cyrilzakka/clinical-trials huggingface dataset:
Skeletal Health and Bone Marrow Composition Among Youth

Children and adolescents experiencing gender dysphoria feel increased distress with the onset of puberty. Gender clinics treat these young adolescents by "blocking" puberty using gonadotropin-releasing hormone (GnRH) agonist medications. This has the possibility of impacting bone development as sex steroids are important to bone mass development. In this multi-site study, the investigators will examine bone marrow composition (by MRI) in 40 transgender youth and bone density and body composition before/after pubertal blockade compared to healthy participants.

The investigators propose to identify the effects of pubertal blockade on bone density and size in pediatric transgender individuals. Information is limited regarding bone health and metabolism for this group, and especially for children who are transgender. Further, the team's expertise in magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), dual-energy x-ray absorptiometry (DXA), and peripheral quantitative computed tomography (pQCT), examining the natal female skeleton in previous NIH funded studies, and extensive clinical expertise, provide an ideal foundation to apply this protocol to examine transgender female and transgender male skeleton. Findings from this study will allow us to identify potential preventative strategies to counter the long-term effects of puberty blockade such as osteoporosis and raise awareness of this medical consequence to medical care providers of transgender patients. The proposed project seeks to answer the clinically relevant question of how bone marrow composition relates to body composition, and its relation to both bone density and skeletal strength, in transgender patients who are undergoing puberty blockade, the first phase of therapy preceding gender-affirming hormone therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Be willing to give informed consent/assent (parent or legal guardian able to provide informed consent)
2. Tanner Stage II/III
3. Age 9-14 years old for assigned male at birth (AMAB) and 9-13 for assigned female at birth (AFAB)
4. Current patient at the Boston Children's Hospital Transgender Clinic or Cincinnati Children's Hospital Medical Center Clinic, within six weeks of initiating pubertal blockade treatment (e.g., GnRH agonist- Lupron or Vantas)
5. Controls are matched on age within 2 years, race/ethnicity, sex assigned at birth and BMI within 25%

Exclusion Criteria:

The participant must not:

1. Have chronic disease known to affect skeletal metabolism (e.g. cystic fibrosis, celiac disease, sickle cell disease, inflammatory bowel disease etc.)
2. Receipt of other medications within previous 3 months known to affect skeletal metabolism (e.g., glucocorticoids, anticonvulsants, etc.)
3. Have metal implants or hardware in their body that would not allow them to get an MRI
4. Have a diagnosis of a developmental disorder or claustrophobia that would prevent them from undergoing an MRI
One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* Six months history of asthma
* Daily use of inhaled glucocorticosteroids
* FEV1 40-85% of predicted normal
* Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion Criteria:

* Other clinically relevant disease or disorders
* History of smoking of more than 10 pack years
* Respiratory infection within 30 days
A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1595043 in healthy male subjects following oral administration of single rising doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
  * Sexually abstinent
  * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom)
* Unprotected sexual intercourse with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus

The aim is to investigate the effect of probiotic bacteria on symptoms and clinical manifestations in patients with oral lichen planus (OLP).

The hypothesis is that probiotic bacteria can favor an oral environment that reduces the risk of symptomatic candidal and bacterial infection in OLP.

The negative influence of improper oral hygiene on OLP is established and overgrowth of Candida is a common problem. Nystatin is the only topical antifungal that does not interact with other drugs and to which the majority of the candida species are susceptible. Symptomatic treatment with fluocinolone is initiated in patients without candidal infection. Probiotic bacteria can affect the microbial homeostasis by reducing the overgrowth of pathogens e.g. candida. Different probiotic species have been shown to produce antifungal substances and reduce the growth of candida albicans in vitro. The probiotic strain Lactobacillus rhamnosus has been found to reduce the salivary count of yeasts among elderly in a randomized clinical study.

The study is planned as a blinded, randomized controlled study with four parallel arms. 120 OLP patients with symptoms form the mucous membranes are included in the study and will receive nystatin or fluocinolone treatment depending on positive or negative diagnosis of candidosis. In addition, they will be assigned to either the probiotic (A) or the placebo group (B) by randomization. The groups will be encouraged to take three tablets per day (morning, noon and evening)for eight weeks. The lozenges containseither two strains of the probiotic bacterium L. reuteri (A) or placebo (B). Cytosmears, saliva sample, and saline mouth wash will be taken at baseline, after the treatment period and at follow-up visits at 8, 16, 24 weeks and 1 year. Salivary counts of the probiotic strains, the clinical manifestations and symptoms associated to OLP will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Oral Lichen Planus

Exclusion Criteria:

* Antibiotic treatment within 3 months
Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies (ECCO Trial)

To assess the size of the common bile duct in a large cohort of patients with jaundice following a malignant tumor of the head of the pancreas or the distal bile duct receiving a diagnostic EA for biopsy and / or for evaluation of tissue resectability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with jaundice and an injury to the head of the pancreas recommended for EUS-guided tissue acquisition or staging
* Patients with jaundice and distal CBD lesion suggestive of cholangiocarcinoma or Vater's ampulla carcinoma recommended for EUS-guided tissue acquisition or staging
* Serum bilirubin level ≥ 3 mg / dl
* Age ≥ 18 years old
* Subject affiliated or beneficiary of a social security scheme.
* Subject having been informed of this study and having given his no objection

Exclusion Criteria:

* Presence of altered anatomy due to previous gastric surgery (Billroth II or Roux-en-Y anastomosis)
* Sphincterotomy performed previously, plastic biliary stent or metal stent placement
* Percutaneous drainage of the bile ducts performed previously
* Pregnant, breastfeeding or parturient woman
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; hospitalized without consent.
28-day Repeat Dose Study of GSK573719

The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Eligibility Criteria:
Inclusion Criteria:

* A signed and dated written informed consent prior to study participation
* Males or females of non-childbearing potential
* 40 to 80 years of age
* COPD diagnosis
* 10 pack-years history or greater of cigarette smoking
* Post-bronchodilator FEV1/FVC ratio of 0.70 or less
* Post-bronchodilator FEV1 of 25 to 70% of predicted normal

Exclusion Criteria:

* Asthma
* Other significant respiratory disorders besides COPD, including alpha-1 deficiency
* Previous lung resection surgery
* Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
* Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
* Hospitalization for COPD or pneumonia within 3 months of screening
* Any significant disease that would put subject at risk through study participation
* BMI greater than 35
* Pacemaker
* Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C)
* Cancer
* Allergy or hypersensitivity to anticholinergics or inhaler excipients
* Diseases that would contraindicate the use of anticholinergics
* Use of oral corticosteroids within 6 weeks of screening
* Use of long-acting beta-agonists within 48 hours of screening
* Use of tiotropium within 14 days of screening
* Use of theophyllines or anti-leukotrienes within 48 hours of screening
* Use of short-acting bronchodilators within 4 to 6 hours of screening
* Use of investigational medicines within 30 days of screening
* Use of high dose inhaled corticosteroids
* Use of long-term oxygen therapy, CPAP or NIPPV
* Participation in acute phase of pulmonary rehabilitation program
* History of alcohol or drug abuse within 2 years prior to screening
* History of psychiatric disease limiting validity of consent
* Affiliation with the investigative site
* Previous use of GSK573719
Platelet Rich Plasma for Patients With Recurrent Implantation Failure

Patients with recurrent implantation failure are among the most difficult patients to treat, with no proven standard treatment. Platelet rich plasma stimulates cellular processes involved in endometrial regeneration, and in a small case series has shown efficacy for this patient population. We hope to conduct a randomized controlled pilot study to determine whether PRP is indeed an effective treatment for recurrent implantation failure.

Patients considered to have recurrent implantation failure will undergo randomization to receive intrauterine infusions of platelet rich plasma or a placebo of embryo culture media prior to their embryo transfer. All patients will undergo a blood draw to obtain 60ml of blood from which 0.5ml of platelet rich plasma will be obtained. Those randomized to receive the platelet rich plasma will have platelet rich plasma placed into the uterine cavity at least 48 hours prior to the embryo transfer, while those randomized to receive placebo will have embryo culture media placed into the uterine cavity at the same point in time. Those randomized to the placebo group will have the opportunity to be placed into the treatment group if no pregnancy was attained. Transfer outcomes including implantation rate, pregnancy rate, and live birth rate, will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All women who have undergone 3 or more embryo (blastocyst stage) transfers without establishing a clinical pregnancy or 2 or more euploid embryo transfers without establishing a clinical pregnancy, aged 18 - 45, with a normal uterine cavity established within 12 months by hysteroscopy or saline infusion sonogram, planning in vitro fertilization with an embryo transfer at Stanford Fertility and Reproductive Health. The planned transfer must consist of any of the following: a PGS proven euploid embryo, a good quality blastocyst from a patient younger than 37, or a donor oocyte blastocyst.

Exclusion Criteria:

* Abnormal uterine cavity, planning in vitro fertilization with use of a gestational carrier. patients enrolled in other experimental interventions for RIF will be excluded. Patients with only poor quality or cleavage stage embryos.
Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer

Primary:

* To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.

Secondary:

* To assess the safety and tolerability of oxaliplatin
* To assess time to progression and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix
* Prior therapy with cisplatin allowed
* First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy
* Must have measurable disease
* Histologically Proven Carcinoma of the cervix
* ECOG PS ≤2
* No other serious concomitant illness
* Fully recovered from any prior therapy
* Lab: ANC \>1500 mm³, Platelets \> 100000 mm³, Creatinine ≤ 1.5 x Normal value, Bilirubin ≤ 1.5 x Normal value, SGPT (ALT) ≤ 2.5 x Normal value

Exclusion Criteria:

* Known allergy to one of the study drugs
* Peripheral neuropathy \> grade2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Treatments for Benign Paroxysmal Positional Vertigo (BPPV)

The purpose of this study was to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular habituation exercises. These procedures involve exercises and head manipulations. Vertigo intensity and frequency, the presence/absence of slow-phase eye movements, the degree of dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained the effects of co-morbid conditions on the response to treatment. While BPPV is a common and significant public health problem that has been recognized for several decades, this is the first systematic study of the relative treatment efficacy of different physical treatment modalities for this disorder.


Eligibility Criteria:
Inclusion Criteria:

Patients may be eligible for this study if they:

* Are at least 21 years old.
* Have a diagnosis of unilateral posterior semicircular canal BPPV according to established clinical test criteria.
* Have functional to normal range of motion of the neck and the back.

Exclusion Criteria:

Patients will not be eligible for this study if they:

* Have a history of prior ear surgery or prior treatment for BPPV.
* Have an orthopedic or connective tissue disorder that impairs functional neck or trunk range of motion.
* Have a significant neurological disorder or spinal cord damage.
* Are on vestibular suppressant medications.
* Have Meniere's disease or acoustic neuromas.
Role of 18F-FDG PET/CT in Gastric Cancer

The objective of the study is to assess the value of PET/CT in diagnosis, staging, response evaluation, and relapse monitoring of gastric cancer.

gastric cancer (GC) is the fifth most common malignancy and the third leading cause of cancer mortality worldwide (1) It carries a poor prognosis, with a 5-year survival of only 20%-30% (2) Clinical staging, based mainly on imaging, is critical in determining the best treatment.There is a widely accepted consensus of the usefulness of FDG PET/CT in staging and restaging of gastric cancer. According to evidence-based data, this modality can evaluate gastric cancer more accurately and is helpful for evaluation of tumor biologic characteristics, detection of lymph node and distant metastases, assessment of tumor response to therapy(9).

retrospective and prospective study will conducted at Sohag oncology hospital, nuclear medicine unit\& Assuit university hospital, nuclear medicine unit including 50 patients in 12 months .

Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed as GC on surgically resected specimens;
2. Patients with gastric and extragastric metastasis.
3. patients with gastric cancer either operated or not.

Exclusion Criteria:

1. Patients with second malignancy.
2. Patient without proven pathology of cancer stomach.
3. Severely ill patient (patient with disturbed conscious level, or couldn't lay supine during the imaging).
4. uncontrolled diabetic patient with blood glucose level more than 200mg\\dl.
5. pregnant women
Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder

Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.

The main questions we aim to answer are:

Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.

The main questions we aim to answer are:

Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 with clinical diagnosis of idiopathic OAB
* Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
* Able to understand the procedures, advantages and possible side effects
* Willing and able to complate the voiding diary and QoL questionnaire
* The strength of PFM 3/5 and more

Exclusion Criteria:

* Women with stress urinary incontinence
* History of conservative therapy (BT, T-MPNS and TTNS/PTNS) within 6 months
* Pregnancy or intention to become pregnant during the study
* Current vulvovaginitis or urinary tract infections or malignancy
* Anatomic or posttraumatic malformations/skin disorders of medial plantar/tibial nerve region on inner foot/ankle that cannot allow to apply the electrodes
* More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
* Cardiac pacemaker, implanted defibrillator
* Previous urogyneceological surgery within 3 months
* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
* Ultrasonographic evidence of PVR volume more than 100 ml
Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive Luteinizing Hormone Releasing Hormone (LHRH) Analogues

The intention of this study is to investigate how many patients with prostate cancer, planned to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS symptoms over time will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Adult men with locally advanced or metastatic prostate cancer scheduled to receive LHRH analogues. A patient who has completed an IPSS questionnaire in his last visit, before the start of LHRH analogues, will be able to participate in the study. This last visit has to be done 6 months before the baseline visit.
* Patients having provided written informed consent
* Patients mentally fit for completing a self-administered questionnaire

Exclusion Criteria:

* Any surgical or radiotherapy treatment performed at prostate level before the entry of the study
* Patient with castrate levels of testosterone ( \< 50 ng/dL) at his first IPSS questionnaire
* Patients who are also participating in any other clinical study within the last 2 months before study entry
* Life expectancy of less than 12 months