cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC

This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen exposures in the Alyatec environmental exposure chamber (EEC).


Eligibility Criteria:
Inclusion Criteria:

* Subjects having signed the informed consent
* Subjects affiliated to a social security scheme
* Subjects with birch pollen rhinitis and conjunctivitis with:
* A history of rhinoconjunctivitis for at least the last 2 consecutive pollen seasons.
* A positive skin prick-test to birch (wheal diameter \>6 mm compared to the negative control),
* Specific immunoglobulin E (IgE) for birch\> 0.1 kIU/l
* Women of childbearing potential must have a negative pregnancy test during the entire study period with an effective means of contraception: oral contraceptives, intrauterine device, condom with spermicide for at least one month before inclusion in the study and for the duration of the study. At each study visit and each exposure on D1, a urine pregnancy test will be performed.
* A positive conjunctival provocation test to birch during the screening visit at a dilution of 100IR/ml maximum

Exclusion Criteria:

* Known asthmatic subjects allergic to birch pollen
* Use of oral corticosteroids in the 4 weeks preceding inclusion in the study
* Use of biotherapy in the 4 months preceding inclusion in the study
* Desensitization to birch pollen in the last 5 years
* Uncontrolled chronic pathologies (hypertension, cardiac, respiratory, renal pathology).
* Active autoimmune disease
* Uncontrolled systemic hypertension
* Subjects who participated in another clinical study in the three months prior to inclusion
* Pregnancy and breast feeding
* Inability to understand and act upon the information provided
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with a first invasive non-metastatic breast carcinoma histologically confirmed,
* BMI \> 25,
* within 6-month/one year of completion of main cancer treatment,
* being able to participate in the intervention,
* agree to wear the wrist-based activity monitor during the study period,
* agree to be randomized to either group,
* written informed consent.

Exclusion Criteria:

* severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period,
* contraindications to exercise due to history of heart condition, stroke, chest pain during activity or rest, severe hypertension
* orthopaedic disability that would prevent optimal participation in the physical activities prescribed,
* patient is unable to find transportation to the study location over the study period, - or
* plans to move away from Lombardy or to be out of town for more than 3 weeks during the study period.
Platelet Rich Plasma Testis Treatment for Infertile Men

Investigate the effect of intratesticular injection of autologous platelet rich plasma (PRP) on sperm retrieval rates and IVF outcomes in infertile men who already underwent a negative sperm retrieval. Currently, there is no alternative treatment after failed TESE. Prior series suggest that intratesticular PRP injections may improve TESE outcomes. We hope to determine whether PRP is an effective treatment for this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Men over the age of 18 diagnosed with NOA and at least one failed TESE, negative mapping or negative biopsy

Exclusion Criteria:

-
A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature

After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* All subjects who have completed the first stage (52 weeks) of Phase II clinical trial (including negative controls) with completed follow-up records may be enrolled in the extension period study.
* Before the extension period study, the investigator shall fully inform the subjects and their guardians of all the information about the extension period study, including detailed follow-up procedure, treatment plan, laboratory examination items during follow-ups and possible benefits and risks. The extension period study shall only be initiated after the subjects and their guardians are well informed, and agree to cooperate and complete the treatment, follow-ups and examinations during the study, and sign the written informed consent.

Exclusion Criteria:

* Subjects who have taken the following medications within 2 months before entering the extension period study:

  1. Aromatase inhibitors (which include but are not limited to Lelrozol and Anastrozole), with continuous medication ≥1 month;
  2. Gonadotropin releasing hormone analogues (which include but are not limited to Triptorelin, Leuprorelin and Goserelin),, with continuous medication ≥1 month;
  3. Sex steroids (which include but are not limited to any type of estrogen, progestin and androgen) , with continuous medication ≥1 month;
  4. Protein anabolic drugs (which include but are not limited to Oxandrolone, Danazol and Strombafort), with continuous medication ≥1 month;
  5. Glucocorticoids via oral/intravenous administration for more than 1 month..
Funguria in Hospitalized Patients

The purpose of the study is to test the hypothesis that a subpopulation of patients with candiduria are at significant risk for disseminated disease and would benefit from treatment, while others are at low risk from complications and therefore require no antifungal therapy.

This protocol will attempt to generate a detailed clinical profile of patients with funguria and identify subgroups of patients with funguria at high risk for candiduria and determine the relative risks for obtaining candiduria. In addition, it will look at identifying subgroups of patients with funguria at high risk for candidemia and identifying subgroups of patients with funguria at high risk for death. Finally, it will attempt to determine if funguria independently predicts fungemia or death. Data will be complemented by surveillance of a comparable population without funguria.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with fungi isolated from the urine of any colony count.
2. Patients seen at either Harbor-UCLA Medical Center or Cedars Sinai Medical Center.

Exclusion Criteria:

1. Persons with a previously positive urine fungal culture during the current hospital admission.
Standard Versus Mnemonic Counseling for Fecal Incontinence

This study compares standard versus mnemonic counseling for the treatment of fecal incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women randomised to mnemonic counseling will higher recall of treatments, satisfaction with the physician visit and greater improvement in their quality of life when compared to women who received standard counseling.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosed with fecal incontinence by on of the attending physicians
* Bothersome fecal incontinence symptoms for at least 3 months
* Able to give informed consent
* Able to speak, read and comprehend English

Exclusion Criteria:

* Younger than 18 years
* Fecal Incontinence \<3 months
* Unable to give informed consent
* Unable to speak, read and comprehend English
* Diagnosis of active colorectal or anal malignancy, inflammatory bowel disease, recto-vaginal fistula, and rectal prolapse
HIV Counseling Intervention for Methadone-Maintained Patients - 2

The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.

The purpose of this proposal is to evaluate, in methadone-maintained patients the association between an ADHD diagnosis and high-risk HIV/Hepatitis behavior. In addition, the investigators would like to determine whether a new manually-guided HIV intervention; RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounters is superior to standard HIV/Hepatitis psycho-education.

Eligibility Criteria:
Inclusion Criteria:

* Must meet DSM-IV criteria for opiate dependence and currently in methadone maintenance treatment
* Able to give informed consent and capable of complying with study procedures
* Women who are of childbearing age and/or pregnant may be included
* Individuals who are HIV-positive or have Acquired Immunodeficiency Syndrome may be included
* Patients who demonstrate moderate to high HIV risk behaviors will be included
* Patients with low to no HIV risk behaviors will be excluded
* Patients receiving a stable dose of methadone for three weeks will be included

Exclusion Criteria:

* Currently meets DSM-IV criteria for current Axis I psychiatric disorders (other than ADHD or substance abuse) which requires medical intervention, i.e., active suicide ideation, active psychosis, anxiety disorders, depression requiring hospitalization
* Patients who have exhibited suicidal or homicidal behavior within the past two years
* HIV positive patients must have knowledge of their status for a minimum of three weeks
Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients


Eligibility Criteria:
Inclusion criteria:

* History and subjective symptoms of cat dander allergy including cat specific allergic rhinitis
* Age 18 to 65 years
* Positive reaction to at least one concentration of cat dander allergen in skin prick test, intradermal provocation test and nasal provocation test

Exclusion criteria:

* Chronic infectious disease
* Acute infections
* Episode of non-allergic rhinitis within the last 4 weeks
* Use of allergen known to predict anaphylactic reactions
* Treatment with any other investigational drug within 3 months before trial entry
* Vaccination within the last week
* Nasal surgery within the last 8 weeks
* Progressive fatal disease
* Drug or alcohol abuse within the last 5 years
* Cat ownership
* A history of significant cardiac insufficiency (NYHA stage III-IV)
* Coexisting severe disease, e.g. cardiovascular diseases
* Acute or history of obstructive respiratory insufficiency ( FEV1 \<70%)
* Hepatic insufficiency
* Relevant anaemia (as judged by investigator)
* Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation)
* Pregnancy or breast feeding
* Sexually active woman of childbearing potential not actively practicing birth control by using a medically accepted device or therapy
* Lack of compliance or other sililar reason, that the investigator believes, precludes satisfactory participation in the study
* Systemic glucocorticoid therapy
* Allergic asthma and chronic medication with steroids at doses exceeding 200ug/day Treatment with ATII antagonists, B-blocker, ACE inhibitors
Effects of Acupuncture as Adjunctive Therapy in Patients With Type 2 Diabetes Mellitus

This study aims to determine the effect of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR) and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus.

This is a randomised, double-blind, placebo controlled and parallel design trial. Participants will be randomized to either acupuncture (n=30) or placebo (n=30) using a 1:1 ratio. The permuted blocks with a block size of 2 will be used. Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment. Secondary outcome of HRQOL will be measured at the time of recruitment (baseline), after completion of 5 sessions (week 3/4) and 10 sessions (week 7) of the treatment while outcomes of body mass index and waist circumference are measured at the time of recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit. The sequence generation and allocation will remain concealed from the patient and practitioner.

Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose (FPG) ≥ 7.0 mmol/L \[126 mg/dL\] or HbA1c ≥ 6.5%.
* Subjects have had type 2 diabetes mellitus for more than one year
* Receive oral anti-diabetic agents on a stable dose over the previous 3 months.

Exclusion Criteria:

* Under insulin therapy
* With other acute or chronic health problems
* Body mass index (BMI) ≥ 40.0 kg/m²
* Needle phobia or allergy to adhesive plaster
* Planning to move out from Malaysia within 4 months'
* Being pregnant, planning for pregnancy or lactating women
Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism

Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.

Hypogonadism (low testosterone level) is frequently observed in men presenting with non obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal manipulation in patients with hypogonadism. However, it is possible that hormonal therapy increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm production and surgical success with microTESE improve.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Man seeking fertility treatment.
* Azoospermia confirmed in at least 2 semen analyses with centrifugation.
* Testosterone \<300 ng/dL and Bioavailable Testosterone\<156 ng/dL.

Exclusion Criteria:

* Presence of genetic disorders: Y chromosome deletions or abnormal karyotypes.
* Luteinizing hormone (LH) \>25 IU/mL.
* Estradiol \> 40 ng/dL.
* Hypogonadotropic hypogonadism (LH \<2 IU/mL and Follicle Stimulating Hormone (FSH) \<1 IU/mL).
* Obstructive azoospermia (FSH \<7.6 IU/mL plus testicle longitudinally axis \>4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy).
* Clinical varicocele (palpable or visible in physical exam)
* Previous history of cryptorchidism.
* Use of chemotherapy, testosterone, or anti-androgen in the last two years. Partner \>40 years or female factor infertility associated.
* Contraindications to clomiphene use: depression, heart and liver impairment, uncontrolled thyroid/adrenal dysfunction, organic intracranial lesions.
The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy

The purpose of this study is to compare the effect of heart rate on cardiac index in patients with or without left ventricular hypertrophy. The study will be conducted in postoperative heart surgery patients with a pacemaker.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled heart surgery including thoracotomy
* Ejection fraction \> 45%
* Duration of QRS complex \< 120 milliseconds
* Sinus rhythm
* Planned perioperative temporary pacemaker

Group: Left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall \>11 mm.

Group: No left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall \<11 mm.

Exclusion Criteria:

* Active endocarditis
* Severe mitral insufficiency
* No patient consent
A Study of NKTR-358 (LY3471851) in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in healthy participants. The study will last about 50 days for each participant.

LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males and females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Previous or current autoimmune disease/disorder
* Current active bacterial, viral, or fungal infection
* Administration of an inactivated vaccine within two weeks of study drug administration or live attenuated vaccine within 90 days of dosing .
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* CP-CML who prove resistant or intolerant to imatinib (Cohort 1)
* Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)
* Newly diagnosed, treatment naive CP-CML (Cohort 3)
* Lansky or Karnofsky scale \>50
* Life expectancy ≥12 weeks
* Adequate hepatic and renal function
* Written informed consent
* Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
* Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
* Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
* Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
* Target Population for the PK substudy subjects must meet relevant inclusion criteria

Exclusion Criteria:

* Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
* Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
* Isolated extramedullary disease
* Prior therapy with Dasatinib
* Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria
* Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy

Other inclusion/exclusion criteria may apply
Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

Small-incision vitrectomy techniques have become increasingly popular, with a number of advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23- and 25-gauge trocar systems theoretically do not require sutured closure. However, a certain fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require suture placement. Poor wound closure puts the patient at increased risk of post-operative hypotony and is associated with increased risk of endophthalmitis. Currently, surgeons are divided as to which suture is the best for sclerotomy closure. The current standard of care is 8-0 polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to work with; however, it triggers a robust inflammatory response. The alternative is 6-0 plain gut suture, which is more difficult to manipulate and thicker, but causes less tissue inflammation1. The purpose of this study is to prospectively evaluate these two options for sclerotomy closure. The results of this study will enable us to minimize patients' post-operative discomfort while maximizing safety outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patient of Dr. Michael Dollin
* Age 18 years and older
* Scheduled to undergo 23-gauge pars plana vitrectomy for any indication that would most likely require sutures (E.g. retinal detachment)

Exclusion Criteria:

1. History of previous vitrectomy in the study eye
2. History of scleral buckling in the study eye
3. Currently on peri-operative corticosteroid medicines (topical or systemic)
4. Systemic chemotherapy within the preceding 6 months.
5. History of any disorder or medication use associated with conjunctival, scleral, or episcleral inflammation and/or scarring
6. History of narcotic abuse