cyrilzakka/clinical-trials huggingface dataset:
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). Lung nodule \<1.0cm will directly treated as group C

The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical characteristics of patients were compared, especially chemotherapy cycles to achieve hCG normalization and failure to first-line chemotherapy.

Lung nodule \<1.0cm will directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)

Eligibility Criteria:
Inclusion Criteria:

1. pathologic confirmed hydatidiform mole
2. the lung nodule was detected by lung CT at the suction evacuation of molar pregnancy or during weekly hCG surveillance and lung metastasis cannot be excluded
3. the hCG level do not meet FIGO diagnostic criteria of GTN
4. good compliance
5. consent informed

Exclusion Criteria:

1. history of lung nodule
2. lung nodule was conformed as other diseases such as Tuberculosis, pneumonia
3. already accepted with chemotherapy or hysterectomy
4. pathologic confirmed GTN
5. immunosuppressive diseases status or take immunosuppressive drugs
6. Participating in other clinical trials
7. unable or unwilling to sign informed consent
8. cannot or unwilling to comply with research requirements
Financial Incentives for Smoking Treatment II

Financial incentives for motivating changes in health behavior, particularly for smoking and other morbid habits, are increasingly being tested by health insurers, employers, and government agencies. However, in using incentive programs for smoking cessation, key unanswered structural and theoretical questions remain regarding their effectiveness, acceptability to patients, and economic sustainability. This trial aims to advance the science and implementation of financial incentives for smoking cessation interventions among high-risk, hospitalized smokers. The investigators will pursue two specific aims: 1) comparing the impact of three approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life and 2) comparing the short-term and long term return on investment of using goal directed and outcome-based financial incentives to promote smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years
2. smoked tobacco during the prior 30 days,
3. have an active U.S. phone number and address,
4. can provide consent in English or Spanish and
5. are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit

Exclusion Criteria:

1. use only smokeless tobacco,
2. are pregnant or breastfeeding,
3. are discharged to an institution (e.g., nursing home, long-term care facility),
4. are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study
Effects of PDT and Bioceramic Filling on Periapical Healing and Postoperative Pain After Endodontic Retreatment

The purpose is to investigate influence of bioceramic filling of the root canal and photodynamic therapy on periapical healing and development of postoperative pain after endodontic retreatment. Patients are divided into two main groups and each of the group is divided into two subgroups. Main groups are patients receiving photodynamic therapy and patients receiving passive ultrasonic irrigation. Each of the main group is divided by the root canal filling material on the AH+ group and BioRoot group.

Clinical trial will be conducted in Dental clinic Zagreb. Patients will be chosen for this randomized prospective trials from the everyday patients referred by general dentist for endodontic retreatment. In the research will be included only patients with symptoms of chronic apical periodontitis and previous endodontic treatment. It includes teeth sensitive to palpation, percussion or visible sinus tract or swelling and asymptomatic inadequate endodontic filling. Patients that are immunocompromised, pregnant women, teeth with pocket depth bigger then 3mm, teeth with signs of vertical root fracture, teeth that are impossible to restore are excluded from research.

Every patient will be assigned to one group and one subgroup using "wheeldecide" programme. Patients will not be aware what group or subgroup they are assigned. endodontic retreatment will be conducted by one specialist in endodontics. Therapy is single visit retreatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms of periapical disease after endodontic treatment,
* teeth sensitive to percussion and palpation,
* teeth with present sinus tract and
* asymptomatic teeth with radiologically inadequate root canal filling.

Exclusion Criteria:

* Immunocompromised patients,
* pregnancy,
* teeth with signs of vertical root fracture,
* teeth that can't be restored,
* antibiotic usage within last month,
* teeth with acute apical abscess
Dietary Sources of Lysophospholipids

This study aims to test the hypothesis that dietary intake of phosphatidylcholine (PC) and lysophosphatidylcholine (LPC) acutely alters plasma lysophosphatidic acid (LPA) levels and autotaxin activity in normal weight and obese subjects.

Lysophosphatidic acid (LPA) is a simple glycerophospholipid that is found at biologically-relevant levels in plasma and has important effects on isolated or cultured blood, vascular and fat cells. The main enzyme responsible for generation of plasma LPA is the secreted lysophospholipase D, autotaxin (ATX). Adipocytes contribute substantially to plasma ATX levels. The investigators have demonstrated rapid production and metabolism of plasma LPA in animals. More recently, the investigators have observed that plasma LPA levels increase in mice fed a high fat ("Western") diet in comparison to levels found in mice fed normal chow. The investigators have also found that diet-induced obesity increased circulating ATX levels in mice. The investigators hypothesize that diet, and in particular dietary phosphatidylcholine (PC), may regulate the autotaxin substrate lysophosphatidylcholine (LPC), from which LPA is derived. Obesity may amplify the response by increasing plasma ATX levels and/or activity. The current study will test whether dietary PC in normal weight and obese subjects acutely alters LPA levels and autotaxin activity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years old
* Body Mass Index of 20 and above
* Must be able to consume a low fat meal, unlimited fruits and vegetables and not eating after midnight the night before the lipid tolerance test
* Report to the clinical research unit fasting (no food since the meal the night before)
* Able to consume a liquid meal consisting of a commercial nutritional product supplemented with fat
* Able to have an indwelling catheter placed on one arm and have hourly blood draws for 8 hours

Exclusion Criteria:

* Unstable medical condition (recent or unstable cardiovascular disease)
* Active cancer
* Renal insufficiency Glomerular Filtration Rate \<30
* Use of steroids
* Chronic inflammatory conditions
* Use of anticoagulants, anti-inflammatory, or lipid-lowering medications
* Lipodystrophy
* GI conditions that result in lipid intolerance
* Pregnant women have a tendency to be anemic and therefore will be excluded.
LMWH Compliance in Pregnancy

This is a prospective chart study that will aim to assess objective data on compliance levels to low molecular weight heparin (LMWH) injections among pregnant and postnatal women undergoing VTE thromboprophylaxis treatment at Cork University Maternity Hospital. This is a study that will help shine light on accurate data for compliance and possible factors affecting it, which will be useful for more individualised treatment plans for future patients. Patients at higher risk of Venous thromboembolism undergoing VTE thromboprophylaxis will be invited to participate in the study. Once the patient reads the information leaflet and signs consent, data will then be collected from the patients medical record. The patient will be given a smart sharps bin with an individual, unique product code. This device will be provided by HealthBeacon, a Dublin based start-up company. The device will be personalised with the treatment schedule pre-loaded onto it. When a used LMWH injection is disposed into the smart sharps bin, an infrared sensor is activated. The system captures an image of the injection in the chamber before moving it to the normal 'sharps' container of the bin for disposal. The captured image is time-stamped and sent to HealthBeacon's electronic database. HealthBeacon will only have the data pertaining to the disposal of injections for each sharps bin (i.e. the timing of the disposal of each used injection in each pre-coded bin). We are blinded to the compliance information and will only will receive the raw Data once treatment is completed. Data will be analysed to determine compliance of LMWH injections. This study will enable us to have a better insight on accurate compliance rates for LMWH injections in pregnant women at higher risk for venous thromboembolism (VTE). Understanding compliance with LMWH injections and the factors which can affect it, will hopefully guide future information and education that we offer to patients who are prescribed LMWH injections and help decrease maternal mortality rates in future.


Eligibility Criteria:
Inclusion Criteria:

* current VTE
* previous history of VTE
* class III obesity
* history of placenta mediated complications
* pre-eclampsia
* Advanced Maternal Age
* inherited thrombophilia
* prolonged immobilization
* varicose veins
* other risk factors that predispose them to VTE

Exclusion Criteria:

* life-long anti-coagulation
* mechanical heart valves
* other forms of injectable therapy for other illnesses
* long-term severe physical disability affecting mobility (eg: paraplegia, paralysis
Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients

The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of schizophrenia according to DSM-IV；
* 18～55 years old；
* schizophrenic illness duration longer than one year;
* The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
* Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
* Able to adhere to the treatment schedule;
* IQ≥80;
* Dextromanual, normal vision and hearing;
* Signed an informed consent

Exclusion Criteria:

* rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;
* Acute risk of suicide and impulse；
* patients to be diagnosed according to DSM-IV for substance abused, development delayed;
* suffering from serious physical disease and can not accept the treatment;
* history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
* difficult to maintain the current drug treatment for at least 1 month;
* undergoing ECT or MECT in last 3 months;
* current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.
APP-based Emotion Recognition Training Improve ASD Social Function

The main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children.

50 ASD children age ranged from 4-10 years old will be randomly allocated to either app-based emotional recognition training or memory training groups for 2 months. Before and after training, some assessements were measured including Autism Diagnostic Observation Schedule-2, Childhood Autism Rating Scale, Wechsler Intelligence Scale and Psychoeducational Profile-3. Some other questionnaires are also collected including Social Responsibility Scale-2,Repetitive behavior scale-Revised,Caregiver Strains Questionnaire，Social Communication Questionnaire，Social Anxiety Scale for Children，Adaptive behavior assessment Schedule. Four eye-tracking tasks as follows: (1) Dynamic geometrical paired with dynamic child dancing; (2) Static neutral and emotional faces; (3) A dynamic gaze-following task; (4) social interaction behaviors paired with the toys alone; (5) spinning actions conducted via children paired with objects.

Eligibility Criteria:
Inclusion criteria: Clinical diagnosis of Autism Spectrum Disorder and follow these criteria: (1) Age range: 4-10 years old, gender not limited;(2) Ethnicity: Han nationality;(3) Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Comparison Score greater than or equal to 5 points (Le et al., 2022);(4) Considering that only high-functioning autism individuals can successfully complete the eye-tracking tasks, children with a Wechsler score greater than or equal to 60 points are selected; Exclusion criteria: (1) No neurological complications, such as epilepsy, cerebral palsy, fragile X syndrome, etc.;(2) No prior medical interventions, such as taking antipsychotic drugs, receiving transcranial magnetic stimulation, acupuncture, etc.;(3) No abnormal imaging diagnosis or any brain injury.
Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules

The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study, before any study related procedures take place
* Willing and able to adhere to the prohibitions and restrictions specified in the protocol
* If a woman, must be of non-childbearing potential, defined as either: a) Postmenopausal: A postmenopausal state is defined as no menses for at least 12 months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (greater than \[\>\]40 international units per liter \[IU/L\] or milliinternational units per milliliter \[mIU/mL\]). b) Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), bilateral oophorectomy, and/or transcervical sterilization
* If a woman, must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and on Day -1 of each treatment period
* Non-smoker for at least 2 months prior to screening

Exclusion Criteria:

* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen/paracetamol, topical therapies, and hormone replacement therapy within 14 days before the first dose of the study drug is scheduled
* History of clinically significant allergies, especially known hypersensitivity or intolerance to sulfonamide or beta-lactam antibiotics
* Known allergy to the study drug or any of the excipients of the formulation
* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
* Positive test for human immunodeficiency virus type 1 (HIV-1) or HIV-2 antibodies at screening
Carbon Dioxide Insufflation Versus Conventional Air Insufflation

The safety and effectiveness of esophagogastroduodenoscopy and colonoscopy in the detection of gastrointestinal-tract pathology in children has been established during the last three decades. Insufflation of the intestinal tract, usually with room air, is necessary to improve visualization during the procedure; however, air in the bowels can also result in abdominal distension and increased pain. This potential discomfort associated with upper endoscopy and colonoscopy may be an important barrier to patients undergoing this procedure. Insufflation with carbon dioxide is another method used in endoscopic procedures for distention of the lumen and is currently used at the Children's Hospital of Wisconsin based on provider preference. The aim of this study is to perform a randomized controlled trial comparing insufflation with room air to carbon dioxide in patients undergoing routine upper endoscopy and colonoscopy. The investigators primary outcome is measurement of patient comfort level as measured by pain scores during recovery. The investigators hypothesize that carbon dioxide insufflation during endoscopy and colonoscopy improves patient comfort level as compared with insufflation with room air. Secondary outcome measures include changes in end tidal carbon dioxide, time to discharge, duration of colonoscopy and cecal intubation rate, changes in abdominal girth, rescue pain medications used during recovery and post-procedure events. This is a prospective randomized single-blinded study. The investigators will recruit consecutive patients, between the ages of 8 and 21 years, scheduled for elective outpatient upper endoscopy and colonoscopy at children's hospital of Wisconsin from March 2015 until we reach target population numbers. The investigators will exclude all inpatients, non-English speaking patients, children under 8 years of age, patients undergoing colonic manometry studies, and patients with hemodynamic instability, gastrointestinal bleeding, acute abdomen, previous colectomy, oxygen-dependent pulmonary disease and obstructive sleep apnea requiring the use of continuous positive airway pressure device. On the basis of a computer-generated randomization scheme in a 1:1 ratio, patients will be assigned to receive room air or carbon dioxide for insufflation during colonoscopy. Power calculation was done and determined that we will need to enroll 100 patients in each arm of the study. Informed consent will be obtained from all patients by the endoscopist or gastrointestinal fellow.


Eligibility Criteria:
Inclusion Criteria:

* ages of 8 and 21 years
* elective outpatient upper endoscopy and colonoscopy

Exclusion Criteria:

* inpatients
* non-English speaking patients
* children under 8 years of age
* patients undergoing colonic manometry studies
* patients with hemodynamic instability
* GI bleeding
* acute abdomen
* previous colectomy
* oxygen-dependent pulmonary disease and obstructive sleep apnea
Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures.

PICOTS:

P: Kennedy class І patients

I : Mandibular removable partial denture with OT Cap attachment

C: Mandibular removable partial denture with gingival approaching clasp assembly

O: 1ry outcome: Oral Health Related Quality of Life

2ry outcome: Biting force

T: 1 Year

S : Randomized control trial

Research question:

In Kennedy class І patients will the removable partial denture with OT Cap attachment compared to conventional removable partial denture with clasp assembly results in difference in Oral Health Related Quality of Life of Patients?

In bilateral edentulous mandible with missing molars, the clasp retained partial denture will be compared with precision attachment partial denture for better quality of life for patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mandibular free end saddle cases.
2. Patients less than 75 years old.
3. Patients who approved to be included in the trial and signed the informed consent.
4. Patients are not suffering from diabetes mellitus.

Exclusion Criteria:

1. Patients are suffering from diabetes mellitus.
2. Patients above 75 years old.
3. Patients are receiving chemotherapy or radiotherapy.
4. Patients with severe Temporomandibular Joint problems.
5. Patients who refused the trial.
Effect of Postoperative Ferric Carboxymaltose

The primary purpose of this study is to evaluate the safety and efficacy of postoperative intravenous ferric carboxymaltose in patients with anemia undergoing Simultaneous Bilateral Total knee replacement in terms of Quality of life (QOL) and objective measures (Hemoglobin and Iron parameters).

Both preoperative and postoperative anaemia are common in patients undergoing total knee arthroplasty. Allogeneic RBC (red blood cell) transfusion and anaemia are related with higher postoperative mortality and morbidity. It is important to have a strategy of patient blood management.

Hb(hemoglobin) level of 10 g/dl will be used as a cut-off value for our study. In postoperative period in total knee arthroplasty for osteoarthritis, consented patients with postoperative anemia will be administered Ferinject® or placebo (normal saline) based on the results of randomization.

Study Group: Ferinject® administration as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg(milligram) single administration) for body weight ≥50 Kg (kilogram) or 6 minutes (for 500mg(milligram) single administration) for body weight \< 50Kg( kilogram) .

Control Group: Placebo in the form of normal saline administration as same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL(milliliter) as infusion or 20mL(milliliter) as bolus injection) for body weight ≥50 Kg ( kilogram) or 6 minutes (100mL normal as infusion or 10mL(milliliter) as bolus injection) for body weight \<50 Kg (kilogram).

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age and signed written informed consent
* Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
* Hb \< 10.0 g/dl after operation
* Ferritin \< 100 μg/l or 100-300 with transferrin saturation \< 20%

Exclusion Criteria:

* Suspicion of iron overload (Ferritin \>300 μg/l or/and transferrin saturation\>50%)
* Active severe infection/inflammation (defined as serum C reactive protein \> 20 mg/l) or diagnosed malignancy
* Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
* Known history of hepatitis B/C or HIV-positive
* Liver values 3 times higher than normal
* Immunosuppressive or myelosuppressive therapy
* A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
* Pregnancy or lactation
* Transfusion within 1 month prior to study inclusion, erythropoietin treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
* Participation in any other therapeutic trial within the previous month
* History of thromboembolic events in the family or the patient
* Severe peripheral, coronary or carotid artery disease
* Bodyweight \< 50 kg
* Patients not able to understand the German language