cyrilzakka/clinical-trials huggingface dataset:
Micronutrient Sprinkles in a Daycare Center

Diarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of micronutrient deficiencies including zinc. The primary aims of the proposed study are to evaluate the effect of the use of multiple micronutrient sprinkles including zinc on compliance of supplement use and the incidence of recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.

The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children attending day care

Exclusion Criteria:

* Chronic medical problems including sickle cell disease, congenital heart disease
Nitrous Oxide as a Putative Novel Dual-Mechanism Treatment for Bipolar Disorder

This study is a 7-day randomized, double-blind proof-of-concept pilot study of nitrous oxide vs. midazolam in 40 adults (20-60 years) with bipolar disorder (BD) (type I or II). Ongoing pharmacological and psychosocial treatments may continue, provided that they have not been initiated or significantly modified in the preceding 2 weeks. Participants' current treatment as prescribed by clinical psychiatrists will not be modified or interfered in this study. The study involves 3 visits. During study visit 1, participants will complete screening to ensure study eligibility. This will be done using interview measures. During study visit 2, participants will complete anthropomorphic measurements, measurement of endothelial function, screening blood work, ECGs, and an anaesthesia screener. During study visit 3, participants will receive the treatment (nitrous oxide or midazolam), complete an MRI scan, and complete interview measures and self-reports. There will be anthropomorphic measurements taken as well. The participant will be required to complete phone interviews and self-reports over the subsequent 7 days. There are 4 main predictions: 1. Nitrous oxide will significantly reduce depression symptoms vs. midazolam. 2. Nitrous oxide will significantly increase frontal cortical perfusion vs. midazolam. 3. Lower perfusion in frontal cortical regions at baseline will be associated with greater improvement in depression symptoms following nitrous oxide treatment. 4. Poorer endothelial function will be associated with greater improvement in depression symptoms following nitrous oxide treatment.


Eligibility Criteria:
Inclusion Criteria:

English-speaking; age 20-60 years; BD-I or BD-II, current major depressive episode ≥4 weeks duration; MADRS≥22; taking ≥1 mood stabilizing medication/s (i.e. antimanic anticonvulsant, antipsychotic, and/or lithium).

Exclusion Criteria:

New medications or changes in dosing, or ECT or TMS, in the preceding 2 weeks; MADRS item 10, \> 4; YMRS≥12; acute significant suicidality; psychosis; substance abuse (past 3 months); active major medical conditions (hepatic, renal, respiratory, or cardio/cerebrovascular disease; diabetes; esophageal reflux; sleep apnea); B12 deficiency/disorders; pregnant; MRI contraindications; history of adverse anaesthetic reactions; anaesthesia class \>2; scuba diving in preceding week.
RCT of Low-dose Clomiphene vs. High Dose Gonadotropin Protocol for IVF Poor Responders

The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.

The objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 IU) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol.

Patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the LH surge, with high dose gonadotropins (600IU) alone, starting on day 2 of the cycle. After randomization, patients will undergo routine IVF procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-42 undergoing IVF
* AFC \<7 (see definition above) and AMH (see definition above) \<0.5 and/or prior poor IVF response

Exclusion Criteria:

* BMI (body mass index) \>30
* PGD (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities)
* Age \>42
* Fragile X carriers (a condition associated with premature ovarian aging)
* TESE (Testicular sperm extraction)
* Asherman's syndrome (uterine scarring which can affect implantation and pregnancy)
* Untreated hydrosalpinx (accumulated fluid in the fallopian tube which may be toxic to embryos)
* \>6 prior attempted cycles
Predictors of Postoperative Pain

This is a retrospective chart review using TriHealth Electronic Privacy Identification Center (EPIC) and previously developed databases for TriHealth Institutional Review Board (IRB) approved research studies within the Division of Urogynecology and Reconstructive Pelvic Surgery to determine the predictors of postoperative pain specific to the urogynecologic patient population.

Postoperative pain remains the most important consideration for both patients and surgeons. Therefore, there has been much attention brought toward investigating predictive factors of postoperative pain. A systematic review of 48 eligible studies with 23,037 patients showed preexisting pain, anxiety, age, and type of surgery are the four most significant predictive factors for the intensity of postoperative pain. However, this paper evaluated all types of surgical approaches. More recently, a prospective observational study showed that preoperative State Trait Anxiety Inventory (STAI) and Numerical Rating Scales (NRS) for anxiety and pain expectations are independent predictors of pain and morphine consumption following abdominal hysterectomy. To date, little is known about the predictive factors of postoperative pain in the urogynecologic patient population.

The purpose of this study is to determine the predictors of postoperative pain specific to the urogynecologic patient population. We aim to investigate the relationship between perioperative factors (such as demographics and medical history) and postoperative pain scores on postoperative day 1 with patients who have undergone urogynecologic surgery, specifically vaginal reconstruction for pelvic organ prolapse.

This information would not only fill a gap in knowledge, but would also allow us to counsel our patients more accurately in regards to postoperative expectations. Furthermore, if we find any positive correlation between modifiable perioperative factors and postoperative pain scores, we may be able to minimize these effects in future surgical cases.

Eligibility Criteria:
Inclusion Criteria:

* Participant in one of six research studies previously performed by the Division of Urogynecology and Pelvic Reconstructive Surgery (#13090, #13072, #12136, #12132, #10072, or #09001)
* Postoperative pain scoring data complete and available
* Vaginal reconstructive surgery as primary treatment
* General anesthesia

Exclusion Criteria:

* Incomplete or unavailable postoperative pain scoring
* Robotic sacrocolpopexy patients will be excluded
Effect of Ketamine+Propofol vs Remifentanyl+Propofol on Laryngeal Mask Insertion Conditions

Laryngeal mask airway is a common tool for airway management during anesthesia in many surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to compare the insertion conditions of laryngeal mask by using ketamine+propofol versus remifentanil + propofol.


Eligibility Criteria:
Inclusion Criteria:

* Surgery requires laryngeal mask

Exclusion Criteria:

* Patient refusal, abdominal surgery required muscle relaxant, any allergy to ketamine or remifentanyl
Rehabilitation by Multifactorial Approach After a Latarjet Procedure

Kinesiophobia (fear of physical movement) is common after a previous shoulder dislocation and persists after one year, regardless of the occurrence of a recurrence. This kinesiophobia is associated with a lower level of physical activity and a lower return to sport. Increased kinesiophobia, combined with other psychological factors such as depression and fear of re-injury in patients with shoulder instability, results in poor outcomes after treatment. Given that there is currently no postoperative protocol that takes this psychological component into account, a new rehabilitation protocol focused on reducing kinesiophobia was recently designed as part of an international consensus study based on the method Delphi. This protocol includes a core set of evidence-based interventions aimed at regaining functional stability of the shoulder and reducing fear of recurrent dislocation and kinesiophobia. The goal of this study is to determine if we can reduce kinesiophobia in patients who have undergone stabilization surgery for anterior shoulder instability using this new rehabilitation protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Primary or recurrent traumatic anterior dislocation of the shoulder
2. Indication of abutment according to Latarjet (arthroscopic or open sky)
3. Age: 18-67 years
4. Understanding of the French language spoken and written
5. Written informed consent (in accordance with to ICH-GCP guidelines)

Exclusion Criteria:

1. Posterior or multidirectional instability of the shoulder (Beighton score \>5)
2. Age \<18 or \>67 years.
3. Patients with additional rotator cuff tear.
4. Patients with a history of surgery on either shoulder.
5. Patients with connective tissue disorders (eg Ehler-Danlos).
6. Patients with (current) anxiety disorders or using anxiolytic medications (eg, antipsychotics) (criterion based on patient record/indications).
7. Patients with neurological disorders or systemic disease.
8. Patients with inflammatory disease, rheumatoid arthritis or active malignancy.
9. Patients previously hospitalized for shoulder pain
10. Patients with upper tubercle fracture
11. Patients with motor neurological deficit
12. Pregnant or breastfeeding patient
13. Patient protected under protective measure
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.

A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate

Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of RA according to the 2010 ACR/EULAR Classification Criteria .
* Must be on a stable MTX dose (7.5 to 25 mg/week)
* Subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.
* Are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.

Main Exclusion Criteria:

* Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years.
* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
* Subjects who have taken any investigational drug within the previous 30 days before randomization.
* Use of all other synthetic disease-modifying antirheumatic drugs (DMARDS) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization.
* Use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
* Use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
The Effect of COVID-19 Pandemic on Adolescent and Young Adult Cancer Patients and Survivors

The study investigates how the COVID-19 pandemic has impacted the psychological, financial, physical, and social well-being of adolescent and young adult (AYA) cancer patients and survivors. AYA cancer survivors have inferior long-term survival compared to the general population, and the negative impact of the global COVID-19 pandemic may be even higher in this vulnerable group. The information gained from this study may provide an opportunity to determine the self-reported COVID-19 specific psychological distress in AYA cancer survivors, and may lead to the development of a targeted intervention to improve physical and psychosocial health for AYA cancer patients and survivors.

PRIMARY OBJECTIVE:

I. To determine the self-reported coronavirus disease 2019 (COVID-19) specific psychological distress in adolescent and young adult (AYA) cancer survivors diagnosed between the ages of 15 to 39 and are currently between the ages of 18 to 39.

SECONDARY OBJECTIVES:

I. To determine the COVID-19 specific health care utilization, health behavior, financial and social disruptions, and health-related quality of life (HRQoL).

II. To determine associations between patient demographic and treatment-related variables with COVID-19 specific psychological distress, healthcare utilization, health behavior, financial and social disruptions, and HRQoL.

III. To determine associations between resilience factors (i.e., social support, perceived benefits under times of stress, and the ability to manage stress) with self-reported COVID-19 specific psychological distress, healthcare utilization, health behavior, financial and social disruptions, and HRQoL.

IV. To determine the changes in COVID-19 specific psychosocial distress, healthcare utilization, health behavior, financial, and social disruptions.

OUTLINE:

Patients and survivors complete a survey online over 20-30 minutes at baseline about COVID-19 specific psychological distress, health care utilization, health behavior, social and financial disruptions, HRQoL, their social support, perceived benefits under times of stress, and the ability to manage stress. Patients and survivors may be contacted again at 6 months and 1 year for COVID-19 research.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT COHORT INCLUSION:
* Initial cancer diagnosis between the ages of 15 to 39
* Received any cancer treatment at MD Anderson Cancer Center with data available in the MD Anderson Cancer Center Tumor Registry
* For questionnaire provision: confirmed alive at time of contact

Exclusion Criteria:

* PATIENT COHORT EXCLUSION:
* Inability to complete questionnaires in English
* Seen at MD Anderson for a second opinion or non-treatment related visit
Ultrasound-Guided Percutaneous Neuromodulation in Spasticity

The Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterised by the appearance of lesions, characterised by heterogeneity in their anatomopathological, clinical and radiological presentation.

Its aetiology is complex and multifactorial, with genetic and environmental interactions with a predominance in women (3:1) and is the second leading cause of disability in young adults (25-30 years). It has a socio-economic impact, affecting interpersonal relationships and causing a significant reduction in quality of life.

MAIN OBJECTIVE To assess the effect on spasticity of the Percutaneous Ultrasound-guided Neuromodulation (PMN) technique in patients diagnosed with MS with upper limb spasticity.

SECONDARY OBJECTIVES

* To assess changes in the strength parameter of the wrist flexor musculature wrist before and after the application of a PMN programme.
* To assess changes in the functionality scales (modified Asworth, established for spasticity
* To assess changes in the range of motion (ROM) of the joints under study.
* Assess changes in the quality of life scale (MSQOL54).
* To assess the adverse effects of the technique.

All patients will receive a Percutaneous Echoguided Neuromodulation (PNM) in the median nerve at the elbow, medial to the brachial artery, running between the humeral and ulnar heads of the pronator teres muscle. Once the nerve is located, a needle shall be inserted in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 Hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle cont raction for 1.5 minutes.

After assessing the correct application of ethics in the study, it was decided to use the individual's own baseline data as a control group, as simulating the technique is complex.


Eligibility Criteria:
Inclusion Criteria:

* Sign the consent form to participate in the study
* Be a patient diagnosed with Multiple Sclerosis.
* Be over 18 years of age and less than or equal to 55 years of age.
* Have spasticity (Asworth 2) in the upper limb.
* Be able to travel to the place of the session

Exclusion Criteria:

* Failure to comply with the above
* Withdrawal of informed consent
* Having a disease associated with MS that is incompatible with the technique. Use of anticoagulation
* Cognitive impairment
* Belenophobia
SMS Messaging as a Tool to Improve Cancer Screening Programs

The aim of this project is to assess the impact on health and economics of the implementation of text messaging (SMS) in cancer screening programs. Three interventions with SMS will be evaluated through community trials. In the colorectal cancer screening program the following interventions will be tested: a) Participation reminder: six weeks after sending the invitation letter of the colorectal cancer program if there has not been a response, a reminder SMS will be sent in front of the usual method by letter; b) Reminder to return the fecal occult blood test: SMS reminder of test delivery versus no intervention. This reminder will be sent to the individuals who have gone to the pharmacy to pick up a fecal occult blood test and they have not returned it after 14 days. The impact on participation will be analyzed and, if applicable, the proportion of advanced neoplasms will be calculated by increase in participation. In the breast cancer screening program, the invitation by SMS versus the usual invitation by letter will be studied in women who had participated in the previous screening round. The impact on participation will be analyzed. A cost-effectiveness analysis of the three interventions will be carried out. The incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated.

Main Hypothesis:

The implementation of SMS in population-based cancer screening programs will improve participation, especially in colorectal cancer screening, will allow a better resource management and reduce costs in both programs.

Specific Hypothesis:

Sending the reminder SMS will have an impact on participation greater than that obtained with the standard reminder (letter) in the colorectal cancer screening program.

The effect of the colorectal cancer screening reminder SMS will be greater among the individuals who have been invited for the first time and not previous participants.

Participation after receiving the invitation by SMS in breast cancer screening will be equal to or better than the letter invitation.

The alternative that includes sending SMS will be cost-effective in relation to the current alternative that you use postal shipping.

Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals for colorectal cancer screening (intervention 1 and 2)
* Eligible women for breast cancer screening (intervention 3)
* Registered at the HealthCare Database (RCA)

Exclusion Criteria:

* Individuals without a mobile phone number registered at the RCA
* Opt out from breast cancer screening and/or colorectal cancer screening
Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer

The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
* Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or metastatic disease.
* CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
* Measurable and/or non-measurable disease as defined according to RECIST v1.1
* Age ≥ 18 years
* Written informed consent
* ECOG performance status (PS) 0-1
* Life expectancy \> 3 months

Exclusion Criteria:

* Prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment
* Known HIV infection or known symptomatic hepatitis (A, B, C)
* Clinical symptoms of cerebral metastases
* Pregnancy or breastfeeding
* Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
* Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum calcium \< 8 mg/dl (2 mmol/L) or \> 12 mg/dL (3.0 mmol/L)