cyrilzakka/clinical-trials huggingface dataset:
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.

This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and target patient population and Part 2 will be expansion of the dose and patient population selected in Part 1. For eligible patients, there will be an optional extension dosing following the completion of Part 1 or Part 2 of the trial.

Obtaining of informed consent and screening may be performed up to 28 days prior to enrollment. Each patient will be able to receive his specified regimen for 3 consecutive cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit assessments will be used to determine outcome and dosing may continue up to an additional 2 weeks until the results of all assessments are obtained. Eligible patients may continue treatment in an optional extension period following the completion of the primary parts of this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the prostate
2. Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
3. Demonstration of progression while on androgen blockade
4. Eastern Cooperative Oncology Group (ECOG) Performance Status \<2

Exclusion Criteria:

1. Depending upon patient prior treatment the following apply:

   * Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole\*, enzalutamide, or galeterone) - Treatment naïve only
   * Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole\*) or AR antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory only
   * Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole\*) or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only
2. Prior chemotherapy (unless allowed for some study arms)
3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
4. Prior use of any chronic systemic glucocorticoids .
5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
6. Prior treatment with Alpharadin® (Xofigo®)
7. Treatment with anti arrhythmia therapy for ventricular arrhythmia \< 4 weeks prior to enrollment
8. Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) \< 4 weeks prior to enrollment
9. Severe systemic diseases or active uncontrolled illnesses.
10. Abnormal heart function
11. Liver metastases
12. Brain metastases (unless stable disease \>3 mos. by scan without additional CNS-directed therapy)
13. The patient has known allergy to any of the treatment components
14. Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial procedures
15. History of excessive alcohol consumption
16. Use of any substance known to cause AME
Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures

The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥16 years. Subjects under 18 years may only be included where legally permitted and ethically accepted
* Subjects in the neurological intensive care unit (NICU) (or equivalent closely monitored environment) having brain insult including traumatic brain injury and having nonconvulsive electrographic seizures (NCES) confirmed by electroencephalogram (EEG), lasting a minimum of 10 seconds but not \>30 minutes (minimum of 1 seizure in the last 6 hours) and treatment with an antiepileptic drug (AED) is required according to the physician's clinical judgment
* Subject is expected to be under cEEG monitoring with video surveillance in the Neuro ICU for at least 36 hours from the first administration of study drug

Exclusion Criteria:

* Subject has history of severe adverse hematologic or cutaneous reaction to any drug
* Subject presenting with status epilepticus or nonconvulsive status epilepticus (NCSE) (ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting \>30 minutes during Visit 1)
* Subject has been diagnosed with anoxic brain injury
* Subject has a known history of status epilepticus during the 6 months preceding Visit 1
* Subject is currently treated with Levetiracetam (LEV) or Phenytoin (PHT) or has been treated within the last 30 days before Visit 1 with LEV or PHT
* Subject is on felbamate with \<18 months' exposure before Visit 1
* Subject has presence of any sign (clinical or imaging techniques) suggesting a rapidly progressing process such that the subject is not expected to survive \>48 hours
* Subject has any clinical condition that would impair reliable participation in the study or necessitate the use of medications not allowed by the protocol
Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction

Hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,Some studies have shown that hypofractionated radiotherapy had similar toxicities to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Results from a phase III randomized controlled study in China showed that Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare. Literatures report that reconstruction failure is a well-known complication of radiation therapy in breast cancer patients with reconstruction. Results may vary based on RT timing and technique. Some studies have shown that hypofractionated radiotherapy had similar reconstruction failure to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of stage I-IIIc invasive breast cancer (ductal, lobular, mammary, medullary, or ductal)

  ≤ T3 or N+
* negative surgery margins
* positive postoperative pathologic axillary lymph nodes after neoadjuvant chemotherapy (ypN+).
* Undergo mastectomy+expander+RT（hypofractionated radiotherapy）+delayed prosthesis reconstruction
* Sign the informed consent form

Exclusion Criteria:

* T4,
* axillary sentinel lymph node biopsy without axillary dissection
* Recurrent breast cancer or history of prior breast radiation therapy (neck, chest wall, axilla)
* Uncontrollable co-morbidities, including but not limited to active collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis), persistent or active infection, symptomatic congestive heart failure, unstable angina, mental illness incapacitating participation in this study
* Pregnancy or breastfeeding
* History of malignancy other than the following： (At least 5 years of tumor free survival with a very low risk of recurrence, e.g., carcinoma in situ of the cervix and basal cell or squamous cell carcinoma of the skin）
* requiring bilateral breast/chest wall radiation therapy
Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips

The goal of this clinical trial is to compare the efficacy of two different daily doses of tetrahydrocannabivarin impregnated mouth strips in healthy non-diabetic obese adults. The main questions to answer are:

* Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
* Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
* Is one dose better than the other dose?

Participants will take either the low dose, high dose or placebo dose daily for ninety days and have physical measurements and blood tests obtained at the beginning and the end of the study.

Fifty-six adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease will be selected for this study. Social media outreach and advertising will be used to identify potential subjects. Prior to starting the study, all subjects will undergo an entrance examination by a blinded independent physician to confirm that they did not have diabetes, active cardiovascular disease, or other confounding health conditions. Initial and final biometric measurements will be taken to include blood pressure, blood oxygen, temperature, height, weight, and abdominal girth. Due to the natural fluctuations in weight, abdominal girth and blood pressure that tend to occur throughout the menstrual cycle, those study participants with active menstrual periods will be scheduled to have their ending biometrics taken during the same phase of their menstrual cycle as when they had their initial biometrics taken, approximately 90 days later. Fasting bloodwork will include a lipid profile, blood sugar, HgbA1c, liver and kidney function studies. LabCorp Inc. will be used for all blood testing.

Each subject will assigned at random to one of three groups: Group A (single dose group), Group B (double dose group,) and Group P (placebo/control group). Subjects will be provided with a 90-day supply of their respective dose (based on group assignment), and instructed to take their assigned dose by mouth, once per day in the morning on an empty stomach. All subjects will be asked to agreed from the outset to refrain from the use of cannabis, CBD, or other hemp-related products throughout the duration of the study. Subjects will be advised to make no changes in their diet or exercise routines.

Each subject will be sent a daily reminder via text message when it was time to take their dose, and was asked to reply with confirmation once they had taken their dose. Additionally, they will be invited to provide feedback on any adverse effects or questions.

Eligibility Criteria:
Inclusion Criteria:

Adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease were selected for this study.

Exclusion Criteria:

Under age 18 BMI less than 30 presence of diabetes or cardiovascular disease.
Investigation From Biopsychosocial Perspective of Patients With Rheumatic Disease With Covid-19 Who Participated in a Biopsychosocial Exercise Program: A Case Series With 6-Month Follow-up

Objective: This novel study aimed to interrogate from a biopsychosocial perspective the health conditions during the Covid-19 infection and long-Covid periods of 5 patients with rheumatic disease infected with Covid-19 who had acquired the habit of regular exercise before the pandemic.

Method: This case study included five patients suffering from Covid-19 infection among patients with rheumatic disease who had acquired the habit of regular exercise before the Covid-19 pandemic. It was applied a questionnaire to the patients from a biopsychosocial perspective to see the short and long-term effects of Covid-19 during and after quarantine. Moreover, the study used the BETY-Biopsychosocical Questionnaire (BETY-BQ) to evaluate a biopsychosocial point, Health Assessment Questionnaire (HAQ) to measure functional status, and the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression.

Results: In BETY-BQ, HAQ, and HADS, there was an unfavorable increase in overall scores of all patients during Covid-19. After six months, although the results from these three scales improved, some of the patients could not return to their pre-covid state.

Conclusions: The patients participating in the telerehabilitation were able to return to everyday life after Covid more efficiently and overcome post-Covid symptoms easily. This study is important in guiding the exercise approach for patients with rheumatic diseases in pandemics such as Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the rheumatic disease passed for at least six months after their Covid-19 infection between the ages of 18-65 were included in the study.

Exclusion Criteria:

* Exclusion criteria were the presence of deformity that does not allow exercise, cardiopulmonary disorders, uncontrolled endocrine system diseases, severe psychiatric illnesses, and insufficient skills in using a smartphone.
Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck

Primary Objective:

To evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Secondary Objective:

To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

The treatment duration for each patient will be around six months. Patients included in the study will be treated with induction regimen followed by chemo radiotherapy. Within the induction period there are three cycles (Docetaxel + Cisplatin) every 21 days, with follow-up post-induction at day 21 after cycle three. This is followed by chemoradiotherapy consisting of radiotherapy for six weeks and cisplatin every week for four weeks. The post-consolidation follow up is at eight weeks after end of chemoradiotherapy.

Eligibility Criteria:
Inclusion criteria :

* Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases.
* No prior chemotherapy or radiation therapy.
* Having at least one measurable lesion in one dimension.
* Age ≥18 and \<65 years with Eastern Cooperative Oncology Group ≤ 1.
* Adequate organ function:
* Adequate hematological function
* Adequate hepatic function
* Renal function within normal limits

Exclusion criteria:

* Peripheral neuropathy \> grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer).
* Being treated concomitantly with corticosteroids (except as pre-medication).
* Patients having another type of cancer.
* Previous chemotherapy or radiotherapy.
* Any previous definitive surgery for squamous cell carcinoma of head and neck.
* Severe weight loss (\> 20 % of body weight) in the preceding 3 months.
* Hearing loss (\> grade 2).
* Pregnancy (pregnancy test result for women of childbearing potential).
* Sexually active females with lack of adequate contraception.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A First in Human Study of STT-5058, an Antibody That Binds ApoC3

A First in Human Study of STT-5058, an Antibody That Binds ApoC3, investigating single and multiple ascending intravenous doses and ascending subcutaneous doses of STT-5058 in otherwise healthy volunteers with elevated triglyceride levels

The study is in five parts. Part A is up to 6 single ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs \>150mg/dL. Part B is up to 4 multiple ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs \>150mg/dL who will receive 3 doses at 2 week intervals. Part C will recruit a single cohort of patient volunteers with TRG \>200mg/dL who will receive 3 doses at 2 week intervals of STT-5058. Part D will investigate up to 2 single ascending doses of subcutaneous STT-5058. Part E will recruit a single cohort of otherwise healthy volunteers with TRG \> 150mg/dL to receive 4 doses subcutaneously of STT-5058 over 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* in good health
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception Parts A, B and D
* BMI between 18 and 35 kg/m2 inclusive
* Fasting Triglycerides between 150 and 400mg/dL inclusive Part C
* Fasting Triglycerides between 200 and 400 mg/dL inclusive
* Fasting LDL-C between 70 and 160 mg/dL inclusive
* BMI between 18 and 40 kg/m2

Exclusion Criteria:

* significant history or clinical manifestation of metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator
* Confirmed (eg, 2 consecutive measurements) systolic blood pressure \>150 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, and heart rate \>90 or \<40 beats per minute at Screening, Check-in, or prior to dosing on Day 1.
* History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (if known), whichever is longer, prior to dosing.
Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients

In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down.

ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body.

The aim of this study is to determine whether it is possible to correct apoC1 function by improving glycaemic balance.

240 persons will be recruited in this study and allocated to one of two groups:

* 160 Type-1 diabetes patients with uncontrolled diabetes:

  * 4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later.
* 80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays.

  * 4 blood samples will be taken at the time of inclusion.


Eligibility Criteria:
Inclusion criteria for patients:

* Patients over 18 years
* Patients with type-1 diabetes and glycated hemoglobin (HbA1C) \>9%

Inclusion criteria controls:

* Subjects over 18 years
* Normal glycaemia (Fasting glycaemia \<1.10 g/L) and normal lipids (Low-density lipoproteins (LDL) \<1.6 g/L, triglycerides (TG) \<1.5 g/L)

Exclusion Criteria:

Exclusion criteria patients:

* Adults under guardianship
* Patients without national health insurance
* Pregnant or breast-feeding women
* Progressive cancer
* Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)

Exclusion criteria controls:

* Adults under guardianship
* Persons without national health insurance
* Pregnant or breast-feeding women
* known dyslipidemia and/or lipid-lowering treatment
* Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair

Patients with skin injury treated with Umbilical Cord Blood-derived Mesenchymal Stem Cells,such as deep burn damaged sweat glands,Effectiveness of Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair is determined.


Eligibility Criteria:
Inclusion Criteria:

* Burn area:10-20％TBSA

Exclusion Criteria:

* Have influence on the speed of wound healing of patients with chronic diseases
Lactation Fortification Study

To investigate the impact of nutrient supplementation during lactation on levels in breast milk.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

1. Mother with singleton birth, 37-42 weeks gestation and ≥ 2490g
2. Pre-pregnancy BMI \</= 30
3. Mother is ≥ 18 years of age
4. Mother is 4-6 weeks postpartum and has been successfully continuously lactating
5. Mother agrees to abstain from the use of any Docosahexaenoic acid (DHA), lutein and/or vitamin E containing supplements for at least 10 days prior to providing a baseline breast milk sample
6. Mother agrees to abstain from the use of non-study supplements throughout the study
7. Mother plans to continue breastfeeding for at least 6 weeks from the start of the study
8. No significant ongoing medical problems in the infant as determined from infant's medical history as related by the parent(s) to the enrolling center personnel

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. Subject had adverse maternal and/or fetal medical history
2. Subject is participating in a non-Abbott approved concomitant trial
3. Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport