cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003

The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma

The primary endpoint is best overall response rate within 20 weeks after registration

The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.

The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Cancer confirmed by histology or cytology
* At least one measurable lesion
* Advanced disease refractory to standard therapy or for which no standard therapy exists
* Life expectancy of at least 3 months

Exclusion Criteria:

* Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma
* Body weight below 45 kg
* Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
* Confirmed diagnosis of HIV
* Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II
* Chemotherapy or radiotherapy less than 4 weeks prior to entry
* Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
* Participation in a clinical trial less than 30 days prior to entry into study
Stress Reactivity Study in Adolescents

The goal of this study was to examine the glucocorticoid and behavioral responses to a psychological stressor in obese African-American and non-Latino white adolescents. Participants were exposed to the Trier Social Stress Test (TSST) and a control condition on separate days. Immediately following each condition, participants were provided with snacks to eat at their leisure. Reactivity was assessed via salivary cortisol and alpha-amylase area under the curve (AUC), and adolescents were categorized as high or low reactors.

In the United States, pediatric obesity has more than tripled in the last 30 years, particularly among certain racial/ethnic groups including African-Americans. This disparity is partially attributable to greater exposure to psychological stress reported in this group (relative to non-Latino whites). Chronic psychological stress leads to weight gain directly through prolonged exposure to biological stress mediators such as cortisol and indirectly through behavioral pathways involving cortisol-induced increases in food consumption. An exciting arena of scientific advancements is focusing on identifying the specific pathways through which chronic stress influences eating behavior with emerging evidence to suggest that food intake, which is commonly increased during periods of stress, may serve as one key mechanism linking stress and obesity, particularly in African-American youth who are disproportionately exposed to chronic stress and have greater access to, and consumption of, energy-dense palatable foods. It is critical to advance understanding of the interplay between stress and food intake in understanding racial/ethnic disparities in pediatric obesity because stress eating represents a modifiable health behavior. That is, increased food intake during periods of elevated stress can be targeted for intervention in ways that may ameliorate the deleterious effects of stress on obesity risk. This project investigated the role of stress eating as a pathway linking chronic stress and obesity in African-American and non-Latino white adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese adolescents ages 14- 19 years

Exclusion Criteria:

* Currently pregnant
* Had been enrolled in a weight loss program in the last 6 months
* Were current smokers (e.g., tobacco, marijuana, vaping)
* Were diagnosed with a mental health condition (e.g, depression)
* Were diagnosed with a chronic condition known to affect weight, appetite, blood glucose or insulin levels (e.g., diabetes)
* Were taking medications known to affect metabolic processes (e.g., growth hormone, ritalin, metformin, etc)
* Had food allergies, intolerances, or other dietary restrictions
Pompe Disease Registry Protocol

The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes.

The objectives of the Registry are:

* To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
* To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
* To characterize the Pompe disease population.
* To evaluate the long-term effectiveness of alglucosidase alfa.

Study Design Time Perspective: Retrospective and Prospective

Eligibility Criteria:
Inclusion Criteria:

All patients with a confirmed diagnosis of Pompe disease who have signed the informed consent and authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as documented GAA enzyme deficiency from blood, skin, or muscle tissue and/or documentation of 2 GAA gene mutations.

Exclusion Criteria:

There are no exclusion criteria in this Registry
Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

The primary aim of this study is to investigate the effect of 5-fluorouracil, imiquimod, and melatonin for actinic keratosis on immunological gene, and protein expressions profiles. Secondarily, the aim is to assess the effect of the treatment on the histopathology of actinic keratoses.


Eligibility Criteria:
Inclusion Criteria:

* Participants should have a clinical diagnosis of actinic keratosis
* Participants should be 18 years old or above
* Participants must sign an informed consent

Exclusion Criteria:

* Known allergic reaction to either 5-fluorouracil , imiquimod, or melatonin
* Immunomodulating treatment
* Predictable poor compliance (due to i.e. dementia, substance abuse, psychiatric disease, life-threatening disease or language barriers)
* Pregnant or breastfeeding
* Females not in menopause (defined as no menstruation during the last 12 months) should use a secure birth control (intrauterine devices, hormonal contraceptives including - oral pills, patches, vaginal rings and injections) during the entire period of the trial
Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate

This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study. Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and have urine collected over 72 hours following administration of risedronate for all 4 treatment periods).


Eligibility Criteria:
Inclusion Criteria:

* Females 40 - 70 years at time of first dose
* BMI less than or equal to 32 kg/square meter
* Non-lactating and either surgically sterile or postmenopausal

Exclusion Criteria:

* Clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
* Had a major surgical operation requiring inpatient hospitalization within 1 month prior to screening or plans to have a major surgical operation during the course of the study
* A history of cancer within the past 5 years, except for basal cell carcinoma with documentation of a 6-month remission at screening. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded, provided there is documentation of a 12-month remission
* Any disease or surgery known to alter normal gastrointestinal structure or function
* A history of gastrointestinal disease (peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, irritable bowel syndrome, or moderate to severe gastro-esophageal reflux disease that requires prescription or frequent \[\> 3 times/week\] nonprescription medicinal intervention \[eg, antacids\])
* A history of gastrointestinal surgery, with the exception of appendectomy and hernia repair that did not require bowel resection (subjects who have undergone appendectomy or hernia repair within the 12 months prior to screening will be excluded from the study)
* Acute gastritis, diarrhea or constipation within the 14-day period prior to the predicted first dosing day. If screening occurs \>14 days before the first dosing day, subjects will be re-evaluated for eligibility at admission. Diarrhea will be defined as the passage of liquid feces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as having less than 3 bowel movements per week or as having fewer bowel movements than is usual for the subject

Exclusion at Admission:

* Any significant change from screening which in the investigator's opinion would impact safety of subject or interfere with the evaluation of the study drug.
* Had any acute illness within the past 2 weeks.
* Consumed alcohol, grapefruit or grapefruit juice, orange juice, chocolate, or caffeine within 72 hours of dosing.
* Used a bisphosphonate since screening.
* Reported exposure to any known enzyme inducer or inhibitor, transport induceror inhibitor or nonmedical enzyme-inducers such as paint solvents or pesticides since screening.
* A positive pregnancy test.
Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* 18 years of age and over
* A minimum of 20 stable intra occlusal contacts after planned restoration
* In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25

Exclusion Criteria:

* Untreated rampant caries and uncontrolled periodontal disease
* Use of smoking tobacco at time of inclusion
* History of pre-surgical bone augmentation, within 4 months, in the planned implant area
* History of extraction without augmentation, within 3 months in the planned implant area
* Absence of opposing dentition
* Absence of adjacent (mesial and/or distal) natural tooth
* Uncontrolled diabetes
* Known pregnancy at time of inclusion
* Present alcohol or drug abuse
* Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Unable or unwilling to return for follow-up visits for a period of 5 years
* Unrealistic esthetical demands
* Unlikely to be able to comply with study procedures according to Investigators judgment
* Already included in this study
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.

InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the result of a unique fatty acid composition on the glycerol backbone, which ensures high level of palmitic acid at the middle (sn-2) position.

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters, anthropometric parameters and stool characteristics in formula fed term infants.

Eligibility Criteria:
Inclusion Criteria:

1. Parental/ legal guardian written inform consent
2. The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
3. Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
4. Birth weight appropriate for gestational age (AGA).
5. The infant is apparently healthy at birth and entry to study.
6. Apgar after 5 minutes \>7
7. Enrolled within their first 7 days of life
8. The infant is a product of normal pregnancy and delivery, including C-section.
9. Parental ability to attend visits and interviews and willing to fill questionnaires.

Exclusion Criteria:

1. Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant or according to PI discretion may interfere with study results.
2. The infant suffers from a major congenital abnormality, a disease or chromosomal disorder with a clinical significance that can be detected at or around birth.
3. The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
4. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
5. The infant or mother was treated with antibiotics around birth.
Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have msDBP ≥ 90 mmHg and \< 110 mmHg at the visit immediately prior to Visit 3
* Patients must have msDBP \>OR= 95 mmHg and \< 110 mmHg at Visit 3
* Patients must have an absolute difference of \< or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

* Severe hypertension (grade 3 WHO classification; msDBP \>or= 110 mmHg and/or msSBP \>or = 180 mmHg).
* History or evidence of a secondary form of hypertension.
* History of transient ischemic cerebral attack within 12 months of visit 1.
* Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
* Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8% at Visit 1.
* Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.
LH/HCG Receptor Expression and Retrieval Rates

The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG administration or the day of oocyte retrieval and the retrieval rates at oocyte pick up

The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG or the day of oocyte retrieval and the retrieval rates at oocyte pick up.

For this purpose, m-RNA copy numbers will be assessed in the blood serum of patients undergoing ovarian stimulation for IVF on different days.

Furthermore, detailed ultrasound scans will be perfomed, as well as assesment of hormonal levels during ovarian stimulation.

Eligibility Criteria:
Inclusion criteria:

* Age \<39 years,
* Body mass index (BMI) between 18 and 29 kg/m2,
* Presence of both ovaries,
* FSH levels \<10 IU/l.

Exclusion criteria:

* Endometriomas,
* Polycystic ovarian syndrome.
Exploring the Psycho-traumatic Impact of a Violent Act Commited at the Bordeaux-Gradignan Penitentiary Center

The study will seek to explore the possibility of developing post-traumatic stress disorder following a violent offense commited, among the population of prisoners of the Bordeaux-Gradignan penitentiary center.

The overrepresentation of psychiatric disorders among prisoners has been the subject of numerous studies and the significant increase in the number of prisoners over the past 3 decades, make research in prisons a major public health issue.

Recent studies have been able to highlight an over-representation of post-traumatic stress disorder in the prison population. Leading to questionning the factors that could explain the overrepresentation of this disorder in prison with various hypotheses raised. Among these hypotheses, the possibility of developing post-traumatic stress disorder following a violent offense commited has been proposed.

The study will thus seek to explore the development of a Post-traumatic Stress Disorder following a violent act committed using the PCL-5 questionnaire

Study design :Observational, descriptive, monocentric study with completion of an anonymous self-questionnaire.

Participation in the study is voluntary and anonymous with signature of a non-opposition form.

Expected outcomes : better knowledge of this disorder in detention and a hypothesis to explain its overrepresentation. Earlier detection of this pathology in prison could thus be considered, in particular by improving the identification of people at risk according to the presence of contributing factors. More specific support and improved access to care for inmates could be considered, allowing early treatment and thus avoiding progression to other co-morbidities or risk of recidivism.

Eligibility Criteria:
Inclusion Criteria

* Aged over 18
* Have as a reason for imprisonment one of the following: Homicide and willful violence resulting in death, Rape or sexual assault, Violence and other personal injury.
* Having signed and duly completed the Non-Objection form for participation in the study
* Mastery of the French language
Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

This is an enhanced safety surveillance study that will occur within the military Service Member population.

Primary Objective:

* To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.

Secondary Objectives:

* To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
* To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.

The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.

Eligibility Criteria:
Inclusion Criteria :

* Male and female military personnel \>= 17 years of age.
* Have received the ACAM2000® smallpox vaccine.

Exclusion Criteria :

* Not applicable.
A User Study With Vernivia® for Bacterial Vaginosis.

This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material.

The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 - 49 years Informed consent to take part in the study Bacterial vaginosis (based on self-assessment or diagnosed by a doctor or midwife) Access to a smartphone

Exclusion Criteria:

* Symptoms of vaginal candida infection and/or Pregnancy
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)

A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis

Exclusion Criteria:

* Person has had a previous fracture
* Person has rheumatoid arthritis. Person has has certain types of cancer
* Person has donated blood or has been in another investigational study within the last 4 weeks
Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal Hysterectomy

The investigators aimed to assess if use of aromatase inhibitors could decrease volume of uterine leiomyoma and cause same percentage of adverse effects during its use compared to GnRH analogs.

Uterine leiomyoma is the most prevalent benign gynecologic tumor in women. Standard treatment is surgical (hysterectomy or myomectomy), and depends of many variables. If these tumors are large, preoperative assessment with clinical treatment may be useful in order to decrease its volume, improve hematologic patterns and modify surgical approach (vaginal or abdominal). It is well know that GnRH analogs can cause these goals; however, aromatase inhibitors are new promising drugs which are being used for reducing uterine leiomyoma's volume and few observational studies have shown this fact. The investigators are aiming to compare both treatments in a randomized controlled trial and see if it both treatments are similar or not in decreasing uterine leiomyoma's volume, influencing operative time, blood loss during surgery.

Eligibility Criteria:
Inclusion Criteria:

* WOMEN OVER 40 YEARS, UTERINE VOLUME HIGHER THAN 300 ML, MINIMAL ANATOMIC CONDITIONS FOR VAGINAL SURGERY

Exclusion Criteria:

* ACTIVE GYNECOLOGIC MALIGNANCY
Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)

The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.

This is a prospective, randomized, crossover trial. Patients will be randomized 1:1 to undergo two full night sleep studies with the Transcend Auto and a commercially available device.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years of age or older
* Diagnosis of obstructive sleep apnea
* Presently using CPAP or APAP therapy

Exclusion Criteria:

* Central or mixed apnea