cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Daily Supplementation With 400 IU Vs 200 IU of Vitamin D in Term Healthy Neonates

The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin D on serum Vitamin D levels in term healthy newborns. It has been found in various studies that vitamin D is highly deficient in Indian mother infant diads. There is a need to supplement vitamin D from neonatal period to prevent various metabolic disturbances due to vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal requirements in Indian infants.

Vitamin D deficiency is highly prevalent in India as reported in various studies. Vitamin D supplementation is necessary as vitamin D is required not only for prevention of rickets as traditionally thought, but also for its emerging role in development of diseases such as myopathic disorders, proneness to infection, autoimmune disorders and cancers .However supplementation studies are limited and predominantly from foreign countries. Moreover most of them report variable outcomes with no unanimous outcome with respect to optimum dose and duration of supplementation of vitamin D. Various national authorities recommend different doses of vitamin D for supplementation. American Academy of Pediatrics, The Institute of Medicine of National Academics, The Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society, the Canadian Pediatric Society and European Society for Pediatric Endocrinology recommend that 400IU of vitamin D should be supplemented in all infants starting from within a few days of birth throughout childhood. ESPGHAN recommends 800-1000 IU for high risk infants, Ireland recommends 200IU vitamin D per day, UK does not recommend any supplements upto 6 months of age , however if formula milk intake \<500ml/day then 300 IU is recommended. There are no such guidelines for India. Hence this study aims at evaluating the proportion of vitamin D deficient

Eligibility Criteria:
Inclusion Criteria:

* Gestation \> 37 weeks
* Birth weight \>2.5 kg
* Informed consent of one of the parents
* Place of residence\<10km

Exclusion Criteria:

* Presence of gross congenital malformation
* Need of resuscitation at birth
* Need for admission to neonatal ICU
* Refusal of consent
Preoperative Counseling in Cholecystectomy

The investigators examined whether a written plus verbal preoperative counseling for patients undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting and pain.

This was a randomized, single-blinded, clinical study carried out at the Julio Muller University Hospital (Mato Grosso State, Brazil). This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving human subjects/patients were approved by the hospital Research Ethics Committee registered under number 697/CEP-HUJM/09. Written informed consent was obtained from all patients.

Except for the preoperative counseling which was received only by the intervention group, all patients received the same protocol of perioperative care.

The main endpoint of the study was the presence and the intensity of postoperative symptoms such as nausea, vomiting and pain. A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked. The questions were: "how severe was your pain during this period of 24h after the operation?", "how severe was the intensity of your nausea during this period of 24h after the operation? ", and "how great is your well-being at the present moment". For the first two questions the words at each end of the line were "no pain" and "severe pain", and "no nausea" and "severe nausea". For the well-being question the words were "no well-being" and "greatest well-being". The Vomiting was also recorded as a categorical variable (yes or no). The length of stay and postoperative complications were also collected.

Eligibility Criteria:
Inclusion Criteria:

* adult age (18-65 years-old),
* both sexes and
* candidates for an elective open cholecystectomy

Exclusion Criteria:

* having diabetes mellitus,
* chronic kidney failure,
* chronic liver disease,
* serum bilirubin \> 2 mg/dL,
* body mass index (BMI) \> 35 kg/m2,
* American Anesthesiologists Association (ASA) score \> 3,
* gastro-esophageal reflux,
* gastroparesis or intestinal obstruction.

Patients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (\> 4 h) operative time were also excluded.
The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

Tooth hypersensitivity due to dental erosion is one of the most common problem related to swimming in improper pH chlorinated pools. Because the teeth are exposed to acidic water for a long time, which cause the loss of dental hard tissue. Tooth hypersensitivity can lead to a negative effect on daily life such as dietary selection, maintaining optimal dental hygiene and beauty aspects. It has been found that using mouthguard while swimming can prevent the teeth directly contact to chlorinated water, so it can protect tooth structure and decrease tooth hypersensitivity. Moreover, using mouthguard with viscous products can seal the gaps between mouthguard and teeth which can help to protect tooth structure and decrease dental hypersensitivity more effectively. At present, there are many desensitizing products such as toothpaste, mouthwash and chewing gum. Desensitizing toothpaste is the most common over-the-counter (OTC) materials in desensitizing. Many research has endorsed the properties of desensitizing toothpaste that can reduce tooth tissue loss and helps to reduce tooth hypersensitivity effectively. So it can be hypothesize that when use the combination of mouthguard with desensitizing toothpaste, it might have synergistic effect on reducing tooth hypersensitivity in swimmers.

Tooth erosion is the loss of dental hard tissue due to acidic agents without bacteria involvement.

Mouthguard is a protective appliance use for covering the teeth and gums to prevent the teeth from acidic chlorinated water.

Desensitizing toothpaste is toothpaste containing 8 percent arginine and calcium carbonate that can reduce tooth demineralization and promote remineralization.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-25 years (age under 18 years must obtain consent from parents)
* Swimming at least 5 hours/week
* Having tooth hypersensitivity from erosion
* Can read or understand Thai language

Exclusion Criteria:

* History of allergic to toothpaste
* Having any tooth which will affect to the tightness of mouthguard
* Having fixed orthodontic appliance
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.

This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.This phase IB trial is Multi-center and open。

Eligibility Criteria:
Inclusion Criteria:

18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.

Exclusion Criteria:

adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction \< 50%
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.


Eligibility Criteria:
Inclusion Criteria:

PTPs:

* Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
* Males 0 to \<65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.

PUPs:

* Males 0 to \<18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%)
* No prior exposure to any Factor VIII product (with the exception of short-term use of blood products).

ITI substudy:

* PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.

Exclusion Criteria:

* Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
* Currently receiving a therapy not permitted during the study.
* Serum creatinine \> 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase \> 5 x upper limit of normal at Screening (if specified)
* Any first-order family (eg, siblings) history of FVIII inhibitors
* For PTPs not rolling over directly from a CSL-sponsored clinical study with rVIII-SingleChain: any history of or current FVIII inhibitors
Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults

This study will examine the safety and immune response to a two-part HIV vaccine. Healthy volunteers who are at low risk of HIV infection will receive either active vaccine or a placebo.

The purpose of this study is to examine the safety and immunogenicity of a candidate vaccine strategy for HIV prophylaxis using a DNA-prime plus recombinant fowlpox boost. The DNA plasmid and fowlpox vector contain HIV genes. However, these vaccines contain only some HIV genes and cannot themselves cause HIV or AIDS.

Eligible volunteers at low risk of HIV infection will be randomized to receive either active vaccine or placebo injections at Day 0, Week 4, and Week 8. Intensive immunologic and safety monitoring will be done during the first 16 weeks of the study. Follow-up will continue to Week 52.

Eligibility Criteria:
Inclusion Criteria

* HIV negative.
* Acceptable methods of contraception.

Exclusion Criteria

* Identifiable risk behavior for HIV infection, including: sexual partners of HIV positive people, sexual intercourse with a partner of unknown HIV status if that partner is reported to be at higher risk for HIV infection, gay men reporting any unprotected anal intercourse with partners of unknown status in the 12 months preceding study entry, individuals diagnosed with a sexually transmissible infection (STI) in the 12 months preceding entry that may have been acquired through anal or vaginal intercourse, individuals reporting sharing of injecting equipment in the last 12 months.
* HIV candidate vaccines in a previous HIV vaccine trial.
* Live attenuated vaccines within 60 days prior to entering the study. Whole killed, toxoid, or sub-unit vaccines (e.g., influenza, pneumococcal, tetanus, and hepatitis B) are not exclusionary within 4 weeks prior to the scheduled experimental HIV vaccines.
* Hypersensitivity to egg products or a known history of anaphylaxis or any other serious adverse reactions to vaccination.
* History of serious allergic reaction requiring hospitalization or emergency medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) to any substance.
* Significant illness requiring immunomodulatory or cytotoxic therapy.
* History of cancer unless there is evidence of surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
* Blood products or immunoglobulins within 6 months prior to entering the study.
* Experimental or investigational agents within 30 days prior to entering the study.
* Recreational and/or therapeutic drug use that might compromise the study participant's safety.
* Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
* Pregnant or lactating women.
Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone

The objective of this study was to analyze the features of monotherapy with L-T4 in comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.

We conducted a randomized controlled study with a crossover design in 36 premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones. All patients were divided into two groups: patients from Group A (n=20) were randomized to L-T4 in dose of 1,6 μg per kg, followed by combined L-T4 and L-T3; and 16 women from Group B received the combination of L-T4+L-T3 (the dose of L-T4 was reduced by 25 μg and replaced with 12,5 μg of L-T3), followed by monotherapy with L-T4. The treatment periods lasted for 6 months. Patients were examined at baseline and at the end of each treatment period.Blood samples were obtained to measure serum TSH, free T4, free T3, lipid profile, osteocalcin. Urine samples were collected to measure urinary deoxypyridinoline / creatinine ratio. 24-hour ECG-monitoring, osteodensitometry and psychological testing were also performed at baseline and at the end of each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones

Exclusion Criteria:

* Peri- and postmenopause
* Pregnancy
* Major comorbidity
* Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.
Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.

This study will be conducted in the US and in Spain.

Eligibility Criteria:
Key Inclusion Criteria:

* 22 years old or older at Visit 1.
* Able to understand and sign an approved informed consent form.
* Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
* Documented medical history and required pre-operative baseline information available for retrospective data collection.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
* Pregnant or nursing at the time of enrollment.
* Childbirth after IOL implantation.
* Other protocol-specified exclusion criteria may apply.
Implementing Spiritual Care in Inpatient Palliative Care

The goal of this observational study is to is to ascertain the spiritual needs of palliative patients in a standardized manner using the Spiritual Needs Questionnaire and to promptly address those needs by (specialized) spiritual care.

To determine whether the effort of implementing the Spiritual Needs Questionnaire on a sustainable basis on the one hand brings the expected benefit to the patients and on the other hand can be provided by the pastoral care personnel, at Muenster University Hospital (specialized) spiritual care interventions will be documented in detail and retrospectively and prospectively collected data will be compared.


Eligibility Criteria:
Inclusion Criteria:

* All individual indication for general and specialised Palliative Care in clinical setting/routine (e.g.):

  * Progressive, malign tumours
  * Progressive, chronic obstructive pulmonary disease
  * Patients with progressive disease and limited life expectancy (\< ca. 12 months)
* Patients attended by Palliative Caregivers in counselling services or on palliative ward
* Life expectancy \> 2 weeks
* Sufficient comprehension of German language and writing that allows an autonomous or supported completion of the questionnaire.
* Existence of an independently signed written consent.

Exclusion Criteria:

* Severe cognitive impairment
* capacity for consent lacking or impaired
* impaired comprehension of German language and writing that would not allow an autonomous or supported completion of the questionnaire.
Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement

Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA can be given either intravenously or topically (placed directly on the open wound) before wound closure. Patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous TXA, which may lead to serious complications. However, to date, no high-risk patients have been identified for use of topical TXA. This study will look at thrombogenic markers (proteins found in blood that promote clot formation) after TXA is given either intravenously or topically. If the effect on these markers is similar between intravenous and topical use of TXA, then the safety of topical TXA should be questioned. Of note, these markers have never been measured after TXA has been given topically. As a result, this information would be important for the medical community.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary unilateral total knee replacement with a participating surgeon
* Patients aged 18-80

Exclusion Criteria:

* All patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively
* Patients who will require postoperative use of Coumadin, Xarelto, or Plavix
* Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery
* Hypersensitivity to tranexamic acid
* Renal dysfunction (Creatinine clearance \< 40 ml/min)
* Hepatic dysfunction (AST or ALT 2x upper limit of normal)
* Cardiac exclusions: coronary stent, history of myocardial infarction, positive stress test, atrial fibrillation, advanced coronary artery disease
* Advanced chronic obstructive pulmonary disease or advanced interstitial lung disease
* History of venous thromboembolism
* Hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or without prior venous thromboembolism)
* History of stroke or transient ischemic attack
Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.


Eligibility Criteria:
Key Inclusion Criteria include:

* Male and female age ≥18 years.
* Diagnosis of moderate or severe alcohol use disorder.
* Currently seeking treatment for alcohol use disorder.
* Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.

Key Exclusion Criteria include:

* Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.

Other protocol-specific inclusion and exclusion criteria may apply.
Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat

Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity.

Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max.

In addition to this we will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.


Eligibility Criteria:
Inclusion Criteria:

* healthy men
* Body mass index (BMI) 20-26
* age 18-45 years

Exclusion Criteria:

* any kind of disease
* any use of medicine