cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity

This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity response relative to a clinically-controlled stimulus.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
* agree to not participate in any other oral care study for the duration of this study
* agree to return for scheduled visits and follow all study procedures
* have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the examiner applied cold water challenge

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed facial orthodontic appliances
* a history of kidney stones
* self-reported pregnancy or nursing
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
High-dose Etoposide Could Discriminate Patients With Refractory/Relapsed Lymphoma Benefit From APBSCT

patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48 hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs. Peripheral blood counts were performed daily for all patients following the initiating of rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L with blood cell The harvested cells reached at least 2\*108/kg for mononuclear cells and/or 2\*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen in liquid nitrogen.Auto-PBSCT


Eligibility Criteria:
Inclusion Criteria:

* relapsed/refractory lymphoma ,siut APBSCT

Exclusion Criteria:

* bone marrow without involvement by lymphoma cells
Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)

The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.

Tyrosine kinase inhibitors (TKIs) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. TKIs are metabolized in liver into inactive metabolites before eliminating from body. Liver function might plays a significant role in inter-individual differences of pharmacokinetics of TKIs. Hepatitis B is a disease of high prevalence in south China. The liver function will be compromised if the infection of hepatitis B virus has not been controlled. This study aims to compare the pharmacokinetics of TKIs before and after controlling HBV with standard treatment in Chinese patients of non-small-cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed non-small-cell lung cancer
* with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genetic mutation required by different TKIs
* liver function, ALT and/or AST \<= 2\*upper limit of normal (ULN)
* diagnosed of chronic hepatitis B
* Hepatitis B negative as controlled group
* receiving one type of TKIs
* Age between 18-70

Exclusion Criteria:

* diagnosed of acute/ active hepatitis B
* diagnosed of AIDS
* unable to make decision because of metastasis to central nervous system
Alcohol Use and Relationships - III

The investigators hypothesize that individuals receiving the brief substance use intervention will have better substance use and intimate partner violence outcomes than individuals receiving the general health improvement intervention. All participants receive standard batterer intervention.


Eligibility Criteria:
Inclusion Criteria:

* Participation in Batterer Intervention Program in RI
* Hazardous Drinking

Exclusion Criteria:

* drinks too much
Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study

A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

Objective: To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

Study design: Single center prospective observational non-randomized clinical study.

Study population: A total of 20 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
* Requiring treatment for dysphagia (Ogilvie score of 2-41);
* Life expectancy of less than 12 months;
* Written informed consent;
* Age ≥ 18 years.

Exclusion Criteria:

* Stenosis after laryngectomy;
* Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
* Tumor length of more than 14 cm;
* Previous stent placement for the same condition;
* Coagulopathy (not corrected prior to stent placement);
* Patients with eosinophilic esophagitis or an esophageal motility disorder;
* Nickel titanium (Nitinol) allergy.
Effectiveness of Self-Help for Dually-Diagnosed Persons - 1

The purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders.


Eligibility Criteria:
Inclusion Criteria:

Admission to psychiatric day treatment program 18-64 years old

Exclusion Criteria:

Did not understand or speak English, appeared intoxicated on drugs or alcohol, carried a diagnosis of mental retardation, were deemed actively psychotic by the clinic's intake coordinator, appeared unable to understand and give informed consent.
Physical Activity and Fertility Care Study

Randomized control trial to determine if performing the US Health and Human Services recommended amount of weekly physical activity during ovarian stimulation will differentially affect mental health or clinical outcomes of individuals who are usually active, insufficiently active, or inactive in their everyday lives. The goal overall is to assess for safety and value of physical activity during fertility treatment.

Consenting participants will be separated into groups based on current average level of physical activity: Active women (complete \>75 minutes of vigorous exercise or \>150 minutes of moderate exercise per week) and Insufficiently active women (\<75 minutes of vigorous exercise or \<150 minutes of moderate exercise per week).

Between time of study enrollment and first ultrasound at start of ovarian stimulation cycle, the participants will be sent a link to questionnaires to assess general mental health parameters and physical fitness. They will be asked to complete the questionnaire prior to first ultrasound visit. At time of first ultrasound, participants who have completed the pre-stimulation survey will be randomized into one of two arms depending on their group: the active group will be randomized to (A) maintenance or (B) decreased activity arm, and the insufficiently active group will be randomized to (C) increased or (D) maintenance activity arm.

Also at first ultrasound, participants will be given a wearable heart rate monitor in order to track heart rate during the time from ovarian stimulation to first pregnancy test in order to monitor compliance to randomized activity level of each participant. The data from the monitors will be collected through a central university provided, password protected laptop utilizing an app platform. Furthermore, all participants will be asked to complete a daily mood, stress, discomfort questionnaire throughout stimulation. Participants will be expected to continue recommended physical activity level and questionnaires until day of egg retrieval. Wearable monitors will continue to be worn until time of first pregnancy test. Within the two weeks after completion of egg retrieval, participants will be sent a follow-up questionnaire to assess overall treatment stress and satisfaction with ovarian stimulation cycle. Those who completed in vitro fertilization and fresh embryo transfer will be sent a second follow-up questionnaire about 1-2 weeks after pregnancy test.

Eligibility Criteria:
Inclusion Criteria:

* First ovarian stimulation cycle for egg freezing or for in vitro fertilization
* English speaking/reading
* Patient at the Center for Reproductive Health, University of California San Francisco

Exclusion Criteria:

* Serious health conditions that limit amount of physical activity
* BMI\>40
Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot

Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (PACU). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.


Eligibility Criteria:
Inclusion Criteria:

1. Adults having major non-cardiac surgery expected to last ≥2 hours;
2. American Society of Anesthesiologists physical status 1-3;
3. Age 21-85 years old;
4. Planned endotracheal intubation

Exclusion Criteria:

1. Planned neuraxial or regional block;
2. Local anesthetic infiltration at surgical field;
3. Clinician preference for an opioid other than, or in addition to, fentanyl;
4. Non-sinus heart rhythm;
5. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
6. Lack of English language fluency;
7. Routine user of psychoactive drugs other than opioids;
8. Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
9. Intracranial surgery
10. BMI \> 40
Effect of Scapular Stabilization Exercises in Individuals With Adolescent Idiopathic Scoliosis

Idiopathic scoliosis is a three-dimensional deformity of the spine that accounts for approximately 70% of all scoliosis anomalies, and adolescent idiopathic scoliosis (AIS) is the most common type. AIS not only changes the shape of the trunk, but also the relationships between body parts. Considering the close anatomical relationship between the scapula and the rib cage, AIS is associated with changes in scapular position and orientation. Scapular stabilization exercises; these are exercises that aim to restore the position and orientation of the scapula and the motor control and movement pattern of the muscles, thus providing scapula stability for better shoulder kinematics. There are studies reporting that scapular stabilization exercises should be included in the rehabilitation program of patients with scapular dyskinesia and various shoulder pathologies. However, no study has been found in the literature examining the effects of scapular stabilization exercises on changes in scapular position, shoulder imbalance and curve severity seen in scoliosis. Therefore, the aim of the study is to investigate the effect of scapular stabilization exercises applied in addition to Schroth exercises used in the treatment of individuals with AIS, on scoliosis severity, scapula position and shoulder imbalance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with adolescent idiopathic scoliosis,
* Having Cobb angle between 10°-30°,
* Those with main thoracic curvature,
* Risser stage between 0-3,
* Volunteer individuals

Exclusion Criteria:

* Individuals who have had surgery related to the spine and upper extremity,
* Using a supra-axillary trunk orthosis,
* Having any systemic or neurological disease
Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)

The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD).

Kava kava (KAV) is a plant-derived treatment widely used in Europe to treat anxiety disorders. Several studies suggest that KAV may be effective in reducing anxiety symptoms; however, trial data are limited. This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of GAD.

This study will last 10 weeks. Participants will be randomly assigned to receive KAV, VEN, or placebo for 8 weeks. Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation. Self-report scales and questionnaires will be used to assess the anxiety, depression, and functional impairment of participants. Side effects, vital signs, and laboratory measures will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of generalized anxiety disorder (GAD)
fMRI Cholinergic Mechanisms in Schizophrenia

This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.

This study will use functional magnetic resonance imaging (fMRI) to study patients treated with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those treated with clozapine to determine which brain areas are involved in clozapine's normalization of sensory gating in schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* age 18-60 yrs

Exclusion Criteria:

* claustrophobia
* weight \> 250 lbs
* metal in body other than dental fillings
Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma

Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory CD20+ B-cell lymphoma.
2. Measurable disease.
3. Performance status ECOG 0-2.
4. Age:18-65.
5. Fertile females/males must consent to use contraceptives during participation of the trial.
6. Signed informed consent

Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Patients with primary CNS lymphoma.
3. Known human immunodeficiency virus (HIV) infection.
4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
7. Patients that do not consent to that tissue and blood samples are stored in a biobank.
8. Pregnancy.

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Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models

Prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal aortic aneurysm repair (EVAR).

Fifty patients undergoing LEA and EVAR will be randomized into two groups: Group upper body blanket and Group underbody blanket. All patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. The warming unit used (Bair Hugger 750 warming unit, Arizant Healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (Bair Hugger 522 upper body blanket, 3M) and underbody blanket (Bair Hugger 635 full acess underbody blanket, 3M). Surgical and anesthetic complications will be noted. Only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing LEA and EVAR
* American Society of Anesthesiologists physical status (ASA) : 1-4

Exclusion Criteria:

* Non-endovascular surgery
* pregnant patients
* patient refusal
* less than 45 minutes duration of surgery
Fesoterodine "add-on" Male Overactive Bladder Study

To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 40 years and above.
* On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
* Persistent symptoms of OAB with urinary frequency \>=8 times/24 hours and micturition-related urgency episodes \>=3 episode/24 hours.

Exclusion Criteria:

* Contraindication to fesoterodine (antimuscarinics).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes

The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery


Eligibility Criteria:
Inclusion Criteria:

* ASA 2 \& 3 for elective breast cancer surgery

Exclusion Criteria:

* ASA \> 3
* BMI \> 35 kg/m2
* Contraindications to LA (coagulopathy and local infection)
* Allergy to the drug
* Cardiac, hepatic and renal patients
Anti-FLEX: Flexed Levering of Gluteal Vessels

The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone and jackknife positions.

This is a prospective collection of contrast-enhanced CT images of healthy female volunteers in prone and jackknife positions in order to determine if position impacts gluteal venous vasculature.

Eligibility Criteria:
Inclusion Criteria:

* Females age 20 - 50 years
* BMI between 20 - 35 kg/m2
* Willingness and ability to provide written informed consent
* Willingness and ability to comply with all study procedures
* Interested or planning to have a gluteal augmentation

Exclusion Criteria:

* Males
* Females age \< 20 or \>= 51 years
* BMI between \< 20 or \> 35 kg/m2
* Prior gluteal augmentation surgery
* Any prior gluteal soft tissue filler
* Known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium
* Documented history of chronic kidney disease that contraindicates the use of contrast dye
* Pregnant
* Currently breast-feeding
* Any reason (in addition to those listed above) that, in the opinion of the principal investigator, precludes full participation in the study
Pilates Exercises Versus Resistance Exercises Among Geriatric Population With Sarcopenia

The goal of this clinical trial is to compare the effectiveness of two exercises to improve physical functioning of older adults with sarcopenia. the primary aim of this RCT is:

To measure the influence of pilates exercises versus resistance training in elderly with sarcopenia.

To introduce an affordable, effective and safe exercise care program, which prioritizes to make geriatric population independent.

Participants will be assessed for all outcome measures change at baseline and after 3 weeks following an exercise intervention. Participants enrolled in pilates exercise group will receive total of 9 exercises and participants enrolled in resistance exercise group will receive total of 8 exercises.

A total sample of 70 of geriatric population with sarcopenia will be collected from Dow University Hospital Ojha. Non-probability purposive sampling technique will be used. Participants will be screened and referred from medicine, family medicine and neurology OPD to physiotherapy OPD. Outcome measure assessment will be performed in all patients at two time points: baseline and follow up at the end of last session.

Outcome measures include short physical performance battery assessment tool (SPPB). Strength and gait are first evaluated by the ability to perform the tasks of getting up and sitting on a chair five consecutive times and performing the walking speed test (3 meters), Time up and go test, sit and reach test, and 2-minute step test as a measure of physical functioning.

After complete assessment at baseline all participants will be randomized to different treatment groups using 70 opaque sealed envelopes containing notes written with "new treatment" or "Standard treatment" on (n= 35 of each). The envelops will be scrambled before each participant allow to draw an envelope and thus find out in which group they will be allocated. Treatment will be provided to both groups. Group 1 will be provided with pilates exercises and group 2 will be provided with resistance exercises. Both groups will perform generalized warm up for up to 10 minutes at the beginning and 10 minutes of relaxation exercises at the end of treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Referred and screened patients with sarcopenia from medicine, family medicine and neurology OPD at Dow University Hospital Ojha Campus, Karachi.
* Patients from 60 to 70 years of age
* Both male and female.
* Patients who consent to participate

Exclusion Criteria:

* Being bedridden
* Implanted pacemaker
* Recent history of any fracture
* Patients with cognitive \& neurological impairment
* Already enrolled in any exercise intervention program
* Known case of patients with malignancy
* Patients on steroids