cyrilzakka/clinical-trials huggingface dataset:
Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic for regulation of bowel movements.

The purpose of this study is to determine the efficacy of the probiotic B. subtilis DE111® for regulation of bowel movements. A single capsule containing 1 x 10\^9 CFU B. subtilis is to be consumed once a day per participant. 50 adults (18-65 years of age at the time of participation) suffering from occasional constipation and/or diarrhea will be enrolled. Participants will be double-blindly and randomly assigned to either the probiotic (Bacillus subtilis) or the placebo (maltodextrin) group. Efficacy will be assessed with participant-reported bowel movement (BM) records. As a secondary outcome, the study will provide further insight into the tolerance of the supplement. Tolerance will be assessed using a digestive health questionnaire and blood samples to analyze pertinent metabolic biomarkers. Participants will be asked to complete a daily dietary intake record as well. Prior to capsule consumption, participants will complete a two-week pre-testing phase in order to provide a more inclusive diagnostic baseline. This phase will consist of daily BM and dietary intake record keeping.

Eligibility Criteria:
Inclusion Criteria:

* Participants suffering from occasional constipation and/or diarrhea will be eligible for participation.

Exclusion Criteria:

* Blood CRP levels for each participant will be monitored at days 0, 60 and 105 of this study. Participants with CRP levels greater than 5mg/l on day 0 of the study will be excluded from further participation as this level is indicative of underlying inflammatory bowel disease. Participants excluded under such conditions will be instructed to seek further treatment with their health care provider.
Anti-CD19 CAR-Engineered NK Cells in the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia

This study is a single arm clinical study to observe the safety ，dose tolerance and pharmacokinetic characteristics of CAR NK-CD19 in patients with recurrent or refractory CD19 positive acute lymphoblastic leukemia, and preliminarily evaluate the effectiveness, the immunogenicity of the product and the correlation between the changes of cytokines after infusion and CRS , ICANS.

It is planned to select 9-21 patients with recurrent or refractory CD19 positive acute lymphoblastic leukemia （ALL）, from the lowest dose group. It is expected that 3-6 cases will be enrolled in each dose group. The protocol will be performed into screening period (-30\~-10 days), prophase of lymophodepletion (-10\~-5 days), Lymophodepletion (-5\~-3 days), pre-infusion evaluation (-2\~-1 days), infusion (day 0), and follow-up period (1-720 days). The incidence of DLT is observed after infusion. There are three preset dose groups in this clinical trial. The initial dose is 1.0 × 107 CAR positive NK cells/kg (body weight). Subsequent dose groups included 2.0 × 107 and 3.0 × 107 CAR positive NK cells/kg (body weight). The specific dose is determined by SRC based on the patient safety data and PK data. The maximum sample size of this study is tentatively 21 cases.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 years in the single-dose exploration phase, age ≥3 years in the dose exploration phase, both sexes;
* Meet the diagnostic criteria for recurrent or refractory CD19 positive acute lymphoblastic leukemia.
* The main organs have good organ function.
* The estimated survival time is ≥12 weeks.
* Blood pregnancy tests for women of childbearing age are negative.
* The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form.

Exclusion Criteria:

* Central nervous system involvement；
* Simple extramedullary leukemia or simple extramedullary recurrence；
* Received hematopoietic stem cell transplantation within the last 3 months and had graft-versus-host disease (GVHD) in the last 2 weeks, requiring immunosuppressive agents；
* Treated with high-dose corticosteroids in the last 1 week；
* Allogeneic cell therapy, major surgery, and live or attenuated vaccine had been received within 4 weeks prior to CAR NK-CD19 infusion；
* Had received other antitumor therapy or had an uncontrolled infection within 2 weeks prior to CAR NK-CD19 infusion；
* Systemic steroids were used within 3 days before CAR NK-CD19 infusion；
* Toxicity caused by previous treatment do not fully recover or do not stabilize to grade 1；
* Concomitant autoimmune diseases, central nervous system diseases, other active malignancies, infectious diseases, severe cardiovascular diseases, etc；
* Known allergies to study drugs or drugs that may be used in the study；
* Other conditions determined by Investigator which are not suitable for participation in the study
Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of breast cancer
* Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
* Patients with at least one measurable lesion as per RECIST

Exclusion Criteria:

* Inflammatory breast cancer
* Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* 16 years or older
* At least 1 seizure/month with alteration of consciousness
* Documented seizure diary, at least 3 months prior to implantation (baseline)
* No change in anti-epileptic drugs 1 month before implantation
* At least one or more AEDs

Exclusion Criteria:

* Active cardiac, pulmonary or gastrointestinal disease
* Vagotomy
* Concomitant use of an investigational drug
* Unstable medical condition
* Unstable psychiatric condition
Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention

To decrease CDI incidence by implementing an electronic health record-integrated CDI-risk classification tool for Clostridioides difficile infection (CDI) to focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients.

This study aims to use a pre/post implementation design to evaluate the use of a novel risk classification tool to improve existing methods of identifying patients eligible for routine antimicrobial stewardship (AMS) care processes targeting reduction of Clostridioides difficile infection (CDI). Antimicrobial stewardship is an established, evidence-based quality improvement program that is required by The Joint Commission and a condition of participation by the Centers for Medicare and Medicaid. AMS processes of care are evidence based, supported by published research demonstrating outcomes benefits, are recommended by national guidelines and are not investigational. Treatment decisions remain at the discretion of clinicians and patients

Eligibility Criteria:
Inclusion Criteria:

* adult acute care patients identified as high-CDI risk by the CDI risk classification tool. This sub-group represents approximately 6% of all acute care admissions

Exclusion Criteria:

* Behavioral health units
* Inpatient rehabilitation units
* Labor and Delivery units
* Same day surgery and observation units
A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis

The purpose of this study is to see if it is safe to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus.

In this open-label study, patients receive intravenous L-743,872 every 24 hours at one of three dose levels for 14 days. Post-study safety evaluations continue for 4 weeks after the final dose. Pharmacokinetics and safety measurements are taken throughout the 6-week study.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are an 18- to 65-year-old man with candidal esophagitis.
Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission

The purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerprints" are found on many cancer cells, especially from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this study is to see if investigators can help the immune system to recognize that cancer cells are not normal and should be removed.


Eligibility Criteria:
Inclusion Criteria:

* Any histologically documented stage III or IV epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.
* History of cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment.
* Patients must be in a first complete clinical remission. Complete clinical remission is defined as serum CA-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0cm are often present in the pelvis and will not be considered definite evidence of disease. Eligibility is determined by anatomical imaging only (ie. MRI or CT). Positive PET image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative.
* Adequate organ function defined by
* Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,000/mm³, grade 1. Platelets greater than or equal to 100,000/mm³.
* Renal function: Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1.
* Hepatic function: Bilirubin, SGOT, and alkaline phosphatase less than or equal to 2.5 x ULN
* Negative stool hemoccult (or negative endoscopic evaluation if positive). External hemorrhoids are a common source of a positive hemoccult and should not exclude patients.
* TSH not elevated above normal range
* KPS \> or = to 80%.
* Patients have signed the informed consent document and signed the authorization permitting release of personal health information.
* Age \> 18 years
* Patients must have recovered from clinically significant side effects from prior chemotherapy

Exclusion Criteria:

* Pregnant or nursing women
* Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years, or whose previous cancer treatment contraindicated this protocol therapy are excluded. Non-melanoma skin cancers are an exception and will not exclude any patient.
* Patients with a history of a seafood allergy.
* Patients who have previously received a vaccine with any of the antigens in the current trial.
* Patients with a history of immunodeficiency or autoimmune disease (excluding treated hypothyroidism).
* Patients with active CNS tumor.
HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
6. Received at least 2 cycles of HAIC；
7. Has repeated measurable intrahepatic lesions;
8. Child-Pugh class A or B.

Exclusion Criteria:

1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
2. With other malignant tumors;
3. Unable to meet criteria of combination timeframe described above.
Patients' Preferences for Traditional Medicine Doctor's Attire

Doctors' attire has known to impact patients' trust and confidence for better clinical practice. However, few survey research regarding this topic has been conducted in traditional asian medicine field. The aim of our study is to determine whether traditional medicine doctor's attire impacts on patients' confidence and trust.

Participants will be given randomly one set of photographs from the 2 kind of photographs, i.e., photographs of a male or female doctor, each set dressed in 4 different styles.

After this, they will be asked to report their preferences for the 4 styles of dress according to given questions and they will answer the degree of their feeling on the importance of Korean Medicine doctor's appearance.

After seeing one set of photographs, participants will answer the questions below.

Choose the most appropriate attire from the four dressing styles (a.formal wear b.conventional white coat c.white coat in traditional form d. casual wear) to the questions below (1-10).

1. Which attire of Korean medicine doctor would you trust the most?
2. Which attire of Korean medicine doctor would you be more likely to follow their advice?
3. Which attire of Korean medicine doctor would you recommend to your acquaintance?
4. Which attire of Korean medicine doctor would you be the most comfortable ?
5. Which attire of Korean medicine doctor would you prefer to discuss an intimate social problem or a private issue?
6. Which attire of Korean medicine doctor would you prefer for a minor medical problem(eg, a cold)?
7. Which attire of Korean medicine doctor would you expect to be the most clean?
8. Which attire of Korean medicine doctor would you expect to be the most hygienic?
9. Which attire of Korean medicine doctor would you expect not to spread infectious germs to others?
10. Which attire of Korean medicine doctor would you have the most confidence in their diagnosis and treatment when they perform clinical examination by touching you?
11. How strongly do you feel about the importance of Korean medicine doctor's appearance?

    1. extremely important
    2. quite important
    3. important
    4. a little important
    5. not at all important

Eligibility Criteria:
Inclusion Criteria:

* More than 19 years old, less than 80 years old at the time of the study
* Outpatients from diverse clinic departments in Korean Medicine Hospital of Pusan National University, Yangsan, Korea

Exclusion Criteria:

* Subjects who are demented, noncommunicative, or blind
* Companion(s) of the interviewee
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors

This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1.
* Has an ECOG PS 0-1.
* Has a life expectancy of ≥ 3 months.
* Has adequate organ function

Exclusion Criteria:

* Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
* Has received HER2 antibody drug conjugates,.
* Central nervous system metastasis or meningeal metastasis with clinical symptoms
* Has active infection requiring systemic treatment.
Osteoporosis Treatment in Post-menopausal Women

The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.

Fracture is one of the important complications in female. Osteoporosis should be treated in postmenopausal female due to high risk of fracture. Recently, there have been many classes of medications developed for preventing bone loss. Raloxifene, an oral form of anti-osteoporosis medication, has been reported to improved central nervous disorders. Therefore, this study is designed to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female
* Osteoporosis

Exclusion Criteria:

* Psychological disorders
Validation of the Utility of Strabismus Intelligent Diagnostic System

Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Current strabismus evaluation technologies are heavily dependent on model eyes. Here, the investigators use deep learning to develop an artificial intelligence (AI) platform consisting of three deep learning (DL) systems to screen strabismus, evaluate deviation and propose a surgical plan based on corneal light-reflection photos. The investigator also conduct clinical trial to validate its versatility in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the outpatient clinic of strabismus department.

Exclusion Criteria:

* Patients or their parents diagree to participate in the trial.
* Patients with blepharoptosis.
* Patients can't facing forward or lacking fixation.
Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache

The purpose of the study is to determine whether ibuprofen reduces post-ECT headache or reduces its severity.

The aim of the study is to compare the severity of headache between patients who are receiving ibuprofen prior to ECT treatment with patients receiving placebo prior to ECT treatment.

Patients will be randomly assigned to receive either 600 mg ibuprofen 90 min prior to treatment or placebo orally, blinded to patient, physician and treatment team.

Patients will be asked about their headache with a visual analogue scale (VAS) 2 hours prior to and within 2 hours after treatment, 2-month, 6- month and 1 year follow-up \[5\].

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving ECT

Exclusion Criteria:

* Pregnancy, contraindications to ibuprofen
Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments.

Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination.

Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
* Patients from whom written consent was obtained

Exclusion Criteria:

* Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
* Presence of neurological diseases or peripheral vascular disease
* Uncontrolled diabetes mellitus
* Congenital anorectal malformations
* Recent colorectal or gastrointestinal surgery
* Presence of external full-thickness rectal prolapse
* Inflammatory bowel disease
* Chronic diarrhoea
* Use of tibial nerve or sacral nerve stimulations
* Ongoing pregnancy
* Any malignant disease
F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis

The purpose of this research study is to evaluate tau distribution in the brain of subjects with: ALS caused by different genetic mutations, any mutation carriers (with or without symptoms), any non-mutation carrier, any sporadic FTD, normal controls.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants, at least 18 years of age.
2. Clinically diagnosed with amyotrophic lateral sclerosis (ALS), fronto-temporal dementia (FTD), or both; or a carrier of a mutation known to cause ALS or FTD (with or without symptoms); or a normal control.
3. Participant is able and willing to undergo testing (psychometric testing, MRI or CT, PET, radioactive tracer injection; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
4. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.

Exclusion Criteria:

1. Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with significant respiratory involvement may not be able to lie flat during the scanning procedures).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
4. Has hypersensitivity to F 18 T807 or any of its excipients.
5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
6. Severe claustrophobia.
7. Currently pregnant or breast-feeding.