cyrilzakka/clinical-trials huggingface dataset:
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).

This is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl or placebo, in the ratio of 4:1. The study includes a screening phase and a double-blind treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. Participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. The total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months.

Eligibility Criteria:
Inclusion Criteria:

* body mass index between 18 and 30 kg/m², inclusive
* body weight not less than 50 kg
* have a normal electroencephalogram under basic and stimulated conditions
* have a 12-lead ECG that is consistent with normal cardiac conduction and function
* have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration

Exclusion Criteria:

* any personal or family history of epileptic seizures or convulsions
* have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection
* have suffered from loss of consciousness of unknown origin
* drowning or sudden infant death syndrome in a first degree relative
Effect of Laughter Therapy on Perceived Stress and Quality of Life

Breast cancer is the most common type of cancer seen in women worldwide and ranks first. Chemotherapy is one of the commonly used methods of treatment in breast cancer. Physiological and psychological symptoms that occur due to chemotherapy treatment affect women negatively and reduce their quality of life. For this reason, there is a need for an intervention that could decrease psychological symptoms such as stress and improve quality of life in women with breast cancer. In the literature, it is stated that laughter therapy which is one of the non-pharmacological methods, can be an effective nursing intervention to decrease stress and improve the quality of life in women with breast cancer.

This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of laughter therapy on perceived stress and quality of life in women with breast cancer.This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All patients were women with breast cancer who received a once-weekly Paclitaxel regimen.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older women,
* Stages II or III breast cancer
* Receiving Pacitaxel chemotherapy regimen per a week

Exclusion Criteria:

* Using any complementary and alternative (CAM) treatment method during practice
* Having psychological diseases
Long Term Open Label Continuation Study

The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.

Study DE020 was a multicenter, open-label continuation study for patients with rheumatoid arthritis who had participated in a prior Phase 1, 2, or 3 adalimumab study in the United States or Canada, had a favorable safety and efficacy profile when treated with adalimumab, and met the eligibility criteria for the continuation study. Participants received subcutaneous injections of adalimumab every other week (eow) or monthly based on the adalimumab regimen received in the prior study (i.e., participants who received monthly dosing in the prior study began the continuation study on monthly dosing; all other participants began adalimumab dosing at eow intervals). Participants who maintained an American College of Rheumatology 50% (ACR50) response for 2 consecutive visits could have their dosing interval lengthened to a monthly dosing schedule. Safety and efficacy data were collected over 520 weeks (10 years). Both safety and efficacy data were analyzed using all participants who received at least 1 dose of open-label adalimumab in the 10-year continuation study DE020 (the Full Analysis Set, n=846). Three patients who entered the continuation study but were never dosed were excluded from all analyses.

Eligibility Criteria:
Inclusion Criteria

* Participant was in a prior D2E7 (adalimumab) study
* Participant was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.

Exclusion Criteria

* Participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant
* Participant had any ongoing chronic or active infection
A Study of Ustekinumab Treatment in Children With Crohn's Disease

The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving clinical remission in pediatric participants (greater than or equal to \[\>=\] 2 to less than \[\<\] 18 years and weight \>= 40 kilograms \[kg\] at baseline).


Eligibility Criteria:
Inclusion Criteria:

* Having at least one ICN visit with documented new use of ustekinumab
* Participants with a documented Crohn's disease (CD) diagnosis at the time ustekinumab was initiated (that is, Baseline); If diagnosis at baseline is missing, then the diagnosis from previous visit within study window will be utilized
* Having at least one ICN visit prior to the ICN visit when ustekinumab is first documented
* Having received first dose of ustekinumab on or before June 22, 2019
* Having provided informed consent for use of ICN data for research purposes

Exclusion Criteria:

* Documented exposure to ustekinumab before enrollment in ICN (by chart review)
Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward

There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life.

Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known.

The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.


Eligibility Criteria:
Inclusion Criteria:

* Written consent of parent
* Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward

Exclusion Criteria:

* person not affiliated to a health insurance scheme
* Sepsis
* Ductal dependent heart disease
* Neurological impairment (anoxoischemic encephalopathy Sarnat\>1, pH\<7 and/or lactates\>11, meningitis)
* Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas)
* Potentially lethal malformation
* Anemia (hemoglobin\<14g/dl)
* Polyglobulia (hemoglobin\>22g/dl)
* Small for gestational age (weight\<10th percentile)
* Large for gestational age (weight\>97th percentile)
* Proven gestational diabetes (non-insulin-dependent and insulin-dependent)
* Maternal medical treatment (cardiac or anti-epileptic)
* Inadequate parent understanding
Evaluation of High-Density Lipoprotein in Obesity Study

Obesity is associated with an impaired functioning HDL (good cholesterol) resulting in an acceleration in the development of atherosclerosis. This study will evaluate HDL functionality in patients with BMI (Body Mass Index) 20 - 25 and BMI \>30

This study will determine if the protective function of high-density lipoprotein (HDL) is impaired in obese patients and will help to enhance cardiovascular risk prediction. Carotid intima-media thickness (cIMT) will be captured as a means of assessing early vascular changes associated with low HDL levels in obesity. A novel measurement for clinical correlation has also been introduced called carotid extra-medial thickness (cEMT) which will be compared to cIMT in this obese population.

Eligibility Criteria:
Inclusion Criteria:

* Group 1:

  * Age 20-80
  * English speaking
  * BMI 20-25 kg/m2
* Group 2:

  * Age 20-80
  * English speaking
  * BMI \> 30 kg/m2
  * TG \> 150 and
  * HDL \> 50 (females) \>40 (Males)
* Group 3:

  * Age 20-80
  * English speaking
  * BMI \> 30 kg/m2
  * TG \> 150 and
  * HDL \< 50 (females) \< 40 (males)

Exclusion Criteria:

* Self-reported history of:

  * Diabetes mellitus
  * Any previous lipid therapy within the last three months
  * Macrovascular events including TIA, stroke, myocardial infarction, heart failure, claudication, or known peripheral vascular disease
  * Current pregnancy
ICE COPD PikoLogic® Cohort Study.Implementation, Compliance, and Effectiveness of Integrating the PikoLogic®

This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to the current disease management COPD discharge protocol subsequent to an admission for COPD exacerbation.

Candidate subjects participating in the cohort study will receive training by the clinical research associate (CRA) on the use of PikoLogic® for home disease management prior to discharge from the hospital. The CRA will also confirm COPD discharge education was completed by a discharge coordinator and the patient understood the instructions. The CRA will review "seek medical care if:" and "seek immediate medical care if:" instructions at discharge. The discharge CRA will also evaluate subjects for their ability to use the PikoLogic® correctly and will score the patient using an objective and subjective measurement tool. A modified Discharge Knowledge Assessment Tool© will be utilized.1 Objective measurements will include training time and patient compliance with PikoLogic® prior to discharge. Subjective data scores and objective measurements will be utilized for program implementation evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of COPD at or prior to hospitalization.
2. Be hospitalized for one of the following reasons:

   * COPD exacerbation
   * COPD
   * COPD with pneumonia
3. Be an ex-smoker or current smoker with a smoking history of ≥ 10 pack years (i.e., 1 pack \[20 cigarettes\] per day for 10 years).
4. Be judged by the investigator to be in stable health (except for COPD variability) on the basis of medical history, physical examination, and routine laboratory data, and appears able to successfully complete this study.
5. Be willing to perform daily objective and subjective measurements using the PikoLogic® device and maintain daily utilization for 1 year following discharge.
6. The subject is fluent in English for reading and writing.
7. The subject provides written informed consent for the trial.

Exclusion Criteria:

1. Has a current diagnosis of any disease with chronic airflow obstruction other than COPD.
2. Is unwilling to use the PikoLogic® and unwilling to maintain a written record of hospitalization for 1 year.
3. Lives in a neighborhood with poor or no cellular coverage.
4. Is currently homeless or in jeopardy of being homeless during the 1 year study period.
5. Does not have a means to be transported to the follow up study visits.
6. Cannot be contacted easily.
7. Discharges against medical advice.
8. In hospice within one year prior to admission.
9. Is associated with the administration of the study. No family member of the investigational study staff may participate in this study.
Radiological Examination of the Mentally Handicapped Patients

Aim of this study is to evaluate the necessity of the radiological examinations of mentally handicapped or uncooperative patients.

Dental radiography has become an indispensable part of routine dental examination with the help of the technological development of radiological devices. However, medical procedures like dental treatment and medical imaging (magnetic resonance imaging-MRI, computed tomography-CT, orthopantomography- OPG, etc.) that require cooperation are usually hard to apply to mentally handicapped (MHP) or uncooperative patients (UCP). Treatments that will be done without radiological examination can be missing or incorrect.

Eligibility Criteria:
Inclusion Criteria:

1. Mentally Handicapped patients that radiological examination cannot performed
2. Suitable for IV sedation

Exclusion Criteria:

1. Healthy Patients
2. Patients in which the radiological examination performed
Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer

To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial.

To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC) as part of a prospective clinical trial. Investigators will also assess pain control, quality of life, and drug related toxicity during RT and during short term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced cancer of mucosa of the head and neck.
* Eligible subsites will include nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, major salivary glands, oropharynx, larynx, hypopharynx, cervical esophagus, or unknown primary site with lymph node metastases.
* Clinical or pathologic stage III-IV
* Scheduled to receive RT with curative intent with the expectation that some portion of the mucosa of the upper aerodigestive tract will receive a dose of at least 50 Gray.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Age \> 19 years
* Subjects given written informed consent

Exclusion Criteria:

-
Endoscopic Suturing System for Tissue Apposition

The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Post-procedure weight will be followed to assess whether weight loss is resumed.

The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to facilitate endoscopic gastrointestinal procedures.


Eligibility Criteria:
Inclusion Criteria

Subjects must fulfill the following criteria to be entered in this study:

* Review and sign informed consent;
* Between 21 and 65 years of age (inclusive) at time of trial enrollment;
* Documented Roux-en-Y Gastric Bypass (RYGB) surgery date
* Documented baseline weight at the time of RYGB procedure;
* \> 12 months post RYGB);
* Body mass Index (BMI) \> 30 and at least 20 pounds in excess of post-RYGB weight nadir;
* Patients initially achieved at least 50% excess weight loss (EWL) post RYGB;
* Visible anastomotic junction (between gastric pouch and the Roux-limb);
* Stoma size at screening \> 15mm; and
* Negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria

Subjects will be excluded from the trial for any of the following:

* Documented history of esophageal pathology (e.g., esophageal varices, Barrett's Esophagus);
* American Anesthesia Association (ASA) Class IV or V and/or any contraindications to monitored anesthesia;
* Documented history of GJ anastomosis stricture (within 6 months);
* Documented history of previous RYGB revision;
* Presence or documented presence of gastric/duodenal ulcers;
* Presence of sepsis;
* Medical or physical endoscopic contraindications, including esophageal varices or bleeding, laryngeal perforation, trauma to pharynx, aspiration pneumonia, acute peritonitis, and other conditions where general endoscopic techniques and/or placement of overtube are contraindicated;
* Chronic Non-Steroidal Anti-Inflammatory Drug (NSAID) use (subjects taking a single aspirin tablet per day for cardioprotection are considered acceptable);
* Uncontrolled diabetes;
* Physical or psychological condition which would impair trial participation per investigator discretion;
* Binge-eating or similar eating disorders;
* Unable or unwilling to attend follow-up visits and examinations;
* Concurrent surgical procedure (intra-operative exclusion during ESS procedure);
* Participation in any other investigational device or drug trial within 30 days prior to enrollment; or
* Any condition, which precludes compliance with the trial.
X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction Survey

In this survey of X-Lined Hypohidrotic Ectodermal Dysplasia (XLHED) carrier females, Edimer proposes to review responses to an XLHED Carrier Outlook toward Reproduction Survey in order to understand attitudes toward reproduction, potential treatments and genetic testing in order to improve the understanding of the decisions that XLHED carrier females make regarding their reproductive future.

The full survey is available here: https://www.surveymonkey.com/s/X-CORS

For more questions or more details you may contact the Principal Investigator, Carrie Milliard: MILLIC@mmc.org or 207-662-6712

Eligibility Criteria:
Inclusion Criteria:

1. Provide signed informed consent;
2. 18 years of age or older
3. Females with:

   * the clinical characteristics of HED, including at least two of the following characteristics:

     * clinical signs and symptoms of HED:

       * a history of decreased sweating;
       * abnormal teeth (fewer permanent teeth, teeth are smaller than average and often have conical crowns);
       * sparseness of scalp and body hair;
   * AND

     * a clinical diagnosis from a healthcare professional;
     * or at least one HED affected family member
   * OR genetically confirmed HED or XLHED;
Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 \[week 26\]) in japanese patients with type 2 diabetes mellitus.

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia

The duration of study will consist of:

* Up to 2-week screening period;
* 6-month open-label comparative efficacy and safety treatment period;
* 6-month open-label comparative safety extension period;
* 4-week post-treatment safety follow-up period

Eligibility Criteria:
Inclusion criteria :

o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit treated with basal insulin in combination with oral antihyperglycemic drugs (OADs) for at least 6 months before screening visit;

Exclusion criteria:

* Age \< 18 years at screening visit;
* BMI(body mass index) ≥ 35 kg/m2 at screening visit;
* HbA1c \< 7.0% or \> 10% (national glycohemoglobin standardization program \[NGSP\] value) at screening visit;
* Diabetes other than type 2 diabetes mellitus;
* Patients on self-monitoring of blood glucose less than 6 months before screening visit;
* Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit;
* Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit;
* Use of insulin pump in the last 6 months before screening visit;
* Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit;
* Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. Follow-up will be done during 2 years.


Eligibility Criteria:
Inclusion Criteria:

* isolated rupture of the anterior cruciate ligament with instability of the knee joint
* meniscal tear possible to suture
* partial meniscectomies

Exclusion Criteria:

* chronic laxity (more than 9 months)
* associated collateral laxity (grade III)
* subtotal or total meniscectomy
* infection or inflammatory disease of the knee joint
* large cartilage lesion