cyrilzakka/clinical-trials huggingface dataset:
Effect of Referral Card on Neonatal Medical Care Seeking for Institutional Births in Urban Lucknow

Neonatal mortality rate in Uttar Pradesh, Northern India is 53.6 per thousand, and accounts for 8% of global neonatal deaths.It has been argued that prompt and appropriate care-seeking for sick neonates can substantially reduce neonatal mortality. This pre and post intervention trial was done to assess the impact of a pictorial "Neonatal referral Card" and one-to-one counseling of mothers on the qualified medical care-seeking behavior for sick neonates in urban Lucknow.

The study hypothesis was that the counseling on danger signs along with neonatal referral card has no impact on availing services of a qualified medical practitioner by caregivers of sick neonates.

The study was conducted in two government maternity hospitals in Lucknow. Neonates enrolled in the pre intervention phase were followed up for 6 weeks+15 days but did not recieve the study intervention. While, the mothers of the neonates enrolled in the post intervention phase recieved the study intervention within 48 hours of institutional delivery.Enrollment and follow-up procedures were same in both the phases.

Eligibility Criteria:
Inclusion Criteria:

* Neonates born in the participating hospital within last 48 hours and the parents on which gave written informed consent to participate in the study.

Exclusion Criteria:

* Neonates presenting with any clinically detectable congenital malformation at birth or who required any resuscitation at birth or who were admitted for any morbidity immediately after birth or those who were not the residents of Lucknow or were likely to leave the city limits within next one month.
Delayed Effects of Treatment in Cancer Survivors (DETECS)

Hypotheses and Specific Aims: There is limited data on the long-term consequences of cancer therapy on young, reproductively aged cancer survivors. The investigators objective is to characterize some of these effects in the cancer population.

Specific Aim 1: To compare markers of ovarian reserve between cancer survivors and healthy controls.

Hypothesis: Cancer survivors will have lower serum Anti-Mullerian Hormone (AMH) and antral follicle count (AFC), and higher Follicle Stimulating Hormone (FSH) than healthy controls.

Specific Aim 2: To compare cardio-metabolic, endocrine and bone profiles between cancer survivors and controls using a combination of anthropometric measures, fasting serum markers, and urinary markers of bone health.

Hypothesis: Cancer survivors will have higher total cholesterol and lower 25-OH vitamin D than healthy controls.

Specific Aim 3: To evaluate potential associations between ovarian reserve and markers of metabolism, obesity, and tumor bone health in young female cancer survivors.

Hypothesis: As BMI and total cholesterol increases, serum AMH will decrease.

Specific Aim 4: To compare quality of life markers, as assessed by validated instruments, between cancer survivors and controls using recommended scoring techniques.

Hypothesis: Cancer survivors will have lower quality of life markers as compared to controls.

The investigators will conduct a prospective study to characterize the quality of life and cardio-metabolic, endocrine, and bone profiles of female cancer survivors using a combination of anthropometric, serum, urinary, and ultrasonographic markers in combination with QOL instruments.

Eligibility Criteria:
Inclusion Criteria:

* Exposed: Females between the ages of 18 and 45, at least 2 years from the completion of cancer therapy. Subjects will have one of the following cancer diagnoses: breast, leukemia, lymphoma, and/or any gynecologic cancer. Subjects must also be postmenarchal, have a uterus, at least one intact ovary, and must be willing and able to comply with study procedures. Subjects can be of any menopausal status and within 10 years post treatment.
* Unexposed: Females between the ages of 18 and 45 with no prior history of cancer treatment.

Exclusion Criteria:

* Exposed: Pregnancy, lactation within the previous 3 months, any medical condition other than cancer with a known correlation with premature menopause (i.e. Turner's syndrome, Fragile X, gonadal dysgenesis, polyglandular autoimmune syndrome, lupus, etc.), hormonal contraceptive use within 3 months.
* Unexposed: Healthy controls with a history of polycystic ovary syndrome (PCOS), diabetes, thyroid dysfunction, hypertension, and hypercholesterolemia will be excluded in addition to cancer patients or survivors with one of the aforementioned diseases diagnosed prior to cancer diagnosis or treatment.
Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03

The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age\<70
* Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
* A untreated squamous esophageal carcinoma
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* Adequate organ function
* No known history of drug allergy
* Blood routine examination : WBC≥4.0
* hepatic and renal function are normal

Exclusion Criteria:

* Age≥ 70 or ≤ 16
* Already received the treatment of chemotherapy or radiotherapy
* Pregnant or lactating females
* Known drug allergy
* Without agreement of informed consent form
* Insufficient hepatorenal function or Blood routine examination
* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs Therapy

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
* 2.Previously Failed Or Are Intolerant To TKIs Therapy(such as sunitinib, Sorafenib)
* 3.With measurable disease (using RECIST1.1)
* 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
* 5.Last TKIs Therapy≥4 weeks
* 6.Main organs function is normal
* 7.Signed and dated informed consent

Exclusion Criteria:

* 1.patients has many influence factors toward oral medications
* 2.Known brain metastases
* 3.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\>10mmol/L);urine protein≥++,etc.
* 4.patients failed to heal wounds or fractures for Long-term
* 5.patients occurred venous thromboembolic events within 6 months
* 6.patients has HIV-positive or organ transplantation
Lurasidone Extended Use Study

This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.


Eligibility Criteria:
Inclusion Criteria:

* The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
* The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
* The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
* The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone

Exclusion Criteria:

* The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
* The subject resides in a country where lurasidone has been approved for any indication.
* The subject is currently enrolled in any other investigational study.
* The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis

The use of an endoprothesis in a pancreatic duct is a measure to minimize the incidence and severity of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis. In this study we will evaluate the use of a Biodegradable Endoprothesis: Archimede Fast Biodegradable Pancreatic Stent in patients with high risk of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis.The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography. The efficacy and the security of the device will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors

Exclusion Criteria:

* Pregnant or breastfeeding women
* Recent diagnosis (\<1 month) of acute pancreatitis
* contraindication to endoscopy
* Hypersensitivity to indomethacine
Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol

Each Whitsunday mask or AirFit N30i Quiet mask is worn for 7 nights. The overall purpose of this study is to evaluate the performance of the Whitsundays nasal mask system (a prototype mask) compared to the ResMed AirFit N30i Quiet mask system (a benchmark mask) in relation to seal, comfort, usability, overall performance, and efficacy.

This is a randomized, open label, cross over study to evaluate the Whitsundays nasal mask system (prototype mask) against a released mask system, the ResMed AirFit N30i Quiet mask system.

The Whitsundays nasal mask system will be compared with a released mask, ResMed's AirFit N30i Quiet, as it is also a nasal mask and the most appropriate benchmark. Study participants are experienced with CPAP masks and devices and therefore will use their experience to identify areas for potential improvement.

Recruitment will be done via phone calls/ SMS messages/ emails \<TBC with PI\>. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.

Visit 1: Participants will provide written informed consent. Participants will be shown the mask systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the mask systems. If the participant and assessor are happy to proceed, the participants will use the mask and loan CPAP for trial.

Visit 2: After trialing the mask systems, participants will be asked to complete a questionnaire regarding the seal and comfort of the mask system(s). Participants will then take the second mask system home to test.

Visit 3: The participant will return the masks and CPAP device to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients who ≥ 21 years of age
* Patients being treated for OSA with PAP therapy for ≥ 6 months
* Patients currently using a suitable mask system (any nasal mask )
* Patients who can trial the masks for up to 7 nights each

Exclusion Criteria:

* Patients using Bilevel flow generators
* Patients who are or may be pregnant
* Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* Patients believed to be unsuitable for inclusion by the researcher
Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective

The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores


Eligibility Criteria:
Inclusion Criteria:

* Must identify as Hispanic/Latino/a descent
* Have an adolescent between the ages of 15 and 17 years old living in their home a majority of the time
* Have English or Spanish proficiency

Exclusion Criteria:

* Adolescent or parent currently in opioid treatment
* Parent self-reports a substance use (including opioid use) disorder for themselves or adolescent
A Prospective Sub-Study of the Global Hypophosphatasia Registry

In this prospective observational sub-study, participants with pediatric-onset hypophosphatasia (HPP) (perinatal/infantile- or juvenile-onset) of any age will be followed for a minimum of 5 years at sites in the United States and potentially 1 or 2 other countries.


Eligibility Criteria:
Inclusion Criteria:

* Any age or sex with a confirmed diagnosis of pediatric-onset HPP (that is, first HPP sign or symptom presented at \< 18 years of age).
* Currently receiving asfotase alfa treatment at Enrollment (not treatment-naïve) or the Physician has decided to resume (not treatment-naïve) or start (treatment-naïve) the participant's asfotase alfa treatment within 6 months after Enrollment.
* Participant must have documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, and a documented ALPL gene mutation (Note: An exception is made for infants with clinical features of HPP plus low ALP who need to start asfotase alfa treatment right away, at the Physician's discretion, but do not yet have a genetic result. In this case, ALPL gene documentation is not required at the time of sub-study enrollment but should be documented within 6 months after Enrollment).
* Participant or participant's parent/legally authorized representative is able to read and/or understand the informed consent and study questionnaires in the local language.
* Participant or participant's parent/legally authorized representative must be willing and able to give signed informed consent for this sub-study, and the participant must be willing to give written informed assent, if appropriate and required by local regulations.

Exclusion Criteria:

* Currently participating in an Alexion-sponsored interventional clinical study. Participants who have concluded participation in an Alexion-sponsored asfotase alfa clinical study are eligible to enroll in this sub-study.
Helping Problem Drinkers on the Internet

The main aim of this study is to compare the impact of a minimal and a full Internet-based self-help intervention for problem drinkers in the general population.

Many problem drinkers never access any treatment services. Because of the individual as well as societal costs of heavy alcohol consumption, it is essential to find ways to intervene and provide assistance to problem drinkers. The Internet takes treatment to problem drinkers rather than requiring them to come to treatment, resulting in increased options for help for alcohol abusers. There is a preponderance of internet websites which are designed for self change in areas that include alcohol use. To date, however, there has been minimal scientific evaluation regarding the efficacy and safety of such programs.

Our own previous research found that we could reduce alcohol consumption by about three drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. Building on this, the current project will attempt to increase the impact of Internet-based interventions as well as produce sustained reductions in drinking by adding an extended online self-help service to this already promising minimal intervention. More specifically, this randomized, double blinded study will compare and evaluate the efficacy of two different degrees of treatment intervention for problem drinkers: a minimal one ("Check your Drinking") and a full one ("Alcohol Help Centre").

Eligibility Criteria:
Inclusion Criteria:

* Resident of Ontario
* 19 years of age or over
* Have consumed alcohol in the one month prior to the telephone survey.
* Have consumed alcohol in the one month prior to the telephone survey.
* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
* Indicate an interest in receiving self-help materials
* Have home access to the Internet
* Are willing to participate in follow-up at six and twelve month intervals

Exclusion Criteria:

* None
TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis

The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention.

The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study.

The comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, where the laying of a brace phase of interception or contention after dental-facial orthodontic treatment is indicated (an intended age range of 8-18 years, not exhaustive or limiting) , recipient of a social security scheme, for which a management of the orthosis is acquired.
* incisor width compatible with the sizes of TwiCare® orthotics available, according to manufacturer's recommendations
* patient in good general health
* parent or guardian able to receive clear information, and express their opposition not to the patient's participation in this research
* for patients with malocclusions, the incisors (maxillary and mandibular) should be aligned.

Exclusion Criteria:

* General chronic health problem, unbalanced
* obvious oral ventilation
* history of temporomandibular dysfunction
* nocturnal episodes of severe bruxism
* unbalanced periodontal disease
* allergies or intolerances known to one of the constituents of the orthosis
* opposition of representatives of the parental authority (parent or guardian) or the patient himself at the patient's participation in this research
* patient unable to respond to the questionnaire
* monitoring difficulties (going on holiday, imminent change, remoteness, lack of motivation)
* simultaneous participation in intervention research
* pregnant Patient on examination of the latter, according to his age
* Incisive (maxilla and / or mandible) unaligned
Personalized Anticoagulant Therapy for Pulmonary Thromboembolism

The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are:

* To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors).
* Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Adult patients with objectively diagnosed pulmonary thromboembolism (PTE) (with or without concomitant deep vein thrombosis);
3. Specific populations meeting any of the following criteria: elderly patients (≥75 years old); patients with impaired kidney function (creatinine clearance estimated by the Cockcroft-Gault formula, CrCl \< 60ml/min); patients with active malignancies (under treatment or with unrecovered malignancies);
4. Patients who have not started anticoagulant therapy before enrollment and are planned for anticoagulant treatment after evaluation by the attending physician;
5. Ecpected life expectancy longer than 3 months.
6. Patients who understand and agree to participate in this study, sign the informed consent form, and adhere to regular follow-up visits.

Exclusion Criteria:

1. Moderate or severe liver dysfunction (Child-Pugh class B or C);
2. Spontaneous bleeding tendency, such as coagulation disorders or thrombocytopenia (PLT\<20×10\^9/L);
3. Contraindications to anticoagulant drugs, including allergy to anticoagulants, clinically significant active bleeding, significant risk of major bleeding due to lesions or conditions, significantly abnormal coagulation function, liver disease with clinically relevant bleeding risk, thrombocytopenia, etc., as determined by the attending physician;
4. High-risk pulmonary embolism requiring thrombolysis;
5. Patients currently participating in other clinical trials.
Study to Evaluate the Efficacy of Adalimumab in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints

Patients will be randomized into two groups (1/1) during one year:

* 40 mg adalimumab subcutaneously (sc) every other week
* placebo

The effect on x-rays and clinical parameters will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Clear erosive image on x-ray of at least one interphalangeal finger joint
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to tinidazole or any comparable or similar product.