cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)

The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.

Background:

Infant colic is one of the most common disorders in the first year of baby´s life. It is estimated to affect between 10 to 40 % of healthy born children in their first year of life. To determine the effectiveness of a protocol manual therapy in the treatment of colic, using the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in which children received the protocol manual therapy and counseling to parents and the Control group, in which parents received advice only.

Objectives:

To assess the effectiveness of visceral manual therapy to improve the symptoms on infant colic.

Eligibility Criteria:
Inclusion Criteria:

* Infants with medical diagnostic of colic following Wessel criteria.

Exclusion Criteria:

* Infant's parents without full capacity to answer the survey questions, such as the existence of intellectual disability.
* Babies with neurological disorders such epilepsy, meningitis, encephalitis, cerebral palsy, spina bifida, hydrocephalus, encephalopathy, Arnold Chiari malformation, syringomyelia and Huntington's disease.
* Babies with digestive disorders, such Crohn's disease, irritable bowel syndrome, peritonitis, intestinal malabsorption, hepatitis, diverticular bowel disease, esophagitis, Intussusception and Ulcerative Colitis.
* Babies with congenital diseases such Angelmen syndrome, Down syndrome, cystic fibrosis, haemophilia, Klinefelter syndrome, Neurofibromatosis, Patau syndrome and Tay Sachs syndrome.
* Babies with traumatology - orthopedic pathologies such idiopathic scoliosis, spondylolisthesis, Perthes disease, Meyer dysplasia, Marfan syndrome, Morquio syndrome and congenital hip dislocation.
* Babies with dermatological diseases such Atopic dermatitis, staphylococcal scalded skin syndrome, psoriasis, urticaria and disorders of skin pigmentation.
* Babies who are subjected to drug treatments that are not specific to the treatment of colic.
Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest

Survivors of a cardiac arrest frequently develop severe postanoxic encephalopathy. Derangements in cerebral blood after return of spontaneous circulation play an important role in the pathogenesis of postanoxic encephalopathy. In the present study we examine the effect of mild therapeutic hypothermia on cerebral blood flow and carbondioxide reactivity in patients after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* GCS after return of circulation \< 7
* Induced mild hypothermia for 24 hours
* primary rhythm ventricular fibrillation

Exclusion Criteria:

* Thrombolysis
* Cardiogenic shock with expected survival \< 24 hrs
* Pregnancy
* No informed consent
Pain Control Following Sinus Surgery

Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).

This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI).

The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English-speaking
* Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS)
* Can commit to follow up for at least one postoperative visit

Exclusion Criteria:

Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery)

* Doyle splints to be used
* Alcohol or opioid use disorder
* History of chronic pain disorders
* Regular use of acetaminophen/NSAIDS (\>4x per week)
* Patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average.
* Gastrointestinal ulcers or bleeding
* Chronic kidney disease/known decreased renal function (estimated glomerular filtration rate \<60)
* Liver cirrhosis or other hepatic impairment
* Prior adverse reaction to opioids or NSAIDS
* Other contraindications to any drug classes in either group.
Anidulafungin in Treating Immunocompromised Children With Neutropenia

RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia.

PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.

OBJECTIVES:

* Determine the safety, tolerability, and pharmacokinetics of anidulafungin in immunocompromised children with neutropenia.
* Determine the frequency of deeply invasive fungal infections in children receiving this drug for early empirical therapy.

OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).

Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of 6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days or until patients recover from neutropenia or become eligible for standard empirical antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.

Patients are followed at 7-9 days.

PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Neutropenia due to cytotoxic chemotherapy or aplastic anemia

  * Duration expected to be 10 days
  * Absolute neutrophil count less than 500/mm\^3 OR less than 1,000/mm\^3 and expected to fall below 500/mm\^3 within 72 hours
* No deeply invasive fungal infection confirmed prior to study entry

PATIENT CHARACTERISTICS:

Age

* 2 to 17

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics

Hepatic

* AST or ALT no greater than 5 times upper limit of normal (ULN)
* Bilirubin no greater than 2.5 times ULN

Renal

* Creatinine clearance at least 30 mL/min

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 30 days after study participation
* No prior anaphylaxis attributed to the echinocandin class of antifungals
* No other concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* More than 4 weeks since prior investigational drugs
* No prior participation in this clinical trial
* No prior anidulafungin
* No other concurrent investigational drugs
* No other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents)

  * Concurrent oral, nonabsorbable azoles and topical antifungal agents (e.g., nystatin and/or azole formulations) allowed
* Concurrent broad-spectrum antibiotics allowed
The Efficacy and Tolerability of Canagliflozin in Healthy Individual

The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.

The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol.

This study is designed to mitigate the effects of glucose with intermittent oral Canagliflozin for healthy, non-diabetic volunteers of any sex who enroll in the study. Participants will provide informed consent via AgelessRx electronic medical record. If eligible, prescriptions will be provided online through the AgelessRx website (www.agelessrx.com). Participants will be randomized into two arms: Arm A will take 100 mg of canagliflozin each day for a total of 7 doses, while Arm B will take 150 mg of canagliflozin every other day for a total of 4 doses. Participants in Arm B will also be provided a pill cutter to use throughout the trial on the 300mg tablet.

All participants will begin the trial on the day that they apply a continuous glucose monitor (considered Day 0) and will be asked to take daily blood pressure reading. After one week of baseline readings, both arms will start their canagliflozin dosing protocols.

Participants will be asked to complete 7 total surveys to outline side effects and tolerability, one each day starting after their canagliflozin consumption.

Participants will be asked to complete a dietary intake journal through Day 0 -Day 14. Lifesum (https://lifesum.com/) should be used to track Carbohydrate/Protein/Fat consumption. Participants will share their dietary intake journal twice over their participation (Day 7 \& Day 14).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-85
2. Any sex
3. Any ethnicity
4. Interest in taking Canagliflozin
5. Approved by the AgelessRx Medical team to take Canagliflozin
6. Willing and technically able to use and operate a continuous glucose monitor
7. Own a CGM-compatible phone
8. Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
9. Adequate cognitive function to be able to give informed consent

Exclusion Criteria:

1. Diabetes of any type
2. Taking metformin or any other glucose-lowering medication
3. Other diabetes medication
4. Active malignancy of any kind
5. Clinically relevant renal or kidney disease or dysfunction
6. History of eating disorder
7. Any diuretic
8. Taking any medication, or having any medical condition, that might interfere with the action of canagliflozin or the CGM sensor
Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed locally recurrent prostate adenocarcinoma \> 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
* Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
* Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
* American Urological Association Symptom Index Score (ie. IPSS) \< 15
* Baseline (post-XRT) serum PSA \< 10 ng/mL
* Prostate volume as measured by transrectal ultrasound (TRUS) \< 50cc
* ECOG performance status 0-1

Exclusion Criteria:

* Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
* Evidence of castrate resistance (defined as PSA \> 3 ng/mL while testosterone is \< 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases

This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.

Increasing evidence exist regarding the role of diet in the pathogenesis of inflammatory bowel diseases. One possible mechanism for the effect of diet on intestinal inflammation is modification of the gut microbial composition. However, the relationship between diet, the microbiome and intestinal inflammation is still vague.

The investigators plan to perform a crossover clinical trial. Seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the Mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. Based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75;
* Able and willing to sign an informed consent;
* Underwent pouch surgery because of refractory UC or Familial Adenomatous Polyposis (FAP) and have a functioning pouch.

Exclusion Criteria:

* Patients with ileostomy, stricturing disease, use of antibiotics in the month prior to inclusion, significant comorbidity that precludes the patient from participating according to the physicians' judgment, non-Hebrew readers, pregnant and lactating women.
Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic liver cancer that cannot be removed by surgery.

OBJECTIVES:

* Determine the efficacy of arsenic trioxide in patients with unresectable metastatic hepatocellular carcinoma.
* Determine the safety and tolerability of this drug in these patients.

OUTLINE: Patients receive a loading dose of arsenic trioxide IV over 1-2 hours once daily on days 1-5\* in week 1 and then twice weekly in weeks 2-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

NOTE: \*The 5-day loading dose is only administered during course 1.

After completion of study treatment, patients are followed at 30 days and then periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed hepatocellular carcinoma

  * Unresectable metastatic disease
* Ascites allowed provided it is minimal

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC \> 2,500/mm\^3
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 75,000/mm\^3

Hepatic

* Bilirubin \< 2.5 mg/dL
* AST \< 2.5 times upper limit of normal

Renal

* Not specified

Cardiovascular

* QTc interval ≤ 460 msec AND potassium and magnesium normal

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for ≥ 4 weeks after completion of study treatment for male patients)
* No blood, ova, or sperm donation during study treatment
* Potassium \> 4.0 mEq/dL
* Magnesium \> 1.8 mg/dL

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent biologic therapy

Chemotherapy

* More than 4 weeks since prior and no other concurrent chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* More than 4 weeks since prior and no concurrent radiotherapy

Surgery

* Not specified

Other

* No other concurrent investigational agents
Coronary Anatomy Study and Times Since the Onset of Acute Myocardial Infarction Symptoms in Women Until the Opening of the Artery (TAPAC Study)

TAPAC study is an an investigator-driven, observational, prospective,cohort aimed at evaluating differences between men and women in patients undergoing primary angioplasty : hospital medical care, successful markers myocardial reperfusion and the anatomical substrate by describing the underlying coronary anatomy will be compared.

TAPAC study is an an investigator-driven, observational, prospective,cohort aimed at evaluating differences between men and women in patients undergoing primary angioplasty : hospital medical care, successful markers myocardial reperfusion and the anatomical substrate by describing the underlying coronary anatomy will be compared.

Eligibility Criteria:
Inclusion Criteria:

Patients with:

* Aged 18 years or over.
* AMI (Acute Mycardial Infarction ) with ST segment elevation and indication of primary angioplasty in whom at least one diagnostic procedure with coronary angiography is performed.

Exclusion Criteria:

Patients with:

* Life expectancy of less than one year.
* Previous AMI.
* Previous coronary revascularization.
A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet

The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of healthy volunteers, when administered as an intact tablet taken orally, or as a crushed tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric (NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive a single dose of BMS-986205 twice during the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* Signed written consent form.
* Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
* Women participants must have documented proof they are not of childbearing potential.
* Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986205, and for a total of 110 days after the last dose of BMS-986205; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
* Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2).
* Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding.
* Any significant acute or chronic illness.
* Active tuberculosis (TB) requiring treatment, documented latent TB within the previous 3 years, or evidence of a past TB infection without documented adequate therapy. All participants will be required to have a QuantiFERON -TB Gold test performed at screening.
* History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital hemolytic anemias.
* History of cardiac arrhythmias and/or autonomic instability.
* History of pulmonary, renal or liver disease.
* History of Gilbert's Syndrome.
* Recent (within 6 months of study drug administration) history of smoking or current smokers, including use of electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
* Participants with active, known or suspected autoimmune disease. Participants with vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may enroll.
* Major surgery within 4 weeks of study drug administration.

Other protocol defined inclusion/exclusion criteria could apply.
The Use of a Recombinant DNA-based Hyaluronidase to Dissolve Fixed Amounts of Hyaluronic Acid Dermal Fillers

The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA) dermal fillers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Able to speak/write in the English language
* Negative Pregnancy Test on Day 1
* Proposed injection site must be free of any active inflammation

Exclusion Criteria:

* Pregnant or breast feeding
* History of keloid formation
* History of allergic reaction to hyaluronic acid dermal fillers, hyaluronidase, or any ingredients of the aforementioned products
* Active, uncontrolled inflammatory condition of any type
* History of allergic reaction to lidocaine