cyrilzakka/clinical-trials huggingface dataset:
Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.

In this trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health-related quality of life in infants exhibiting symptoms possibly related to cow's milk, compared to a cow milk-based formula.

Gastrointestinal symptoms are frequent in the first 6 months of life in otherwise healthy infants fed cow milk-based infant formulas (CMF). In management special infant formulas may be considered, although none is routinely recommended. Goat milk-based infant formulas (GMF) have shown promising effects on digestion and increased gastric emptying in several in vitro studies.

In this trial, a total of 158 participants at age 14 to 90 days, who exhibit gastrointestinal and/or other symptoms associated with CMF consumption, as assessed with the Cow's Milk-related Symptom Score (CoMiSS) between 6 and 10 will be randomly allocated to GMF or CMF for four weeks. The primary outcome will be the proportion of infants showing a reduction of at least 4 points in CoMiSS following the four-week intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants with a gestational age between 37 and 42 weeks.
* Infants who have received cow's milk infant formula for at least 7 consecutive days.
* Exclusive formula feeding.
* Cow's Milk-related Symptoms Score (CoMiSS) value at baseline between ≥6 and \<10.

Exclusion Criteria:

* exclusive or partial breastfeeding (or feeding human milk)
* introduced to solid food/supplementary feeding
* any congenital or chronic condition
* previous or present gastrointestinal illness or malformation that could interfere with study parameters
* diagnosed cow's milk allergy
* receiving medication with regard to functional gastrointestinal disorders (i.e., reflux medication)
* sibling already participating in this study, and/or participating in another clinical trial.
The Effect of Inhibitory Control Processes Induced by Rectal Distension on Impulse Control Measured by Stroop Task Performance and Intertemporal Discounting.

The aim of this study will be to investigate the effect of rectal distension, controlled by electronic barostat, on cognitive control ability in healthy subjects. We will use the Stroop task and an intertemporal choice task as standard instruments. Like bladder control and rectal control, both Stroop task performance and intertemporal choices - though very different tasks at the surface - are dependent on the conflict monitoring function of the anterior cingulate cortex. The Stroop task requires the naming of the print color of a series of visually presented color words, and reaction time and error rates are typically used as performance indicators. When word color and word meaning do not match, performance of the task (color naming) requires the inhibition of a (near) automatic response (word reading). The intertemporal choice task consists of a series of choices between a sooner smaller monetary reward and a larger but later reward. The choices are constructed such that they allow the estimation of a discount parameter, which is an index for the level of impulsiveness manifested by the participant at the time the choices are made.

The hypothesis is that the inhibition induced by the urge generated during rectal distension will improve cognitive inhibitory performance, as has previously been shown for bladder filling.


Eligibility Criteria:
Inclusion Criteria:

* healthy male and non-pregnant, non-breastfeeding female participants, aged 18-60 years old at the time of consent.

Exclusion Criteria:

* use of medications within 48 h of dose initiation; structural or metabolic diseases that affect the gastrointestinal system and functional gastrointestinal disorders; previous abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as diabetes, cardiovascular or lung disease; current psychiatric disorders (anxiety, depression, substance use); use of agents that influence bowel habit, i.e. anticholinergics (not including antihistamines with anticholinergic properties), spasmolytics and prokinetics in the 7 days before the study.
Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer

This clinical trial evaluates the feasibility and acceptability of acupressure to the ear (auricular) to address appetite and weight in patients with stage II-IV gastric, esophageal, or pancreatic cancer. Cancer anorexia, the abnormal loss of appetite, directly leads to cancer-associated weight loss (cachexia) through malnourishment, reduced caloric intake, treatment side-effects, and other modifiable risk factors. Cachexia prolongs length of hospital stay for patients, negatively impacts treatment tolerance and adherence, and reduces overall patient quality of life. Auricular acupressure is a form of micro-acupuncture that exerts its effect by stimulating the central nervous system using adhesive taped pellets applied to specific locations on the external ear. The use of these pellets to deliver auricular acupressure has been shown to improve pain, fatigue, insomnia, nausea and vomiting, depression, and quality of life in both cancer and non-cancer settings. Auricular acupressure is a safe, inexpensive, and non-invasive approach to addressing cancer-related symptoms and treatment side-effects and may be effective at improving appetite and weight loss in stage II-IV gastric, esophageal, and pancreatic cancer patients.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.

ARM II: Patients receive usual care on study. Patients also undergo collection of blood samples on study.

After completion of study treatment, patients in Arm II are followed up at 8 weeks after active treatment ends.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Stage II-IV gastric, esophageal, or pancreatic cancer
* Appetite score on visual analog scale =\< 70/100
* Functional Assessment for Anorexia/Cachexia Treatment Subscale (FACT-ACS) score \< 37
* At least 60 days of planned systemic treatment, whether already initiated or scheduled to be initiated
* Access to phone and electronic device for study contacts and questionnaires
* Willing and able to attend 4 in-person auricular acupressure treatments at the Fred Hutch South Lake Union Clinic
* Willing and able to perform 4 at-home self-applied treatments of auricular acupressure
* Participants must not have received acupressure or acupuncture for low appetite within last 30 days
* Participants must not be actively using corticosteroids or immunomodulators for appetite stimulation at baseline
* Participants must be able to intake food orally and not require sole or supplemental intravenous nutrition at baseline
* Participants must not have a history of physiological eating disorders (e.g., anorexia nervosa) in the last 3 years
* Participants must not have a current known or diagnosed immunodeficiency
* Participants must have an intact auricular pinna
* Able to understand and willing to sign written informed consent in English
N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS

This project wants to determinate whether there is a relationship between the N680S polymorphism genotype of the FSHR gene and the nature of the FSH used in controlled ovarian stimulation.

It is a non-interventional, observational, cross-sectional and retrospective, national and multicenter study, in which a genetic test will be carried out to determine the genotype of the N680S polymorphism in samples of blood of patients who have undergone two cycles of controlled ovarian stimulation in the last 8 months.

The investigators want to investigate whether the N680S polymorphism of the FSRH gene could affects ovarian response with different nature of the FSH used (human FSH and recombinant FSH) in patients undergoing two consecutive cycles of IVF/ICSI with controlled ovarian stimulation.

All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital. The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation.

In order to avoid any bias, the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS (i.e., half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH; and, conversely, the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH). In order to avoid potential modifications to the inclusion criteria, the time elapsed between the two cycles should not exceed 6 months.

Eligibility Criteria:
Inclusion criteria:

* Signature of Informed Consent
* Age ≤ 37 years
* BMI \< 30 kg/m2
* Antral follicles count 1st cycle COS = 5-15
* Antimüllerian hormone basal 1st cycle COS \> 1,1 ng/ml and \< 3,1 ng/ml
* COS protocol: equal starting dose in the 2 cycles of COS (150-225 UI/day) with dose adjustment from the 5th day of COS; pituitary suppression protocol in the 2 cycles of COS with GnRH antagonist with onset when ≥ 1 follicle of ≥ 14 mm in diameter or E2 ≤ 600 pg/ml; and triggering with hCGr or GnRH agonist
* Optional the use of oral contraceptives (OC) (however, same in the 2 cycles)
* 4-9 recovered oocytes in the 1st cycle of COS
* ≤ 6 months between the 2 cycles of COS

Exclusion criteria:

* Use of the LH activity during the cycles of COS
* Presence of severe male factor
* Grade III-IV endometriosis
* Patients with polycystic ovary syndrome, a history of uterine or ovarian surgeries, hydrosalpinx visible by ultrasound, or uterine fibroids measuring \> 30 mm
* Major systemic or uncontrolled endocrine-metabolic diseases affecting the pituitary gland, the thyroid gland, the adrenal glands, the pancreas, the liver, or the kidneys
Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement

reverse shoulder replacement surgery is performed to improve the functionality and reduce pain of the affected shoulder. Now, it is necessary to carry out an appropriate rehabilitation process to optimize surgical results. The lack of health resources makes it essential for the patient to work autonomously once hospital rehabilitation is completed. But lack of adherence is one of the main barriers to recovery

The objective is to evaluate the effectiveness of a Chatbot that interacts with patients via instant messaging to supervise home rehabilitation and increase adherence. Conduct a feasibility study with a pilot sample

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing reverse shoulder replacement
* With a personal smartphone
* An instant messaging application installed
* Familiar with the use of such an application (i.e., at least three accessess per week)
* Able to write and read in the Spanish language

Exclusion Criteria:

* Condition, whether cognitive, neurological, integrative or musculoskeletal, that obviously prevents understanding or performing the exercises of the rehabilitation program or may pose a risk to the patient's health.
Reinitiation of Anticoagulation After Temporary Withdrawal of Vitamin K Antagonist

It is not known how to best restart warfarin after temporary withdrawal. Participants will be randomized to two groups. Group 1 will restart warfarin at their usual maintenance dose, group 2 will restart warfarin at double their maintenance dose for two days followed by their usual maintenance dose. The main outcome parameter will be the number of patients who are back in therapeutic INR (international normalized ratio) range 4, and 9 days after restarting anticoagulation with warfarin. Thromboembolic and/or bleeding events will be recorded as additional parameters. These data will be collected by a standardized telephone interview at 1 month. In addition, the investigators will evaluate a possible prothrombotic state by measuring the potential of thrombin generation and D-dimers in the subset of patients visiting HHS-General Hospital for their INR tests.

We will investigate if it is feasible to use double maintenance dose for the first two administrations of vitamin K antagonists when these drugs were temporarily interrupted and thus keep the time of an increased risk of thromboembolism and duration of "bridging" at a minimum. The control group will consist of patients who resume vitamin K antagonists at their usual maintenance dose. The aim of the study is to establish how to best restart anticoagulation with vitamin K antagonists after temporal withdrawal of these drugs. The main outcome parameter will be the proportion of patients who are back to a therapeutic international normalized ratio (INR) ratio at certain days after restarting vitamin K antagonists. Two additional parameters will be evaluated: Firstly, bleeding and thromboembolic complications will be reported and secondly, a possible prothrombotic state, measured as an elevation of D-dimer, at the initiation of anticoagulation will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Current treatment with warfarin
* Need for temporary interruption for invasive procedure or surgery

Exclusion Criteria:

* Need for post-operative hospitalization more than one day
* Participation in another clinical trial
* No consent given
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied


Eligibility Criteria:
Key Inclusion Criteria:

* Men and women age 18 and older
* 6-36 months after kidney transplant receiving cyclosporine or tacrolimus
* calculated GFR ≥35 and ≤75mL/min/1.73 m²
* subjects must have completed 1 year in the IM103-010ST and remained on study treatment (Long Term Extension)

Key Exclusion Criteria:

* Significant infection
* acute rejection within 3 months
* prior graft loss due to rejection
* pregnancy
* positive crossmatch
Mottling Score and Central Venous Oxygen Saturation in Septic Shock Patients

Mottling score and central venous oxygen saturation are described as a clinical evaluation of tissue perfusion. This study describes mottling incidence and mottling score in septic shock patients according to central venous oxygen saturation.

This study prospectively analyzed the data of patients admitted to our ICU between October 2022 to December 2022. All septic patients in whom the ScvO2 was measured and mottling scores were evaluated were included. This study enrolled patients aged ≥ 18 years in septic shock. Those excluded have peripheral arterial disease, black skin, cutaneous infection of the lower limbs, pregnancy, and relative refusal. The characteristics of patients were recorded at admission (H0), including demographics (age, sex, body mass index (BMI), admission the Acute Physiology and Chronic Health Evaluation (APACHE II) score, Glasgow Coma Scale (GCS) and sequential organ failure assessment (SOFA) score. Variables such as plasma lactate level, daily urine output, plasma creatinine level, the ratio of arterial oxygen pressure related to inspired oxygen fraction (PaO2/FiO2), hemoglobin level, heart rate, mean arterial pressure, pulsatile saturation in oxygen (SpO2) and body temperature were recorded at H0 and 6 hours after initial resuscitation (H6).

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years in septic shock.

Exclusion Criteria:

* patients having the peripheral arterial disease
* black skin,
* cutaneous infection of the lower limbs
* pregnancy
* relative refusal
68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies

68Ga-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer.

Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-JH04.

Eligibility Criteria:
Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency
European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.


Eligibility Criteria:
Inclusion Criteria:

* Men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice
* Germany only: Enzalutamide will be prescribed according to the current SmPC (Summary of Product Characteristics)

Exclusion Criteria:

* Patients with the following will be excluded from study participation in France only:

  * Patients who have previously been treated with abiraterone acetate (Zytiga®) after docetaxel chemotherapy.
  * Patients who have previously been treated with cabazitaxel (Jevtana®)
  * Patients who have previously been treated with Xtandi®
  * Patients taking part in an interventional clinical trial
Liver Positron Emission Tomography (PET) Study of Non Alcoholic Fatty Liver Disease

The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or without NAFLD who are scheduled to undergo gastric bypass surgery.

This study involves a multidisciplinary approach that will address the metabolic mechanisms responsible for Non-alcoholic Fatty Liver Disease (NAFLD) in humans. Nonalcoholic fatty liver disease (NAFLD) has become an important public health problem in many industrialized countries because of its high prevalence, potential progression to severe liver disease, and association with cardiometabolic abnormalities, including diabetes, the metabolic syndrome, dilated cardiomyopathy, and coronary heart disease. Although obesity is an important risk factor for NAFLD many obese persons have minimal or no steatosis. The mechanism responsible for the pathogenesis of steatosis is not known, but must involve one or more of the following:

1. Increased hepatic fatty acid (FA) delivery
2. Decreased hepatic FA oxidation
3. Increased de novo lipogenesis (DNL)
4. Inadequate hepatic triglyceride secretion

We hypothesize that alterations in all of these metabolic processes are involved in the pathogenesis of NAFLD. However, a comprehensive evaluation of these factors in individual cohorts of subjects has never been performed, and the ability to measure hepatic FA oxidation in vivo in human subjects has not been available.

The following Specific Aims will be evaluated in obese women with and without NAFLD, who are scheduled for bariatric surgery:

1. Determine hepatic FA uptake and oxidation by using novel PET techniques in combination with measurements of DNL using stable isotope tracers and by assessing liver tissue FA oxidative capacity by evaluating gene expression of FA oxidative enzymes and mitochondrial content.
2. Determine hepatic fatty acid delivery by using stable isotope tracers to assess the rate of free FA (FFA) release into plasma and cellular biology methods to determine the expression and protein content of the major tissue FA transporter (CD36).
3. Determine hepatic very-low-density lipoprotein TG (VLDL-TG) secretion rate by using stable isotope tracers.
4. Determine liver histology and factors involved in inflammation and fibrosis by using routine staining and immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* Obese females with a BMI of greater then or equal to 45.
* Age range between 18-45 years.
* Patients undergoing bariatric surgery at Barnes-Jewish Hospital-St.Louis,MO.

Exclusion Criteria:

* Any prior history or evidence of liver disease other than Non-Alcoholic Fatty liver Disease, severe hypertriglyceridemia and diabetes mellitis.
* Consumed greater then or equal to 20 grams of alcohol per day.
* Taking medications that are known to cause hepatic steatosis \& liver damage.