cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)

The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first week of ovarian stimulation in terms of the number of vital pregnancies (ie, presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent for trial P06029 as well as for the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the pharmacogenetic analysis (if applicable).
* Female and \>=35 to \<=42 years of age with indication for COS and IVF/ICSI.
* Body weight ≥50.0 kg, body mass index (BMI) \>=18.0 to \<=32.0 kg/m2.
* Regular spontaneous menstrual cycle with variation not outside the 24-35 days.
* Ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed).
* Results of clinical laboratory tests, cervical smear, physical examination within normal limits or clinically acceptable to the investigator.
* Adhere to trial schedule.

Exclusion Criteria:

* A recent history of/or any current endocrine abnormality.
* A history of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS).
* A history of/or current polycystic ovary syndrome.
* More than 20 basal antral follicles \<11 mm (both ovaries combined) in the early follicular phase.
* Less than 2 ovaries or any other ovarian abnormality.
* Unilateral or bilateral hydrosalpinx.
* Intrauterine fibroids ≥5 cm or any clinically relevant pathology, which could impair embryo implantation or pregnancy continuation.
* More than three unsuccessful COS cycles for IVF/ICSI since the last established ongoing pregnancy (if applicable).
* A history of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment.
* A history of recurrent miscarriage.
* FSH \>15.0 IU/L or luteinizing hormone (LH) \>12.0 IU/L during the early follicular phase.
* Positive for human immunodeficiency virus (HIV) or Hepatitis B.
* Contraindications for the use of gonadotropins or gonadotropin releasing hormone (GnRH) antagonists.
* A recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment.
* Smoking or recently stopped smoking (ie, within the last 3 months prior to signing informed consent).
* A recent history or presence of alcohol or drug abuse.
* The participant or the sperm donor has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indication or for the health of the offspring.
* Prior or concomitant medications disallowed by protocol.
Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.


Eligibility Criteria:
Inclusion Criteria

* Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test
* Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
* Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
* Subjects with a pathological stool fat during run in period (\> 10g/24 h)

Exclusion Criteria

* Ileus or acute abdomen
* Any type of malignancy involving the digestive tract in the last 5 years
* Presence of pseudo pancreatic cysts \>= 4 cm
* Current excessive intake of alcohol or drug abuse
* Hypersensitivity vs porcine proteins / pancreatin
Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS)

This study will help determine the frequency and magnitude of nocturnal hypoglycemia (low blood sugar at night during sleep), in children with type 1 diabetes who are on a standard insulin regimen, by using a Continuous Glucose Monitoring System (CGMS). Secondary objectives include the establishment of a definition of nocturnal hypoglycemia for the CGMS and for the calculation of sample size needed for future studies using CGMS. Nocturnal hypoglycemia (NH) can be associated with significant morbidity including seizure and coma. The investigators intend to use the CGMS in a future study investigating the use of a new insulin combination aimed to decrease the frequency of NH in the pediatric population.

Thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a CGMS for 3 days. During this time the participants will be required to test and record self-monitored blood glucose readings at designated time periods and if they have symptoms of hypoglycemia. The comparison of these values with each other and with different previously defined values of NH will allow for a clear definition of NH to be made. A survey has also been designed to assess participant satisfaction with the CGMS.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* less than 18 years of age
* \>2 year duration of diabetes
* on a conventional TID insulin regimen (morning and bedtime NPH) for a minimum of 3 months
* informed consent and assent

Exclusion Criteria:

* medical conditions other than treated hypothyroidism or asthma requiring oral glucocorticoids more than once per year
* intention to move outside of CHEO's catchment area within the next 4 months
* more than 17 years of age and unwilling to continue receiving diabetes care at CHEO until study completion
* intention to switch to a different insulin regimen prior to study completion
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy

In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. The specific indicators included retinal microvessel diameter, macular area，optic disc vascular density and FAZ(Foveal Avascular Zone)area, etc., to clarify the effect of evolocumab on retinal microvessels after intensive lipid-lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 50-75 years old, gender unlimited;
2. Diagnosed as coronary atherosclerotic heart disease
3. The informed consent for the study has been signed

Exclusion Criteria:

1. Those who are unable to cooperate with the examination;
2. Poor imaging quality of refractive interstitial opacity;
3. Macular edema or complicated with macular membrane and senile macular degeneration;
4. Have a history of previous fundus surgery;
5. Those with eye diseases that can cause changes in the microvessels of the fundus;
6. Abnormal elevated intraocular pressure;
7. Moderate or above refractive error (≥ ± 3 diopters)
8. People with cognitive impairment, material dependence, and serious mental illness;
9. Those who do not cooperate with follow-up;
10. Those who participate in other clinical trials at the same time
Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.

Fractures of the distal end of the radius are one of the most frequent fractures diagnosed in the emergency room. The initial management, and in many cases definitive, is carried out through manipulation, closed reduction and immobilization in the emergency room. Different methods of anesthesia have been described to reduce pain during the manipulation and reduction procedure, such as: hematoma block, periosteal block, general anesthesia, intravenous regional anesthesia, nitrous oxide, intramuscular sedation, and conscious sedation. Despite the use of different methods of anesthesia, none is fully effective and each of these methods is not free of complications. Adjuvant measures could play an important role in improving the patient's experience during the procedure, however, there is little evidence in this regard.

Music is increasingly being studied and developed as an adjunctive therapy in the management of pain and anxiety in different medical procedures, demonstrating a statistically significant reduction in pain and anxiety. However, in the literature there is no evidence of studies that evaluate the effect of music during the reduction of fractures in traumatology as an adjuvant therapy for the management of pain and anxiety.

In our experience, despite the anesthesia used, reductions of distal radius fractures are usually a painful procedure that involves a certain degree of discomfort for the patient. For this reason, the investigators believe this study is necessary, as it could demonstrate a new adjuvant therapy that reduces pain and anxiety and improves the overall experience of the patient, in addition to being music, a low-cost tool with no risks for patient safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Clinical and radiological diagnosis of a fracture of the distal end of a closed radius that has an indication for closed reduction.

Exclusion Criteria:

* Diagnosis of other concomitant fractures.
* Allergy to local anesthetics.
* Significant hearing impairment and/or use of hearing aids.
* Patients whose comorbidities prevent correct participation in the procedure (such as cognitive impairment, diagnosis of psychiatric diseases, patients under the influence of drugs...).
INFLUENCE of COMBINED INTERFERENTIAL CURRENT STIMULATION and ABDOMINAL DRAW-IN EXERCISES in the TREATMENT of CHRONIC NON-SPECIFIC LOW BACK PAIN

The purpose of this study is to investigate influence of a combined interferential (IF) current stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP) CNSLBP is considered the second most common health problem after headache. The lifetime of LBP among Egyptian patients in a family center reached 48%, which indicates that LBP is a prevalent symptom that deserves more attention.

One hypothesis for the development of LBP is due to a dysfunction in the control of the abdominal and back muscles and this change in spinal control is due in part to in local segmental muscles dysfunction, such as the transversus abdominis (TrA). Interferential therapy (IFT) is capable of achieving uniform stimulation and high reproducibility, it is thought to be less stressful, as well as enhance deep muscle contraction.

Also, there is the specific training of the TrA provided functional and therapeutic benefits, such as unloading of the spine, anticipatory postural control, intersegmental stabilization of the spine, and long-term pain relief. Draw-in is a typical TrA exercise.

Many studies have mainly focused on the morphological aspects of paraspinal muscles which play an essential role in patients with CNSLBP while our study focused on influence of a combined IFT stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP

60 patients suffering from chronic non-specific low back pain will participate in this study. Both sexes will participate in this study; aged 20-45 years. will be diagnosed and referred from Orthopedist. The study will be conducted at outpatient clinic of Deraya university Elmina government. The patients will be divided randomly into two groups equal in numbers (group A), (group B).

Group(A): (Experimental group) :( 30 patients will receive IFC stimulation, Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles).

Group(B): (control group) (30 patients will receive Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles).

Eligibility Criteria:
Inclusion Criteria:

* 60 patients with chronic non-specific low back pain (\>3 months).
* 2. Age of participants will range from 20 to 45 years.
* 3.Both sexes will participate in this study.
* 4.Body mass index (BMI) will range from 25 to 29.9 (Kg / m2).

Exclusion Criteria:

* Subjects will be excluded from the study if they have previous spinal surgery, spinal cord injury or unstable neurological signs, Lumbar intervertebral disc, congenital postural deformities, inability to contract the abdominal muscles, cauda equine symptoms related to the spine including changes in bowel and bladder control, cardiac pacemaker, and females during pregnancy.
Tailored Drug Titration Using Artificial Intelligence

The purpose of the ARTERY Outcomes study is to compare optima-for-blood pressure (optima4BP), a clinical decision support system for hypertension (HTN) treatment optimization to standard of care in patients with essential HTN.

Nearly 34 million Americans have their blood pressure (BP) uncontrolled. Hypertension (HTN) claims 1000 deaths every day. Despite medication and life-style management, the cost of HTN associated hospitalizations had escalated to $113 billion in 2016, or 15% of all hospital costs, with \>135 million Emergency Department (ED) visits.

Uncontrolled HTN for even a few weeks is associated with increased risk for acute cardiovascular (CVD) events \[stroke, heart failure (HF), myocardial infarction (MI)\] and death. Medication treatment optimization to BP goal reduces the incidence of stroke by 35-40%, HF by up to 64%, and MI by 15-25%.

optima-for-blood pressure \[optima4BP\] transforms the episodic and reactive nature of uncontrolled HTN pharmacological treatment management into a process that is continuous, proactive, and personalized. The innovation simulates the established clinical reasoning treatment decision process undertaken during a patient's visit.

Eligibility Criteria:
Inclusion Criteria:

* Two or more blood pressure (BP) readings of ≥ 140/90 mmHg during UCSF primary care or cardiology office visits within the last 12 months
* Therapy with medications from at least 1 anti-HTN pharmacological agents at the time of the last office visit
* At least minimally "tech-savvy" defined as Ownership of a compatible smartphone and Ability to access the internet
* Active Electronic Health Record MyChart account

Exclusion Criteria:

* Home anti-HTN medication therapy doesn't match the electronic health record medication list
* Anti-HTN medication therapy changed within 30 days prior to enrollment
* Inability to operate a BP cuff
* Incompatible smartphone device (Galaxy S5 Android 5.0)
* Less than minimally "tech-savvy" defined as Inability to use the Internet
* Non-compliance with medical follow-up (\>3 "no shows" in the previous 12 months)
* Planned coronary revascularization in the next 12 months
* Myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days
* GFR \< 30 (CKD stage IV/ V)
* Treating physician rules out the patient due to superseding health management concerns
* Treating physician rules out the patient due to other concerns
Multiomics Biomarkers for Urolithiasis

This is a prospective case series study. To compare urine sample of recurrent stone-formers and non-stone former by multiomics approach to identify potential markers for stone recurrence.

A total of 100 Chinese patients with history of recurrent urinary stone and no history of urinary stone disease (control) will be recruited for the study.

Urine will be saved for multiomics analysis, including metabolomics, proteomics, etc. Thereafter, integrated multiomics calculation of recurrent stone can be studied for the differentiation of recurrent stone former and non-stone former.

After completing the preliminary and screening experiments, a large validation cohort (1000 Chinese patients with history of recurrent urinary stone) will be carried out. The patients will then be follow-up in clinic for at least 3 years, with minimum annual review and imaging to detect for any stone recurrence, as defined as increase in stone size and number, or symptomatic stone events. Targeted biomarkers measurement, based on part 1 result, will be done and the result will be used to correlated with the clinical outcomes of stone recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients with history of recurrent urinary stone
* Age greater than or equal to 18 years old
* Have more than 2 episodes of radio-opaque stone disease (bilateral stones were counted as two episode)

Patients with no history of urinary stone disease

* Age greater than or equal to 18 years old
* With no history of urinary calculi, from history and imaging.

Exclusion criteria:

* Patient refused or unable to provide consent for the study
* Patient with active urinary infection
* Patient with radiolucent stone or infective stone
* Patients with no history of urinary stone disease (for control group)
* Patient refused or unable to provide consent for the study
* Patient with active urinary infection
Simultaneous Versus Sequential Antiretroviral Therapy (ARV) Therapy and Mycobacterium Tuberculosis (MTB) Treatment

The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and HIV infection in patients with AIDS and active tuberculosis.

AIDS and tuberculosis are two international and national priority public health problems. The best time for starting antiretroviral therapy in patients with AIDS and active tuberculosis is not clear, despite of the guidelines regarding CD4+ count. The debate surrounding this issue is mainly due to the difficulty among adherence of anti-MTb and anti-HIV treatment, the pharmacological interaction, the adverse events related to drugs and the risk of inflammatory reconstitution syndrome, especially in patients with advanced HIV infection. Moreover, there is great debate upon the lack of knowledge of the degree of immune reconstitution throughout time against Mtb induced by the anti-HIV therapy.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* \< 200 CD4+ cells/mL
* Active pulmonary tuberculosis (with or without extrapulmonary involvement)

Exclusion Criteria:

* Meningeal tuberculosis
* Unable to attend 96 wk follow-up
Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / Docetaxel

The study compares two combinations of chemotherapy in patients with advanced or metastatic NSCLC: 50% of the patients are treated with cisplatin and docetaxel, the other 50% with oxaliplatin and docetaxel. cisplatin is today the standard therapy, but the toxicity profile is often not tolerable. Especially in elderly patients or patients with comorbidities, oxaliplatin based chemotherapy may have lower toxicities but comparable or even better response rates.

Cispaltin based chemotherapies are standard for palliative first-line therapy in patients with advanced or metastatic NSCLC. Due to contraindications to cisplatin, this substance can not be used in a high number of patients. Especially in elderly patients, patients with comorbidities and patients with reduced general condition, cisplatin is a therapy which often induces intolerable toxicities. Thus, therapy often has to be interrupted or finished prematurely. Due to its favorable toxicity profile, oxaliplatin can be used also for the treatment of elderly patients and patients with comorbidities. Based on toxicity data from a phase II study of our group in patients with gastric cancer, the dosage for oxaliplatin/docetaxel was adopted for this actual study. In previous phase II trials, response rates of oxaliplatin based combination chemotherapies were comparable to those with cisplatin in patients with metastatic NSCLC.

In this study we will analyse, if a oxaliplatin based combination chemotherapy has a more tolerable toxicity profile and comparable or even better response rate in comparison to a cisplatin based chemotherapy. 44 patients in each arm will either be treated with a maximum of 6 cycles cisplatin/docetaxel or a maximum of 8 cycles oxaliplatin/docetaxel.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed NSCLC stage IIIB or IV.
* no previous chemotherapy in metastatic state
* male and female patients aged \> 18 years
* ECOG ≤ 2
* Leukocytes \> 3.000/µl
* Thrombocytes \> 100.000/µl
* Serum creatinine ≤ 1.25x normal value, or Creatinine Clearance \> 45 ml/min
* previous radiation \< 25% bone marrow region allowed. Previous radiation of whole pelvis not allowed
* parallel radiation allowed, if target lesion outside of radiation field
* written informed consent
* life expectancy \> 3 months

Exclusion Criteria:

* hypersensibility against Cisplatin, Oxaliplatin or Docetaxel
* Neoadjuvant or adjuvant chemotherapy within the last 6 months
* radiation within the last 28 days
* severe systemic comorbidities
* Cardiomyopathy or cardiac insufficiency stage II-IV according to NYHA
* malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
* brain metastases
* severe non-surgical comorbidities or acute infection
* peripheral polyneuropathy \> NCI grade II
* severe liver dysfunction AST/ALT\>3,5xULN, AP\>6xULN, Bilirubin\>1,5xULN)
* participation in parallel trial
* pregnancy and lactation
* reduced hearing
Legacy of the Special Olympics World Games Berlin 2023

This research aims to evaluate the impact of the project "170 Nations - 170 Inclusive Communities" of the Special Olympics World Games 2023 (SOWG 23) on sustain inclusive structures for people with intellectual disabilities (ID). The research utilizes a quasi-experimental research design and a qualitative research design and will synthesize qualitative and quantitative data to display successful and non-successful interventions for more inclusive communities. The research will target 56 host communities of SOWG 23 and 56 non-host communities, interviewing 200 people with ID and a minimum of 400 key stakeholders, as well as conducting qualitative interviews and focus groups.


Eligibility Criteria:
Inclusion Criteria:

* legal age

Exclusion Criteria:

* none