cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease

This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a 12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After participation in one of the aforementioned studies, subjects will be followed yearly for up to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits

At each long-term follow-up visit, subjects will be assessed for adverse events relative to their previous long-term follow-up assessment. Blood samples for the determination of antibodies to AUX-I and AUX-II and neutralizing antibodies to AUX-I and AUX-II will be collected at each long-term follow-up visit.

At each long-term follow-up visit, a flaccid penile examination will be performed and a curvature deformity measurement (with the penis in the erect state) will be recorded. Subjects will also be asked to complete the Peyronie's Disease Questionnaire (PDQ) and the International Index of Erectile Function (IIEF) questionnaire. At each visit, medical, surgical, or other treatments for Peyronie's disease since the last assessment will also be collected and recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Have received at least one injection of AA4500 and completed at least the first or last follow-up visit in one of the Auxilium-sponsored studies (AUX CC-802, AUX-CC-803, AUX-CC-804, or AUX-CC-806).
2. Be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator.
3. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).

   -

   Exclusion Criteria:

   None

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Use of Pedometer Following Radical Prostatectomy

This is a study to evaluate whether use of a pedometer following radical prostatectomy decreases post-operative narcotic use and time to return of bowel function.

This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical prostatectomy on return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 14. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until initial post-operative visit.

Eligibility Criteria:
Inclusion Criteria:

This study will include men 18-75 undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer at Virginia Mason Medical Center.

Exclusion Criteria:

* Long-term opioid use, defined by CDC as use of opioids on most days for \>3 months
* History of inflammatory bowel disease
* Prior abdominopelvic radiation
* Travel to Europe during study period
* Concurrent surgery during radical prostatectomy
* Inability to ambulate
* Gastroparesis or other baseline bowel dysmotility issues
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Self-Assessment Tuberculin Skin Test

The research team/investigator/nurse/professional health care workers will teach the participants how to read the results for TST test. The investigator will compare the reading results done by the participants to the results read by the nurses.

This is a cross-sectional study of HIV-infected patients from 2 HIV clinics in Bangkok: HIV-NAT, Thai Red Cross AIDS Research Centre and Taksin Hospital. Research team/investigator/nurse/professional health care workers will assess whether the reading of TST test between the participants and the nurses are the same or not. The investigator and team believe that the readings of the TST tests between the participants and the nurses will be the same. If the investigator and team hypothesis is correct, then this will lessen the workload of the nurses and reduce the number of times the participants have to come to the clinic to see the nurses and the doctors. This is a pilot study to test this innovative method to teach the participants to read the TST results by themselves. If this technique is successful, then the investigator and team can expand the method to other hospitals in Thailand as well as in the region.

Eligibility Criteria:
Inclusion Criteria:

1. Documented HIV-1 infection
2. Aged ≥18 years old
3. No sign and symptom of active TB

Exclusion Criteria:

1. Refuse to read TST by themselves
Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation

This study examines if monitoring serum Follicle Stimulation Hormone (FSH) levels can predict oocyte yield and progesterone levels, considering factors like age, baseline FSH, Antral Mullerian Hormone (AMH), antral follicle count, body weight, kidney function, and urinary FSH. The aim is to find a minimum FSH level that ensures optimal ovarian response and enables tailored FSH dosages for better outcomes.

Ovarian stimulation typically uses transvaginal ultrasound to monitor follicle growth and endometrial condition, with some clinics also tracking serum estradiol and progesterone levels, but often neglecting serum Follicle Stimulation Hormone (FSH). FSH is essential for follicle development, yet its levels can vary widely among women receiving the same dose due to factors like body weight, renal function, and ovarian reserve.

This study aims to identify a minimum effective FSH threshold that ensures optimal follicular growth while avoiding excess administration.

Eligibility Criteria:
Inclusion Criteria:

* regular 21 - 35 days cycles
* BMI between 19 - 30 kg/m2
* serum AMH level between 1.5 to 3 ng/ml
* a total antral follicle count between 10 to 24
* endogenous early follicular phase serum FSH level \<10 IU/L
* normal glomerular filtration rate

Exclusion Criteria:

* hypogonadotropic hypogonadism
* history of ovarian surgery
* permanent ovarian cysts of any form
* older than 39 years
* abnormal thyroid stimulating hormone (TSH)
* renal disease
* elevated prolactin levels
* intake of oral contraceptives 3 months before stimulation start and estradiol pretreatment will be excluded
A Study to Assess the Adverse Events and Effectiveness of BOTOX Injections for the Treatment of Moderate to Severe Forehead Lines in Chinese Adult Participants

Facial lines (such as glabellar lines \[GL\], lateral canthal lines \[LCL\], and forehead lines \[FHL\]) are perhaps the most visible signs of aging. Hyperfunctional facial lines that develop from repeated facial expression may be treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess adverse events and effectiveness of BOTOX in Chinese adults with moderate to severe FHL.

Participants are placed in 1 of 2 groups, called treatment arms. Around 140 adult participants with moderate to severe FHL will be enrolled in the study.

Participants in the treatment group will receive intramuscular injections on Day 1 and followed for up to 180 Days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at the study site. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.
* Participant must have symmetrical FHL of moderate or severe rating at maximum contraction as assessed by both investigator and participant using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment.
* Participant must have glabellar lines (GL) severity of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.

Exclusion Criteria:

* Participants with history of known immunization or hypersensitivity to any botulinum toxin serotype.
* Participants with history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
* Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed.
* Participant with history of treatments to the mid- or upper face.
The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction

Aim: The aim is to investigate the effect of olfactory training with essential oils versus olfactory training with placebo-oils in patients with COVID-19 induced olfactory dysfunction

Study design: The study is a placebo-controlled randomized clinical trial with an intervention group and a control group. The intervention group receive four essential oils with scents of orange, lavender, clove, and peppermint. Patients in the control group receive a fragrance kit, consisting of the same containers, but with fragrance-free oils added. Both groups are instructed to smell each of the four oils for 30 seconds in the morning and evening, over a three-month intervention period. Patients are given a diary in which to record their olfactory training. The nurse or medical student instructing the patients in the training and performing the smell and taste tests is blinded.

Study population: Patients referred to the Unit for Sense of Taste and Smell in the Department of Otorhinolaryngology Head \& Neck and Audiology at Rigshospitalet.

Inclusion criteria:

* Impaired sense of taste and smell following COVID-19 \> 3 months
* Hyposmia (16.25-30.5) or anosmia (\<16) assessed by Sniffin' Sticks Olfactory Test for Threshold, Discrimination and Identification (TDI) performed in the Unit for Sense of Taste and Smell with or without parosmia based on medical history
* \> 18 years of age

Exclusion criteria:

* Cause of hyposmia, anosmia or parosmia other than COVID-19
* Does not read or speak Danish
* Lack of compliance to perform daily olfactory training

Procedures:

- TDI-test: To assess patients' sense of smell, the TDI-test with Sniffin' Sticks is used, which is a validated tool with normative data.

Questionnaires:

- 'Taste and Smell Tool for Evaluation' is used to investigate quality of life related to impaired sense of taste and smell.


Eligibility Criteria:
Inclusion Criteria:

* Olfactory dysfunction caused by COVID-19
* Hyposmia (16.25-30.5) or anosmia (\<16) with or without parosmia assessed by TDI test with Sniffin Sticks performed in the Unit for Sense of Taste and Smell
* \> 18 years of age

Exclusion Criteria:

* Cause of hyposmia, anosmia or parosmia other than COVID-19
* Does not read or speak Danish
* Lack of compliance to perform daily olfactory training
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

Primary Objective:

To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.

Secondary Objectives:

* To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
* To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.

The study duration per subject will be up to 41 days and will consist of a screening period of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.

Eligibility Criteria:
Inclusion criteria :

* Male or female subjects, between 18 and 45 years of age, inclusive.
* Body weight between 50.0 and 95.0 kg, inclusive, for male or female subjects; body mass index between 18.5 and 27.9 kg/m2, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, electrocardiogram, and clinical laboratory parameters.

Exclusion criteria:

* Any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
* Blood donation any volume, within 2 months before inclusion.
* Symptomatic postural hypotension.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* History or presence of drug or alcohol abuse.
* Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
* If female, pregnancy, breast-feeding.
* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease

This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD
* Age from 50 to 85 years, inclusive
* Rosen Modified Hachinski ischemic score less than or equal to 4
* Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD
* Fluency in English
* Stable doses of medications

Exclusion Criteria:

* Significant neurological disease other than AD
* Major psychiatric disorder
* Significant systemic illness
* History of stroke or seizure
* Weight greater than 120kg (264 lbs.)
* History of autoimmune disease
* Smoking more than 20 cigarettes per day
* Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
* Prior treatment with experimental immunotherapeutics or vaccines for AD
* Presence of pacemakers or foreign metal objects in the eyes, skin, or body
Cardiovascular Changes in Infants of Preeclampsia Mother

Preeclampsia (hypertension during pregnancy) is a common problem affecting 2-8% of pregnancies worldwide and is typically diagnosed by increased blood pressure and proteinuria. The rate of preeclampsia has increased since the 1980s with higher rates at extreme maternal ages as well as during the first pregnancy. Pre-eclampsia is a serious hypertensive disorder of pregnancy affecting outcomes for both mother and infants. These infants not only have increased risk of neonatal complications including preterm birth, intrauterine growth restriction, abnormal Doppler parameters, feed intolerance, intestinal problem, poor growth, and long term lung condition but also have increased risk of cerebral palsy, abnormal neurodevelopmental outcomes, cardiovascular disease, stroke, and mental disorders during childhood and adulthood.

Preeclampsia is diagnosed according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria: BP \> 140/90 on two occasions in previous normotensive mother after 20 weeks of gestation and one of the following; proteinuria in urine \> 0.3 gram/kg/day or acute kidney or liver dysfunction or signs of uterine dysfunction. The onset of preeclampsia can be early before 34 weeks of pregnancy (Early-onset preeclampsia) or late after 34 weeks of pregnancy (Late-onset preeclampsia). Early-onset preeclampsia, especially between 28-32 weeks gestation, is characterized by a high prevalence of microvascular changes in the placenta that makes mothers and their infants are more liable to complication. The pathogenesis of preeclampsia is unclear.

Preeclampsia affects hematopoiesis and the fetal myeloid lineage leading to thrombocytopenia, neutropenia, decrease phagocytic function, decrease T regulatory cells, and an increase in cytotoxic natural killer cells in neonates. Innate and adaptive immunity are regulated by myeloid cells and the immune changes in infants of preeclampsia mothers could lead to increased incidence of neonatal sepsis and the development of chronic inflammatory conditions.

Eligibility Criteria:
Inclusion Criteria:

* Infants born from Pregnant women with preeclampsia, their mother willing to give consent.

Exclusion Criteria:

* 1-Infant with a major heart problem.
* Infants with major congenital and genetic anomalies.
Open Retropubic Versus Laparoscopic Colposuspension (Burch Operation) Techniques for Female Stress or Mixed Urinary Incontinence; A Ten-year Experience in a Tertiary Center

To evaluate postoperative course, efficacy, and complication rates of Open Burch Colposuspension and Laparoscopic Burch Colposuspension techniques in stress or mixed urinary incontinence at a single training and research hospital over the last 10 years in Istanbul, Turkey.

A retrospective cohort study was conducted in all Burch Colposuspension cases performed between January 2001 and May 2022 at Kanuni Sultan Süleyman Training and Research Center. All patients' data were reviewed from the electronic medical records and analyzed who underwent Burch colposuspension surgery either with an open or laparoscopic approach. The primary outcome was surgical success, whereas secondary outcomes were perioperative and postoperative data including surgical type (open or laparoscopic), operating time, duration of hospital stay, estimated blood loss, complications during surgery, and additional interventional procedure types.

Eligibility Criteria:
Inclusion Criteria:

* patients having SUI or mixed urinary incontinence whom conservative therapy (Kegel's pelvic floor exercises, bladder training, electrical stimulation, or medication) failed
* SUI had been proven by urodynamic assessments.
* patients who had urethral hypermobility supported by a Q-type test with a cotton swab angle greater than 300
* patients having a residual urinary volume of less than 100 mL were included.

Exclusion Criteria:

* history of anti-incontinence surgery
* pelvic inflammatory diseases
* urinary retention
* SUI with intrinsic sphincter deficiency
* neurogenic bladder
* suspected malignancy
* urge incontinence
* chronic cystitis
* urinary tract infection
* prescription of anticoagulant or antipsychotic treatment
* coagulation disorders
* physically and medically unsuitable for colposuspension surgery
* pregnancy and loss to follow-up.
Staccato Prochlorperazine Single Dose PK Study

The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine

The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.

Exclusion Criteria:

* Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey

The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.

In adult heart transplantation, clinical situations differ between patients (elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving). At investigator's knowledge, there is not recommendations in France about antibiotic prophylaxis in adult heart transplantation. So, investigators aimed to study the antibiotic prophylaxis use in adult heart transplantation in France.

Investigators conduct a French national survey about antibiotic prophylaxis used in adult heart transplantation center. Clinical situations such as elective, emergency, redux surgery, ventricular assisting device or extracorporeal live saving are investigated.

Study was performed after Institutional approval was obtained from the local Ethics Committee (Comite de Protection des Personnes Nord Ouest III). An electronic survey was sent to all French adult heart transplantation centers (22) on march 1st, 2015. Reminders were planned on week 2 and 4 after initial sending. On june 2015, nonresponding centers were contacted by phone. Data were collected by a single investigator.

Eligibility Criteria:
Inclusion Criteria:

* All French centers performing adult heart transplantation in 2015

Exclusion Criteria:

* not responding center
* no adult heart transplantation
Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance

The investigator investigated the effect of lower limb flexibility on functional performance of children with Duchenne Muscular Dystrophy.

Thirty children whose functional levels were in 1 or 2 according to the Brooke Lower Extremity Functional Classification Scale were included in the study. Flexibilities of hamstrings, hip flexors, tensor fascia latae, and gastrocnemius muscles were evaluated in dominant lower limb. Popliteal angle test, hip flexor flexibility test, tensor fascia latae flexibility test and gastrocnemius flexibility test were used for flexibility asssessments. Functional performance was assessed with 6 Minute Walk Test (6 MWT) and Timed Performance Tests. The correlation between the flexibility of lower limb muscles' and performance tests were examined.

Eligibility Criteria:
Inclusion Criteria:

* Having a Duchenne Muscular Dystrophy diagnosis,
* Being in the ambulatory period and climbing four steps independently,
* To be able to cooperate the physiotherapist's directions,
* Not having any severe contracture in the lower limbs which may prevent assessments,
* Not having any injury or surgery involving the lower limbs during the last 6 months.

Exclusion Criteria:

Children who did not provide these criteria and did not will to participate the study were excluded.