cyrilzakka/clinical-trials huggingface dataset:
Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.

Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.

In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"

Eligibility Criteria:
Inclusion Criteria:

Patients should fulfill the "Bologna criteria" for poor ovarian response

At least two of the following three features must be present:

i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \<7 follicles or AMH \<1.1 ng/ml).

Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).

Exclusion Criteria:

-
Combination Tissue Plasminogen Activator (Tpa) and Dornase Alfa (Dnase) Administration Through Intrapleural Catheters for the Treatment of Loculated or Non-Draining Malignant Pleural Effusions

The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tPA administered to patients with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical failure of small-bore chest tube with persistent pleural effusion
2. 18 years of age or older
3. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
4. Life expectancy ≥ 6 weeks
5. Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.0 g/dL
6. Serum creatinine ≤2.0 times the upper limit of the normal range, total bilirubin ≤ 2.5 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
7. At least 2 days from administration of chemotherapy
8. At least 7 days from prior major surgery
9. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
10. Patient judged to be 'medically stable' by primary investigator.

Exclusion Criteria:

1. Prior treatment with intrapleural fibrinolytic agents
2. Presence of any intracranial mass
3. Traumatic hemorrhagic pleural effusion
4. Major hemorrhage, coincidental stroke, or major trauma
5. High-risk for systemic bleeding
6. Allergy or intolerance to dornase alfa
7. Active clinically serious infection \> CTCAE (version 4.03) Grade 2.
8. Serious non-healing wound, ulcer, or bone fracture.
9. Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
10. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
11. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
12. Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation in this study)
13. Expected survival less than six weeks
OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Registered male or female primary double lung transplant candidate
* Age ≥18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion Criteria:

* Prior solid organ or bone marrow transplant
* Single lung recipient
* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine

The purpose of this study is to investigate if B vitamin substitution have effect on NFL (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected individuals with increased plasma homocysteine


Eligibility Criteria:
Inclusion Criteria:

1. The ability to understand and give informed consent to participate.
2. HIV-1 infected with stable ART \> 12 months
3. Plasma HIV-RNA \< 50 copies/ml
4. Plasma homocysteine ≥ 12 μmol/L (subjects with \< 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4).
5. Male or female, age 18 or older.

Exclusion Criteria:

1. Treatment with trimethoprim-sulfamethoxazole or methotrexate
2. Ongoing B6, B12 or folate substitution
3. Antiepileptic treatment
4. Small bowel or ventricular resection
5. Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease)
6. Ongoing neurological disease or severe psychiatric disease
7. Any malignant tumor in the history.
8. Severe ongoing infection or opportunistic infection
9. AUDIT \> 7 for men and \> 5 for women
10. MADRS \> 20
11. Significant B12 or folate deficiency that indicate substitution (all subjects will be offered adequate substitution, they will be included in the analysis of secondary endpoint 3 (see 5.4)).
12. Pregnancy at screening visit, or planning pregnancy during study period is an exclusion criteria. (Not due to toxicity of Triobe, but to elevated risk of being prescribed B-vitamins outside of trial. If study object gets pregnant during study, she can continue the study but must be excluded if she starts treatment with other B-vitamin treatment than Triobe.)
Epigenetic Regulation of BDNF in Major Depression

The investigators will (1) detect the associations between brain-derived neurotrophic factor (BDNF) DNA methylation, histone modification, depressive symptoms, suicidal behavior and antidepressant responses in major depressive disorder (MDD) patients, (2) check the correlation between blood BDNF protein and RNA and BDNF rs6265 gene, and (3) discuss the possible mechanisms of epigenetic regulation of BDNF in Taiwanese major depressive patients.

Brain-derived neurotrophic factor (BDNF) had been chosen as a candidate gene for a development of major depressive disorder (MDD). BDNF had been reported to have an important role on neuronal plasticity, axonal growth and connectivity, and participating in the local response to various types of neuronal stressors. BDNF also influences the differentiation of neurons.

In the past studies, the investigators had found that major depressive women had lower serum BDNF protein levels than healthy controls, and their BDNF levels became significantly increased after antidepressant treatments. In addition, some authors had found that reduced expression of BDNF was noted in postmortem brain of completed suicide subjects. Suicidal major depressive patients also had lower plasma BDNF levels than non-suicidal major depressive patients. These findings suggested that BDNF might play an important role in the suicidal behavior.

However, in past studies, the results did not fully explain why major depressive patients with same genotypes had different clinical expression, including the severity of depression, with/without suicide, and the treatment response. Recently, some papers found that there were relationships between epigenetic regulation, including DNA methylation and histone modification, and psychopathology of major depression. Therefore, we try to investigate the relationships between epigenetic regulation of BDNF and major depression.

Eligibility Criteria:
Inclusion Criteria:

The clinical screening and assessment in patients with major depression：

1. 40 major depression will be recruited in psychiatric inpatients according to DSM-IV criteria by a semi-structured interview. The assessment will be done by two senior psychiatrists. The intra-rater and inter-rater reliability will be done before this project started.
2. The patients had the ability to complete the written inform consent.
3. The choice of antidepressant drugs depended on the need of patients in natural treatment procedure. They included selective serotonin reuptake inhibitors (SSRI), eg. fluoxetine or paroxetine.
4. The 17-item Hamilton Depression Rating Scale (HAM-D) was used to assess severity of depression. The minimum baseline score of the 17-item HAM-D was 18.

Exclusion Criteria:

1. The patients had systemic diseases, including metabolic, heart, and liver diseases。
2. The patients had received any drugs before entering this protocol.
3. The patients were heavy smokers or dependent on alcohol.
4. The use of secondary generation anti-psychotic drugs and mood stabilizers.
Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China

In the study, the composition and content of human milk oligosaccharides in premature delivery mothers in China will be examined to investigate the differences in oligosaccharide concentrations in preterm breast milk from different gestational weeks. This study will fill a gap in human milk research in China, provide theoretical basis for the superiority of breastfeeding, and provide more powerful nutritional support for the catch-up growth of preterm infants

Objective:

1. Analyze and compare the differences in HMOs components among mothers who give birth at different gestational weeks;
2. Longitudinal observation of weekly changes in HMOs concentrations of premature mothers within 1 month of delivery;
3. Validate the association between HMOs components in preterm mothers and fecal intestinal flora in infants at 6 months of age.

Research content

1. The LC-MS method will be used to detect the content of HMOs in preterm mothers and compared with the corresponding components in term breast milk during the postpartum period to analyze the effects of different gestational weeks on HMOs;
2. The intestinal flora 16S rDNA high-throughput sequencing method will be used to determine the bacterial gene profile in the fecal DNA samples of infants, and the differences between the gestational age groups (term and preterm infants) were compared, and the preterm infants in this group were plotted Evolution of intestinal flora within 6 months of birth;
3. Use statistical methods to verify the association between HMOs components in preterm mothers and the establishment of intestinal flora in infants.

Eligibility Criteria:
Inclusion Criteria:

* (1) Be healthy, have no acute or chronic diseases, have no severe complications during pregnancy
* (2) Breastfeeding for more than 6 months and Volunteer to participate in this study (signed informed consent)
* (3) Age of maternal women: 20\~35years
* (4) Breast milk is sufficient, and the amount of milk secreted each time is more than 30ml
* (5) No fatal, important organ system deformities and metabolic defects in neonates

Exclusion Criteria:

* (1) for infants: Rescued to death or hospitalized due to critical illness during the study period
* (2)for lactating mothers: exposure to tobacco and alcohol during lactation, severe postpartum depression and other mental and psychological diseases, obesity (BMI\> 28), use of antibiotics or antimetabolites, mastitis with fever within 7 days before specimen collection (T\> 38.5 ℃),Suspension or termination of breastfeeding in the state of maternal and infant illness
Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.


Eligibility Criteria:
Inclusion criteria:

* Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation

Exclusion criteria:

* Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria may apply
Impact of Medical Education of Physician Action 2

This is a retrospective and prospective designed study, included hospitals are 1:1 assigned into two groups: ①Interventional hospital, which will receive 3-month medical education; ②Non-interventional hospital, which will not receive 3-month medical education. During 1 month before education, all the electronic records of outpatients and inpatients who visit the included rheumatologists will be collected and the data of test and evaluation results of spondyloarthritis (SpA) patients diagnosed according to new Assessment of Spondylo-Arthritis International Society (ASAS) criteria will be collected from outpatient electronic records and inpatients medical charts; in the 3 months after education, the same data will be collected and compared with the data before education, and the impact of medical education on physician behaviour will be analyzed. Meanwhile, the understanding and acceptance level will be evaluated by the questionnaire, the differences before and after education and the impact of education on physician cognition will be evaluated.


Eligibility Criteria:
Interventional hospital will be selected based on following criteria:

1. having complete outpatients and inpatients electronic records;
2. more than 50% of registrars and/or consultants in the department participated the professional education event;
3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;
4. except for rheumatic diseases have been clearly diagnosed.

Non-interventional hospital will be selected based on following criteria:

1. having complete outpatients and inpatients electronic records;
2. no professional education event covered;
3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection;
4. except for rheumatic diseases have been clearly diagnosed.
Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer

A phase II, multicenter, open-label, single-arm study to evaluate the efficacy, safety and pharmacokinetics of SC10914 in subjects with gBRCA1/2 mutated advanced ovarian cancer in china.

A total of 104 subjects with gBRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety and PK profile of SC10914.

The subjects oral administration SC10914 tablets 400mg on an empty stomach, three times a day, for 28 consecutive days as a treatment cycle, until disease progression (PD) or the toxicity was intolerable. PK blood samples are planned to be collected for each enrolled subject on C1D28 visit.

Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent voluntarily;
2. ≥18 years old;
3. Histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma);
4. gBRCA1/2 mutation positive;
5. Had recived at least 2 prior lines of chemotherapy;
6. Platinum sensitive patients;
7. The last line of therapy befor enrollment failed；
8. ECOG≤2；

8. Had at least one measurable lesion.

Exclusion Criteria:

1. Any previous treatment with PARP inhibitor;
2. Symptomatic brain metastases;
3. Large amount of fluid in the third gap；
4. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<100g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases) Cr \>1.5×ULN
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.


Eligibility Criteria:
Inclusion Criteria:

* Successfully completed Study 191622-099

Exclusion Criteria:

* Known immunization or hypersensitivity to botulinum toxin of any serotype
* Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Anticipated need for surgery or hospitalization during the study
Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines

This study will evaluate the safety and efficacy of two different types of botulinum toxin type A for the treatment of glabellar frown lines.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe glabellar frown lines

Exclusion Criteria:

* Diagnosis of myasthenia gravis or Eaton Lambert syndrome
* Aesthetic treatment with botulinum toxin within 6 months or planned treatment with botulinum toxin for any reason during the study
* Prior filler treatments, surgeries, insertion procedures in/to the glabellar region
* Facial cosmetic procedures in the glabellar area within 6 months
* Bleeding disorders or use of anticoagulants within 10 days
* History of facial nerve palsy
Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus

Single center, open label crossover study with 2 treatment phases in healthy volunteers.

The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age over 18 years
* Written informed consent

Exclusion Criteria:

* Female
* Medical comorbidities
* Use of concomitant medication
Intervention Study for Smoking Cessation in Spanish College Students

This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking.

This study hipotetize that a multicomponent intervention, tailored to college student and conducted by a nurse is more effective than brief advise.

The intervention was a multi-component intervention based on the Theory of Triadic Influence and on previous recommendations made in the Surgeon General's report . The strategies of this program consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The smoking-related Self-efficacy, Belief and Intention scale was used to assess outcomes.

Eligibility Criteria:
Inclusion Criteria

- Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months

Exclusion Criteria

- Students who are ex-smokers