cyrilzakka/clinical-trials huggingface dataset:
Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients with functional constipation.


Eligibility Criteria:
Inclusion Criteria:

1. Adults: 18 to 70 years old (not less than 50% of the final population over 45 years old, and not less than 30% of men);
2. Patients with functional constipation (refer to Rome IV diagnostic criteria for functional constipation); \* Symptoms appeared for at least 6 months before diagnosis, and met the above diagnostic criteria in the past 3 months

Exclusion Criteria:

1. Pregnant and lactating women;
2. Unable to take the test sample and complete the inspection items as required due to inability to take food by mouth, weakness, allergies or other reasons (including the inability to complete all items due to recent travel plans);
3. Unclear main complaint and obvious abnormal mental state;
4. The liver and kidney function indexes are obviously abnormal (combined with the results of physical examination within the past 1 year);
5. Acute gastrointestinal diseases occurred in the past month, and constipation caused by surgical operations in the past month;
6. Take antibiotics, laxatives or topical agents, anticholinergics, antidiarrheals frequently in the past 1 month, and the frequency is more than 1 time/week
7. Have been diagnosed with the following diseases: cancer (especially cancer of the digestive tract), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness;
8. Have been diagnosed with the following diseases: severe systemic diseases such as stroke, heart disease, liver cirrhosis, renal failure, hematopoietic system, or qualitative intestinal diseases caused by colonoscopy or imaging display;
9. In the past 3 months, there are often abdominal pain, abdominal pain accompanied by changes in bowel characteristics or frequency, blood in the stool, diarrhea or involuntary weight loss;
10. Clinical manifestations or diseases that other researchers believe are not suitable for participating in the project.
A Long-term Follow-up Study in Participants Who Received CTX001

This is a multi-site, open- label rollover study to evaluate the long-term safety and efficacy of CTX001 in pediatric and adult participants who received CTX001 in parent studies 111 (NCT03655678) 141 (NCT05356195) or 161 (NCT05477563) (transfusion-dependent β-thalassemia \[TDT\] studies) or Study 121 (NCT03745287) or 151 (NCT05329649), 161(NCT05477563),171 (NCT05951205) (severe sickle cell disease \[SCD\] studies).


Eligibility Criteria:
Inclusion Criteria:

* Participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form
* Participants must have received CTX001 infusion in a parent study

Exclusion Criteria:

* There are no exclusion criteria
11C-5-HTP PET in Clinical Islet Transplantation

In people with type I diabetes, the insulin producing cells in the pancreas have been destroyed. Presently one can only evaluate the function of the graft through laboratory tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and their location are not known. The possibility to study the mass of insulin producing cells is of importance when developing new treatment regimes, in order to evaluate their efficacy on this parameter.

The researchers in this study are aiming to develop methods to measure the mass of insulin producing cells. A method (positron emission tomography, PET) previously used for the diagnosis of tumors of insulin producing cells may also be used to measure the amount of insulin producing cells in patients with type I diabetes. They plan to evaluate participants with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be used to measure the beta cell mass after islet transplantation.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be considered eligible for participation in the study:

1. Subjects who are able to provide written informed consent and comply with the procedures of the study protocol.
2. Patient that has received an islet transplant in or outside the CIT01 trial (post primary endpoint).

Exclusion Criteria:

Subjects who meet any of these criteria are not eligible for participation in the study:

1. For female subjects: Positive serum pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures at the time of PET scan +/- 2 weeks.
2. Known history of severe co-existing cardiac disease, characterized by any one of the following conditions:

   1. Recent myocardial infarction (within past 6 months).
   2. Evidence of ischemia on functional cardiac exam within the last year.
   3. Left ventricular ejection fraction \<30%.
3. Persistent elevation of liver function tests at the time of study entry. Persistent Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase), Alanine Aminotransferase (serum glutamate pyruvate transaminase), Alkaline phosphatase or total bilirubin, with values \>1.5 times normal upper limits will exclude a patient.
4. Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment.
5. Use of any investigational agents within 4 weeks of enrollment.
6. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems

Children on the autism spectrum often show aggressive behavior. Treatment can train children to be more aware of their emotions. Investigators studied the effectiveness of an attention-based intervention tailored on aggressive behavior problems and the use of anger coping strategies of school aged autistic children with anger regulation problems.

Investigators studied the effectiveness of an attention-based intervention tailored on aggressive behavior problems and the use of anger coping strategies of school aged autistic children with anger regulation problems. Using a randomized controlled trial (RCT), children were allocated to the attention-based treatment in combination with a psycho-educational parent-training (treatment group) or to the parent-training only (active control group).

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of autism spectrum disorder
* age 8 - 13
* seeking treatment for aggressive behaviour problems

Exclusion Criteria:

* psychotropic medication still being set
Role of NLRP3 in Periodontitis and Diabetes

NLRP3 plays a key role in endothelial function and may be a link for the known interaction of periodontitis and diabetes. The investigators compared the impact of gingival health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum NLRP3levels.

The aim of this study was to evaluate a possible association between NLRP3 and gingival health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum NLRP3 levels.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)

The Purpose Project intervention is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of women with breast cancer to evaluate the feasibility of the Purpose Project intervention in terms of demand/acceptability, implementation, and limited-efficacy testing. Findings will be used to inform a later study to evaluate the efficacy of the Purpose Project intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Between 25 and 74 years of age
2. Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment
3. English speaking
4. Graduated from high school
5. Able to see, hear, speak (with or without assistive devices)
6. Able to provide own transportation to sessions
7. Willing and able to commit to attend all 8 intervention sessions, 2 testing sessions, and the one-to-one interview that occurs after completing the 8 intervention sessions.

Exclusion Criteria:

1. Stage 4 breast cancer or any other stage 4 cancer
2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
3. History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
4. Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
Exercise Timing on the Morning Blood Pressure Surge

The goal of this clinical trial was to assess the effects of morning vs. evening high-intensity interval exercise on the magnitude of the morning blood pressure surge in young healthy adults. The main questions it aimed to answer were:

* Does the timing of high-intensity interval exercise modulate the magnitude of the morning blood pressure surge?
* Do sex differences exist?

Participants came in and completed a bout of high-intensity interval exercise in the morning (8-10 am) and evening (5-7 pm) as well as a no exercise control, and ambulatory blood pressure was assessed for 24 hours afterwards.

Introductory Visit:

Participants came in for 4 visits. The first visit was an introductory visit where chronotype, eligibility for exercise, and anthropometrics were measured. This was followed by a maximal incremental exercise test to determine aerobic capacity (i.e., V̇O2peak) on a cycle ergometer, and instrumentation of an ambulatory blood pressure monitor for familiarization during daily activities and sleep.

Intervention Visits:

Three intervention visits (control, morning exercise, and evening exercise) were completed. The order was randomized using and each visit was separated by a minimum of 36 hours. Each intervention visit began by obtaining the participant's resting blood pressure and heart rate and ended with the instrumentation of the ambulatory blood pressure monitor. No exercise was performed during the control visit. The morning exercise visit included a bout of high-intensity interval exercise between 8-10 am and the evening exercise visit included a bout of high-intensity interval exercise between 5-7 pm. The high-intensity interval exercise protocol consisted of a light intensity, 3-minute warm-up at 15% peak power followed by ten 1-minute work intervals at 80% of peak power, with each interval separated by 1-minute rest intervals at 15% peak power. A 3-minute cool down was performed at 15% peak power.

Eligibility Criteria:
Inclusion:

* Between 18-50 years of age.
* No history of known disease.
* None smokers.
* No use of chronic medications other than oral contraceptives.

Exclusion:

* \<18 years of age.
* \>50 years of age.
* Cardiovascular disease.
* Metabolic disease.
* History of smoking (within the past 3 months).
* Chronic medications (other than oral contraceptives).
Treatment of Mild and Subthreshold Depressive Disorders

The purpose of this study is to determine the efficacy of a SSRI, cognitive-bahavioral-therapy and a free choice between SSRI and CBT in a sample of primary care patients suffering from mild to moderate depression.

Hypotheses:

* SSRI is superior to placebo
* CBT is superior to a non-specific supporting group therapy


Eligibility Criteria:
Inclusion Criteria:(e.g.)

* subthreshold and mild depressive disorders including dysthymia (HAMD: 8-22)
* informed consent
* 18 years

Exclusion Criteria:(e.g.)

* severe mood disorders
* bipolar disorder
* recurrent brief depression
* suicidality
* alcohol or drug dependency
* obsessive-compulsive disorder
* schizoaffective disorder / schizophrenia
* pregnancy
Multimodal Sexual Dysfunction Intervention In HCT

This research study is evaluating the impact of an intervention to improve sexual function in stem cell transplant survivors on participants' sexual function, quality of life, and mood.

It is expected that about 120 people who have undergone a stem cell transplant will take part in this research study.

Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The Investigators want to know if the introduction of an intervention focused on improving sexual function may improve a participant's overall care and quality of life.

The main purpose of this study is to compare two types of care - the study intervention versus enhanced standard care which includes receiving an educational handout about sexual dysfunction. The main goal is to assess if the intervention will improve participant's sexual function, quality of life, and mood.

The intervention includes a comprehensive assessment by a transplant clinician (a transplant physician or nurse practitioner) who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve symptoms.

-- If the transplant clinician feels additional help is needed by a sexual health expert, the participant will be referred to the sexual health clinic. In the sexual health clinic, the participant will be evaluated by an expert physician who will also focus on strategies to improve sexual function.

The study will use a series of questionnaires to measure sexual function, quality of life, physical symptoms, and mood. Study questionnaires will be completed in the clinic or remotely with assistance provided as needed.

.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years) with hematologic malignancy who underwent autologous or allogeneic HCT ≥ three months prior to study enrollment.
* Positive screen for sexual dysfunction that is causing distress based on the National Comprehensive Cancer Network (NCCN) survivorship guidelines
* Ability to read and respond to questions in English or to complete questionnaires with assistance from an interpreter.

Exclusion Criteria:

* Patients with relapsed disease requiring treatment
* Patients with a planned second transplant
* Patients \> 5 years from their HCT
* Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures.
The Bioseal Vascular Study

To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects between 18 and 75 years of age;
2. Undergoing elective vascular surgical procedures and with the presence of an appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ;
3. Able and willing to comply with procedures required by protocol;
4. Signed and dated written informed consent prior to any study related procedures.

Exclusion Criteria:

1. Subjects with any intra-operative findings that may preclude conducting of the study procedures;
2. Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS;
3. Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
4. Subjects with known allergies to or previously used porcine derived products;
5. Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period.
6. The subject, in the opinion of the investigator, would not be suitable for participation in the study.
7. Subjects who participated in another trial within 30 days prior to the planned start of treatment.
Prismatic Lenses and tDCS in Neglect

The goal of this study is to to evaluate the effect and feasibility of a rehabilitation protocol with prismatic lenses associated with tDCS, compared to a prismatic lens rehabilitation protocol associated with sham stimulation, in reducing the signs of neglect in a group of patients with spatial heminegligence following ischemic stroke of the right hemisphere.

The secondary objective is to evaluate the impact of this rehabilitation protocol on functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* ischemic stroke
* hospitalization within 90 days of the event

Exclusion Criteria:

* heamorrhagic stroke
* history of neurological disease
* history of psychiatric disease
* use of alchool and drugs
Antibiotic Resistance In Eye Surgeries

In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of California, San Francisco (UCSF). We seek to gain a better understanding of how antibiotic use during the perioperative period influences local and systemic antibiotic resistance at the individual level.

Antibiotic use has saved millions of lives globally. However, this comes at the cost of selecting for antibiotic-resistant organisms at the individual and the community level. It is estimated that every year, approximately 700,000 deaths are associated with drug resistance globally. This places a significant burden on the public health system and the judicious use of antibiotics is more important than ever before.

The proposed masked, randomized controlled trial evaluates the effects of topical antibiotic use on the selection of antibiotic resistance determinants at the local and systemic levels. The results will provide guidance for antibiotic usage in ophthalmology and may have the potential to inform public health policies.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age
2. Undergoing cataract surgeries that would benefit from intracameral antibiotics
3. Able to provide swabs
4. Able to provide consent
5. Surgery of the second eye occurs at least 8 weeks after surgery of the first eye

Exclusion Criteria:

1. Same-day bilateral cataract surgeries
2. On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or anti-TNF inhibitors within past 3 months
3. On systemic antibiotic within past 3 months
4. On topical antibiotics within past 8 weeks
5. Allergies to fluoroquinolone
6. Patients needing glaucoma drainage device or trabeculectomy
7. Inability to consent
Post Anaesthesia Care Hypotension Prevention

The goal of this clinical trial is to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension both during and after surgery (24 hrs) in adults undergoing major abdominal surgery. The main question this trial aims to answer is:

• Does the use of the hypertension prediction index (HPI) decrease hypotension during surgery and in the post-operative period?

During and after their surgery, participants in the intervention group will be treated according to the HPI-algorithm.

Participants in the control group will be treated following the standard of care.

Rationale: Hypotension during and after surgery is associated with serious complications. Using a machine learning algorithm, hypotension can be accurately predicted. Edwards Lifesciences developed this algorithm, called "Hypotension Prediction Index" and integrated this in their hemodynamical monitors. Recent studies have shown a decrease in intraoperative hypotension when using the hypotension prediction index.

Objective: To investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension (time weighted average) both during and after surgery (24 hrs).

Intervention: Patients in the intervention group will be treated using the hypotension prediction index algorithm to prevent hypotension. In case of actual hypotension the treatment thereof is at the discretion of the anaesthesiologist.

Main study parameters/endpoints: The decrease in time weighted average of hypotension in the peri- and post-operative period.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Patients planned to undergo laparotomy surgery
* Patients that will receive an invasive arterial catheter as part of their procedure
* Patients that are planned to go to the post anaesthetic care unit (PACU) post-operatively

Exclusion Criteria:

* Patients with known arrythmias
* Patients with known severe heart valve disease
* Patients with the need for dialysis
* Clamping of the aorta or Pringle's manoeuvre during surgery
* Emergency procedures
Phase Analysis and Obstructive CAD on Rubidium PET

Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal blood flow to the heart secondary to narrowing of the heart vessels.

Phase analysis is a computer method that is applied after the PET test is done. It is used to determine when a region of the heart contracts relative to other heart regions in the heart beating cycle. Initial data suggest that regions of the heart with abnormal blood flow change the pattern of contraction from rest to stress conditions. That is, regions of the heart with abnormal blood supply become dyssynchronous when compared to the normal regions of the heart.

This study will investigate whether phase analysis may aid the visual interpretation of rubidium myocardial perfusion PET studies by determining the areas of the heart that are not beating in synchrony with the normal heart regions. This information will be used as a proxy for poor blood supply. The gold standard will be coronary angiography by which the percent narrowing of the heart vessels is assessed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* referred for myocardial perfusion imaging for suspected obstructive CAD
* 18 years of age or older.

Exclusion Criteria:

* Contraindications to regadenoson radionuclide imaging including severe reactive airway disease, unstable crescendo angina, high grade AV block, caffeine within 24 hours
* Documented prior myocardial infarction
* Severe claustrophobia
* Patients who may be pregnant.