cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System

Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
* Ability to demonstrate willingness to participate and adhere to study protocol

Exclusion Criteria:

* Known or suspected pregnancy
* Lactating women
* Anticipates use of condoms or any other form of back-up contraception during the study
* History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
* Has a contraindication to combined estrogen-progestin contraceptive use
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Smoker who is 35 years old or over
Thalassaemia Severity

This study aims to develop a nuanced understanding of thalassemia severity in Upper Egypt by integrating various clinical parameters beyond transfusion frequency. By doing so, it seeks to enhance patient management and ultimately improve quality of life for those affected by this condition.

Thalassemia syndrome classified as hemoglobinopathies, represent one of the most prevalent classes of single-gene disorders globally. The mutations in the HBB gene lead to variable impacts on the production of globin proteins, which in turn affects the overall function of hemoglobin. The genetic variants contribute significantly to the diverse clinical presentations and severity of thalassemia. Traditionally, thalassemia has been categorized into Major, intermediate, and Minor based on the frequency of blood transfusions required for survival It has been observed that anemia may not be the sole determinant of thalassemic disease severity, other factors are also responsible for overall clinical status.

Accordingly, clinical conditions of the thalassemia patient, cannot classified based on the transfusion status.

Phadke et al. (2006), proposed a classification that considers multiple parameters beyond transfusion status . Similarly, Sripichai et al , (2008) classified HbE/β-thalassemia into the 3 categories of mild, moderate, and severe. Another classification was also introduced by Thalassemia International Federation (TIF) , which 'was bit modification Sripichai et al 2008 . Despite these advancements, existing classifications still tend to simplify thalassemia into three categories Globally, An estimated 1-5% of the global population are carriers of a genetic thalassemia mutation.Although the epidemiology of the various clinical forms remains poorly recognized, the disease is known to be highly prevalent in the area extending from sub-Saharan Africa, through the Mediterranean region and Middle East, to the Indian subcontinent and East and Southeast Asia.Thus, \&gt;90% of patients with these disorders live in low- and middle-income countries

Eligibility Criteria:
Inclusion Criteria:

- Children and adolescents aged from 18 month to 18 year old. Those with thalassemia

Exclusion Criteria:

* Non Thalassaemia children
Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg

The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-64
* ASA Physcial Status classification 1-3
* Foot and ankle surgery at Ben Taub General Hospital

Exclusion Criteria:

* diabetes mellitus
* peripheral neuropathy
* coagulopathy
* allergy to study drugs
* systemic glucocorticoid treatment (for 2 weeks or more) within 6 months of surgery
* chronic opioid use at home
* patient inability to properly describe pain to investigators
* pregancy
* prisoners
* patient or surgeon refusal
Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic

This study focuses on how enriched environment along with the traditional physical therapy improves the gross motor function in spastic quadriplegic cerebral palsy children. And how much dosing is required to gain that clinically significant improvement.

There is still a blurred area regarding dosage parameter in cerebral palsy rehabilitation. This study is focused primarily on the fact that level appropriate selection of time, type, frequency, and intensity of intervention (sensory and motor) plays a very vital role in developing gross motor functions. Secondly it is very important to establish the impact of enriched environmental inputs and foster parent capacity as an early intervention taking into account cerebral palsy (CP) specific positioning and handling along with level appropriate sensory inputs.

Eligibility Criteria:
Inclusion Criteria:

Age Group between 7 months to 5 years.

* Spastic Quadriplegia
* Gross Motor Function Classification System (GMFCS) level IV and V
* Modified Ashworth Scale (MAS): level 2
* Both Gender

Exclusion Criteria:

* History of fits

  * Medications
  * Dislocation and fracture
  * Visual/Auditory Impairment
  * Patients taking therapy from multiple places
Continuous Femoral Nerve Blocks: Relative Effects of Basal Infusion and Bolus Doses on Sensory and Motor Function

This is a research study to determine if the way local anesthetic- or numbing medication- is delivered through a tiny tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.

Specific Aim: Research study to test the null hypothesis that differing the delivery method (continuous basal infusion vs. repeated bolus doses) but providing an equal total dose of Ropivacaine has no impact on quadriceps muscle strength. These results will help define the optimal delivery method of local anesthetic used for continuous peripheral nerve blocks and help guide future research in this clinically relevant area.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* willing to have bilateral femoral perineural catheters place with a subsequent ropivacaine infusion and motor/sensory testing for 9 hours
* willing to stay overnight in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning.

Exclusion Criteria:

* current daily analgesic use
* opioid use with in the previous 4 weeks
* any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
* pregnancy
* incarceration
Safety of REL-1017 for Major Depressive Disorder

This was a 1-year, multicenter, open-label, long-term study to assess the safety of REL-1017 once daily (QD) as monotherapy or as adjunctive treatment of Major Depressive Disorder. Adjunctive study participants continued to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.

This was a multicenter, open-label, long-term study of REL-1017 to evaluate the long-term safety and long-term durability of response in patients with MDD. Patients who completed previous randomized, double-blind Phase 3 trials (NCT04688164, NCT04855747, NCT05081167) of REL-1017 as adjunctive therapy or monotherapy for MDD were asked to continue treatment with REL-1017 25 mg daily for up to 1 year. De novo patients who satisfied inclusion/exclusion criteria also were enrolled and received a 75 mg loading dose of REL-1017 on Day 1 followed by a maintenance dose of 25 mg REL-1017 daily for the remainder of the study (Days 2-365). When REL-1017 was administered as adjunctive treatment, patients continued to use a stable dosage of their concomitant antidepressants.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 65 years, inclusive.
* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
* Current major depressive episode.

Exclusion Criteria:

* Any current and primary psychiatric disorder other than Major Depressive Disorder.
* History of bipolar I and II disorder, psychosis, and/or mania.
* Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
In Vitro Follicle Activation

The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI).

The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI; also known as premature ovarian failure). Patients diagnosed with POI are infertile due to a lack of follicle growth and ovulation; oocyte donation is the only treatment option currently available to enable these women to have a child. IVA treatment may result in the rescue of the remaining primordial follicles within the ovary, thus making oocytes available for IVF, embryo production, transfer and pregnancy. In this experimental treatment, ovarian tissue is removed from the patient and cultured in vitro for 48 hours with specific compounds to activate dormant primordial follicles. Following activation ovarian tissue is auto-grafted to the serosa of the fallopian tube, and the patient is monitored for signs of follicle growth. Growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and IVF.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with primary ovarian insufficiency (POI), seeking pregnancy and eligible for IVF at Colorado Center for Reproductive Medicine (Lone Tree, CO).
* Patients can be of any race, culture, sexual orientation or ethnicity.

Exclusion Criteria:

* Minors are excluded from participation in this study.
Microbiome Individuality and Stability Over Time

Microbial derived uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) are present in blood and excreted into the urine. Uremic solutes have high inter-individual variability of unclear etiology, that the investigators hypothesize is due to intestinal microbiome variation and/or dietary variation between people. In this study, the investigators will collect baseline samples on participant's habitual diet. The investigators will then administer a homogenous diet to all participants for 7 days and examine levels of uremic solutes in the urine via 24-hour urine collection during this period. In parallel, the investigators will monitor microbiome composition. The investigators predict that during the period subjects are consuming the same, homogenous diet, their excretion of uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) into the urine will have less inter-individual variation.

Participants will be asked to eat exactly the same meal for one week and to eat this same meal three times each day. Subjects will be allowed to eat as much of this meal as they want and to eat enough so that they do not lose weight. The food will provide a nutritionally adequate diet, designed by a registered dietitian. Participants will be asked not to eat anything else including candy, snacks, etc. and not to drink anything except water including coffee, tea, sodas, or alcoholic drinks.

Samples will be collected at 5 time points:

2 weeks prior to starting test diet, Baseline (day 1 on diet), day 4 on the diet, day 7 on the diet, 7 days after end of diet.

Samples collected include:

Blood sample Stool sample 24 hr urine collection Diet and Gastrointestinal questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* pregnancy
* diabetes
* gastrointestinal disease
* use of medications thought by the investigators to have a significant effect on the microbiome
A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer

The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.


Eligibility Criteria:
Inclusion Criteria:

* Any women \>18 years of age at time of informed consent
* Diagnosed with breast cancer and schedule for NAT

Exclusion Criteria:

* History of kidney disease, creatinine level \>1.3 or eGFR \<45.
* Known allergic reaction to gadolinium or iodinated contrast media.
* Contraindication to contrast-enhanced breast MRI.
* Lesion not included in the field of view of either pre- or post-NAT MRI or CEM
* Presence of pacemakers or automated implantable cardioverter defibrilator
* Pregnant women
Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)

The aim of this study is to assess the impact of preoperative physical activity on physical capacities of patients undergoing liver resection for primary or secondary liver cancer.

The purpose of this study is to investigate the effects of a preoperative exercise program in patients with primary or secondary liver cancer undergoing hepatectomy. Preoperative exercise programs have been shown to be effective in other cancer populations, but have been poorly studied in patients with liver cancer. For these patients, it remains unclear what the optimal composition of such programs should be and how they should be delivered. Outcome measures in this study will include preoperative outcomes (oxygen consumption, quality of life, fatigue and physical activity level, anthropometric measures, plasma concentrations of hepatokines) and postoperative outcomes (length of hospital stay and postoperative complications).

After the study is explained and consent obtained, subjects will be tested on a submaximal exercise on cycloergometer with gas exchanges analysis and with pre and post blood test. Then, they will answer various questionnaires assessing physical activity, quality of life and fatigue.

Patients scheduled for liver resection will be randomized to one of two groups. The first group (experimental group) will be subdivided into two groups: interval training 1 and interval training 2, which differentiate themselves by two different intensities.The second group (control group) will receive standard care.

The prehabilitation program will last 6 weeks with 3 sessions per week and will consist in two interval training programs on a cycloergometer with two different intensities.

One month after surgery, peri and postoperative complications will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>18 years old.
* Patients with primary liver cancer, biliary tract cancer, liver metastasis endorsed in the University Hospital of Besancon
* No opposition of patients
* Join a French social security or receiving such a scheme

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Patients being in the disqualification of another study or under the national register of volunteers
* Patients unlikely to cooperate or anticipated low cooperation
* Patients with a maximal oxygen consumption above 35 ml/min/kg
Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI

Objective: To investigate the clinical efficacy of acupuncture combined with biofeedback electrical stimulation on female stress urinary incontinence. Methods: 90 patients diagnosed in a hospital from January 2020 to January 2021 were randomly divided into three groups A, B and C, and group A was treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times. Group B used acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times. Group C was treated with acupuncture combined with biofeedback electrical stimulation. All three groups were combined with pelvic floor muscle training. After treatment, the changes in class I, II muscle fiber, ICI-Q-SF score, and urine leakage in the 1h pad test were compared.


Eligibility Criteria:
Inclusion Criteria:

* meet the diagnostic criteria of SUI
* Aged over 18 years old and have a history of sexual life
* No treatment related to SUI within three months
* Mental illness without cognitive dysfunction, able to cooperate with examination and treatment
* Voluntarily participate and sign the informed consent

Exclusion Criteria:

* combined with urge urinary incontinence, uterine prolapse, vaginal anterior and posterior wall prolapse
* pregnancy, postpartum lochia or abnormal vaginal bleeding
* Acute phase of inflammation (pelvic cavity, vagina, urinary system)
* There are metal substances such as pacemakers and metal stents in the body
* Denervation of pelvic floor muscles (no sensation, no contraction)
* coagulation dysfunction
Neural Correlates of Compulsivity

This study aims to collect data from individuals with obsessive-compulsive disorder (OCD) and healthy controls in order to clarify how learning strategies are employed differently by individuals with compulsive psychopathology and healthy individuals. Behavioral and electroencephalogram (EEG) data will be collected during one experimental reinforcement learning tasks from participants diagnosed with OCD (n = 30) and healthy controls (n = 30). Computational modeling, an advanced data analytic approach that can directly link neural measures with behavior, will be used to quantify learning processes. These parameters then will be related to measures of neural events obtained using EEG, a neuroimaging method that has high temporal resolution, to test for evidence of neurocognitive alterations.

Learning and decisions making are thought to be directed by multiple parallel cognitive systems. These systems account for automatic, inflexible responding to stimuli, as well as more deliberate, effortful representations of relationships in an environment. It has long been suggested than an imbalance in these cognitive control systems explains the emergence of compulsivity, a trait in which behaviors persist despite adverse outcomes. Compulsivity is a characteristic of a number of psychological disorders, however, current theories of how abnormalities in cognitive systems involved in learning and decision making lead to the onset of these disorders remain incomplete.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-50 years of age
* English-speaking
* Capacity to provide informed consent
* Primary diagnosis of OCD with at least moderate severity

Exclusion Criteria:

* Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation
* History of any significant medical condition that may increase the risk of participation
* Alcohol or substance use disorder in the past year
* Exposure and response prevention for OCD within the last six weeks
* Currently taking psychotropic medication
Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease

Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age ≥ 18 years
* patients with indication for routine coronary angiography

Exclusion Criteria:

* transplanted liver
* resection of right liver lobe
* transaminases of \> 5-fold upper limit
* pregnancy or lactation
* choleastasis on ultrasound imaging
* active malignant or consuming disease 12 month before inclusion
* congestive heart failure (EF\<30%, NYHA III or IV, diastolic dysfunction °III or IV
* pulmonary hypertension (WHO °III or IV) Exclusion criteria for MR diagnostics
* pacemaker or ICD
* non removable magnetizable metal implants
* claustrophobia
ROTEM Versus aPTT/PT in Pediatric Surgery

Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European guidelines for hemostasis management. ROTEM has more advantages then standard tests. However, both tests have only grade 1C recommendation, and most of trials have been done on adults. The goal of the study is to compare a relationship between standard tests and ROTEM in pediatric patients in perioperative period to find out which test has better correlation with clinical status, to compare therapeutic strategies and time necessary for gain both of tests and to compare the difference in blood loss and blood products consumption in group treated by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion is expected to be found in ROTEM group, representing lowering risk for the patient, all due to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.

Pediatric patients who underwent spine surgery (under 18 years old) will be recruited in our study.

Retrospective data will be analysed from these patient who underwent scoliosis surgery before ROTEM implementation to daily practice and after ROTEM implementation do daily practice in our department.

Time to available results of ROTEM versus aPTT/PT tests will be compared. Blood loss and blood products used in these both groups will be analysed and compared between 2 groups.

Eligibility Criteria:
Inclusion Criteria:

• pediatric patients after surgical correction of scoliosis

Exclusion Criteria:

• patients older than 18 years