cyrilzakka/clinical-trials huggingface dataset:
Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities

This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors.

PRIMARY OBJECTIVES:

I. To evaluate program by assessing in combination with standard of care metformin: Changes in participants' knowledge, attitudes, and behavior.

II. To evaluate program by assessing in combination with standard of care metformin: Changes in body measurements.

III. To evaluate program by assessing in combination with standard of care metformin: Changes in biomarkers.

OUTLINE:

Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration.

Eligibility Criteria:
Inclusion Criteria:

* Agrees to group consent at week 1
* Age over 18
* Able to speak and understand English and/or Spanish

Exclusion Criteria:

* Don't agree to group consent at week 1
* Age younger than 18
* Not able to speak and understand English and/or Spanish
* Can't participate in physical activity
SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA Esophageal Squamous Cell Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histological or cytologic diagnosis of esophageal squamous carcinoma;
2. Aged 18-75 years;
3. KPS ≥ 70;
4. Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;
5. Stage I-IVA(AJCC 6th,2009);
6. Not able to be surgically resection or rejected;
7. Not have received any prior anticancer therapy;
8. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10\^9/L, platelet count ≥100x 10\^9/L, serum creatinine\<1.5 mg/dL,urea nitrogen \<8 mmol/L;
9. No history of malignancy;
10. No perforation of esophagus, no deep ulcer of esophagus;
11. Joined the study voluntarily and signed informed consent form.

Exclusion Criteria:

1. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
2. Patient who has metastasis such as lung, liver metastasis;
3. Other malignant tumors;
4. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
5. Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;
6. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;
7. Combination of pure red cell anemia or gamma globulin;
8. Allergic to any medication component studied.
Socket Preservation Using Autogenous Bone Graft Versus MPM

Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion.

To assess bone quality, stability of implants placed in fresh extraction sockets of mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).

Eligibility Criteria:
Inclusion Criteria:

1. Medically free patients.
2. Patients with mandibular anterior and premolar hopeless teeth indicated for extraction.
3. Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).
4. Age between 18 and 40 years.
5. Both sexes.
6. Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
7. Highly motivated patients.

Exclusion criteria:

1. Smokers.
2. Pregnant or lactating females.
3. Presence of any pathosis in the pre-implant site.
4. Presence of Para functional habits.
5. History of oral radiotherapy.
6. History of prolonged steroids use
7. Psychological disorders.
Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients

This is a prospective, multi-center, post-marketing observational study to evaluate the effectiveness and compliance of ibuprofen in a sustained release form in the treatment of Egyptian osteoarthritic patients.

This was a prospective, longitudinal, multicenter observational study conducted in a clinical practice setting where the study product was used in osteoarthritis patients as indicated in the approved package insert; the dosing regimen of Brufen retard is 2 tablets as a single dose once daily.

Eligibility Criteria:
Inclusion Criteria:

* Patients seeking treatment for osteoarthritis and there are clinical or radiological evidence of the disease,
* Male or female, age ≥ 18
* Designated to treatment with Ibuprofen in a sustained release form (Brufen Retard) according to the best criterion of the physician and if he decides to treat the patient according to labeled indication and dose for 4 weeks.
* Patients who have given their written informed consent to participate in the study
* Patients who are currently taking non steroidal anti inflammatory drugs (NSAIDs), should complete an initial washout phase 10 days depending on the half life of the drug taken

Exclusion Criteria:

* Contraindications as described in company core data sheet (CCDS) and specifically
* Patients with active peptic ulcer
* Patients who have presented reactions of hypersensitivity (asthma , rhinitis or urticaria ) with ibuprofen or other anti-inflammatory non steroids
* Patients with active cardiovascular disease and those taking aspirin/warfarin for prophylaxis for myocardial infarction (MI) or stroke
* Patients with moderate to severe renal diseases
* Patients with moderate to severe hepatic disease
* Patients with Crohn's disease
* Patients included currently in another study
* Women of childbearing potential must not be pregnant
* Any patients the investigators consider ineligible for this study
Spirometry in Esophageal Intubation

The primary objective of the study is to describe the pressure patterns during esophageal and tracheal ventilation and to validate the diagnostic algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Patients, requiring total anesthesia for a surgical procedure where the use of the easytube could be indicated.

Exclusion Criteria:

* ASA III
* Expected difficulty for oral intubation.
* Expected operation time \>3 hours
A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
2. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR)；
3. There is active PsA before randomization;
4. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
5. Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.

Exclusion Criteria:

1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all LDL-C-lowering drugs and nutritional supplements
* Men and nonpregnant, nonlactating women
* Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks

Exclusion Criteria:

* Fasting blood triglycerides greater than or equal to 400 mg/dL
* Body Mass Index (BMI) greater than 50 kg/m2
* History of clinically significant cardiovascular disease
* History of type 1 or type 2 diabetes
Adding Intra-articular Dexmedetomidine to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery

The purpose of this study to search efficacy of intra-articular dexmedetomidine addition to levobupivacaine for postoperative analgesia in arthroscopic knee surgery.

Patients between 18-65 years and with American Society of Anesthesiologists' (ASA) Physical Status class I-II, who were scheduled for arthroscopic knee surgery, were enrolled in a randomised comparative clinical trial. Blinding or masking began in the preoperative holding unit. Exclusion criteria were psychiatric illness, younger than 18 yo, who has analgesic treatment before the surgery and known hypersensitivity to relevant drugs. All patients received a standard anaesthetic protocol; ECG, heart rate, non-invasive blood pressure, oxygen saturation and temperature were monitored. After preoxygenation, general anaesthesia was induced with sodium pentothal 4 to 7 mg/kg, 1 mcg/kg fentanyl and neuromuscular block was achieved with rocuronium 0.5 mg/kg and trachea was intubated. Anesthesia was maintained with desflurane 6% and 50% oxygen in the medical air.

Randomised patients were achieved dexmedetomidine and levobupivacaine or levobupivacaine intra-articularly 10 minutes before medical tourniquet deaerated.

Postoperative analgesia was maintained with morphine in patient-controlled analgesia. Patients postoperative VAS values and analgesic consumptions were recorded in postoperative 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 yo
* scheduled for arthroscopic knee surgery

Exclusion Criteria:

* younger than 18 yo
* known allergy relevant drugs
* contraindication for general anesthesia
Long Term Effect of an Education and Training Program for Patients With Chronic Obstructive Pulmonary Disease

A parallell group study comparing the effect of an education program with an education and training program for patients with COPD. 30 participants in each group. Participants self-select which group they wanted to be in. Main outcome is SGRQ (a HQoL for patients with COPD).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COPD (FEV1\<75% of expected) who have the ability to conversation and active participation will be included.

Exclusion Criteria:

-
Reiki Therapy - an Intervention in Hematology/Oncology Cancer Patients Hospitalized

Researchers are trying to determine if offering and providing reiki therapy in hospitalized hematology/oncology cancer subjects has any effects on symptoms and feeling during the subjects hospital stay.

Primary Aim:

The primary aim of this study is to evaluate the feasibility of offering and providing Reiki Therapy in hospitalized hematology/oncology cancer patients. The intervention should not - interfere with the medical management of the participants. The investigators hypothesize that Reiki Sessions will be successfully integrated into conventional care of hospitalized cancer patients.

Secondary Aim:

The secondary aim is to evaluate the patient reported outcomes of their symptoms (pain, fatigue, anxiety) and feelings (happy, energetic, relaxed, and calm) before and after Reiki Therapy. The investigators' hypothesis is that there will be improvement of patients' symptoms/feelings score after the Reiki Therapy.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized hematology-oncology patients age 18 - 80
* Able to speak English and complete surveys
* Able to read, understand and sign inform consent.

Exclusion Criteria:

* Patient unwilling for reiki therapy.
* Unable to give written consent.
* Already having received or receiving other reiki treatment.
* Pregnant women. (As verbalized by participant)
A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children.

The study will investigate the influence of NNC0194-0499 on the blood levels of the two components of a birth control pill, Microgynon®. Participants will get the birth control pill in form of tablets in two periods of 8 days each.

Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks.

The study will last for about 11 to 15 weeks, depending on the length of the screening period.

Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.


Eligibility Criteria:
Inclusion Criteria:

* Female of non-childbearing potential.
* Age 18-65 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 18.5 and 29.9 kg/m\^2 (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Any contraindications for the use of the oral contraception used in the study according to the Prescription Drug Information.
* Sitting blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic.
* Pulse outside the range of 50-89 beats/minute at screening
* Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reaching systemic circulation.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
Turkish Validity and Reliability of Baltimore Orthopedic Subscapularis Score

The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society and to make its validity and reliability in Turkish. The BOSS was developed by Hameker et al to differentiate subscapularis tears from other rotator cuff muscle tears in patients with rotator cuff injuries. The BOSS has 5 questions. This study will be conducted with patients with rotator cuff injuries. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 25 participants will be included in the study. In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of the shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.

The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of BOSS will be able to be modified. The data of BOSS will be collecting through face-to-face when the patients came to the rehabilitation center. 25 participants will be included in the study.

In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over 18 years of age who have been diagnosed with a rotator cuff injury,
* Patients whose native language is Turkish,
* Individuals with a Mini Mental State Examination score of \>24,

Exclusion Criteria:

* Individuals with pain and disability due to any shoulder pathology other than rotator cuff injury,
* Individuals who cannot read or write Turkish,
* Individuals with shoulder fractures, surgical interventions and other accompanying shoulder pathologies,
The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index

The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.

The clinical daily routine indicates that slowing the rate of administration of propofol can lead to a reduction of up to 50% in the dose of propofol required to achieve the onset of a clinical endpoint of anesthesia (i.e. loss of consciousness) when titrating to effect. Therefore, it has been concluded that a slow injection requires a smaller dose of propofol as the graded effect is weakened by fast injection. This conclusion contradicts pharmacologic considerations, that a fast injection would lead to a higher peak concentration and in consequence, to a higher peak effect at the effect side, the brain.

The present study was designed to measure the Electroencephalogram (EEG) peak effect of a propofol bolus (2 mg/kg) injected with different infusion rates.

Although it is known that propofol has cardiovascular effects, the influence of injection rate on these cardiovascular changes is less clear. Others found that faster injection rates of propofol caused greater reductions in blood pressure. Other similar studies have shown no difference in blood pressure for different injection rates. An additional aim of this study was therefore to investigate the influence of different injection rates on hemodynamic parameters.

Eligibility Criteria:
Inclusion criteria:

* American Society of Anesthesiologists (ASA) physical status 1-3
* scheduled for elective surgery under general anesthesia.

Exclusion criteria:

* emergency surgery
* obesity
* indication for rapid sequence induction
* drugs that affect the central nervous system
* history of alcohol or drug abuse
* neurological or psychiatric diseases
* contraindications against the use of propofol
Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).

Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)

Memantine + riluzole x Placebo + Memantine

Inclusion criteria:

* \< 75 years at disease onset
* \< 3 years of disease progression
* ALS-FRS \> 24
* FVC \> 60
* Probable or definite disease (revised El Escorial criteria)
* No other medical condition
* Normal blood tests
* Regular medication on riluzole \> 1 month
* Nerve conduction studies ruling out conduction block
* EMG with widespread loss of motor units (revised El Escorial criteria)
* At least one hand with ADM strength \> 2 on MRC scale

Duration - 2 years

Evaluation - every 3 months

Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects

Intention to treat analysis

60 patients

number estimated for 50% change in decline rate of ALS-FRS

Eligibility Criteria:
Inclusion Criteria:

* Definite or probable disease - revise El Escorial criteria
* Normal blood tests
* Riluzole treatment during 1 month or more
* EMG in accordance with El Escorial criteria

Exclusion Criteria:

* Other diseases (such as PNP)
* Both ADM muscles \< 3 on MRC scale
* Conduction block on nerve conduction tests
* Disease duration \> 3 years
* ALS-FRS \< 25
* Forced vital capacity - \<60%
Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen

The clinical evaluation of a patient with a cognitive complaint requires neuropsychological tests, evaluating the integrity of memory and other cognitive functions.

The initial evaluation is made most often by a doctor (general practitioner). In case of need for further examination, a neuropsychological report is made in consultation memory by a neuropsychologist, with further cognitive tests.

The Cognitive Neurology Center at Lariboisière Hospital - Fernand Widal has developed a tool on a digital tablet or smartphone to evaluate cognitive functions: MemScreen.

The purpose of this study is to validate this new neuropsychological test on tablet compared to the neuropsychological reference tests.

Characteristics of MemScreen :

* Smartphone / tablet application developed by the Cognitive Neurology Center at Lariboisière - Fernand Widal Hospital to explore a patient with a cognitive disorder.
* The application is a self-test by the patient under the supervision of a doctor.
* The doctor has an account to be able to pass the test to patients.
* The tablet test is anonymous without the possibility to identify the patient.

Eligibility Criteria:
Inclusion Criteria:

* Major patients followed in memory clinic.
* Performing a neuropsychological assessment less than 6 months old.
* No visual or motor deficiency impeding the use of a digital tablet.

Exclusion Criteria:

* None.