cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia

The purpose of this study is to demonstrate the superiority of atorvastatin/perindopril fixed dose combination (FDC) S05167 as compared to atorvastatin reference drug alone or perindopril drug alone on systolic blood pressure decrease and LDL cholesterol decrease respectively in patients presenting with hypertension and dyslipidemia after 8 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women from 18 to 79 years old who can comply with the study requirements and timetable,
2. Patients diagnosed with Essential hypertension (as documented in patient's medical file). The diagnosis of hypertension should be based on at least two BP measurements on at least two visits.

   Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril) for combined systolic and diastolic hypertension (140 mmHg ≤ SBP \< 160 mmHg and 90 mmHg ≤ DBP \< 100 mmHg).

   or Hypertensive patients naïve of treatment with 150 mmHg ≤ SBP \<160 mmHg and 90 mmHg ≤ DBP \< 100 mmHg.
3. Dysplipidemic patients: naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 110 mg/ Decilitre (dL) (or 2.84 millimole \[mmol\] /L) ≤ LDL-c \< 190 mg/dL (or 4.91 mmol/L) according to a previous laboratory result within 12 months.

Exclusion Criteria:

1. Unlikely to cooperate in the study,
2. Pregnant and lactating women,

4. Participation in another study at the same time or having participated in another study within 3 months before selection participation in noninterventional registries or epidemiological studies is allowed,

6.Patients treated with \>1 anti-hypertensive drug or \>1 Lipid lowering drug,

7.Patients previously treated with atorvastatin and/or perindopril,

8.Known resistance to ACE inhibitors,

9.Patients treated with beta-blockers or alpha-blockers,

10. Patients with liver disease or renal impairment,

11.Certain known cardiovascular diseases or cardiac rhythm disorders,

12.Known or suspected symptomatic orthostatic hypotension,

13.Familial hypercholesterolemia,

14.Secondary hypertension or dyslipidemia,

15.Patients who are hypersensitive to atorvastatin, perindopril or to any of the excipients of study drugs,

16.Hypersensitivity to any other ACE inhibitor,

17.History of angioedema associated with previous ACE inhibitor therapy.
Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy

Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy was done and histopathological examinations were done to evaluate the pathology in these patients.

* Study design and settings: Cross sectional descriptive studies conducted from December 2017 till January 2021.
* Patients: 80 patients with supracervical hysterectomy recruited at Tanta University Hospital, gynecology clinics will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The exclusion criteria were patients with total hysterectomy, hysterectomies for malignant indications, and refusal to participate.
* Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint.

Intervention: under general anesthesia cervical biopsy (4 quadrants) were taken from all patients and was sent for histopathological examinations.

Eligibility Criteria:
Inclusion Criteria:

* all symptomatizing patients following supracervical hysterectomy,

Exclusion Criteria:

* with total hysterectomy,
* hysterectomies for malignant indications,
* refusal to participate.
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects

A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects.


Eligibility Criteria:
General Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male (Part A and B) and female subjects (Part B) aged between 18 and 55 years (inclusive) at Screening.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
* Male subjects with a partner who might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use a highly effective method of contraception.

Inclusion Criteria for Part B:

* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a highly effective method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner.
* Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.

General Exclusion Criteria:

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.

Exclusion Criteria for the absorption,distribution, metabolism and excretion (ADME) evaluation:

* Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 milli sievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed workers, as defined in the relevant Ionising Radiation Regulations, must not participate in the study.
* Participation in any study involving administration of any Carbon-14 (14C) radiolabeled compound within the 12 months prior to Screening.

Exclusion Criteria for Part B:

* Pregnant or lactating women.
Teaching Improved Communication To Adolescents and Clinicians

The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention aimed at improving how adolescent patients and their clinicians communicate about behavior change.

The investigators propose a randomized pilot trial across two health systems, Duke University and University of Michigan to evaluate the effect of Feedback Guides on clinician-adolescent communication about high-risk behaviors.

* The investigators consent clinicians prior to any patient recruitment.
* When a patient aged 12-21 years arrives for an annual visit and is a patient of a consented clinician, the front desk staff will provide the teen with an iPad tablet.
* As part of standard clinical care, all teens will complete the Rapid Assessment for Adolescent Preventive Services (RAAPS) questionnaire on the tablet privately (either in waiting room or in clinic room while waiting for the provider).
* The patient and parent will then review a study explanation and informed consent on the tablet and sign electronically if they agree to participate. The study clinician will review the informed consent with the patient and answer any questions.
* Participating teens will then complete a brief baseline survey and those randomized to the intervention arm will print the visit conversation guides using a wireless study printer connected to the tablet. The guides will print in a designated nursing area and clinic staff will add the printed guides to visit-related paperwork for the patient and clinician to use during the visit.
* The teen patient audio records the encounter on the tablet.
* The patient completes post-visit patient survey on tablet.
* The clinician completes a post-visit survey on paper.
* The patient returns tablet to clinic staff.
* The iPad will be connected to a study workstation, where the iTunes application will be used to transfer the audio file from the Voice Memos app to the workstation and then to it's final destination on the file server. Once the transfer has been confirmed, using iTunes, the audio file will be deleted from both the iPad and the workstation, including any residual versions of the audio file.
* Three months after the encounter, staff will provide participating patients a link to a REDCap survey (not the survey itself). The link will be sent using the preferred method selected by the patient through a question in the baseline survey - email or short message service (SMS). To protect the confidentiality of the responses, we will also provide the participant a code to access the REDCap follow-up survey. This will prevent others from accessing the survey results.

Eligibility Criteria:
Inclusion Criteria:

* All English-speaking adolescent patients
* cognitively able to participate

Exclusion Criteria:

* Adolescents less than 12 years of age
* Adolescents over 21 years of age
* cognitively unable to participate.
Hormonal and Bone Turnover Marker Response to an Acute Bout of Resistance or Plyometric Exercise

We are interested in determining if there exist a short-term response in the serum markers and hormones that participate in the regulation of bone tissue formation and breakdown to a single, high-intensity exercise session of weight lifting (resistance exercise) or jumping (plyometrics). We are also interested in determining if the bone marker response to exercise is altered by changing the negative energy state caused by the exercise treatment, when subjects are given a moderate calorie meal.

Bone tissue responds to impact and strain forces, like high-intensity exercise, by upregulating the bone remolding process, resulting in the deposition of calcium phosphate minerals into the collagen matrix of bone. Bone remodeling is a continually active process that involves both activation cells regulating bone formation (osteoblasts) and resorption (osteoclasts). Alterations in the balance between formation and resorption are critical for changes in bone density and mineral content to occur, which is regulated by several hormones including vitamin D and growth hormone, the sex hormones estrogen and testosterone, and parathyroid hormone. Importantly, it remains unclear how single bouts of physical activity contribute to the overall changes in remodeling and whether those acute alterations can be detected in the hours after exercise. Additionally, research studies examining the effects of exercise on bone remodeling often draw blood samples after 24 hours of physical inactivity, potentially diminishing the magnitude of the exercise response. Therefore, we plan to evaluate the acute effects of plyometrics and resistance exercise on changes in serum hormones and markers of bone turnover in non-sedentary, healthy males, with or without a moderate calorie supplement.

Eligibility Criteria:
Inclusion Criteria:

* Male
* No symptoms of disease
* Non-sedentary
* Age 25-65

Exclusion Criteria:

* Medications or supplements that affect bone metabolism or prevent exercise
* Previous or current medical condition affecting bone health, including osteoporosis.
* Cardiovascular disease
* Metallic implants affecting accuracy of bone density scan
* Current smoker
* Current participation in high-intensity jumping or resistance exercise in the last 3 months.
Cigarette Pack Inserts for Smoking Cessation

This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit. To do this, the investigators will conduct a 2 X 2 between-subject experiment in which 380 smokers will be randomized into one of four labeling groups: 1. no inserts or pictorial health warning labels (HWLs); 2. inserts only; 3. pictorial HWLs only; 4. inserts \& pictorial HWLs. Smokers will be given a 14-day supply of their preferred cigarette brand with packs labeled according to their experimental group. Participants will answer a brief survey at the end of each day and four other times each day, using ecological momentary assessment approaches. The investigators will study whether smokers in each group experience different psychological responses and behaviors associated with smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Have smoked at least 100 cigarettes in their lifetime
* Smoked at least 10 cigarettes a day in the prior month.

Exclusion Criteria:

* Use of other nicotine products besides cigarettes in the prior month.
* Pregnant women
Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)

The purpose of this study is to determine the safety of the combination of CHOP plus daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed ATLL requiring treatment

   1. Frank acute leukaemia or lymphoma subtypes
   2. Chronic and smouldering cases should be considered if they are symptomatic and require therapy, or there is evidence of disease progression
2. No previous treatment with anthracycline based cytotoxic chemotherapy

   a. Patients may have received interferon and /or zidovudine and/or non-anthracycline based therapy
3. Age 18-75 years
4. Written informed consent

Exclusion Criteria:

1. HIV 1 or 2 positivity
2. Pregnancy or breast-feeding
3. Concomitant chemo-radiotherapy
4. Prior hepatic or renal insufficiency with a bilirubin or transaminases greater than 5 times the normal range or a creatinine greater than 150μmol/l (not related to hypercalcaemia) following rehydration
5. Other concomitant neoplasms not related to HTLV-I
6. Cardiac or respiratory insufficiency with an ECOG score of greater than 3
7. Any serious active uncontrolled infection
Closed Reduction With Anesthesia and no Anesthesia for Developmental Dislocation of the Hip < 6 Months

The purpose of this study is to compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip \< 6 months

We treated children (\<6 months) with prolonged traction before an attempted closed reduction. And compare the efficacy of closed reduction with anesthesia and no anesthesia for developmental dislocation of the hip. All the patients were followed up for a minimum of 18 months in order to identify any avascular changes in the femoral head. The presence of avascular necrosis was assessed by the criteria of Salter.

Eligibility Criteria:
Inclusion Criteria:

* The patients with GrafⅢ/Ⅳtype DDH diagnosed by ultrasound or if they were IHDI (International Hip Dysplasia Institute) grade III or IV on radiographs，and The infants who were \<6 months of age. Patients were followed for at least 18 months,by which time they had either completed treatment with no evidence of requiring further treatment or were treated surgically after failing brace treatment.

Exclusion Criteria:

* Infants were excluded if they had multiple congenital abnormalities, had prior treatment in other centres, or showed teratological dislocations. The last were defined as fixed dislocation of the hip in association with either a recognised syndrome or a neurological disorder.
Breath Analysis & Malnutrition

The purpose of this research study is to understand how breath is related to nutritional status. The procedures involved in this study include blood and breath sampling, questionnaires about health history, medications, nutritional status and diet, and a physical examination. Breath markers will be compared between individuals with and without malnutrition and be compared to indicators of malnutrition. Some individuals will undergo an interventional study involving 2 days of consuming study beverages and fasting along with providing additional breath samples to see if the breath changes in response to short-term changes in nutritional status.

Research Summary: This research involves a cross-sectional study investigating whether breath molecules (in particular ammonia and nitric oxide) are related to the presence and magnitude of malnutrition as measured by the gold-standard nutrition focused physical examination (NFPE). It also involves an interventional study in a subset of cross-sectional participants looking at whether acute changes in nutritional status through anabolic feeding protocols or fasting protocols is related to short term changes in breath molecules.

Purpose of the Research: The purpose is to identify early evidence of breath biomarkers of malnutrition. It uses a combination of breath analysis and current malnutrition screening tools (questionnaires).

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-95 years
2. Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)

Exclusion Criteria:

1. Chronic kidney, liver or pulmonary disease
2. Anabolic steroid use other than testosterone (e.g., oxandrolone)
3. Patients judged unsuitable for enrollment by the study medical investigator
4. Pregnant women or women who are nursing
5. Unable or unwilling to consume study beverages or fast for 24 hours each arm
Safety and Effects of SLx-2101 Taken for up to 14 Days on Blood Pressure in Patients With Hypertension

The purpose is to determine the effective dosage and to study the effects of this dosage taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.

1. Office seated peripheral systolic and diastolic blood pressure
2. Adverse events and vital signs
3. Plasma concentrations of SLx-2101

Eligibility Criteria:
Inclusion Criteria:

* Male or females between 18 and 80 years, inclusive
* Moderate to severe hypertension
* Body weight within a body mass index range of 18 - 32 kg/m2

Exclusion Criteria:

* Subject is receiving more than four antihypertensive agents
* History of drug abuse
* Exposure to a new chemical entity within 3 months prior to the first day of dosing
Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation

The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis satisfying ACR/EULAR criteria
* Ongoing DMARD therapy

Exclusion Criteria:

* Inhability to consent
Pulmonary Functions in Relation to Gross Motor Function Level

Aim: To investigate the relation between forced expiratory volume at first second and peak expiratory flow with gross motor function level in the children with cerebral palsy.

Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study. The children ages ranged from 3 to 11 years old.

Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study. The children ages ranged from 3 to 11 years old. Children were evaluated using spirometer to assess forced expiratory volume at first second and peak expiratory flow and gross motor function classification system to assess the functional level.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy
* age was from 3 to 11years old
* They were able to sit independently and to follow instructions.
* Children who can blow air independently.

Exclusion Criteria:

* Uncontrolled convulsions
* Any psychiatric disorders
A Pilot Study of Oxaloacetate in Subjects With Treated PD

The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and complete two safety follow-up phone calls over a 4 month period.


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent and follow instructions per the protocol
* Diagnosis of idiopathic PD within 7 years of diagnosis
* Taking stable doses of levodopa and would not predictably need adjustment in PD medications for 4 months
* Unified Parkinson's Disease Rating Scale (UPDRS) II + III at least 30 points at baseline

Exclusion Criteria:

* Previously taken Oxaloacetate
* Participation in other drug studies or use of other investigational products within 30 days prior to baseline
* In the Investigator's opinion, any unstable or clinically significant condition that would impair the subjects' ability to comply with study follow-up
* Other known or suspected cause of parkinsonism
Effect of Bacillus Coagulans in Adults With With Functional Constipation

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.

A previous study has indicated that Bacillus coagulans provided control of abdominal pain, less discomfort during defecation, and a more normalized defecation style, especially in adults with with functional constipation. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans various symptoms and fecal microbial diversity in adults with with functional constipation for 8 weeks; the safety of the compound are also evaluated. The Investigators examine constipation visual analogue scale, Bristol Stool Form Scale type 3 \& 4 ratio, visual analogue scale for irritable bowel syndrome (VAS-IBS) questionnaire score, IBS-symptom severity scale, IBS quality-of-life questionnaire score, fecal microbial diversity at baseline, as well as after 8 weeks of intervention. Eighty adults were administered either 400 mg of Bacillus coagulans or a placebo each day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

- function constipation by Romes criteria IV

Exclusion Criteria:

* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar)
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled thyroid diseases.
* History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
* History of structural abnormalities of colon within 4 year
* History of medication for probiotics and psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
* Alcohol abuser
* Allergic reaction to this test food
* Those who participated in other drug clinical trials within 1 month from the screening date.
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
* Those who are judged to be unsuitable by the PI for other reasons