cyrilzakka/clinical-trials huggingface dataset:
A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Age 18\~70 years old.
3. Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
4. At least one measurable lesion per RECIST v1.1 criteria.
5. ECOG PS score: 0-1.

Exclusion Criteria:

1. Active or symptomatic brain metastases.
2. Previous diagnosis of any other malignancy.
3. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
4. Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
5. Uncontrolled tumor-related pain.
6. Subjects with severe cardiovascular and cerebrovascular diseases.
"Study of Halitosis in Patients With Advanced Chronic Periodontitis"

The objective of this study was to evaluate whether short-term full mouth disinfection protocol could have a greater reduction in the levels of halitosis and volatile sulfur compound or not, when compared to quadrant-wise scaling and root planing

In recent years, several studies have shown that the levels of volatile sulfur compounds are higher in periodontitis patients. However, the relationship between periodontal disease and bad breath is still controversial. Aspects that should be clarified include its relation to periodontitis severity, the influence of risk variables and the subject of the present research, that is treatment choice. To help clinicians and patients when deciding about mechanical periodontal therapy, 30 patients with advanced chronic periodontitis were selected from the periodontics clinic, Dental School, Pontiphical Catholic University of Minas Gerais from April 2013 to May 2014. A complete periodontal clinical examination was performed and the following parameters were recorded: probing depth (PD), clinical attachment level (CAL), bleeding on probing, plaque index, and tongue coating index. Halitosis was assessed by using the organoleptic method and measurements of volatile sulfur compounds (VSC), including hydrogen sulfide (H2S) and methyl mercaptan (CH3SH) by using gas chromatography, at baseline and 90 days after non-surgical periodontal treatment. After periodontal clinical examination, individuals were randomly allocated to full-mouth scaling (FMS) - completed within 24 hours - or to conventional quadrant-wise scaling and root planing (SRP) - completed within 2 months. Halitosis and sulfur gas levels were were statistically compared (Mann-Whitney and Wilcoxon tests, p \< 0.05). For inter- and intra-group comparisons regarding categorical variables Chi-square, McNemar, and Fisher exact tests were used. Primary outcome was halitosis changing.

Eligibility Criteria:
Inclusion Criteria:

* age between 35 and 60 years
* presence of at least 20 natural teeth
* diagnosis of chronic periodontitis
* halitosis
* no smokers

Exclusion Criteria:

* smokers or former smokers
* individuals diagnosed with diabetes and / or immunological disorders
* pregnant or lactating / patients with removable partial dentures and / or fixed or removable orthodontic appliance
* systemic use of antibiotics or anti-inflammatory in the last six months
* need for prophylactic use of antibiotics for performing the treatment
* regular use or use in the last six months of any kind of mouthwash
* individuals who underwent periodontal treatment in the 6 months preceding the start of the study
Reducing High Risk Behavior in Treatment Court

This study will be the first to examine the efficacy of using a brief, computerized HIV risk reduction intervention in treatment courts.

Four hundred consenting treatment drug court participants will be randomly assigned to either an HIV intervention group (n = 200) or an attention control group. All clients will attend their regularly scheduled status hearings which are scheduled approximately every six weeks. Clients in the HIV intervention group will receive a brief computerized, self-administered HIV risk reduction intervention following each of their first three status hearings. Clients in the attention control condition will view a series of educational life-skill videos of matched length following each of their first three status hearings. The primary outcome will be engagement in high risk behaviors as measured by the Risk Assessment Battery (RAB). Secondary HIV-related outcomes will include: (1) rate of HIV testing, (2) condom procurement, and (3) self-reported condom use. Tertiary outcomes related to treatment court compliance will include: (1) drug court graduation, (2) urinalysis-confirmed drug abstinence, (3) case management attendance, and (4) satisfaction with case management. In addition, we will conduct preliminary cost and cost-effectiveness analyses on the delivery of the brief computerized HIV intervention. Assessments will be conducted at baseline and 9- and 15-months post admission.

Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years of age;
2. be charged with a non-violent felony offense
3. have no more than two prior non-violent convictions or diversionary opportunities
4. be willing to participate in the treatment court program for at least 12 months
5. be in need of treatment for substance abuse or dependence as assessed by case management.

Exclusion Criteria:

* Elderly subjects and those with medical problems will be included in the research as long as they do not have any physical or psychiatric condition that would impede their ability to give competent consent to research participation or to understand the research instruments.
* Those individuals who are intoxicated, cognitively impaired, or psychiatrically unstable when approached will not be included; however, such individuals may subsequently be included if the disqualifying condition subsides.
* Spanish speaking only individuals.
* Client remanded to jail or residential treatment facilities at the time of Treatment Court enrollment.
Prevention of Upper Gastrointestinal Hemorrhage Using Albis® in the Patients of Locally Advanced Pancreatic Cancer Who Underwent Concurrent Chemoradiotherapy

Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. About 40% of pancreatic cancer patients were diagnosed as locally advanced unresectable status without distant metastasis. Concurrent chemoradiotherapy (CCRT) was a reasonable treatment modality for locally advanced pancreatic cancer. However, several adverse events of chemoradiation could lead unfavorable treatment results, which included unique gastrointestinal (GI) toxicities, such as ulcer and hemorrhage in the stomach and duodenum that are included in the radiation field. According to the study in the investigators hospital, 45% of locally advanced pancreatic cancer patients treated with CCRT suffered from GI ulcers, and among them, 65% of the patients experienced the significant hemorrhage events. Although these GI toxicities, the studies for radioprotective agents were limited. Albis® is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The investigators will investigate the radioprotective effect of Albis® for locally advanced pancreatic cancer patients treated with CCRT.


Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old and younger than 80 years old
* Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
* ECOG Performance status ≤2
* Scheduled fot concurrent chemoradiation
* Adequate liver function (total bilirubin \< 1.5 X the upper limits of normal (ULN), AST and ALT \<3 X UNL, and alkaline phosphatases \< 3 X ULN or \< 5 x ULN in case of liver involvement)
* Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
* Not remarkable coagulation profile (PT \< 1.5 international normalized ratio(INR), aPTT \<35 sec)
* Subjects who given written informed consent after being given a full description of the study

Exclusion Criteria:

* Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
* Evidence of distant metastasis, such as liver, peritoneum and brain
* history of receiving the chemoradiation for pancreatic cancer in the other hospital
* History of receiving the operation which affect the anatomy of upper gastrointestinal tract
* Any trouble for examination of upper endoscopy
* Evidence of GI ulcers (A1\~H2) on endoscopy before start of chemoradiotherapy.
* Use of aspirin, anti-platelet agent, anticoagulation agent, NSAIDs, or glucocorticoid within 1 week or enable to stop the administration (including start during chemoradiation)
* Use of PPI, Histamine-2 receptor antagonist, antacid, prostaglandin, sucralfate within 2 weeks or enable to stop the administration
* Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
Efficacy of a Propolis-based Denture Cleanser

The purpose of this study is to assess if a propolis solution is able to remove plaque and kill microbes from complete dentures. The investigators will compare the results of the propolis-based denture cleanser with those obtained with an inactive solution.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Patients requesting new complete dentures
* Regular wearing of the same maxillary and mandibular complete dentures for at least one year
* Both denture bases and artificial teeth should be composed by acrylic resin

Exclusion Criteria:

* Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
* Pathologic changes in the oral cavity
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients (≥18 years of age) with metastatic (Stage IV) colorectal adenocarcinoma confirmed either histologically or cytologically, with measurable metastatic disease according to RECIST v. 1.1
* Patients must have PD after receiving the approved standard therapies
* Patients must have ECOG PS of 0 or 1 and a life expectancy of at least 3 months
* Adequate bone marrow, liver and renal function
* Women of childbearing potential and men must agree to use adequate contraception

Exclusion Criteria:

* Unresolved toxicity greater than Grade 1 from prior treatment for mCRC
* Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)
* Subjects unable to swallow oral medications
* Any malabsorption condition
* Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patient's participation in the study
Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment.

PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.

OBJECTIVES:

Primary

* To determine if contrast-enhanced ultrasonography (CEUS) study of target metastasis from renal cancer leads to early assessment of pharmacodynamic effects of antiangiogenic treatment in patients with advanced renal cancer.

Secondary

* To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the time to progression.
* To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the global survey.
* To determine the tolerance to antiangiogenic treatments in these patients.
* To determine the relationship between functional changes of microvascularization and the target lesion and the objective response for the other lesions (RECIST criteria) in cases of other metastasis other than the target lesion.

OUTLINE: Patients undergo contrast-enhanced ultrasonography (CEUS) before and after stabilized sulphur hexafluoride microbubble-based contrast agent injection. CEUS is done within 8 days prior to, 30 days after the first administration, and after 3 months of receiving antiangiogenesis treatment (e.g., sunitinib malate, sorafenib tosylate, or bevacizumab). Patients also undergo computed tomography and magnetic resonance imaging to evaluate tumoral targets.

After completion of study treatment, patients are followed up for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of advanced renal cancer
* Planning to receive antiangiogenic treatment
* Detection of a target hepatic metastasis that is visible, located, and sized with conventional sonography and CT scan and/or MRI

PATIENT CHARACTERISTICS:

* No active cardiac disease
* No severe arterial hypertension

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Role of Low Level Laser Therapy in Acceleration of Teeth Alignment in Lingual Orthodontic Patients

We will treat patients with class I malocclusion who have moderate crowding (4-6 mm) according to Little's irregularity index and asses the efficacy of low level laser therapy in accelerating orthodontic tooth movement .

There is two groups :

1. treated with Low level laser therapy (LLLT)
2. treated traditionally without any irradiation Patients will be randomly allocated in any group and all data will be collected through photographs when leveling and alignment completed.

Also pain levels will be assessed using numeric rating scale to compare between the two groups and if laser really can relief pain or not .

The time of orthodontic treatment is considered to be one of the most concerns for patients. The study will investigate the effect of low level laser therapy on the speed of orthodontic tooth movement during the correction of moderately crowded anterior upper teeth using lingual orthodontic appliance.

The study will be accomplished with two arms, the first is LLLT arm and the other is the control arm without any active intervention.

Low level laser with a wave length of 830 nm, output of 150 mW, energy of 2 J per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 j per each tooth.

Within the limits of our knowledge, this is the first study in the world that will study acceleration of orthodontic tooth movement with lingual orthodontic .

Eligibility Criteria:
Inclusion Criteria:

* Class I malocclusion with mild to moderate crowding
* Old between 17-27 years
* Good oral hygiene
* Patients should be fit and well
* 4-6 mm crowding in upper incisors according to Little's index
* Enough clinical crowns length

Exclusion Criteria:

* Patients who had an old orthodontic treatment
* People who have any drug or disease affect orthodontic movement
* Any contraindication for orthodontic treatment
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics

Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

Pediatric subjects with indication for H.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID® Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. The stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. Safety and overall efficacy will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Be older than 3 and younger than 18 years of age
* Present with a clinical indication compatible with H. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for H.pylori)
* Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed Consent/Assent Form
* Naïve to H. pylori treatment in the past 6 weeks

Exclusion Criteria:

* Participation in other interventional trials
* PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test
* Pregnant or breastfeeding female
* Allergy to test substrates
* Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within four (4) weeks prior to breath test
* Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test.
* Exposure to any 13C-enriched substance 24 hours prior to the breath test.
* Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
* Subjects outside US - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
Self Myofascial Release in Individuals With Piriformis Syndrome

Piriformis syndrome is pain that extends from the hip to the knee, caused by the pressure of the piriformis muscle in the hip on the sciatic nerve. There is no valid protocol for the treatment of this syndrome. Physiotherapists generally use hip strengthening exercises and modalities for pain. In this study, in addition to the classical treatment, we will give two different programs consisting of self-myofascial relaxation and stretching exercises to two different groups for 4 weeks as home exercise. We will question the level of pain that people felt in the hip before starting the exercises and at the 4th week after starting the exercises and measured the hip joint range of motion.

Piriformis syndrome (PS) is a condition caused by compression of the sciatic nerve, causing pain, tingling, and numbness. Although conservative treatment includes hip muscle strengthening and stretching, there is no proven treatment method in the literature.

This study will be conducted to investigate the effect of stretching and myofascial release added to standard physiotherapy treatment in piriformis syndrome.

This prospective, randomized controlled study will be planned to completed with 64 individuals between the ages of 20-40. Participants will be randomized into the Piriformis Muscle Stretch Group (PiM-S) and Piriformis Muscle Self Myofascial Release Group (PiM-SMR). Both groups will be included in a home program of muscle strengthening exercises for 4 weeks. And groups will be subjected to perform stretching and self-myofascial relaxation exercises, respectively, in addition to the home exercise program. The primary outcome of the study is pain intensity, and the secondary outcome is determined as the range of motion (ROM) of the hip.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants
* Aged 20 to 40 years
* Presented leg or hip posterior compartment pain
* Diagnosed with chronic PS and without any other source of pain

Exclusion Criteria:

* Any pathology or acute injury around the hip, sacroiliac joint, or lumbar spine;
* Limb length discrepancy,
* Recent buttock trauma,
* Deep gluteal syndrome,
* Extrapelvic compression of the sciatic nerve or sacral plexus ischiogluteal/ischiofemoral bursitis or impingement, Upper hamstring tendinitis,
* Fibromyalgia, myofascial pain syndrome
* Pregnancy.
Study to Detect Hypotensive Episodes During Spinal Anesthesia for Cesarean Section Using a Noninvasive Continuous Device

Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. The investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* week of pregnancy \>36

Exclusion Criteria:

* emergency cases