cyrilzakka/clinical-trials huggingface dataset:
The Impact of an Investment Based Intervention on Weight-loss and Beliefs About Food in Patients Post Bariatric Surgery

Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous pilot work by the lead researcher shows that successful weight loss is associated with the amount of investment the patient feels that they have made in their operation. For example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their family, social and work lives and has caused pain are more likely to lose weight after their operation. Therefore, it seems as if the greater the sense of investment, the greater the motivation to make the operation a success. The present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made, thus making their investment more salient to them. Using a trial design, half the patients will be asked to rate and describe the investment they have made in their operation just before surgery (focusing on the time and effort to organise the surgery etc) and 3 months after surgery (focusing on time off work for recovery, disruption of family and friends, pain of surgery, pain of having the stitches removed etc). All patients will record their weight, beliefs about food, intentions to change their behaviour and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. The impact of the investment based intervention will then be assessed to explore whether focusing on the investment involved in having surgery improves patient health outcomes by one year.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 or over
* having bariatric surgery at University College Hospital

Exclusion Criteria:

* if the patient does not understand English
* if the patient does not consent to take part in the study
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis

This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.

The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement.

Exclusion Criteria:

* Patients receiving mono-amino-oxidase inhibitors.
* Patients with history of hypertension, cardiac, or cerebrovascular disease.
* Women with confirmed pregnancy.
MyPhonak App Junior Pediatric Usability and Benefit Investigation

Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents between the ages of 7 and 17 years old.
* bilateral mild to severe hearing loss
* experienced hearing aid users for 6+ months

Exclusion Criteria:

* any additional disabilities to the hearing impairment
* inability to complete the study procedures
Uterine Artery Embolization for Symptomatic Fibroids

This study will evaluate the safety, efficacy , quality of life and patient satisfaction of uterine artery embolization for the treatment of symptomatic uterine fibroids. It will provide useful information in the development od guidelines in patient selection, procedural management and subsequent follow up.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms related to the pressence of uterine fibroids serious enough to consider surgical options
* Confirmation of fibroids by endovaginal and transabdominal ultrasound

Exclusion Criteria:

* Pedunculated fibroids
* Desire for fertility
* Carcinoma of pelvic organs
* Previous pelvic irradiation
* Bleeding diathesis and vasculitis
* History of allergiy to contrst medium
Health Outcomes of Parents With Cystic Fibrosis

This project will determine the health impact of parenthood on people with cystic fibrosis (CF). The study team will use retrospective data to provide relatively immediate evidence on parenthood's effect on pulmonary health.

This co-funded study sponsored by the National Institutes of Health and the CF Foundation (CFF) will seek to determine the health impact of parenthood on people with CF in the era of CF transmembrane conductance regulator (CFTR) modulators. To provide relatively immediate evidence on parenthood's effect on pulmonary health and the influence of the introduction and use of all available CFTR modulators, in Aim 1 the study team will assess changes in pre- vs. intra-parenthood percent predicted forced expiratory volume in 1 second (ppFEV1) in a retrospective longitudinal cohort study linking CFF patient registry (CFFPR) data with cross-sectional surveys collected from 249 new parents attending participating United States CF centers between 2012-2022. The study team will identify predictors and timing of lung function loss using 747 non-parents from participating centers as a comparison group and examine the impact of CFTR modulators on parental health.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed CF diagnosis with sweat or genotype analysis
* Participant in the CFFPR
* Became a first-time parent between the years 2012-2022 (exposure arm only)

Exclusion Criteria:

* Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)
* Does not speak/read English or Spanish
T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System

This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.

PRIMARY OBJECTIVES:

I. Perform a phase I clinical trial to clearly define the toxicity profile of IV HER2Bi armed T cells in patients with neoplasms of digestive system.

SECONDARY OBJECTIVES:

I. Evaluate phenotype, cytokine profiles and tumor markers, cytotoxicity directed at laboratory Her2 positive cancer cell lines.

II. Evaluate the clinical symptoms and signs, clinical responses, imaging examination of pretherapy and post-treatment, cytokine profiles and tumor markers in serum before and after treatment, time to progression, and overall survival.

OUTLINE: This is a safety study of IV infused HER2Bi-armed activated T cells. Patients receive HER2Bi armed T cells IV weekly for 4 weeks. Patients also receive low-dose Interleukin subcutaneously (SC) daily beginning 3 days before the first HER2Bi armed T cells infusion. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with Her2-positive neoplasms of digestive system: IHC 3+
2. Clinical staging: Phase III or above
3. Ages: \< 65
4. Expected survival time: \> 1 year
5. Quality of Life: \> 60
6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal
7. The volunteers with informed consent

Exclusion criteria:

1. Patient with Her2-negative neoplasms of digestive system
2. Hepatic renal dysfunction
3. Cardiopulmonary insufficiency
4. Mental disorder
5. Allergic condition
6. With other malignant tumor
7. Lactating women
8. Patients with infection or received chemotherapy in the past two weeks
9. Patient with autoimmune disease using immunosuppressive drug
10. Patient with organ transplantation with long term use of immunosupresive drug
Next-generation Sequencing of Colorectal Cancer Somatic Cells to Guide Genetic Susceptibility Gene Mutations Screening.

This is a prospective, single-center, clinical study.This study is to evaluate the feasibility of genetic susceptibility screening based on the detection of tumor tissue mutations by a NGS panel.

In this study, gene mutation profiling was performed on primary tissue samples from colorectal cancer patients who met relevant clinical screening criteria, unearthing suspected germline pathogenic mutations. At the same time, germline mutation detection was performed on peripheral blood leukocytes of patients, and the consistency between suspected germline mutations in tumor somatic mutation detection and control leukocytes was compared. Establishing the feasibility of tumor somatic mutation-based detection to guide genetic susceptibility screening.Pedigree verification will be carried out for blood relatives of patients with germline mutations which have been identified for colorectal cancer.Through the tumor somatic and germline gene mutation profiles of Chinese hereditary colorectal cancer patients, it reveals the molecular characteristics of hereditary colorectal cancer in Asian populations and provides molecular-level evidence for possible subsequent clinical diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* A biopsy proven histological diagnosis of colorectal carcinoma.
* ≥ 18 years of age on the day of signing informed consent.
* Patients must meet the relevant clinical screening standards, such as the Amsterdam Standard (I / II),etc.
* Patients need to provide tumor tissue samples and matched peripheral blood (leukocyte) samples.

Exclusion Criteria:

* History of other malignant tumors(except for cervical carcinoma in situ, basal or squamous cell skin cancer which has been fully treated).
* There is no detailed histopathological report to judge the nature of the lesions.
* Any social or psychological problems, etc., which are judged by the researcher to be unsuitable for the study.
* For various reasons, the baseline samples (tumor tissue samples, peripheral blood samples) were incomplete.
* Patients who are unwilling or unable to follow the research program for long-term and regular follow-up in current medical institutions.
* Failure to complete the follow-up within 2 years.
Inulin,SCFA Production and Metabolic Response

In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.

Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the ingested prebiotic inulin is fermented into SCFA and these SCFA have metabolic effects.

Eligibility Criteria:
Inclusion Criteria:

* Overweight, obese men

Exclusion Criteria:

* athletes
* diabetes mellitus
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy

This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. The purpose of this NIS is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to keep under control serum \[Na+\] and the guidelines for the management of this population in Italy.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years;
2. Male or female patients with a cytologically or histologically documented cancer diagnosis;
3. Moderate to severe hyponatremia: Na+ level cut off: \[Na+\] \< 130 mmol/L;
4. Physician diagnosed Moderate to severe hyponatremia secondary to SIADH (clinical or laboratory determined as per normal routine practice of treating physician);
5. No use of diuretic agents within the week prior to evaluation;
6. Willingness to participate in the study; subjects must give their written consent to participate.

Exclusion Criteria:

1. Use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction;
2. Subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia;
3. Life expectancy is lower than 3 months.
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)

The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.

The duration of treatment is 65 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen

Exclusion Criteria:

* Problems with immune system
* Recent illness with fever
Vitamin D and Chronic Renal Insufficiency

Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.

Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD) patients, because it is widely believed that any vitamin D deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin D.

However, correction of vitamin D deficiency with native vitamin D seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. It may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin D treatment.

We are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin D3 supplementation (40 000 IE per week in one capsule) is compared with placebo in a trial including 120 CKD patients with vitamin D deficiency. Multiple biological variables are monitored in order to assess any effect on the biological systems of interest.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease (CKD 3-5 amd renal transplanted patients)
* Age \> 18 years
* Vitamin D insufficiency or deficiency (25-OHD \< 50 nmol/l, 3 months before project start)

Exclusion Criteria:

* Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
* Hypercalcaemia (ca++ \> 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D)
* Uncontrolled hyperphosphataemia (s-phosphate \> 2,2 mmol/l)
* Sarcoidosis
* Malignant disease
* Psychotic disorders
* Pregnancy and lactation women
* Allergy to soya and peanut
Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser

The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.

50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated.

Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataracts
* Same variety of IOL inserted in all eyes

Exclusion Criteria:

* Previous glaucoma or retinal surgery
* Pupil not dilating beyond 6mm
* Zonular weakness or pseudoexfoliation
* Extensive corneal scarring
* High refractive error: Myopia greater than 10D, Hyperopia greater than 5D
Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?

This is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and Group 2-Neuropsychological consultation group.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center
* English speaking families

Exclusion Criteria:

* not english speaking
* diagnosed with type 1 diabetes within the last 6 months
Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available.

This study will involve multiple phases to answer specific research questions comparing anterior and posterior interbody fusion in patients with lumbar isthmic spondylolisthesis. The primary end point will be 1-year proportions of patients reaching minimal clinically important difference (MCID) in terms of leg pain measured by NRS leg. The secondary endpoints will be predetermined moderate to severe AEs, reoperations for nonunion, symptomatic adjacent segment disease, radiological alignment correction and correlation with HRQOL as well as economic analysis at 1, 2, 5 and 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older (or who have reached the age of majority in the participating province)
* Require surgical treatment for a diagnosis of single-level lumbar isthmic spondylolisthesis, any grade, in the lumbar and lumbosacral spine.
* Are able to communicate in English or French
* Anterior interbody fusion group will be defined as having had an anterior or oblique approach with a synthetic cage insertion, interbody bone graft without cage or plate-screw construct with or without posterior rod-screw construct
* Posterior interbody fusion group will have only posterior approach procedure.

Exclusion Criteria:

* Previous spinal surgery
* Specific pathology at level above and below:

  * Degenerative anterolisthesis
  * Pars defect above or below index level
BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk

The major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Newborn offspring or siblings of patients with type 1 diabetes with a HLA genotype conferring a high diabetes risk

Exclusion Criteria:

* If infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes
Electrical Vestibular Stimulation (VeNS): Assessment of AMPK & SIRT1 Following Repeated Usage

The vestibular system which is responsible for balance and equilibrium constitutes our sixth sense. Metabolic Syndrome is a constellation of metabolic abnormalities characterized by obesity, insulin resistance (diabetes mellitus), hypertension, and dyslipidemia. It is generally agreed that a combination of three or more of the following components must be present: large waist circumference, elevated triglyceride, decreased high-density lipoprotein (HDL) cholesterol raised blood pressure, and elevated fasting blood sugar (FBS). Sirtuin 1 (SIRT1) is one of seven mammalian orthologs of the yeast protein silent information regulator. It is a conserved NAD-dependent protein deacetylase that decreases in cells that have high insulin resistance. In vivo, insulin resistance and metabolic syndrome were associated with low SIRT1 gene and protein expression. SIRT1 plays an important role to stimulate AMPK in improving mitochondrial function both in-vitro and in-vivo. Adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK) is a key factor in regulating energy metabolism, placing it at the center stage in studies of diabetes and related metabolic disorders like metabolic syndrome. It was reported that over a period of 6 weeks regular vestibular rehabilitation exercises caused an increase in the expression of SIRT1. The sleep inducing effects of vestibular stimulation is well known. Earlier studies reported improvement in the scores of Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) followed by the vestibular stimulation. Hence, we hypothesize that vestibular stimulation will lead to up-regulation of both SIRT1 and AMPK.


Eligibility Criteria:
Inclusion Criteria:

Male and female participants 35-60 years of age group Metabolic syndrome (BMI 25-35 kg/m2) Type 2 Diabetes Hyperlipidemia Willing participants

Exclusion Criteria:

Using Beta blockers Ear problems ( assessed during physical examination) Under any kind of therapy or treatment With severe complications Vestibular disorders
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
* ECOG performance status score of 0, 1, or 2
* Each patient must sign a study-specific informed consent form

Exclusion Criteria:

Laboratory values of:

* Absolute neutrophil count \< 2000/µL
* Platelet count \< 100,000/µL
* AST or ALT \> 2 x the upper limit of normal (ULN)
* Alkaline phosphatase \> 5 x ULN
* Bilirubin \> 2 x ULN
* Creatinine \> 2.0 mg/µL

and

* Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
* Women who are pregnant or lactating