cyrilzakka/clinical-trials huggingface dataset:
A Study of HRS7415 Tablets in Patients With Advanced Malignant Tumors

This study is a multicenter, open phase I clinical study of dose escalation and dose extension of HRS7415 in subjects with advanced malignant tumors. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS7415 tablets.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person.
2. 18 to 75 years old, male or female.
3. ECOG Performance Status of 0 or 1.
4. The estimated survival time is ≥12 weeks.
5. Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology.
6. Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria.
7. Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol.
8. Male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; Fertile female subjects must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation.

Exclusion Criteria:

1. Subjects plan to receive any other antitumor therapy during the study period.
2. Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing.
3. Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing.
4. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing.
5. The damage caused by any previous antineoplastic therapy has not recovered to grade ≤1.
6. Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain.
7. Active heart disease in the 6 months prior to initial dosing.
8. Had other malignancies within 5 years prior to first dosing.
9. Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy.
10. Having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion;
11. Active hepatitis B and C;
12. Serious infections that require intravenous antibiotics, antivirals or antifungals to control;
13. History of immune deficiency or organ transplantation;
14. Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.
Studying the Modification of Attention Bias Remotely After Trauma

The investigators will complete an entirely remote randomized controlled trial (RCT) comparing 14 sessions of attention bias modification (ABM), attention control training (ACT), placebo neutral attention training, and a final control condition with daily questions in 1,897 individuals with clinically significant Post-traumatic Stress Symptoms (PTSS) (defined as PCL-5 score ≥ 33). To assess effects of the training and control conditions, the investigators will administer tests of threat-related attention bias and variability, and self-report assessments of PTSS, depression, anxiety, and perceived stress at baseline, after one and two weeks of training, and at eight-week follow up. The investigators plan to screen and confirm interest from over 3,000 eligible participants over a period of 24 months to enroll and randomize 1,897 participants with the end goal of 1,232 completers (176 per condition).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* Score at or above 33 on the PCL-5,
* Able and willing to perform daily smartphone training for two weeks
* Fluent English comprehension.
* Owns Android or iPhone smartphone

Exclusion Criteria:

* Does not have Android or iPhone Operating System (iOS) smartphone running sufficient software (i.e. at least iOS 10.1), and is not willing to update
* Active suicidality.
Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau

This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau. The genetic basis of the parasites for developing resistance will be examined. Children coming to one of the Health Centres with symptoms of malaria and a positive malaria test will be included. The children will be followed weekly until day 70. In case of reappearance of parasites the child will be re-treated with the opposite study drug.

This study compares treatment of uncomplicated malaria in children in Guinea-Bissau with artemether-lumefantrine (Coartem) with that of treatment with chloroquine 50 mg/kg. Furthermore, the genetic basis of anti-malarial resistance in Guinea-Bissau will be studied by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples from this in vivo trial. We also intend to study whether the recent report that chloroquine sensitive parasites are selected at recrudescence after Coartem is confirmed in Bissau.

Following consent to participate, children visiting one of the Health Centres in the study area with mono-infection with Plasmodium falciparum are by block-randomization allocated to one of the treatment groups. The treatment is given supervised by one of the health workers and malaria film taken on day 2 and 3. The children are visited and malaria films obtained once weekly until day 70. On day seven, 100 microliter of capillary blood are drawn for analyses of analyses of drug concentrations in whole blood. On inclusion and whenever a child has recurrent parasitaemia, a filter-paper blood-sample is collected for later PCR analysis. On the day of inclusion, on day 42 and on day 70 the haemoglobin level is measured.

If parasites reappear in 50% or more of at least 40 children in one of the treatment groups this treatment arm should be terminated. During the study parents are recommended to bring the child to the health centre in case of any illness. Participating children will be examined and treated free of charge. The opposite study drug will be used for re-treatment of children in case of recrudescence, and the child will be followed as previously planned.

The results from this study could be used for the planning of the recommendations for treatment of malaria in Guinea-Bissau. It will provide the National Malaria Programme with information of the efficacy of Coartem before it is implemented.

Eligibility Criteria:
Inclusion Criteria:

* Children presenting at one of the health centres in the study area
* Symptoms suggestive of malaria
* At least 20 P.falciparum parasites per 200 leucocytes
* Living in the study area (to enable follow-up)

Exclusion Criteria:

* Danger signs
* By the responsible doctor evaluated to need to be transferred to the national hospital as an in-patient
* Previous idiosyncratic reactions to any of the study drugs
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.

Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* 1. Signed informed consent form;
* 2. Healthy adult volunteers aged between 18 and 45, male or female;
* 3. Medical examination as required within 28 days, body mass index (BMI) 19.0 \~ 24.0, weight≥50 kg for men, ≥45 kg for women, and≤ 75 kg for both;
* 4. Agreed with taking reliable contraceptive measures, and no fertility planning from the beginning to the end of the study within 6 months;
* 5.Subject can communicate well with the investigators and complete the study according to the study regulations.

Exclusion Criteria:

* 1. Pregnant or lactating women, or positive in either blood or urine pregnancy test; or unwilling to take effective contraceptive measures during the trial and within 6 months after the end of the trial at fertile age;
* 2. Allergic constitution; or history of allergic to experimental drug ingredient or any drug or food or pollen; or abnormal serum immunoglobulin E (IgE) test;
* 3. History of drug abuse, or positive urine test for drug;
* 4. History of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases. History of high blood pressure, or clinically significant systolic blood pressure≥140 mmHg/diastolic blood pressure≥90 mmHg;
* 5. Family history of cancer, or tumor markers (male: CEA, AFP, PSA, CA-125; Female: CEA, AFP, CA-153, CA-125) positive.
* 6. Participated in other clinical trials of drug or used drugs harmful to major organs within 3 months;
* 7. Blood donation within 3 months;
* 8. Used prescription or OTC drugs within 14 days;
* 9. Left ventricular ejection fraction (LVEF) \< 60%;
* 10. ALT or AST \> 1.5 ULN, Cr \> ULN;
* 11. WBC \< 0.8 LLN or \> 1.2 ULN; ANC \< 0.8 LLN; PLT \< 0.8 LLN; HGB \< 0.9LLN.
* 12. HBs-Ag, HCV-Ab, anti-HIV or TP-Ab positive;
* 13. Anti-drug antibody (ADA) test positive;
* 14.History of psychosis;
* 15. History of postural hypotension;
* 16. More than 5 cigarettes per day;
* 17. More than 28 units of alcohol per week; Or alcohol breath test positive within 24 hours before pre-dose;
* 18. History of dizziness of blood or needle;
* 19. Unsuitable for other reasons.
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)

To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
* Colonoscopy within 2 years as part of IBS diagnostic evaluation.
* Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Exclusion Criteria:

* Symptoms of constipation.
* History of other gastrointestinal diseases.
* Type 1 or 2 diabetes.
* Lactose intolerance not controlled by lactose-free diet.
The Effect of Topical Doxycycline Gel on HbA1c in Patients With Type 2 Diabetes Mellitus(DM) ®

Aim:

The purpose of this study is to investigate the effect of nonsurgical periodontal therapy plus subgingivally doxycycline gel 3% on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who have periodontitis.

Materials and methods:

A total of 24 type 2 DM patients with periodontitis will be selected for the study, and randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than 110 have), and also with periodontal disease are chronic moderate (at least in three areas Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical examination and radiographic signs are being); Takes place. The initial HbA1c Patients should be between 7-9 percent over the past three months has changed his medication also found the necessary explanations on how to do that consent, Plaque index (PI) by Loe \& Silness, bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. "Group 1": (12 patients) was treated with oral hygiene instruction, scaling and root planing, and doxycycline gel for 15 days; and "Group 2": (12 patients) has the same treatment but with placebo gel, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated hemoglobin (HbA1c) level, will be reevaluated.

Doxycycline downregulates the activity of matrix metalloproteinases (MMPs), key destructive enzymes in periodontal disease

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus type II (at least 3 months before diagnosis, and A fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis
* Minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, - Had a glycated α hemoglobin (HbA1c) value between 7- 9 percent at screening
* Had reported no changes in diabetes medications within the last 3 months were in the care of a physician for their diabetes.

Exclusion Criteria:

* Pregnancy or lactation
* History of allergy to drugs used in the study
* Smoking
* Diabetes-related emergency within 30 days ago
* Use of nonsteroidal anti-inflammatory drugs
* Or taking low dose daily aspirin (75-325 mg)\\
* Use of immunosuppressive medications; antibiotic use
* Dialysis
* Risk of bleeding complications
* The type of disease periodontal (Aggressive)
* A history of periodontal treatment in the previous 6 months
* Orthodontic treatment
* Using the removal prostheses
* Extensive dental caries
* Dental abscesses or infections.
Outcomes After Tracheal Cannula Removal

This longitudinal observational study involves an integrated knowledge translation (IKT) approach involving key stakeholders in the project team to evaluate the tracheostomy management in patients hospitalized in the Swiss Paraplegic Centre Nottwil (SPC).

Primary objective

- to evaluate the rate of physical complications (that require treatment, intubation, recannulation or lead to death) in patients hospitalized in the SPC over three months following the removal of the tracheal cannula (decannulation).

Secondary objectives

* to describe types of complications short-term (up to 4 days) and long-term (up to three months) post-decannulation
* to assess predictors for short- and long-term complications post-decannulation
* to explore patients' perspectives on decannulation outcomes
* to evaluate individual trajectories of the clinical decannulation protocol

Eligibility Criteria:
Inclusion Criteria:

* at the time of recruitment, tracheotomized adult in-patients (≥ 18 years) of the SPC with any medical diagnosis
* decannulated in the Swiss Paraplegic Center Nottwil within the project's data collection period
* German, French, Italian or English as communication language
* study consent

Exclusion Criteria:

* patients for whom no decannulation is sought (e.g., due to degenerative illness)
* patients for whom decannulation is planned in a clinic other than the SPC (e.g., patients hospitalized in the SPC for weaning only)
Sarcopenia and Osteoporosis in the Patients With Hemophilia

Hemophilia is a bleeding disorder and repeated joint bleeding leads to hemophilic arthropathy. Among patients with hemophilia, vitamin D deficiency and hemophilic arthropathy have been associated with osteoporosis in several clinical studies.There is no data on the prevalence of osteoporosis in hemophilia patients in Taiwan or Asia. To the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. This study will investigate the prevalence and corelation of sarcopenia and low BMD in patients with hemophilia.

patients in Taiwan. The study will estimate the prevalence of sarcopenia and body composition in the hemophilia population and compared baseline demographic and clinical characteristics between the non-sarcopenia and sarcopenia individuals, with particular emphasis on the overlap with osteoporosis and hemophilic arthropathy.


Eligibility Criteria:
Inclusion Criteria:

* Hemophilia patients

Exclusion Criteria:

* History of total hip arthroplasty
* History of instrumentation in lumbar spine
Inspiratory Muscle Training in Patients With Interstitial Lung Disease

The aim of this study is to evaluate the effects of inspiratory muscle training program in inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Inspiratory Muscle Training has been described as an effective intervention and contribute to the improvement of inspiratory muscle function and breathlessness in patients with chronic lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. It is a quasi-experimental study. Patients with interstitial lung disease are recruited from interstitial disease ambulatory. In each session patients performs two times 30 breaths with a minute rest between them. The load is set according with 50% of actual PImax, the Borg score should be between 4 and 6, otherwise the load will decrease (if Borg more than 6) or increase (if Borg less than 4). New PImax is measured weekly and the new load is defined following the same protocol for 8 weeks. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of interstitial lung disease established by a pulmonologist;
* Absence of clinical exacerbations of the disease in the four weeks prior to the initial data collection;
* Present medical research council scale more than 2;
* Absence of a associated or self reported cardiac, orthopedic and psychiatric diseases,
* Not participating in pulmonary rehabilitation programs;
* Do not use supplemental oxygen therapy while resting.

Exclusion Criteria:

- Inability of the participant to understand or perform the procedures proposed during the evaluations and training program.
Optimization of the Parameters of Vagal Nerve Stimulation

Vagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female epileptic patients over 12 years of age
* Suffering from pharmaco-resistant epilepsy
* With newly implanted VNS Aspire SR device
* Surgery performed in the previous 6 months
* Electrode impedance should be within normal range ( \< 4000 Ohms)
* Auto-stim mode working properly
* Mean number of seizures of at least (average 4 (mean value) / months during the baseline period)
* Patient, parents or legally representatives who have given written informed consent to allow the study data collection and procedures

Exclusion Criteria:

* Difficulty to read or understand the French language, or inability to understand the information regarding the study
* Total patient's IQ below 64
* Subject in exclusion period due to enrolment in another study
* Patient with postoperative left vocal cord paralysis
* Patient on VNS since more than 6 months
A Study of Radiation Therapy After Surgery in People with Oral Tongue Squamous Cell Carcinoma

This study will test whether limiting standard photon intensity modulated radiation therapy (IMRT) to exclude the oral tongue surgical site can decrease the risk of side effects caused by oral radiation. The researchers will also find out if this approach affects the rate of disease coming back after treatment (recurrence), and will measure participants' quality of life by having them complete questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT.
* pT1-2,pN0-2b Squamous Cell Carcinoma of the Oral Tongue confirmed on final surgical pathology. Patients must have:

  * at least two of the following pathologic risk features

    * LVI
    * DOI ≥ 4mm OR
  * 1 or 2 pathologically positive nodes N1 to low volume N2b.
* Primary specimen surgical margins ≥3 mm
* Signed informed consent form by the participant or their legally authorized representative (LAR)

Exclusion Criteria:

* N2c/N3 nodal disease
* \>2 pathologically positive nodes
* Primary specimen surgical margin \< 3 mm
* Extensive Perineural Invasion (PNI); non-extensive PNI is permitted.
* Extra-capsular extension in any pathologically positive lymph node
* Surgery at outside institution (PI can give approval for patients operating on outside)
* Prior or simultaneous invasive malignancy that, in the opinion of the PI, represents a competing risk of death equivalent to the patient's oral tongue squamous cell carcinoma.
* Auto-immune conditions that would otherwise preclude radiation in the opinion of the PI (e.g. Scleroderma).
* Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.

The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion:

* Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens.

Exclusion:

* Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment
* Clinically significant pulmonary dysfunction.
* Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment).
* Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
* History of autoimmune disease.
* History of positive serology for human immunodeficiency virus (HIV).