cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Hydroxyzine for Patients With Panic Disorder

The aim of this study is to evaluate the efficacy of hydroxyzine compared to treatment as usual (TAU) for patients with panic disorder. By conducting a pilot study, we hope to provide initial data on the feasibility and potential impact of hydroxyzine for this population. This will inform the design and power calculations of a larger, more comprehensive study in the future.

Objectives:

To assess the feasibility of conducting a randomized controlled trial (RCT) of hydroxyzine for panic disorder.

To evaluate the effectiveness of hydroxyzine compared to TAU in reducing panic symptoms in patients with panic disorder.

To explore the potential side effects and tolerability of hydroxyzine in this population.

Methods:

This will be a single-center, open-label, randomized pilot study. A total of 30 patients with a primary diagnosis of panic disorder will be recruited from a psychiatric outpatient clinic. Participants will be randomly assigned to receive either hydroxyzine or TAU for 8 weeks. The primary outcome measure will be the change in panic symptoms as assessed by the Panic Disorder Severity Scale (PDSS). Secondary outcome measures will include the Hamilton Anxiety Rating Scale (HAM-A) and the Clinical Global Impression-Severity (CGI-S) scale. Participants will be assessed at baseline, 4 weeks, and 8 weeks. Adverse events will be monitored throughout the study.

Expected Results:

This pilot study is expected to provide preliminary data on the feasibility and potential efficacy of hydroxyzine for panic disorder. The results will inform the design of a larger RCT to further evaluate the efficacy of hydroxyzine for this population.

Significance:

There is a need for effective and well-tolerated treatments for panic disorder. If found to be effective, hydroxyzine could provide a new option for patients with this condition, potentially improving their quality of life and functioning. The results of this pilot study will inform the design of future studies and contribute to the development of evidence-based treatments for panic disorder.


Eligibility Criteria:
Inclusion Criteria:

* The study will recruit adult patients (18 years and older)
* Confirmed diagnosis of the panic disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
* Participants will be included if they have had at least one panic attack per week for the last four weeks,
* Have not received any pharmacological treatment for panic disorder in the past four weeks,
* Willing to discontinue any current benzodiazepine or SSRI treatment for the duration of the study.

Exclusion criteria:

* Current substance abuse or dependence,
* Medical diseases
* Psychiatric comorbidities,
* Pregnancy or lactation.
GPR vs Manual PT for Chronic Neck Pain

Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR) with standard manual physical therapy on with respect to pain, function, kinesiophobia, range of motion, perceived effect, and satisfaction.

These study will use two groups: one to receive GPR which is a systematic method of addressing musculoskeletal pain and related functional deficits and the other to receive "usual care" manual PT which will be individualized to the patient's condition. Usual care will include techniques commonly used in clinical practice selected by the physical therapist after initial examination. After nine weeks of treatment, baseline measures will be re-evaluated. After conclusion of the first phase of the study, patients who were randomized to the "usual care" group will cross-over and receive GPR.

Eligibility Criteria:
Inclusion Criteria:

-nonspecific neck pain lasting at least 3 months

Exclusion Criteria:

* acute or subacute cervical pain
* specific or known cause of pain
* central or peripheral neurological signs
* systemic pathology
* rheumatologic pathology
* neuromuscular pathology
* cognitive impairment
* surgical intervention in the last 6 months prior to study
* physical therapy treatment in the last 6 months prior to study
Collaborative Care in Posttraumatic Epilepsy

The purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.

The study will compare collaborative care versus usual care among N=60 adults with post-traumatic epilepsy and anxiety and/or depression symptoms in Veterans Administration (N=20) and civilian university (N=40) settings at the Salisbury VA and Atrium Health Neurology. This single-blind study will evaluate effectiveness and implementation of a remotely-delivered, 24-week team-delivered collaborative care intervention, with features adapted from VA Primary Care Mental Health Integration and Whole Health, as well as an existing Family Medicine Collaborative Care Program at AHWFB.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures
* Diagnosis of post-traumatic epilepsy, defined by the following:

  1. Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis)
  2. History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database
  3. TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form)
* Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) \>13
* Receiving clinical neurological care at one of the study sites

Exclusion Criteria:

* Active ongoing treatment by a psychiatrist without the potential to benefit from additional collaborative care for anxiety or depression in the judgement of the investigators
* Active suicidal ideation
* History of past suicide attempt
* Unstable drug or alcohol abuse
* Unstable or progressive comorbid medical condition
* Current participation in another treatment or intervention study
* Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.
Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures
* Body Mass Index (BMI) between 19-27 kg/m2

Exclusion Criteria:

* Receipt of another investigational drug in the 4 months before dosing in this study
* Acute illness which requires medical intervention within 2 weeks of Visit 2.
* Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure \> 140 mmHg systolic or \>90 mmHg diastolic, pulse\<= 50 or =\> 90 beats per minute
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)

PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.

Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by Sino medical science(SINOMED). BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75, male or non-pregnant female
2. Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
3. Target lesion is primary and de-novo coronary artery disease
4. The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
5. Lesion diameter stenosis ≥70% (visually estimated)
6. For each target lesion, same stent implantation only
7. Acceptable candidate for Coronary Artery Bypass Grafting(CABG)
8. Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up

Exclusion Criteria:

1. Acute MI within 1 week
2. Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
3. More than 3 stents required
4. Patients refuse to be implanted stent
5. Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion
6. In-stent restenosis
7. Planned percutaneous coronary intervention (PCI) within 3 months post procedure
8. Other stents implanted within 1 year
9. Severe heart failure (NYHA above III) or left ventricle ejection fraction(EF) \<40%
10. Renal function damage, blood creatinine \> 176.82 μmol/L
11. Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents
12. Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.)
13. Life expectation \< 12 months
14. Have not reached the primary end point when participating in other trial
15. Poor compliance to the protocol
16. Heart implantation cases
Trigger Point Dry Needling Practice in Colorado: Practitioner and Patient

A retrospective analysis of responses following a descriptive survey to investigate the benefits and harms associated with dry needling as provided by a physical therapists in CO

Two surveys were completed to identify the reported harms by physical therapists in the provision of dry needling in Colorado, and by patients who received dry needling from physical therapists in Colorado in April 2017. Retrospective analysis of the data (de-identified) was completed to provide a representative reporting on harms associated with the dry needling provided and received for patients.

Eligibility Criteria:
Inclusion Criteria:

* Physical therapists providing dry needling to patients in Colorado
* Patients who had received dry needling from Physical Therapists in Colorado

Exclusion Criteria:

* None
Extraluminal Use of the Bronchial Blocker of Univent Tube

intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

One-lung ventilation is desirable for Several clinical procedures, such as thoracic,pulmonary, and cardiac surgery to facilitate lung exposure for these surgical procedures by collapsing the lung and most commonly used device is the double-lumen tube (DLT) for this surgical procedures.Bronchial blockers (BBs), such as univent tube with an bronchial Blocker, has more advantages than the double-lumen tube: no need exchange tube when mechanical ventilation is required postoperative, easier insertion,less postoperative sore throat (ST) and hoarseness. However, BBs requires more time for placement and more difficult to position, especially patients undergoing left-side thoracic surgery. So, this study intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* sixty patients undergoing left thoracic surgery
* ASA classifications of I-II, modified Mallampati classification of 1 or 2, requiring general anesthesia were included.

Exclusion Criteria:

* age younger than 18 yr or older than 70 yr
* BMI\>30 kg/m2
* with upper respiratory tract infection,asthma
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Myofascial Induction Effects on Stabilometry Versus Sham Laser

The objective is to determine the effectiveness of myofascial induction effects on stabilometric variables. Forty healthy subjects will be recruited for a single blind clinical trial. All subjects will be randomly distributed into two different groups: control group (simulated laser) and experimental group (myofascial induction). Result measurements will be performed in the center of the pressure area (stabilometry) using a validated platform. Two trials will be recorded for each condition (eyes closed and eyes open)


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals without pain.

Exclusion Criteria:

* Previous lower extremities surgery
* History of lower extremities injury with residual symptoms within the last year
* Evidence of a leg-length discrepancy of more than 1 cm
* Evidence of balance deficits
Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery

Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.

It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.

The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.


Eligibility Criteria:
Inclusion Criteria:

* patient aged ≥ 18 years old
* first Femtosecond Laser-assisted Cataract Surgery scheduled
* cataract density ≥ 3 according to the lens opacities classification system (LOCS)

Exclusion Criteria:

* corneal guttata, uncontrolled glaucoma
* shallow depth of anterior chamber
* patient's refusal to participate in the study
* pregnant or breast feeding patient
* patient under legal protection
* no health coverage
Observational Study of Dental Outcomes in Head and Neck Cancer Patients

The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.

This is a prospective cohort study to document dental and other oral outcomes in patients who receive external beam radiation therapy with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-five participants will be enrolled. All study participants will receive a baseline oral examination prior to the start of radiation therapy. Follow-up examinations and data collection will be conducted at six-month intervals up to 2 years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.

The proposed research will provide more information to inform the community about the sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current guidelines and to design future studies on the dental management of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older;
* Willing and able to provide signed and dated consent form;
* Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;

OR

* Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The subject must be expected to receive at least 4500 cGy to one of the following sites:

  1. base of tongue
  2. buccal/labial mucosa
  3. epiglottis
  4. floor of mouth
  5. gingiva/alveolar ridge
  6. hard palate
  7. hypopharynx
  8. larynx
  9. lip
  10. mandible
  11. maxilla
  12. maxillary sinus
  13. nasal cavity
  14. nasopharynx
  15. neck
  16. oral cavity
  17. oral tongue
  18. oropharynx
  19. paranasal sinus/orbit
  20. parotid gland
  21. pharynx
  22. retromolar trigone
  23. soft palate
  24. sublingual gland
  25. submandibular gland
  26. tonsil;
* At least 1 natural tooth remaining or expected to remain in the mouth after completion of the pre-RT dental extractions, if any;
* Willing to comply with all study procedures;
* Willing to participate for the duration of the study.

Exclusion Criteria:

* Receiving palliative RT;
* History of prior curative RT to the head and neck region to eradicate a malignancy;
* Incarcerated at time of screening;
* Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Folate-Rich Foods Improve Folate Status

This study evaluates the effects of folate-rich foods regarding improvement of folate status compared with folic acid supplement. A randomized, parallel intervention trial with two active groups (folate-rich foods or folic acid supplement) and one control group (apple juice - 0 µg/d folate) was executed over 12 weeks.

Sixty-two women in reproductive age, apparently healthy, non-smokers, not consuming special diets (vegetarian), not pregnant, not planning conception or not lactating.

A randomized, controlled, parallel intervention trial with two active groups and one blinded control group was carried out for 12 weeks (March to June, 2013). The active food group (n = 21) consumed folate-rich foods (germinated canned faba beans, cookies, orange juice, providing additional 250 μg/d folate); the active folic acid supplement group consumed a supplement (n = 19, providing 500 μg/d folic acid); and the control group (n = 22) received apple juice containing no folate or folic acid) in addition to the freely chosen diet.

Fasted venous blood samples were collected at baseline, two months and three months for quantification of folate in plasma and erythrocytes and of homocysteine in plasma.

Eligibility Criteria:
Inclusion Criteria:

Normal biochemical range for:

* Fasted plasma glucose
* Iron status (haemoglobin, serum ferritin)
* Liver status (aspartate transaminase, alanine transaminase, and γ-glutamyl transferase activities)
* Lipid profile (triglycerides, LDL, HDL)
* Folate status (plasma and erythrocyte folate)
* Plasma total homocysteine (tHcy)
* Vitamin B-12

Exclusion Criteria:

* History of acute or chronic disease
* Use of vitamin or mineral supplements or folic acid fortified foods (within the past one month)
* A body mass index (BMI, in kg/m2) \>18 and \<30
* Any medication interfering with folate metabolism (e.g., antiepileptic drugs, antibiotics, methotrexate, sulfasalazine, or anticonvulsants), smokers, consuming special diets (vegetarian), pregnancy, planned conception or lactation
Assessment of Grazax® Treatment Compliance

This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).


Eligibility Criteria:
Inclusion Criteria:

* Grass pollen induced rhinoconjunctivitis
* Males and females, 18-65 years of age
* Positive skin prick test

Exclusion Criteria:

* Previous treatment with grass pollen allergen
Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects

The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient status at the site
* Written consent obtained from the subject
* Burn injury must have been incurred within 36 hours prior to enrollment.
* Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths
* Burn injury must exceed 3% total body surface area.

Exclusion Criteria:

* Subject is pregnant.
* Bone fractures.
* Inhalation-related trauma.
* Sensitive and/or allergic to materials containing silver.
* Burn injury exceeds 40% total body surface area.
* Burn injury diagnosis indicates deep partial or full thickness wounds.
* Burn a result of electrical/chemical injury or frostbite.
* An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Clinical condition included in the approved Indications For Use for the iTotal® CR
* Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
* Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
* \> 18 years of age

Exclusion Criteria:

* Simultaneous bilateral procedure required
* BMI \> 40
* Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
* Poorly Controlled diabetes
* Neuromuscular conditions which prevent patient from participating in study activities
* Active local or systemic infection
* Immunocompromised
* Fibromyalgia or other general body pain related condition
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
* Diagnosed with or receiving treatment for Osteoporosis
* Other physical disability affecting the hips, spine, or contralateral knee.
* Severe instability due to advanced loss of osteochondral structure
* Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
* Compromised PCL or collateral ligament
* Severe fixed valgus or varus deformity of \>15º
* Extensor lag \> 15 º
* Fixed flexion contracture ≥ 15 º
* Unwilling or unable to comply with study requirements
* Participation in another clinical study which would confound results
* Allergy to any of the implant materials