cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Assess the Efficacy and Safety of AT-5214 in the Treatment of Subjects With Palmar Hyperhidrosis

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group comparison study of AT-5214 in subjects with moderate to severe primary palmar hyperhidrosis (sweaty palms). This study will compare two different oral (tablet) doses of AT-5214 (study drug) versus a matched placebo. Approximately 120 subjects will be enrolled at approximately 10 study sites.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinical diagnosis of primary hyperhidrosis of the palms
* Subject is currently drug-naïve for hyperhidrosis medications
* Females must be post-menopausal, surgically sterile, or use an effective method of birth control

Exclusion Criteria:

* Subject is pregnant, lactating, is planning to become pregnant during the study, or is less than one year postpartum.
* Subject is a user of nicotine products within one year prior to Visit 1/Screening.
* Subject has known history of secondary hyperhidrosis.
* Subject has existence of neurological, psychiatric, endocrine, or other disease that can cause secondary hyperhidrosis or affect sweating.
* Subject has known history of Sjögren's syndrome or Sicca syndrome.
* Subject has used any of the following hyperhidrosis medications or therapies within the specified timeframe:

  1. Iontophoresis to the palms within four weeks prior to baseline visit;
  2. Botulinum toxin to the palms within one year prior to baseline visit;
  3. Prior surgical procedures to the palms (e.g., sympathectomy, debulking of sweat glands);
  4. Prior medical device treatment to the palms (approved or investigational);
  5. Any prescription treatments for hyperhidrosis within four weeks prior to baseline visit.
  6. Any topical antiperspirant treatment to the palms within 7 days prior to baseline visit.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has previously participated in a clinical study of dexmecamylamine or TC-5214.
* Subject has used an investigational drug or investigational device treatment within 30 days prior to baseline.
Use of Pupillometry for Pain Assessment in ICU Patients with Delirium

Pain assessment in intensive care patients is a constant challenge. Approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). Obstacles to pain assessment and management are most often due to interference with communication due to impaired consciousness, airway support and connection to artificial pulmonary ventilation, or the effect of administered medication.

Patients in intensive care are prone to delirium. Delirium can compromise patients' ability to verbalise pain for a variety of reasons (e.g. due to impaired attention, memory, thinking and language barriers). Also, pain and inadequate analgesia are risk factors for delirium.

Pupillary reflex changes and their identification by automated pupillometry have yielded positive results regarding nociception assessment in adult and pediatric patients and in perioperative and postoperative care. At the same time, the response of these patients to opioid administration was investigated. The aim was to improve their analgesia.

The aim of this study is to find out whether, there is an association between automated pupillometry and selected objective pain measurement scales in The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) positive patients after surgery.

Periodically after 6 hours, the incidence of delirium will be assessed using the CAM ICU questionnaire. Subsequently, the incidence of pain will be assessed using 3 valid scales. The Visual Analogue Scale (VAS), the Behavioral Pain Scale (BPS) and the Critical Care Observational Tool (CPOT) will be used. Finally, automated pupillometry will be measured. The measurement values will be entered in the record sheet. Information about the medications administered and the patient's vital signs will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patient after surgery
* possibility to perform CAM - ICU test (patients with Richmond Agitation-Sedation Scale -2 to +2)

Exclusion Criteria:

* eye diseases
* brain injury
* stroke
* epilepsy
* neuromuscular diseases
Sensory Integration for Infants With Cortical Visual Impairment

Our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment .

Cortical vision impairment (CVI) and Cerebral Palsy (CP) lead to decrement in sensory and motor functions of infants. The current study examined the effectiveness of sensory integration interventions on sensory, motor, and oculomotor skills in infants with cortical vision impairment. Thirty-four infants with CVI and CP aged 12-18 months were enrolled to the study. The infants were randomly divided into 2 groups as the control and intervention groups. The intervention group took sensory integration intervention 2 days a week for 8 weeks in addition to conventional physiotherapy two days a week for eight weeks. The control group only received the conventional physiotherapy program 2 days a week for 8 weeks. The duration of the treatment sessions were 45 minutes for both interventions. Before and after the intervention, sensory processing functions were evaluated with the Test of Sensory Functions in Infants (TSFI) and motor functions were evaluated with the Alberta Infant Motor Scale (AIMS).

Eligibility Criteria:
Inclusion Criteria

* Cerepral palsy
* Cortical visual impairment
* 12-18 months

Exclusion Criteria

* Not participating in treatment regularly
Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France

CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP


Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years of age or older
2. Admission to hospital for at least 24 hours
3. Suspicion of community-acquired pneumonia at admission defined as the association of: Radiologic findings consistent with pneumonia (eg, pleural effusion, increased pulmonary density due to infection and/or alveolar infiltrates \[multilobar, lobar, or segmental\] containing air bronchograms), AND The presence of ≥2 of the following signs or symptoms: Fever (oral temperature \>38°C or tympanic temperature \>38.5°C) in the 24 hours preceding admission; Hypothermia (\<35.5°C measured by a healthcare provider) in the 24 hours preceding admission ; Chills or rigors ; Pleuritic chest pain ; New or worsening cough ; Sputum production ; Dyspnea (shortness of breath); Tachypnea (respiratory rate \>20/min) ; Malaise ; Abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation)
4. Written informed consent from the patient

Exclusion Criteria:

1. Suspicion of tuberculosis
2. Individuals placed under judicial protection
3. Individuals who refuse the transfer of biological samples to the USA
4. Patient developing signs and symptoms of pneumonia after having been hospitalized for 48 hours or more
5. Pregnancy
Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL

This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.


Eligibility Criteria:
Inclusion Criteria:

Children (1-17) and adults (18-75 years old);

* Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if \<5%, with at least 1% of molecular disease at PCR;
* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
* Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease.

Exclusion Criteria:

* GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days;
* Patient with concomitant life-threatening infectious disease;
* Lansky/Karnofsky score \<60;
* Patients with hepatic or renal disease as specific above;
* Pregnant or breast-feeding females;
* Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer

To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and efficacy by prospective randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed cervical cancer
* FIGO stage IA2-IIA
* Diameter of tumor is less than 4cm on exam
* One of hitological type written below squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
* Age between 18-70
* Performance status; GOG 0-1
* Normal hematological, hepatic, nephrologic function WBC ≥ 4000 cells/mm3 Platelet ≥ 100,000 /mm3 Hemoglobin ≥ 8.0 gm/dL Serum creatinin ≤ 1.3 mg/dL Serum bilirubin ≤ 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase \< normal X 3
* Patient with informed consent

Exclusion creteria:

* Small cell carcinoma
* Unable to perform surgery because of severe underlying medical disease severe heart disease, congestive heart failure/severe pulmonary disease, pulmonary failure/ active bacterial infectio which needs non oral antibiotic therapy/ associated with other severe medical diseases
* Prior chemotherapy or radiotherapy
* Severe bladder funtion abnormality
* Double primary malignant tumor
* Psychiatric problems
* Pregnant or breast feeding status
* Legally unable to participate clinical trial
* When there is a Doctor's decision that patient is unable to participate clinical trial
Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis

Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.


Eligibility Criteria:
Inclusion Criteria:

Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna

* Ability and willingness to understand and comply with study interventions and restrictions.
* Voluntarily signed informed consent after full explanation of the study to the participant.

Exclusion Criteria:

* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
* Inability to communicate well with the investigator due to language problems or reduced mental development
* Inability or unwillingness to give written informed consent
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients

This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.


Eligibility Criteria:
Inclusion criteria:

* Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment

Exclusion criteria:

* Patients with thrombocytopenia (platelets \<100,000/mm³), with an absolute neutrophil count of \<1,500/mm³ or leucopenia (leucocytes \<3000/mm³), with anemia with Hb \< 8g/dl at time of screening
* Patients with uncontrolled hypercholesterolemia (\> 350 mg/dL; \> 9.1 mmol/L) or hypertriglyceridemia (\> 750 mg/dL; \> 8.5 mmol/L) at time of screening
* Patients with a history of malignancy of any organ system, treated or untreated, during the last five years, whether or not there is evidence of local recurrence or metastases, except squamous or basal cell carcinoma of the skin Other protocol-defined inclusion/exclusion criteria may apply
Safety and Comfort of AL-4943A Ophthalmic Solution

The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.

Eligibility Criteria:
Inclusion Criteria:

* Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
* Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
* History of any clinically significant external ocular disease within 30 days of the start of the study.
* Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
* Other protocol-defined exclusion criteria may apply.
The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on reduction of airtrapping and airway resistance in stable COPD patients as well as to study it's effect in reducing exacerbation, improving exercise capacity and quality of life in stable COPD patients.

Background: The mucolytic and antioxidant effects of N-acetylcysteine (NAC) may be of great value in treatment of COPD patients. However, previous studies fail to demonstrate the beneficial effect of NAC. This may be due to insufficient dose of NAC used as well as inadequate outcome parameters measured in the past studies.

Objective of study: This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on reduction of airtrapping and airway resistance in stable COPD patients as well as to study it's effect in reducing exacerbation, improving exercise capacity and quality of life in stable COPD patients.

Study design: Randomized double blinded placebo controlled trial in Kwong Wah Hospital

Methodology: Patients are recruited in Kwong Wah Hospital if they fulfill the spirometric criteria of COPD. Eligible subjects will be randomized into the treatment (NAC 600mg tablet twice daily) and placebo group after completion of run in period. NAC and placebo will be prescribed accordingly in addition to their usual therapy. Both patients and investigators are blinded about the group allocation. Baseline assessment will be done and patients will be followed up at 16th weeks and 52th week of the study.

During each follow-up visit, hyperinflation parameters like inspiratory capacity (IC) will be measured by plethysmography. Airway resistance will be measured by both plethysmography and impulse oscillometry machine. Exercise capacity (6 min walking distance) and quality of life are also recorded during each follow up.

The difference of the above parameters between the 2 groups (drug and placebo group) will be analyszed by the Repeated measures ANOVA test

Eligibility Criteria:
Inclusion Criteria:

* Spirometry diagnosed COPD with FEV1/FVC ratio less than 70% and FEV1 less than 80% predicted
* clinically stable and exacerbation free in the past 4 weeks
* history of at least one COPD exacerbation in the past one year

Exclusion Criteria:

* patients allergic or intolerant to NAC
* Recent use of NAC in the past one month
* history of asthma, non COPD respiratory disorders like bronchiectasis, pneumoconiosis or any active pulmonary infection
* patients on long term steroid
* patients on long term oxygen therapy or non invasive ventilation
Technique And Results In Endothelial Keratoplasty

To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.
2. Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.

Exclusion Criteria:

N/A
Effectiveness of Ultrasound-Aided Articulation Therapy for Children with Speech Sound Disorders

The study is a prospective randomized controlled procedure to investigate the effect of ultrasound in articulation training and also the effect of treatment intensity in this mode of therapy. Targeted subjects are children with brain tumor or cleft palate with articulation errors which visualization of lingual movement using ultrasound may facilitate their acquisition of the sounds misarticulated. Subjects would be randomized to two groups of high and low treatment intensity, with stratification to the groups by disorders, age and gender whenever possible. Participants will be randomly assigned to either the treatment group or a waitlist control group in a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* No syndromes or obvious dysmorphic features; No language disorders associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder); No oronasal fistula identified in oral examination or diagnosed velopharyngeal insufficiency; Hearing thresholds between 0 to 25 dB in at least one ear, with no hearing loss exceeding 50 dB in the other; Cantonese as the first language

Exclusion Criteria:

* Subjects with syndrome, speech or language disorder associated with biomedical conditions (e.g. cerebral palsy, autism spectrum disorder), hearing threshold higher than 25dB in one ear and hearing loss with more than 50dB in another ear would be excluded from the study. Participants would be excluded fromthe study if they have other planned surgical intervention during the study period.
The Attitudes and Behaviors of Gastroenterology Specialists on Anesthesia Procedures in Endoscopy Units

Most gastrointestinal endoscopic procedures are now performed with sedation and analgesia. Sedation and analgesia affects the quality of the procedure, patient co-operation and compliance as well as endoscopist's satisfaction. A wide variety of procedures have been reported worldwide for anesthesia during gastrointestinal endoscopy in adults.

The current survey was primarily designed to provide national data on the attidutes and behaviors of gastroentorologist on anesthesia procedures in endoscopy units in Turkey.

Most gastrointestinal endoscopic procedures are now performed with sedation and analgesia. Sedation and analgesia affects the quality of the procedure, patient co-operation and compliance as well as endoscopist's satisfaction. Despite the use of numerous sedation and analgesic techniques for GI endoscopy procedures, the best method is still controversial. A wide variety of procedures have been reported worldwide for anesthesia during gastrointestinal endoscopy in adults.The current survey was primarily designed to provide national data on current sedation and monitoring practices that was carried out during gastrointestinal endoscopy. Secondary objectives were to provide data on the endoscopic application of the turkish gastroenterologist.

The questionnaire consisting of 20 questions about the anesthesia methods applied in the procedures in the endoscopy unit will be sent to 1000 gastroenterologists registered in the Turkish Gastroenterology Association by e-mail. The questionnaire is covered the demographic data, types of endoscopic procedures and anesthesia methods applied, anesthetic agents, monitoring methods, anesthesia team, preanesthetic evaluation and consent forms, recovery unit and complications and interventions during anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Being a Gastroenterology specialist

Exclusion Criteria:

-
Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position

The purpose of this study is to test a correction factor which would allow ankle brachial indexes taken in the seated position to accurately predict an ankle brachial index taken in the supine position.

Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of a simple diagnostic procedure know as the ankle-brachial index (ABI). The ABI is the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms and legs using a hand-held Doppler device. In order for the ABI measurement to be accurate, the test is conducted with the patient in the supine position. This eliminates the influence of hydrostatic pressure on the ankle and toes which can lead to a falsely elevated reading. Unfortunately, many patients are unable to lie supine for ABI measurement, including: the wheel-chair bound, patients with degenerative disease of the spine or arthritis with chronic back pain, and patients with advanced cardiopulmonary disease and orthopnea.

Given the importance of detecting PAD across a broad spectrum of patients, there is a need to identify a mechanism for reliable measurement of the ABI for patients who cannot lie supine. The purpose of this study is to test a correction factor for the effects of hydrostatic pressure on the lower extremities to allow for accurate ABI calculation in the seated position.

100 Subjects with suspected arterial disease in the vascular lab will be enrolled. Arm, ankle, and toe pressure measurements will be made in the supine and seated positions. The seated ankle pressures will be corrected for hydrostatic pressure using a mechanical formula. The ABI and toe brachial index (TBI) will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patient at least 60 years of age
* Ambulatory outpatient
* Referred to non-invasive Vascular Laboratory for evaluation of suspected arterial disease.

Exclusion Criteria:

* Unable to give informed consent
* Unable to lie supine for at least 15 minutes