cyrilzakka/clinical-trials huggingface dataset:
A Phase 1, First in Human Study of TORL-4-500 in Patients with Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.

For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-4-500
* Progressive or symptomatic brain metastases
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
* History of significant cardiac disease
* History of myelodysplastic syndrome (MDS) or AML
* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
* If female, is pregnant or breastfeeding
Minimally Invasive Treatment Methods for Pilonidal Disease

Patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol and platelet rich plasma). Sinus healing time, patient satisfaction, complications and recurrence rates will be compared.

Patients with pilonidal sinus disease will be treated by either crystallised phenol or platelet rich plasma application. Treatment results, healing time, postprocedural complications, patient satisfaction and recurrences will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Having pilonidal sinus disease
* accepting to be involved in the study

Exclusion Criteria:

* below the age of 18
* having connective tissue disorders
* diabetes mellitus
* severe anemia
Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia

Dextromethorphan acts as N-methyl-D-aspartate (NMDA) antagonist. In Treatment resistant schizophrenia(TRS) the efficacy of treatment response by clozapine is only around 40%. Numerous augmentation agent have been tried which includes antipsychotics, anticonvulsants, antidepressants and NMDA antagonist. The NMDA antagonist such as Riluzole and Memantine have shown good efficacy in TRS. Therefore we are evaluating NMDA antagonist, dextromethorphan in TRS. The dextromethorphan or placebo will be administered along with clozapine in TRS patients. The study is randomized double blind placebo controlled group sequential trial.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia patients who are diagnosed as treatment-resistant schizophrenia (TRS) defined as having been tried and not responded to any two antipsychotic medication for a duration of 6 weeks with dose equivalent of 600 mg of chlorpromazine and initiated on clozapine for the treatment of the same.
* The patients who are on stable dose of clozapine.
* Patients of either sex with age \>18 years.
* Patients for whom legally authorized representative (LAR) are willing to give informed consent.

Exclusion Criteria:

* Patients with significant medical comorbidity.
* Patients with significant psychiatric comorbidity.
* Patients having active substance abuse history during the time of screening.
* Female patients who are pregnant or in reproductive age not using contraception.
* Female patients who are breast feeding
The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation

Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.

Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.

Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.

Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.

Methods: Forty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Functional capacity will be evaluated using the six-minute walking test (6MWT). The severity of residual limb pain, sound limb pain and low back pain will be evaluated with a 10-point Visual Analogue Scale (VAS). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS. The QoL of each patient will be assessed using the Short Form 36 (SF-36).

Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years
* Medicare functional classification level K4 (very active)
* using the prosthesis for at least 6 months and at least 6 hrs a day
* using active vacuum-assisted suspension system

Exclusion Criteria:

* bilateral amputation,
* the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.
Chewing Gum for Smoking Cessation

The goal of this trial is to assess the feasibility, acceptability, and preliminary effectiveness of chewing gum to reduce cigarette consumption and promote smoking cessation. The main questions it aims to answer are: Do participants in the intervention group report a higher reduction in cigarette consumption, improved smoking cessation outcomes, and healthier oral health than the control group?

Researchers will compare chewing gum intervention to unassisted quitting to see if chewing gum works to cigarette reduction and smoking cessation.

Participants will:

1. Receive very brief smoking cessation advice and booklet at baseline.
2. Take chewing gum or unassisted quitting for 1 week.


Eligibility Criteria:
Inclusion Criteria:

1. Residents of Hong Kong aged 18 or above
2. Smoking at least 1 cigarette per day over the past 3 months
3. Have the habit of chewing gum or are willing to use chewing gum
4. Participants who can communicate in Cantonese (including reading Chinese)
5. Expressing an intention to quit or reduce smoking
6. Capable of using instant messaging tools (e.g., WhatsApp, WeChat) for communication

Exclusion Criteria:

1. Having communication barriers (either physical or cognitive)
2. Currently participating in other smoking cessation programs or services
Proximal Humerus Site for Anesthesia

This will be a prospective, non-controlled study using healthy adult volunteers as subjects receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the insertion technique and IO infusion flow rates.

When using IO access in the perioperative and OR settings, abduction of the arms to the shoulder level prevents use of the traditional proximal humerus insertion site due to the rotation of the humeral head under the acromion process. An alternate proximal humerus IO insertion technique has been developed to meet the needs of anesthesia patient positioning that uses a slightly more distal insertion site and a superior angle of insertion. However infusion flow rate in the proximal humerus using the anesthesia technique has not been measured. This study is needed to evaluate the anesthesia proximal humerus IO insertion technique to determine if the IO infusion flow rates remain unchanged by the alternate method.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older Have no amputation of the upper extremities Able to lay flat on table for up to 2 hours Self-reported as healthy, as confirmed by the PI

Exclusion Criteria:

* Have an active infection in the body Imprisoned Pregnant Cognitively impaired Fracture in humerus, or significant trauma to the site Excessive tissue and/or absence of adequate anatomical landmarks in humerus Infection in target area Humeral IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus Current use of anti-coagulants Current cardiac condition requiring pacemaker or anti-arrhythmic drugs Prior adverse reaction to lidocaine

Volunteers with any of the following characteristics may be excluded from the infusion pathway evaluation involving administration of contrast dye at the discretion of the PI.

Prior adverse reaction to contrast dye Allergy to any food or drug History of impaired renal function History of impaired hepatic function History of cardiac disease History of pheochromocytoma
Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.

PRIMARY OBJECTIVES:

I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.

II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.

OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.

Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.

After completion of study treatment, participants are followed up for up to 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
* Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
* Hemoglobin ≥ 9 gm/dL
* White blood cell count \> 3000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

* Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
* History of infusion reactions to monoclonal antibody therapies
* Pregnant or breastfeeding
* Magnesium or potassium lower than the normal institutional values
* Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
* Prisoners, institutionalized individuals, and patients unable to consent for themselves
Immediate Versus Delayed Loading for Implants Retaining Mandibular Complete Overdenture

The aim of this study will be to compare the amount of marginal bone height changes between immediate and delayed loading for immediately inserted implants used as abutments of mandibular overdenture.


Eligibility Criteria:
Inclusion Criteria:

* Patient having two standing mandibular canines with compromised prognosis (which indicted for extraction, without any preapical lesions nor acute infection) and have an adequate labial bone thickness.
* Patient having opposing completely edenteolous maxilla.
* Patients having normal maxilla-mandibular relationship and sufficient inter arch distance was insured by through tentative jaw relation record.
* Patients with good oral hygiene.
* Enough bone volume for implants in the interforaminal region (adequate bone quality and quantity)

Exclusion Criteria:

* Mental disorder patients who are not capable of making a decision or narcotic drug addicts.
* Patients with Tempro-Mandibular Joint disorders
* Patients undergoing radiotherapy or chemotherapy
* Patients with systemic diseases affecting bone metabolism
* Uncooperative patients who have no understanding of the need of a regular follow-up.
* Patient with pathological defects in the areas of implant insertion.
* Vulnerable group as prisoners, mentally retarded patients.
Study of 0416 Ointment in the Treatment of Atopic Dermatitis

The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent Body Surface Area minimum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis
Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients

The purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients.

Both groups will perform general exercises for back pain (stretch and strength of paraspinal and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the balance or experimental group will perform in addition five minutes of exercises that challenge postural stability in the sitting position. The evolution of the two groups concerning pain level, function and postural control will be compared.

Eligibility Criteria:
Inclusion Criteria:

* must have low back pain longer than three months and age between 40 and 69 years old

Exclusion Criteria:

* balance or neuromuscular disorders, spine surgery, diabetes.
Effects of Positional Therapy on Pulmonary Physiology in Patients Undergoing Mechanical Ventilation.

The aim of this project is to evaluate the effects of positional changes in mechanically ventilated patients.

In critically ill patients undergoing invasive mechanical ventilation (IMV), several negative effects converge, promoting the development of collapse in the dorsal areas of the lung. These among others include deep sedation, relaxation, prolonged immobility and the supine position. This results of an added impairment in lung function both in the mechanical and gas exchange. In addition lung collapse contributes to a significant increase in the heterogeneity the distribution of alveolar ventilation and perfusion that may increase the risk of ventilator-induced lung injury (VILI).

Postural therapy is widely recommended as prevention/treatment of pressure ulcers, whose presence, according to the Spanish Society of Intensive Care Medicine (SEMICYUC), is a quality criterion for intensive care units (ICUs), with a prevalence of 18% in these units compared to 7.8% in adult hospitalization. However, how postural changes may affect lung function is an aspect that has been scarcely studied. Given the strong influence of gravity on lung function, positional changes can produce significant alterations in the distribution of trans-pulmonary pressures (a decrease along the vertical gravitational axis of approximately 0.25 cmH2O per cm). Depending on the severity, distribution and location of the respiratory pathology, positional changes may have a significant effect either benefiting or impairing the patient's condition.

The investigators will dynamically assess the effects of routine lateral positioning up to 30-40º by means of electrical impedance tomography (EIT), a non-invasive, radiation-free functional bedside imaging technique that allows to monitor the regional distribution of ventilation and perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IMV under sedation, in a controlled ventilatory modality in passive conditions (i.e. without any spontaneous inspiratory efforts by the patient).
* Signature of the informed consent by family member or legal representative.

Exclusion Criteria:

* Presence of any clinical contraindication for postural therapy, including patient haemodynamic instability, traumatism, pathology or any other cause.
* Contraindication for the placement of the EIT electrode belt due to unstable spinal cord injury or other skin injuries or wounds in the thoracic region (surgical, traumatic, etc.)
* Assisted ventilatory modes in a non-passive breathing patient.
* Hypernatremia
* Patients with pacemakers or implantable automatic defibrillators (IAD).
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* CHD or CHD risk equivalent;
* appropriately treated for accepted LDL-C level.

Exclusion Criteria:

* treatment with drugs raising HDL-C (eg niacin, fibrates);
* uncontrolled hypertension;
* recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
* severe anemia;
* poorly controlled diabetes.
Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study

Mindfulness is both a natural resource of individuals present in all individuals in varying degrees characteristic ability of attention to the experience that unfolds moment by moment without judgment and a practice based on meditation, mindfulness exercises, which aims to enhance two central skills of mindfulness that are the presence and acceptanc. In the context of recurrent depression, the practice of mindfulness meditation in the frame of MBCT is recognized as effective in psychological suffering and relapse. The mechanisms implied in MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms, reduction of rumination is a major factor in the action of MBCT, especially for patients with less than three depressive relapses.

This exploratory research focuses on the impact of mindfulness functioning (mindfulness resource level at baseline) on the benefits of MBCT for patients with recurrent depressive disorder.

The objective is to assess whether the level of mindfulness resource of patients with recurrent depression is a factor contributing to the positive effect of a MBCT applied in add-on to conventional care.

This objective will be measured by comparing the clinical improvement of patients secondary to MBCT according to the initial categorization of the mindfulness resource.

Clinical improvement will be more important for patients characterized by a lower initial level of mindfulness resource.


Eligibility Criteria:
Inclusion Criteria:

Major patient Patient with recurrent depression Patient have read, understood and signed the non-opposition form.

Exclusion Criteria:

Inability to understand or read English or French. Individuals unable to personally express their opposition not under whose major legal or private protection of liberty by judicial or administrative decision, or hospital emergency
Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

The purpose of this study is to determine whether short- and long-term outcomes are different between open and laparoscopic Nissen fundoplication performed in children younger than 2 years of age.

Nissen fundoplication is a commonly performed procedure in infants and children with gastroesophageal reflux and a variety of other medical conditions including respiratory compromise, severe neurologic impairment, failure to thrive and swallowing dysfunction. Randomized controlled trials in adults have shown that laparoscopic fundoplication is a safe procedure that results in lower morbidity, shorter hospital length of stay and similar 5-year recurrence rates when compared to an open procedure. The aim of this study is to compare laparoscopic and open Nissen fundoplication in children less than 2 years of age.

Children younger than 2 years of age presenting for Nissen fundoplication will be randomized to either a laparoscopic or an open procedure. Patients who have already undergone anti-reflux surgery or whose hospitalization is anticipated to be prolonged by an unrelated illness will be excluded. All procedures will be performed at a single institution by two surgeons who will perform both the open and laparoscopic procedures.

A total of 68 patients will be needed (34 in each group) to detect a 20% difference in length of stay at a significance level of p \< 0.05 and power of 80%. Patients will be followed for up to 2 years postoperatively. Variables to be compared between the two groups will include age, gender, presence of neurologic impairment, presence and specification of any congenital abnormalities, total operative time, total dose of narcotic analgesia required, postoperative day on which the patient tolerated full feedings, postoperative and total lengths of stay as well as the occurrence of postoperative complications (including wound infection and the need for immediate reoperation). The primary outcomes analyzed will be length of stay and amount of narcotic analgesia required. Longer-term outcomes including persistent GERD, wrap failure and need for reoperation within 24 months of the initial procedure also will be determined.

Eligibility Criteria:
Inclusion Criteria:

* clinical or radiographic diagnosis of gastroesophageal reflux
* age less than 2 years (24 months) at the time of surgery

Exclusion Criteria:

* prior fundoplication procedure
* concomitant need for an intraabdominal procedure (except gastrostomy tube placement)
* esophageal dysmotility
* hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)