cyrilzakka/clinical-trials huggingface dataset:
Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome, a Single Center, Randomized Controlled Clinical Trail

Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the popularity of health examination, most patients were diagnosed as HCC in advanced stages so far. Sorafenib is currently recognized worldwide as the only effective treatment for advanced HCC. However, sorafenib need long-term medication, and will bring a series of side effects, including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs swelling, rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously affect patient's quality of life.Besides, this side effects appeared to be dose-related.When severe HFS happened, sorafenib need to reduce dosage or discontinue administration, which could seriously affect the patient's survival. Therefore, investigators designed this prospective randomized controlled study to explore preventive effect of celecoxib for sorafenib related HFS, the influence on the quality of life in patients with, and also the synergistic anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study will explore horizon of improving treatment for sorafenib in patients with advanced HCC,quality of life and tumor control.


Eligibility Criteria:
Inclusion Criteria:

* 1.Diagnosed with HCC according to the Primary liver cancer diagnosis and treatment practices published by the Ministry of Health in 2011 China
* 2.A Karnofsky Performance Status (KPS) score ≥70 points
* 3.Age between 18 and 70 years
* 4.Child-Pugh classA or B (class B patients had scores no greater than 7 points). In addition, the baseline laboratory tests had to meet the following criteria: white blood cells (WBCs) ≥1.5 × 109/L, platelets ≥50 × 109/L, hemoglobin ≥80 g/L, serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 x the upper limit of normal (ULN), serum creatinine ≤ 1.5 x ULN, an international normalized ratio (INR)\<1.5 or prothrombin time \< the ULN + 4 seconds, albumin ≥30 g/L, and total bilirubin ≤34mmol/L
* 5.Patients with advanced hepatocellular carcinoma who failed first-line therapy with surgery，radiofrequency ablation

Exclusion Criteria:

* 1.Pugh Child-Pugh Grade C, or with massive ascites or had a history of hepatic encephalopathy, or previous history of gastrointestinal bleeding
* 2.Poor general condition or cachexia
Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test

To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test

The patients meeting inclusion criteria were initially divided into two groups which are no lesion and having lesion at cervix on colposcopic examination.

Participant in no lesion group were divided into two group, recieving 95% Trichloroacetic acid (intervention) plus aceteic acid (commonly apply at cervix during colposcopic examination) applying to the cervix at T-zone and Acetic acid alone group.

We follow-up each group for 6 months to evaluate the outcome using cytologic examination, HPV testing and colposcopic examination (also biopsy if lesion is seen) compare to previous result (before treatment)

In the group having lesion at cervix, we initially biopsy the lesion and wait for pathologic result. If the pathologic results are high-grade lesion e.g. HSIL, we exclude them from this study. On the contrary, if the pathologic result s are low-grade lesion, we divided them into two group, normal pathologic exam and low-grade abnormality on pathologic examination. Both of them are divided into two groups and follow-up for 6 months, similar to the no lesion group

\* During colposcopic examination, we also repeat cytologic examination and HPV testing as well

\*\* Pregnancy test is done before applying 95%Trichloroacetic acid and at the time of follow-up. If positive at any point of time, participants are excluded from the study

Eligibility Criteria:
Inclusion Criteria:

* Women who have low-grade abnormality result such as ASC-US, LSIL, HPV 16/18 positive, persistent HPV infection after cervical cancer screening test
* No history of endometrial or cervical cancer
* Pregnancy test negative
* Good communication in Thai language
* Vouluntarily participate to the study

Exclusion Criteria:

* Pregnancy test positive after participate in the study
* Pathologic result from colposcopic biopsy (before intervention) is high-grade abnormality such as HSIL, CIN2-3 or AIS
Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.

Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.

Eligibility Criteria:
Inclusion Criteria:

* Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density
* Blindness (at least monocular) or visual functions not appropriate for navigation/orientation
* Period of appropriate visual functions \> 12 years / lifetime
* Visual acuity ≥ 0,05 in earlier life
* Electrically Evoked Phosphenes provide evidence of inner-retinal function.
* willing and able to give written informed consent

Exclusion Criteria:

* Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment)
* Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
* Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
* Retina detected as too thin (\< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT).
* Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study
* Participation in another clinical trial within the past 30 days
SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Prescription opioid misuse and its associated negative effects have become an epidemic in the United States, and post-operative opioid use contributes to this terrible problem. Alternative strategies to opioid prescribing are thus highly sought after in the post-operative setting. Importantly, sleep and pain have a bi-directional relationship, and inadequate or impaired sleep regularly occur following orthopedic operations. Melatonin is an endogenous sleep hormone that can be administered exogenously, and that has been shown to have some potential as an analgesic agent. Here, using the premise that melatonin may improve sleep and pain in the post-operative setting, the investigators propose a randomized clinical trial in 120 participants undergoing total knee arthroplasties. Patients will be randomized to receive either sublingual melatonin 5 mg or matched placebo starting on post-operative day (POD) 0 and through POD . The investigators will measure post-operative opioid usage as the primary outcome, and post-operative pain scores as a secondary outcome. The primary safety outcome will be sedation level, as measured by the Richmond Agitation Sedation Scale (RASS). Sleep will be measured objectively using wrist-worn actigraphy. Participants will be followed through POD 28, and will also have baseline data on sleep, pain, and cognition obtained prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years and older
* Undergoing elective total knee arthroplasty (single knee)

Exclusion Criteria:

* Non-English speakers
* Individuals with dementia
* Patients with liver cirrhosis
* Patients currently taking prescription sleep aids
* Patients with long-term (greater than 3 months prior to surgery), chronic opioid use
A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.

This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is \<50.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* chronic hepatitis D
* positive for HBsAg \>/=6 months, for anti-HDV \>/=3 months and for HDV-RNA at screening
* negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study

Exclusion Criteria:

* antiviral therapy for chronic hepatitis D within the previous 6 months
* previous therapy with pegylated interferon alfa
* treatment with conventional interferon alfa for \>12 months
* hepatitis A or C, or HIV infection
* decompensated liver disease (Childs B-C)
* history or evidence of medical condition associated with chronic liver disease
Navitian PMCF Study ( rEPIC04C )

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Navitian in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with Navitian according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis

Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion;
* severity of nasal symptoms was moderate to severe during the observation period;
* criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge.

Exclusion Criteria:

* history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine;
* history of drug hypersensitivity;
* history of convulsive disorder;
* vasomotor rhinitis or eosinophilic rhinitis;
* asthma requiring treatment with adrenocortical hormones;
* concomitant diseases which could impede the efficacy evaluation of the study drug;
* subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage;
* pollen allergy;
* malignant neoplasm.
Study of the Psychological Development of Children of Parents With and Without Affective Disorders

This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance.

The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders.

In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.

The psychological development of offspring of parents with and without affective disorder is assessed from early childhood to young adulthood. Parents with a diagnosis of major depression or bipolar illness and well parents and their children are studied (SADS-L, RDC, and SCID, DSM-III). A sibling pair is studied in each family. Parent-child interaction is investigated through direct observation of behavior in naturalistic and controlled settings. Family history information is obtained through parent interviews. Behavioral observations, standard tests, physical examinations, and psychiatric interviews, and MRI procedures provide multiple assessments of the offspring. The study has been completed through preadolescence, adolescence, and late adolescence. Follow-up in young adulthood continues.

Eligibility Criteria:
Patients will be drawn from an ongoing longitudinal study begun in 1979 of offspring of parents with affective illness (unipolar and bipolar) and children of normal control parents.
Effects of Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease.

This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease

This study wants to demonstrate that the preservation of the inferior mesenteric artery allow to improve postoperative defecatory function and improve patient\&#39;s quality of life.

Eligibility Criteria:
Inclusion Criteria:

* BMI \&lt; 35
* ASA I-III
* Hinchey I-III

Exclusion Criteria:

* BMI \&gt; 35
* ASA IV
* Hinchey IV
* Previous procedures that could have been modified the nervous mesenteric pattern (surgery, radiotherapy or chemotherapy)
Straw Phonation Exercise Program for Pitch Extension

To investigate the change in fundamental frequency range and vocal fold stability achievable with vocal fold stretching exercise in human populations with high and low vocal activity

The vocal ligament is part of the layered structure of the vocal fold. It is a thin band of tissue near the superior medial edge of the vocal fold. The cord-like appearance of the ligament gave rise to the traditional term "vocal cord". The ligament connects the arytenoid cartilage (lower broad dark region) to the anterior portion of the thyroid cartilage (upper dark region). The slightly thickened endpoints are known as the anterior and posterior macula flava. In the medial-lateral direction, the vocal ligament comprises the intermediate and deep layer of the lamina propria.

The physiological functions of the vocal ligament are not fully understood. One function is to limit mechanical strain (elongation), a general function of most ligaments in the body. A second function may be to produce a firm closure of the glottis by forming a straight edge along the membranous (vibrating) portion of the vocal fold. A strong ligament that can be tensed with exercise is likely to help straighten the edge of the folds. Vocal fold bowing, for example, is a pathological condition often associated with advanced age, but it can also occur in young adults who press their arytenoid cartilages together excessively in speech. Atrophy of the thyroarytenoid muscle, which lies lateral to the ligament, causes the middle of the membranous vocal fold to be retracted from the midline of the glottis. The result is a weak voice because airflow cannot be suddenly shut off for efficient acoustic excitation of the vocal tract. For self-sustained vocal fold vibration, the superficial layer must be very pliable and deformable for mucosal surface-wave motion. The role of the ligament is then to stabilize the vertical motion when large pressures are applied to vocal fold surfaces. The most important known function of the ligament, however, is to widen the fundamental frequency range. The stiffer the ligament, the greater the likelihood that several octaves of fo range can be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years or older
* no current voice disorder
* no history of performance or professional vocal training

Exclusion Criteria:

* history of head/neck cancer, laryngeal surgery, current voice disorder requiring medical management
* cognitive limitations that would prevent them from successfully and safely participating in the study.
* history of gastrointestinal disease or surgery w
* no known neurological or structural abnormalities of vocal folds
* previous laryngeal surgeries;
* allergies to local anesthetics (used to suppress a sensitive gag reflex during laryngeal endoscopic examination);
* cardiac abnormalities;
* recent history of smoking (must be completely smoke-free for six months prior to study commencement because of the effect of smoking on the voice and laryngopharyngeal reflux severity).
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval

In this research study we want to learn more about how effective certain medications are at reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the time between the retrieval and discharge from the hospital. We will compare three types of pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and placebo (no medication), which is the current typical care.

OBJECTIVE: To compare the efficacy of pre-operative IV acetaminophen, PO acetaminophen, versus placebo for adjunctive pain control in the setting of oocyte retrieval in an in vitro fertilization clinic setting.

HYPOTHESIS: Our hypothesis is that patients receiving IV acetaminophen pre-operatively will have improved postoperative pain scores, lower overall opiate consumption, and shortened time to discharge from post analgesic recovery unit (PACU) or recovery than those receiving PO acetaminophen or placebo.

Participants will be consented and enrolled in the study prior to their oocyte retrieval. The patient will then be randomized to one of three treatments:

Group 1: In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed.

Group 2: In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed.

Group 3:

In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed.

The patient and care team will be blinded to the treatment group.

A member of the study staff will review participants' medical record to collect data regarding demographics, clinical history, cycle and pregnancy outcomes, up to 12 months following study completion.

Eligibility Criteria:
Inclusion Criteria:

\[ \] Patient is 18 years or over, undergoing oocyte retrieval. \[ \] Patient is English-speaking.

Exclusion Criteria:

\[ \] Allergy/hypersensitivity to acetaminophen or opiates. \[ \] Any history of liver disease, history of alcohol depending, or renal impairment as reported in the electronic health record.

\[ \] Any history chronic opiate use or chronic pain disorder reported in the electronic health record.

\[ \] Weight less than 50kg as reported in the medical record.
Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer

The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.

This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma
* Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry
* Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer
* Karnofsky performance status of greater than or equal to 70%
* Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
* Women of child bearing age must have negative serum pregnancy test prior to treatment

Exclusion Criteria:

* Known central nervous system tumor involvement
* Evidence of other active malignancy requiring treatment
* Clinically significant heart disease
* Active serious systemic disease, including active bacterial or fungal infection
* Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary
* Prior surgery with curative intent for pancreatic cancer
* Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed
* Breast feeding, pregnant, or likely to become pregnant during the study
* known or suspected hypersensitivity to azacitidine or mannitol
Living Well With Stroke

The overall goal of this study is to conduct a three-armed randomized controlled trial (RCT) in stroke survivors with depression to determine if a brief psychosocial-behavioral therapy intervention delivered in-person (arm A) or by telephone (arm B) is better than usual care (arm C), in terms of percent reduction in depressive symptoms and % of participants achieving remission of symptoms.

This is the second phase of a study whose aim was to evaluate the short and long-term efficacy of a brief psychosocial/behavioral intervention (with adjunctive antidepressant)for the treatment of post-stroke depression (PSD) in survivors of ischemic stroke (registered as clinical trail NCT00194454). In the earlier trial we demonstrated that a pleasant event/problem-solving brief psychosocial-behavioral therapy delivered by psychosocial nurse practitioners was highly effective in treating major depression and promoting remission in ischemic stroke survivors for up to two years. In this phase, we refine the protocol, and potentially make it more cost effective, by conducting a randomized comparative effectiveness trial of in-person versus telephone delivery of the intervention, comparing with usual care control. We also seek to expand our sample to include hemorrhagic stroke survivors (intraparenchymal hemorrhage and subarachnoid hemorrhage) as well as those with ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized for an ischemic or hemorrhagic stroke (intraparenchymal hemorrhage- IPH or subarachnoid hemorrhage - SAH) in the past 3 months
* clinical depression symptoms (Geriatric Depression Score -GDS \>= 11

Exclusion Criteria:

* major psychiatric co-morbidity
* active suicidal ideation without ability to contract for safety
* current substance abuse
* physical inability to tolerate 1-2 hour sessions
* receptive or global aphasia
* reduced level of consciousness (GCS\<15).