cyrilzakka/clinical-trials huggingface dataset:
Long Term Safety Study of Plecanatide

Multi-center, open-label, long-term safety study

This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.

Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals.

Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments.

Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.

Eligibility Criteria:
Inclusion Criteria:

Patients with documented diagnosis of IBS-C who:

* Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
* Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.

Key Exclusion Criteria:

* Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
* Female patient of childbearing potential with a positive urine pregnancy test on Day 1.
* Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
* Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
* In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.
Fecal Amino Acids，Gut Taste Receptors and Irritable Bowel Syndromes

Clinical data, fresh feces and intestinal mucosal tissues of patients with diarrheal IBS were collected. High performance liquid chromatography, immunohistochemistry and immunofluorescence were used to study the amino acid levels in feces of patients with IBS, the expression of taste receptors in intestinal mucosa, and the correlation between symptoms of abdominal pain and diarrhea and the expression of taste receptors, so as to obtain the conclusion that "intestinal amino acid perception abnormalities exist in patients with IBS. And correlated with clinical symptoms."


Eligibility Criteria:
Inclusion Criteria:

* Patients with IBS who meet the Rome IV diagnostic criteria:

  1. that is, recurrent abdominal pain, with symptoms occurring at least 1 day per week or at least 3 days per month on average in the last 3 months, combining 2 or more of the following:

     1. related to defecation;
     2. accompanied by changes in the frequency of bowel movements;
     3. Accompanied by changes in fecal characteristics (appearance). (Symptoms appeared at least 6 months before diagnosis, and above diagnostic criteria were met in the last 3 months) 2. Age ≥18 years old.

Exclusion Criteria:

* 1. History of celiac disease and other organic intestinal diseases, metabolic diseases (thyroid dysfunction, diabetes, etc.); (2) Serious neurological, mental and psychological diseases, or accompanied by serious organ dysfunction; 3. Abdominal surgery; 4. Pregnant, possible pregnant and lactating patients; 5. History of colonoscopy in the past 1 year; 6. Declined to participate in the study.
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Karnofsky\> 80, or ASA I-II
* Primary ovarian adenocarcinoma, or primitive peritoneal
* No retroperitoneal lymph node\> 2cm (CT; MRI)
* Complete surgical staging
* Stage III-IV FIGO classification
* Indication of systemic chemotherapy before surgery or post surgery

Exclusion Criteria:

* Non Invasive Cancer
* non-epithelial or borderline cancer
* Pregnancy
* Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer
* Contraindication to Platinum and Paclitaxel
* Borderline Ovarian Tumor
* tumor recurrence
* Incomplete surgery, resectable lesion, Surgery sub optimal (R\> 1cm)
Studies of the Human Microbiome in Clinical Center Patients

Background:

- The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every person s body contains microorganisms like these. They normally do not make people sick. Researchers are interested in how these microorganisms change when a person is hospitalized. They want to find out if changes take place because of the hospitalization (such as treatments used or changes in medical condition) or because of a person s biology (such as their immune system).

Objectives:

- To understand which microorganisms are most likely to spread through hospitals and what affects that spread.

Eligibility:

- People 2 years of age and older who are going to be inpatients at the National Institutes of Health Clinical Center (NIHCC) for at least 48 hours.

Design:

* Clinicians will take samples from participants up to once a day for as long as they are hospitalized at NIHCC.
* Samples will be taken with a swab, from the rectal area, groin, throat, and armpit, and possibly other areas.
* Participants may give a stool sample or be asked to spit into a cup.
* Clinicians will collect some information from participants medical records. They may request some samples of tissue that are left over from procedures already scheduled at NIHCC.
* After participants leave the NIHCC, samples may be taken when they return for follow-up visits from their hospitalization, for up to 2 years. They will not have to return as a follow-up for this study only.

The goal of this protocol is to explore changes to microbial communities during the course of hospitalcare, and to determine the extent to which these alterations affect whether hospitalized patients become colonized with healthcare-associated organisms. The study enables collection of clinical specimens and associated medical data to evaluate the natural history, epidemiology, and genomics of patients who might become colonized or infected with a multidrug-resistant organism. Biological specimens including stool, sputum, and swabs will be taken from Clinical Center inpatients at least 2 years of age as frequently as daily through discharge, and at follow-up visits for up to 2 years from the date of enrollment. To understand possible pathogen colonization and infection of hospitalized patients, this protocol will assess the full complement of the microbial-host-environmental contributions including: (1) microbial genome and community;(2) patient s genotype, underlying medical condition, medical treatment; and (3) hospital practices and environment.

Eligibility Criteria:
* INCLUSION CRITERIA:

Individuals must meet the following inclusion criteria to participate in the study:

* Be inpatients in the NIH CC with an expected hospitalization of at least 48 hours beyond the date of referral.
* Be 2 years of age or older
* Allow storage of tissue samples for future analyses.
* Allow genetic testing of body fluids, and tissue specimens.

EXCLUSION CRITERIA:

A patient will not be eligible if he/she has any condition which, in the investigator s opinion, places the patient at undue risk by participating in the study.
Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection

The objective are to assess the nature and incidence of drug intolerance observed with a new antiretroviral triple therapy, Truvada® \[0-0-1\] + Isentress® 400 mg tablets \[1-0-1\], prescribed in a setting of the treatment of individuals with recent exposure to a risk of transmission of HIV infection and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.


Eligibility Criteria:
Inclusion criteria

* age 18 years or over
* consultation immediately following exposure to the risk of transmission of HIV infection (less than 48 hours, except in the case of rape when this period may be increased to a maximum of 120 hours)
* person capable of understanding the principle of the study and giving his/her informed consent

Exclusion criteria

* subjects recently exposed to a risk of transmission of HIV infection in which the source patient is known to be infected with HIV and treated, and whose therapeutic history justifies the introduction of PET other than that proposed in this study
* subjects with a contraindication to the prescription of Truvada® and/or Isentress® (renal impairment, allergy, etc.)
* subjects previously treated with phenytoin, phenobarbital and rifampicin, since combination with raltegravir is contraindicated subjects known to be infected with hepatitis B virus, whether or not treated with lamivudine
* subjects refusing to take part in the study
* pregnant women
Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.

Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that build up in the bone marrow and interfere with the production of normal blood cells.

In this study, the patients' own T cells will be genetically modified with lentiviral vectors expressing chimeric antigen receptors. The multi-CAR T cells recognize specific molecules such as CD33, CD38, CD123, CD56, MucI, and CLL1, which are often found expressed on the surface of AML cells. The engineered CAR T cells will be infused into patients.

The purpose of this clinical study is to assess the feasibility, safety and efficacy of the multi-CAR T cell therapy against AML. Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 2 years.
2. CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 2 months.
4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
5. Hgb≥80g/L.
6. No cell separation contraindications.
7. Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria:

1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
2. Active bacterial, fungal or viral infection not controlled by adequate treatment.
3. Known HIV or hepatitis B virus (HBV) infection.
4. Pregnant or nursing women may not participate.
5. History of glucocorticoid for systemic therapy within the week prior to entering the test.
6. Previously treatment with any gene therapy products.
7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
UZ Brussel HRMC Registry of Brugada Syndrome

The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).

The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.

These includes:

1. demographical data: age, sex
2. antropometric data: height, weight, BMI
3. clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy

3) data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation

Eligibility Criteria:
Inclusion Criteria:

* Brugada syndrome diagnosis

Exclusion Criteria:

* Other diagnosis different from Brugada syndrome
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in fasted subjects.

This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fasting conditions. Subjects were confined to the SFBC Clinical Research Facility from at least 10 hours prior to drug administration, until after the 24-hour post-dose blood draw, in each period. The treatment phases were separated by a washout period of 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate?
* Is s/he at least 18 years of age?
* Is his/her BMI between 19 and 30, inclusive?
* Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
* Has s/he provided written informed consent?

Exclusion Criteria:

* Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides?
* Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
* Does s/he have serious psychological illness?
* Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
* Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test?
* Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?
* Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken?
* Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
* Is s/he unable to refrain from the use of all concomitant medications during the study?
* Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
* Has s/he donated plasma during the two week period preceding study initiation?
* Has s/he received an investigational drug during the 30 day Period preceding study initiation?
Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP

NewGam (current working title for a new IGIV formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate the safety and efficacy of three different dosages of NewGam 10% in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

This is a Phase 2/3 study that will take place in 2 stages. The primary objective of Stage 1 (Phase 2 dose-finding part)is to determine and select one dosage from three NewGam maintenance dosage arms in comparison with a placebo arm, based on the percentage of responders (response defined as a decrease, meaning improvement, in the adjusted INCAT disability score by at least 1 point). The selected NewGam dosage and placebo will be employed and compared in Stage 2.

The primary objective of Stage 2 (Phase 3 confirmatory part) is to demonstrate superiority of the maintenance dosage regimen selected at study Stage 1 over placebo in patients with CIDP as assessed by the percentage of responders.

The secondary objective is to evaluate the safety (measured by number of adverse events)and efficacy of NewGam administration in patients with CIDP compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having CIDP based on fulfilment of clinical criteria of the INCAT Group and the definite electrophysiological criteria for CIDP ; patients with MADSAM or pure motor CIDP will be included provided they fulfil these criteria
* Worsening of disability and objective increase in weakness or sensory deficit during the 6 months prior to screening
* \>=18 years of age

Exclusion Criteria:

* Unifocal forms of CIDP
* Pure sensory CIDP
* MMN with conduction block
* Treatment of CIDP with immunoglobulins (intravenous or subcutaneous) at any time prior to study entry
* Steroids of any type equivalent to prednisolone or prednisone \> 10 mg/day or equivalent plasma exchange (PE) during the last 3 months prior to baseline visit
* Treatment with cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil, interferon or other immunosuppressive or immunomodulatory drugs during the three months prior to baseline visit
* Clinical evidence of peripheral neuropathy from another
* Known diabetes mellitus
* Other serious medical condition complicating assessment or treatment
* Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever
* Known IgA deficiency with antibodies to IgA
* History of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products, or any component of NewGam
* Known blood hyperviscosity
Segment Transport Versus Acute Shortening In The Treatment of Tibial Pseudarthroses With Bone Loss

In this study the investigators are presenting the advantages as well as the disadvantages of ACUTE SHORTENING AND RELENGTHENINIG VS SEGMENT TRANSPORT methods.


Eligibility Criteria:
Inclusion Criteria:TIBIA PSEUDOARTHROSES -

Exclusion Criteria:BONE LOSS GREATER THAN 10 CM

-
Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle

Eligibility Criteria:
Inclusion Criteria:

* Infertile lean women with PCOS as defined by the Rotterdam criteria.
* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities.