cyrilzakka/clinical-trials huggingface dataset:
Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients

The purpose of this study is to evaluate the effectiveness of the drug Crofelemer in the treatment of non-HIV patients with chronic idiopathic diarrhea; to determine the prevalence of identifiable causes of chronic diarrhea in a non-HIV patients; to assess the diagnostic yield, in terms of identification of treatable etiologies, of commercially available diagnostic evaluations in adult, non-HIV patients with chronic idiopathic diarrhea, that is, evaluate which tests, among the standard diagnostic tests commonly conducted as part of the evaluation of chronic idiopathic diarrhea, are most likely to identify a treatable cause of the diarrhea; and to analyze the relationship between chronic idiopathic diarrhea and health-related quality of life and assess the impact of crofelemer treatment on health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic diarrhea (defined as 3 non-bloody loose stools per day or more than 20 non-bloody loose stools per week for more ≥ 4 weeks) and Bristol Stool Form Scale for stool consistency of 6/7 with \>50% stool without an obvious cause after evaluation for organic etiologies.
* Patients from any ethnicity

Exclusion Criteria:

* Hematochezia (potentially related to an organic cause).
* Subjects less than 18 years of age more than 75 years of age (safety and effectiveness of crofelemer has not been established in these age groups).
* Pregnant females (crofelemer is a Category C drug due to lack of well-controlled studies to study its effects in this population).
* Lactating females (it is unknown if crofelemer is excreted in the human milk and thus may have unknown adverse effects on the nursing infants).
* HIV positive individuals.
* Persons within ability to provide consent and understand the study
* Persons with history of alcohol abuse or binge drinking.
* Persons with history of surgical bowel resection or bariatric surgery in the past 12 months.
* Persons who have undergone cholecystectomy (open or laparoscopic) in the past 3 months.
* Persons receiving antibiotics currently or have received antimicrobials in the past 4 weeks.
* Persons with end-organ failures including end-stage renal disease, end-stage liver disease, or severe heart failure.
* Persons with metastatic hematologic and oncologic malignancies.
* Persons receiving chemo-radiation or immune-modulators for oncologic or rheumatologic conditions.
* Persons with any other known organic gastrointestinal or non-gastrointestinal disease process in which diarrhea is a recognized clinical feature.
* Gluten free diet for previous 3 months and refusal to ingest gluten.
Estrogen Replacement and Atherosclerosis (ERA) in Older Women

To determine if estrogen replacement therapy, with or without low dose progesterone, slows progression or induces regression of coronary atherosclerosis in postmenopausal women.

BACKGROUND:

Cardiovascular disease is the number one cause of death in postmenopausal women. Postmenopausal estrogen replacement is associated with a lower incidence of cardiovascular disease in women, especially in those with established coronary artery disease. The strength of the apparent effect of estrogen in epidemiologic studies suggests that estrogen plays a fundamental role in the maintenance of vascular health. Animal data suggest that the current practice of adding the low dose progesterone to prevent endometrial hyperplasia may inhibit the beneficial effects of estrogen on coronary arteries. Before committing millions of postmenopausal women to long-term estrogen use for prevention of coronary artery disease, it is mandatory to demonstrate that it does indeed protect against coronary atherosclerosis, to determine the impact of co-treatment with progestin, and to understand the mechanisms through which estrogen may exert it's cardioprotective effects.

The Office of Research on Women's Health provided $500,000 in Fiscal Year 1995 for recruitment of subjects.

DESIGN NARRATIVE:

Randomized, placebo-controlled, blinded. The minimum diameter of coronary stenotic lesions was measured by angiography before and after three years in a group receiving unopposed estrogen replacement therapy, a group receiving estrogen replacement plus continuous low dose progestin, and a group receiving placebo. The incidence of clinical events was documented in all three groups. Secondary objectives of the trial included examining the effect of chronic and acute estrogen administration on endothelium-dependent coronary vasodilator capacity, plasma lipids and lipoproteins, antioxidant activity, blood pressure, glucose metabolism, and plasma hemostatic factors, as well as on behaviors, physical attributes, and psychosocial parameters. There were four pre-randomization variables in order to pre-stratify. These included current smoking status, insulin dependent diabetes, current lipid-lowering therapy, and the hospital where angiograms were performed.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Postmenopausal women with established coronary atherosclerosis.
Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production.

This study is designed to evaluate the endocrine and metabolic effects of simvastatin and resveratrol on PCOS.

Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering 20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after 3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and the fasting insulin level.


Eligibility Criteria:
Inclusion Criteria:

* PCOs
* insulin resistance
* normal prolactin, TSH, 17 OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly

Exclusion Criteria:

* use of oral contraceptives and/or other steroid hormones 3 months prior to the study
ITI-007 (Lumateperone Tosylate) for Schizophrenia

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.

Patients will be started on ITI-007 and current medication will be slowly discontinued within the first 7 days of starting ITI-007, with some flexibility allowed if clinically indicated. No patients will be left unmedicated because of this study.

Patients will be seen weekly for the first 4 weeks, biweekly for the second month and then monthly for six months. Patients will be monitored by clinical and safety rating scales, and will be required to show improvement after 3 months to remain in this study. Patients not improving at this time will be assessed for the risks/benefits of continuing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
* Has capacity to provide informed consent
* Medically stable for study participation
* Judged clinically not to be at significant suicide or violence risk
* Inadequate response or tolerability to previously antipsychotic therapy, as defined by at least one of the following: prior clozapine failure, a PANSS\>80 despite at least six weeks of a current antipsychotic therapy, a Clinical Global Impressions scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics (retrospective assessment) or failure to tolerate an adequate dose of at least antipsychotics (as defined by the Physicians Desk Reference)

Exclusion Criteria:

* Substance abuse within last 90 days
* ECG abnormality that is clinically significant
* Pregnancy, lactation, or lack of use of effective birth control
* Presence or positive history of significant unstable medical or neurological illness (including any history of seizure disorder, hepatitis, renal insufficiency or mental retardation), history of HIV
* Clinically significant abnormal laboratory tests, positive for hepatitis B or C or liver function tests (LFTs) \> 2x Upper Limit of Normal, use of strong CYP3A4 inhibitors or inducers
* History or presence of concomitant major psychiatric illness.
* Use of other antipsychotic medications at baseline.
* Use of another investigational medication in the previous 4 weeks
Odour Characteristics of Human Breast Milk of Chinese Mothers

It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy the regular nutritional demand of infants. At present, researchers make every effort to simulate the nutritional status of breast milk but mostly neglect the important role that odour plays in guiding the baby to recognize breast milk, promoting the baby's sucking behavior and food intake. The odour changes of the breast milk are so far mainly related to storage, lactational stage and maternal diet. To understand the odour characteristics of the human breast milk from different regions in China, 90 mothers will be recruited from three Chinese cities: Beijing, Chengdu and Wuxi, representing three typical regions with very different climate characteristics and diet habits. The breast milk samples as well as infant formulas will be analyzed using the identical state of the art separation and identification techniques to identify the odorous compounds, determine their concentrations in the breast milk and infant formula as well as determine their importance in contributing to the total odour of samples. The final objective of this study will be to mimic the odour of the breast milk and to understand the difference of breast milk odour from different regions with very different climate and diet composition, as well as to identify the odour deviation of the infant formula from the breast milk. Our results will provide references for the preparation of new infant formula with both nutritional ingredents and odour characteristics simulating that of breast milk.


Eligibility Criteria:
Inclusion Criteria:

* Lactating mother aged 25 \~ 35 years
* Breastfeeding infants (aged 15 \~180 days) and express sufficient breast milk
* Mother is in good health and has balanced nutrition
* Mother is non smoker and non alcoholic, no smokers living in the same apartment
* Voluntarily signed the Informed Consent Form

Exclusion Criteria:

* Mother or newborn infant has major diseases
* Mother participating in any other nutritional or pharmaceutical intervention studies recently
* Other conditions that are not suitable for this study
Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.

ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
* Patients with chronic coronary syndromes
* Signed written informed consent

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled)
* Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
* Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III)
* Inability or unwillingness to undergo CT scan or coronary angiography
* Patients on hemodialysis or with severe hepatic or renal insufficiency
* Left main coronary artery stenosis ≥ 50%
* Target vessel total occlusion
* Pregnancy or intention to become pregnant during the course of the trial
* Patients with a life expectancy less than 2 years
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases

To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer

evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed colorectal adenocarcinoma
2. Disease limited to the liver Unresectable disease by surgery or other local therapies
3. Age \>18 years
4. ECOG performance status 0-2,Child pugh A or B
5. Expected survival ≥ 3 months
6. Adequate hematological, hepatic, and renal function

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with severe organ dysfunction or failure
3. With severe cardiovascular disease, or mental
4. Extraliver metastases
Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19

The purpose of this study is to assess the safety and efficacy of UNI91103 intranasal spray for treatment of coronavirus disease 2019 (COVID-19) in asymptomatic or mildly symptomatic adults.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female aged ≥45 and \<80 years
* Subject is tested to confirm infection with SARS-CoV-2 on a sample taken within 3 days before randomization
* Subject is either without symptoms or has 1 or more of the following symptoms: Stuffy or runny nose, Sore throat, Loss of taste, Loss of smell, Headache.

None of the symptoms should have been present \>5 days.

Exclusion Criteria:

* Subject has an underlying condition that may interfere with intranasal administration of the IMP (e.g., chronic ulcers in the nose).
* Subject has symptoms suggesting engagement of the lower respiratory tract or a systemic engagement
* Subject has an active or acute infection other than SARS-CoV-2
* Subject has another member of the same household recruited to this study
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition

The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 to 55 years
2. Females must be menopause or surgical infertility
3. Signed informed consent form
4. Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. Clinical laboratory test values are outside the accepted normal range at Screening

   * aspartate aminotransferase(AST), alanine aminotransferase(ALT) \> 1.25 times the upper limit of the normal range
   * Total Bilirubin \> 1.5 times the upper limit of the normal range
   * creatine phosphokinase(CPK) \> 1.5 times the upper limit of the normal range
   * estimated Glomerular Filtration Rate(eGFR, MDRD\* formula) \< 60 mL/min/1.73m2 (\*MDRD: Modification of Diet in Renal Disease)
   * Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
   * systolic blood pressure(SBP) ≥ 150 mmHg or \< 90 mmHg, diastolic blood pressure(DBP) \> 100 mmHg or \< 50 mmHg
3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
4. Participated in a clinical trial within 90 days prior to 1st IP dosing
5. Not eligible to participate for the study at the discretion of Investigator
6. Other exclusive inclusion criteria, as defined in the protocol
GapCO2 and Respiratory Rate in Patients Under Volume Mechanical Ventilation

As an approximate of the difference between venous-to-arterial CO2 tension (∆PCO2), ∆PCO2 is proportional to CO2 production and inversely related to cardiac output (Fick equation). Anaerobic CO2 production is thought to occur when tissue hypoxia is present, mostly because of buffering of bicarbonate ions by the protons produced in excess secondary to the hydrolysis of adenosine triphosphate. Therefore ∆PCO2 has been proposed as a marker of tissue hypoxia.

An increased ∆PCO2 (\> 6 mmHg) could be used to identify patients who still remain inadequately resuscitated, when deciding when to continue resuscitation despite a central venous oxygen saturation (ScvO2) \> 70% associated with elevated blood lactate levels.

Under steady states of both VO2 and VCO2, P (v-a) CO2 was observed to increase in parallel with the reduction in cardiac output. However, spontaneous breathing and hyperventilation may reduce PaCO2 and prevent the CO2 stagnation-induced rise in PvCO2.

To date,these studies of ∆PCO2 and respiratory rate in septic shock patients Under Volume Mechanical Ventilation are rarely.

Eligibility Criteria:
Inclusion Criteria:

Patients were included in the study, if the attending physician find the persistence of signs of hypoperfusion (oliguria, mottled skin, central venous oxygen saturation (ScvO2) \<70 % despite a hemoglobin \> 8 g/dl),despite achieving adequate intravascular volume and adequate mean arterial pressure (MAP) \> 65 mmHg as recommended by the Surviving Sepsis Campaign.

Exclusion Criteria:

Exclusion criteria were pregnancy, COPD，age less than 18 years old, unstable hemodynamic condition (change of vasoactive drug dosage or fluid administration within 1 h preceding the protocol) and uncontrolled tachyarrhythmias (heart rate\>140 beats/min).
Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.

Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fistula involving \> 1/3 of the external anal sphincter
* Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton)
* Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug)
* All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up

Exclusion Criteria:

* Fistula tract shorter than 2 cm
* Complex fistula tract system (branching of the fistula tract)
* Age \< 18 years
* Pregnancy
* HIV-positivity
* Fistula caused by malignancy
* Tuberculosis
* Hidrosadenitis suppurativa
* Pilonidal sinus disease
* No internal fistula opening found
* Unable/contra indications to go through MRI scanning
* Crohn´s disease
* Ulcerative proctitis
Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality

The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).


Eligibility Criteria:
Inclusion Criteria:

* Children with Cleft Lip with or without Cleft Palate and their Parents

Exclusion Criteria:

* Children with Cleft Palate without Cleft Lip
* Children born the 35th week of d'amenorrhea
* Children with a birth weight inferior to 1800 g
* Children put under care by court order
* Parents under administrative supervision
* Parents who are not familiar with the french language and/or illiterate