cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Phage Therapy for Chronic Constipation Efficacy and Safety

The overall aim was to evaluate the efficacy of PiB-specific phages for the treatment of refractory constipation through clinical studies, primarily for the publication of scientific papers and to guide the development of phage therapies. The purpose of this study will be subdivided into three aspects from three aspects: target exposure level, target occupation, and functional effects after acting on the target, including:1) The distribution of PIB phage in the intestine of patients with refractory constipation;2) The killing effect of PIB phage on PIB bacteria in refractory constipation patients;And 3) therapeutic effect of PIB phage on patients with refractory constipation.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged 18-70 years, with confirmed chronic constipation and positive fecal bacteria test for PIB, agreed to participate in this experiment and signed an informed consent.

Exclusion Criteria:

* Severe heart failure, hypertension, cerebrovascular disease (e.g. stroke, moyamoya disease, etc.); Secondary constipation caused by psychotropic drug abuse; Pregnant or lactating women.
4Rs for a Better Family

The goal of this clinical trial is to learn about the effects of a family conflict intervention in Chinese New Arrival families in Hong Kong.

The main questions it aims to answer are:

* Is the family conflict intervention group more effective to improve adaptive parent-child conflict resolution skills compared to the control group?
* Is the family conflict intervention group more effective to reduce parent-child conflicts compared to the control group?
* Is the family conflict intervention group more effective to improve adaptive parental conflict resolution skills compared to the control group?
* Is the family conflict intervention group more effective to enhance family harmony compared to the control group?
* Is the family conflict intervention group more effective to enhance family resilience compared to the control group?

Participants will be randomly assigned to one of the two groups: the family conflict intervention group and the handcraft-making group. For each group, parents will participate in 3 sessions independently, children will participate in 2 sessions independently, and parents and children will jointly participate in 1 session. Each session takes around 2 hours, and it takes 4 weeks to complete the full intervention. The family conflict intervention sessions include an introduction to the occurrence of family conflicts, communication skills training to prevent and address conflicts, and role play to practice the skills, etc.

Researchers will compare the family conflict intervention group and the handcraft-making group to see if the family conflict intervention group is effective in promoting conflict resolution skills, reducing family conflicts, and enhancing family resilience.


Eligibility Criteria:
Inclusion Criteria:

1. Parents who have newly arrived in Hong Kong for less than seven years, and their children who are studying in primary school grade 4 to secondary school form 3; or
2. New arrivals who have settled in Hong Kong for less than seven years and are studying in primary school grade 4 to secondary school form 3, and their parents; and
3. Parents and children must live together; and
4. Parents and children must participate together

Exclusion Criteria:

1. Self-reported serious emotional or mental illness by parent or child, or
2. Children with special learning needs
Emotional Dysregulation in Adult ADHD.

Attention deficit disorder in adults with or without hyperactivity (ADHD) is a common disorder, affecting around 3% of the population. ADHD increases the risk of psychiatric disorders (mood disorders, sleep disorders, personality disorders, addictive behavior), risky behaviors, and vocational difficulties. Emotional dysregulation (ED) constitute a major hindrance in the daily life of subjects, with a great impact on the general functioning and the quality of life of the patients.

The investigators want to determine the characteristics of patients with each type of ED (impulsivity, exacerbated emotional intensity, cyclothymia, borderline personality traits), and study the stability of these traits over time. Since circadian rhythms influence mood and circadian rhythms frequently occur in patients with ADHD, the investigators want to determine if there is a link between ED and instability in circadian rhythms. Finally, they would like to observe whether the ED evolves and according to whether or not treatment is taken


Eligibility Criteria:
Inclusion criteria:

* Male or female aged ≥ 18 years
* diagnosis of adult ADHD prior to inclusion
* Affiliated to a social health insurance
* Subject having dated and signed informed consent
* Subject having been informed of the results of the prior medical examination

Exclusion criteria:

* Mobility project preventing follow-up for 1 year (planned move)
* impossibility to give the subject information enlightened (subject in emergency situation, difficulties in understanding the subject, mental retardation, illiteracy or insufficient command of the French language ...)
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Pregnancy
* Breastfeeding
Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease

The benign uterine fibroid is part of the broader term uterine smooth muscle tumour, which also includes malignant myometrial tumours (MSTs) of varying malignancy (uterine sarcoma, cellular fibroid, STUMP (uterine smooth muscle tumours of uncertain malignant potential)).

Magnetic resonance imaging (MRI) is the most effective test for distinguishing a fibroid from a TMM, but its reliability is limited. This leads to inappropriate management in a number of situations. The first is the risk of overtreatment by performing surgery for a suspected TMM on MRI in a patient with few or no symptoms and a final histological diagnosis of fibroid. The second is the risk of unsatisfactory or even harmful cancer surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM. Finally, there is the possibility of treating a lesion labelled as a fibroid on MRI with an alternative technique (embolisation, radiofrequency, HIFU) when it is in fact a TMM, thereby delaying appropriate treatment and worsening the prognosis.

Ultrasound-guided transuterine vaginal biopsy (ETVB) is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis. It would make it possible to obtain a histological diagnosis without the need for surgery, thereby avoiding the inappropriate management described above.

The aim of this study is to validate an innovative minimally invasive surgical technique (BVTE) for the diagnosis of uterine smooth muscle tumours by biopsy, to assess the complications associated with the technique and any potential adverse effects, and to evaluate the feasibility of the technique in current practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age consulting the CHU de la Conception who require surgical treatment for uterine smooth muscle tumours (fibroma or TMM).
* Able to give written consent
* Beneficiary or beneficiary of a social security scheme

Exclusion Criteria:

* Person in a period of exclusion from another research protocol at the time of signing consent/no objection
* Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code, i.e. :
* Pregnant women, women in labour and nursing mothers
* Persons deprived of their liberty by judicial or administrative decision
* Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8
* Minors
* Adults subject to a legal protection measure or unable to express their consent.
* A person who does not have a sufficient command of reading and understanding the French language to be able to consent to participate in the research.
* Any other reason which, in the opinion of the investigator, could compromise the safety of the research participant and/or interfere with the evaluation of the objectives of the research.
Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia

To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

The primary aim of this research is to identify the most robust site for monitoring hypovolemia as well as assess changes in peripheral waveforms monitored by the pulse oximeter collected from different sites (finger, ear, forehead, and nose), blood pressure, cerebral oximetry and peripheral venous pressure during gradual hypovolemia induced by lower body negative pressure (LBNP) in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

\* Healthy volunteers aged 20-45 with

Exclusion Criteria:

* Pregnant women
* Under 20 years of age
* Subjects with coronary artery disease, diabetes, epilepsy and hypertension
Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent；
2. Histological or cytological documentation of adenocarcinoma of the colon or rectum；
3. Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
4. Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
5. ECOG PS:0-1,Life expectancy of more than 3 months；
6. main organs function is normal；
7. main organs function is normal；

Exclusion Criteria:

1. Prior treatment with Anlotinib；
2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
3. Known brain metastases；
4. patients with severe and failed to controlled diseases；
5. patients occurred venous thromboembolic events within 6 months；
The Sense of Small and Inhibition in Obesity

The aim of this research is to verify whether inhibitory control ability is different between a group of individuals with obesity and a group of individuals with normal weight in the presence of olfactory stimuli, different for valence, edibility (food versus no-food), and caloric density (high-calorie vs low-calorie content) of foods associated with odours.


Eligibility Criteria:
Inclusion criteria:

* Right-handed
* diagnosis of obesity (i.e., the level of body mass index (BMI) higher or equal to 30).

Exclusion criteria:

* Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa

This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been implemented among HIV-positive men and women in the general population in North West province, South Africa, by members of this research team.


Eligibility Criteria:
Inclusion Criteria:

* Biological male;
* Age \>=18 years;
* Self-identify as a gay or bisexual man, or a transgender woman;
* Have male sexual partners within the prior six months
* Resident in the Ehlanzeni District Municipality for at least six months of the year;
* Be physically present in Ehlanzeni for at least two weeks per month
* Self-disclosed receiving an HIV-positive diagnosis in the last 5 years;
* Consent to all serological testing for HIV antibodies, ART analytes, and HIV RNA
* Consent for study staff to review participants' clinical records;
* Consent to the randomization process.

Exclusion Criteria:

* Inability to provide written informed consent for participation, including being under the influence of alcohol or drugs.
* Inability to provide laboratory or documentary evidence of HIV diagnosis.
Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions

Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.

This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \>18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study

Exclusion Criteria:

* Patients who refuse to participate in the study.
* Patients with pedunculated, depressed or mixed lesions.
* Patients with lesions smaller than 10 mm or larger than 40 mm.
* Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
* Patients with lesions that were submitted to prior attempt to endoscopic resection.
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of CF
* Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
* Have oxygen saturation greater than or equal to 90% on room air
* Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
* Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

* Have changed their physiotherapy technique or schedule within 7 days prior to screening
* Have clinically significant comorbidities
* Using prior and concurrent medications according to the protocol
Cardiovascular Outcomes Of Diet Counseling

(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Given the current epidemic of overweight and obesity on a global scale ("globesity") and the consequent world public health objective of reducing that obesity, it is evident as a practical matter that, the main line of attack must be through diet. The public health objective and the lack of information regarding the long-term public health effects of alternative weight-loss diets motivated this comparative study of the three major types of weight-loss diets and their long term effects on coronary blood flow. Secondary endpoints are inflammatory and other variables associated with heart disease and obesity.

Specifically we asked: (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Eligibility Criteria:
Inclusion criteria: BMI greater than 30,

Exclusion criteria: pre-existing co-morbid diseases (documented heart disease, diabetes mellitus, cancer, hypertension, hepatic, renal or gastrointestinal disease), pregnancy or plans for pregnancy. Participants could not be smokers (cigarettes, cigars, pipes or chewing tobacco), take medications (prescription or over the counter medications with the exception of antibiotics), nor take vitamin or mineral supplements. Additionally, they could not currently be on a diet or have been on one during the last 6 months, or have food allergies that would influence food choices.
Effect of Fish Oil on Insulin Sensitivity

The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine oil improves insulin sensitivity and glucose control in subjects with impaired glucose regulation.

The incidence of Type 2 diabetes is related both to age and obesity. The disease impacts on quality of life and treatments represent a major health cost. Prevention or delayed onset of the disease remains a key target. Animal studies have shown that provision of high amounts of fish oil in the diet improves insulin sensitivity but human trials have proved equivocal. Recent dose-response trials in animals have shown the improved insulin sensitivity only occurs when the proportion of n-3 long chain polyunsaturated fatty acids (n-3 PUFA), docosahexaenoic acid and eicosapentaenoic acid, exceeds 14% of the total phospholipid fraction within tissue cell membranes. To achieve such values in humans would require a high dose of n-3 PUFA supplied over a prolonged period of time. This is tested within the current study where a daily dose of 6 g day of fish oil (containing a total of 3g docosahexaenoic acid plus eicosapentaenoic acid) is supplied for 9 months. As well as improving control of glycemia increased insulin sensitivity may also enhance protein metabolism and reduce the impact of frailty in older subjects.

Eligibility Criteria:
Inclusion Criteria:

* Men and post-menopausal women aged 40-65 years
* Recruited from the surrounding community of Aberdeen
* Insulin resistance with either

  1. venous plasma fasting glucose \> 5.0, \< 7.0 mmo/l,
  2. venous plasma 2-h 75-g OGTT \> 5.0, \< 11.1 mmol/l
  3. newly diagnosed with type 2 diabetes; must be asymptomatic and detected during our screenings and not require oral hypoglycemic or insulin therapy, HbA1c \< 7.0%

Exclusion Criteria:

* Diabetes requiring oral hypoglycemic therapy or insulin
* Treatment with anticoagulants, regular steroids or non-steroidal anti-inflammatory drug treatment, tricyclic antidepressants, anti-arrhythmics
* Hepatic failure
* Renal failure
* Significant respiratory disease
* Anaemia
* Cardiovascular disease
* Malignancy
* Thromboembolic or coagulation disorders
* Alcoholism or other substance misuse
* Eating disorders or significant psychiatric disorders
Effects of Mexiletine on Colonic Transit in a Patient With Irritable Bowel Syndrome - Constipation (IBS-C)

To understand if Mexiletine will restores normal colonic motility in a patient with irritable bowel syndrome - constipation (IBS-C) and a genetic mutation in SCN5A.

To understand if Mexiletine will restore normal colonic motility in a patient with a missense mutation in SCN5A, which encodes a voltage-sensitive sodium channel NaV1.5 as it is known to rescue certain expression defects of NaV1.5 in vitro.

Eligibility Criteria:
Inclusion Criteria:

* Established IBS diagnosis with a known A997T mutation in NaV1.5T

Exclusion Criteria:

* Normal 48-hour baseline transit study
* Current use of mexiletine
* Inability to stay in Rochester for 9 days for testing
* Known allergy to mexiletine
* Inability to complete daily diary
* Taking a medication known to affect myotonia, had a coexisting neuromuscular disease, or had another serious medical illness including second- or third-degree heart block, atrial flutter, atrial fibrillation, ventricular arrhythmia, history of cardiac arrhythmia requiring medication, congestive heart failure, symptomatic cardiomyopathy, or symptomatic coronary artery disease
* Inability to withdraw medications known to interact with mexiletine. Patient is currently not on any of these medications
Intermittent Compression Maneuver of Upper Arm to Reduce Axillary Brachial Plexus Block Onset Time

This study evaluates the addition of intermittent pneumatic compression maneuver to axillary brachial plexus block in forearm and hand surgery. Half of participants will receive axillary brachial plexus block and intermittent pneumatic compression maneuver, while the other half will receive only axillary brachial plexus block.


Eligibility Criteria:
Inclusion Criteria:

1. adults between ages of 20 and 50
2. patients who are scheduled forearm and hand surgery with axillary brachial plexus block
3. American Society of Anesthesiologists Physical Status classification 1 or 2
4. patients who voluntarily agree to participate in the trial

Exclusion Criteria:

1. patients who are pregnant or lactating
2. patient who does not agree to participate in the study
3. patient with side effects on local anesthetics
4. patient with neurologic deficit of upper arm
5. patients with comorbidities of cardiac, pulmonary, renal, cerebral, and hepatic systems
6. patients with peripheral vascular disease