram orally (2 tablets of 500 mg) from day +5 post-transplant and post-transplant cyclophosphamide (PT-CY) at 50 mg/kg per day on days +3 and +4 and in the experimental group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.

Will document the presence of CRS and its degree, as well as the need for hospitalization, associated infectious processes, and a day to recover neutrophils and platelets. Additionally, 4 blood samples will be taken from the patients to determine the level of cytokines and C-reactive protein.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 16-60 years of age who receive their first haploidentical transplant.

Exclusion Criteria:

* Patients positive for the human immunodeficiency virus (HIV), Hepatitis B or C virus
* Pregnancy or lactation
* Patients with documented infection at the time of transplantation
* Presence of previous autoimmune diseases
* Inability to tolerate the oral route
Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects

The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD

All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either:

* 10 mg foliglurax bis in die (BID) (treatment A)
* 30 mg foliglurax BID (treatment B)
* Placebo BID (treatment C)

Eligibility Criteria:
Inclusion Criteria:

Healthy subjects

* The subject has an acceptable resting EEG at the Screening Visit, as judged by the investigator
* The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.

Patients with PD

* The patient has an acceptable resting EEG performed at the screening period, as judged by the investigator.
* The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
* The patient has been diagnosed with idiopathic PD for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the 'off' state.
* The patient has dyskinesia that is not too severe to cause discomfort for the patient during the EEG assessments

Exclusion criteria:

* The subject has taken disallowed medication \<1 week prior to the first dose of Investigational Medicinal Product (IMP) or \<5 half-lives prior to the Screening Visit for any medication taken.
* The subject has significant alcohol consumption
* The subject has taken any investigational medicinal product \<3 months prior to the first dose of IMP.
* The subjects has a known genetic disorder of human UDPglucoronosyltransferase
* The subject is pregnant or breastfeeding.

Other in- and exclusion criteria may apply
Detection of Bacterial and Viral Pathogens Infection Among Hospitalized Patients Feasibility Study

Detection of bacterial and viral pathogens infection among hospitalized patients using breath analysis - feasibility study.

A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective: To identify a set of breath Volatile Organic Compound biomarkers that enable the detection of pathogens infection and inflammatory response to pathogens infection among hospitalized patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years at the time of consent
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Negative results for SARS-CoV-2
* Diagnosed with suspected respiratory infection

Exclusion Criteria:

* Under guardianship or deprived of liberty
* Pregnant or lactating woman
* Not able to breathe through mask for 8 minutes
* Intubated patients
* Patients in critical condition
* Diagnosed with hospital-acquired infection
* Medical history of malignancies
An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer

This study investigates the feasibility and efficacy of an Internet-delivered intervention for the sexual and intimate re-adjustment of couples in which one partner is living with a temporary or permanent ostomy (e.g., colostomy, ileostomy, urostomy) following treatment for colorectal and/or bladder cancer. The two session intervention will be delivered via online videoconferencing and will focus on facilitating couples' communication around their sexual and intimate relationship. Exercises from sex therapy will be used to scaffold conversations about motivations for having sex, intimacy and sensual pleasure, and relational strengths for coping. The intervention aims to enhance couples' ability to cope with the changes in their sexual and intimate relationship. A group of couples receiving written educational material only will be used as a comparison group to measure change in sexual and intimate adjustment over time.


Eligibility Criteria:
Inclusion criteria:

Patients meeting all of the following criteria will be eligible for the study:

* Patients who have had a diagnosis of colorectal and/or bladder cancer within their lifetime
* Patients who are at least 1-month post active treatment for colorectal and/or bladder cancer
* Patients who have an ostomy due to colorectal and/or bladder cancer (e.g., colostomy, ileostomy, urostomy; permanent or temporary)
* Patients who are in a committed intimate relationship
* Patients who report changes in their sexual/intimate relationship associated with colorectal and/or bladder cancer and/or living with an ostomy
* Patients who have access to the Internet in a private space
* Patients who reside in Ontario
* Patients who are 18 years of age or older

OR

Partners of patients who meet the above criteria and who are 18 years of age or older

Exclusion criteria:

Patients/couples will be excluded from study participation if:

* Patient is undergoing active treatment for cancer
* Patient or partner report high levels of relational distress and would be better suited to couples therapy
* Couple is attending or plans to attend couples or sex therapy concurrently with participation in study
* Patient or partner is currently experiencing mental health concerns that would interfere with study participation (e.g., suicidal ideation, psychotic disorders, substance abuse, spousal abuse)
* Patient or partner lack English proficiency
Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine

A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels.

This study will be a randomized, double-blind, placebo-controlled out-patient study conducted in multiple centers in the United States (US). Up to 700 healthy male and female adult subjects 18 to 55 years of age (inclusive), who have been previously vaccinated or subjects who are naïve to smallpox vaccine will be enrolled. Subjects will be randomized to 1 of 8 treatment groups with 100 (or 50 placebo) subjects per group in which they will receive either ACAM3000 MVA Smallpox Vaccine (1 of 3 dose levels) or placebo on Study Days 0 and 28. All personnel associated with the trial will be blinded as to treatment, with the exception of the study pharmacist who prepares the treatment for administration to each subject. There are 2 control groups in this study. A comparison of adverse events and other safety assessments between placebo and ACAM3000 MVA Smallpox Vaccine will be performed. In addition to serving as a control for safety, the previously vaccinated subjects receiving placebo will serve as a control for antibody and T-cell responses in persons with preexisting immunity who receive ACAM3000 MVA Smallpox Vaccine. Safety, tolerability, and immunogenicity data for 110 subjects undergoing primary immunization with graded doses of ACAM3000 MVA Smallpox Vaccine will be available following completion of Acambis protocol H-249-001, an ongoing phase I clinical trial. The doses levels in this study may be changed following the availability of results from protocol H-249-001. Statistical analysis will focus on comparisons among the dose levels of ACAM3000 MVA Smallpox Vaccine and comparisons of ACAM3000 MVA Smallpox Vaccine to placebo, as appropriate. A separate analysis will be performed for previously vaccinated and naïve subjects. Descriptive statistics will be used to compare demographic and baseline clinical data between stratum.

Eligibility Criteria:
Inclusion Criteria:

* subjects must be in good general health, checked on toxicity grading table.
* for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.
* for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.
* Female subjects must not be pregnant or lactating.

Exclusion Criteria:

* Subjects who participated in a "first responder" program.
* any history of immunodeficiency.
* any autoimmune disease
* any history of cardiac disease
* any diagnosed risk factors for ischemic coronary disease
* any history of heart palpitations or abnormalities in cardiac rhythm.
* any current or history of eczema of any description.
* Known allergy to MVA or any of its components, including eggs or egg products.
* morbid obesity
Breathing After COVID-19

This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.

This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.

Individuals' sternal movements using motion analysis sensors; will be recorded in sitting position, standing, and walking. Sternal movement of the person; It will be recorded during relaxed breathing and deep breathing. They will also be asked to walk on the treadmill in such a way as to collect at least 500 steps.

Eligibility Criteria:
Inclusion Criteria:

* to be voluntary.
* have COVID-19 illness history.
* No COVID-19 illness history.
* treated by a standard medical treatment (vitamins, blood thinners, anti-viral drugs)

Exclusion Criteria:

* have another chronic disease such as systemic, orthopedic or neurologic.
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-EULAR criteria
2. ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7 following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematologic and biologic,
3. Positive anti-Sjögren's Syndrome A (Ro) antibodies or anti-nuclear antibodies (ANA) ≥ 1:320 or rheumatoid factor (RF) \>20 IU/ml during screening period, measured in a central laboratory
4. Stimulated whole salivary flow rate \> 0 mL/minute

Exclusion Criteria:

1. Prior administration within the timeframe described in the protocol of any of the following:

   * Belimumab,
   * Rituximab or other B cell depleting agents,
   * Abatacept,
   * Tumor necrosis factor inhibitors,
   * Tocilizumab,
   * Cyclophosphamide,
   * Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (MMF), azathioprine, or leflunomide
   * Janus kinase (JAK) inhibitors
2. Meeting any of the following conditions:

   * Corticosteroids: \> 10 mg/day oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to randomisation (W000),
   * Antimalarials: any change or initiation of new dose of antimalarials (e.g. chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to randomisation (W000),
   * Methotrexate: \> 25 mg/week of methotrexate; any initiation or change of dose of methotrexate within 12 weeks prior to randomisation (W000); any change in route of administration within 4 weeks prior to randomisation (W000),
   * Non-steroidal anti-inflammatory drugs (NSAIDs): Any change or initiation of new dose of regularly scheduled NSAIDs within 2 weeks prior to randomisation (W000),
   * Cevimeline or pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (W000).
3. Secondary Sjögren's Syndrome