cyrilzakka/clinical-trials huggingface dataset:
A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles

Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* At Visit 1a, subjects must meet ALL of the following criteria:

  1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
  2. Women who either

     1. have never used hormonal contraceptives before consent/assent (naïve users), or
     2. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or
     3. directly switch from another hormonal contraceptive (switchers).
  3. Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:

Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.

Exclusion Criteria:

1. Pregnancy or wish of pregnancy.
2. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
3. History of infertility.
4. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
5. Unexplained amenorrhoea.
6. Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis

Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE and ALS association.

Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify predictiv factors of VTE in this specific population. The studied population is Brest universitary hospital cohort of ALS patient included between 2000 and 2019.


Eligibility Criteria:
Inclusion Criteria:

* patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of Brest Universitary Hospital during 2000 to 2019

Exclusion Criteria:

* no consent
* other neuro-degenerativ diseases
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-65 years old
* Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 4 weeks in duration

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing potential who are not practicing a reliable method of birth control
* Patients with a history of meeting DSM-IV-TR criteria for:

  1. any manic or hypomanic episode;
  2. schizophrenia or any other psychotic disorder;
  3. obsessive-compulsive disorder.
* Patients who are considered a suicide risk
Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers

This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?

OUTLINE:

Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.

After completion of study, patients are followed up at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT PARTICIPANTS
* Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
* English-speaking patients
* PEER MENTORS
* Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
* Over age 18
* PEER MENTORS: English-speaking patients
* This study is open to patients of all races and ethnicities

Exclusion Criteria:

* PEER MENTORS:
* Major psychiatric disease
* Currently undergoing treatment for active gynecologic cancer
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)

In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.

Not provided

Eligibility Criteria:
Inclusion Criteria:

* Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
* Aged 18-80 years old
* ASA physical class 1, 2, or 3
* BMI \</= 42 kg/m2
* Generally healthy

Exclusion Criteria:

* Concurrent condition requiring analgesic treatment during study period
* Opioid tolerant
* Known allergy to capsaicin or other study medication
* Use of prohibited medications
Low Level Diode Laser Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis

a three-arm head-to-head randomized clinical trial assessing two of the promising studied interventions, low-level diode laser and topical Chamomile, comparing them to each other's and to conventional therapy in the management of oral mucositis-induced chemotherapy.

The latest MASCC/ISOO Mucositis Guidelines recommend relieving pain, reducing inflammation, and preventing secondary infection as the main pillars in the management of chemotherapy-induced oral mucositis. Accordingly, our comparator will be conventional therapy, including topical anti-inflammatory, topical analgesic, and topical antifungal.

Eligibility Criteria:
Inclusion criteria:

* Patients with chemotherapy-induced oral mucositis.
* Patients who will agree to participate in the study.
* Adult Patients above 18 years.

Exclusion criteria:

* Patients with any visible oral lesions other than oral mucositis.
* Patients who have received radiotherapy 2 weeks earlier to the diagnosis of the oral mucositis
Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

The first primary research objective of the study is to determine whether high-fat load (150 g of fat) induces increase in hepatic fat content (HFC) three and six hours after meal in insulin-sensitive subjects with normal HFC (\<5% of fat) and in non-diabetic subjects with an increased HFC (\>5% of fat). Furthermore, the other objective of the study is to determine whether the response of HFC to a high-fat load is affected by coadministration of glucose or fructose.

The epidemic of non-alcoholic fatty liver disease (NAFLD) is becoming a major challenge faced by health system worldwide. The hepatic fat comes from the major sources - non-esterified fatty acids (NEFA) released from adipose tissue, dietary fat and de novo lipogenesis. Fat accumulation in the liver then occurs when triglycerides (TG) that are formed are not rapidly enough oxidized or secreted from the liver in very low density lipoproteins (VLDL). It can be hypothesized that the capacity of the liver to eliminate TG can be overcome after high load of dietary fat. High-fat load should induce an immediate accumulation of hepatic fat that could be detected using 1H magnetic resonance spectroscopy (1H-MRS). The accumulation of liver fat can be also affected by coadministration of simple carbohydrates - glucose and fructose. The administration of these carbohydrates can have a pronounced impact on the availability of particular sources of hepatic fat.

Eligibility Criteria:
Inclusion Criteria:

* normal response to oral glucose tolerance test
* normal glycated hemoglobin
* normal aspartate aminotransferase (AST)
* normal alanine aminotransferase (ALT)

Exclusion Criteria:

* BMI \> 30 kg/m2
* use of pharmacological agents affecting insulin sensitivity
* use of pharmacological agents affecting lipid metabolism
* inability to undergo 1H-MRS examination
Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children

This study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. It was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds.

This study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. It was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds. The study sample consisted of males and females aged 11-13 years who were recruited to take part in the study from a UK secondary school. There were two conditions in this parallel groups study: Breakfast and No breakfast (fasting). The breakfast intervention consisted of ad libitum intake of ready-to-eat-cereal with milk. Cognitive function was assessed at baseline and +70 and +215 minutes post-intervention. The Cambridge Neuro-psychological Test Automated Battery (CANTAB; Cambridge Cognition Ltd) was used to assess cognitive function. The battery included: Simple Reaction Time (SRT), 5-Choice Reaction Time (5-CRT), Rapid Visual Information Processing (RVIP), and Paired Associates Learning (PAL), which measured reaction time, visual-sustained attention, and visual-spatial memory respectively. Concomitant ratings of subjective mood, alertness, satiety, and motivation were taken throughout the morning using eight unipolar Visual Analogue Scales

Eligibility Criteria:
The inclusion criteria were as follows: aged 11-13 years, willingness to consume RTEC with semi-skimmed cow's milk during the study, ability to follow verbal and written instructions in English, and normal vision with appropriate corrective lenses if required. The exclusion criteria were as follows: inability to understand the objective of the cognitive tests or carry out the tests, behavioural difficulties or attention disorders, administration of any psychotropic medication in the month prior to testing or during testing, food allergies or intolerances which prevent consumption of RTEC and milk (e.g. coeliac, lactose intolerance), acute illness or feeling unwell within the week prior to testing or during testing, and hearing impairment that precluded the normal use of headphones.
Effect of Endodontic Case Difficulty on Endodontic Mishaps: Clinical Study

The aim of this study investigate the influence of endodontic case difficulty, as categorized by the American Association of Endodontists (AAE) assessment form (low, moderate, high), on the incidence of endodontic mishaps and treatment visit requirements in postgraduate dental students.


Eligibility Criteria:
Inclusion Criteria:

* Primary root canal treatment
* Retreatment

Exclusion Criteria:

* Patients who do not accept to participate to study
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Macular oedema caused by MacTel 1, with CST \>300µm on SD-OCT
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* Type 1 or type 2 Diabetes Mellitus
* Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results
* Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
* Any active ocular / intraocular infection or inflammation in either eye
* Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
Sous Vide Rewarming for Frostbitten Extremities

The purpose of this study is to determine the efficacy of using sous vide devices for heating and maintaining the circulating warm water bath used in the rewarming of acute frostbite.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or up
* Age \<17 with parent or guardian consent
* Ability to understand English
* Ability to provide consent to the study
* Acute frostbite of the hands or feet

Exclusion Criteria:

* Children under age 18 without parent or guardian
* Frostbite that has already thawed
* Frostbite of tissue other than hands or feet
* Inability to understand English
* Inability to provide consent
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Malaysia

This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in subjects with type 2 diabetes in Malaysia.


Eligibility Criteria:
Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 2 years and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy
Long-term Effects of COVID-19 in Adolescents

The overarching objective for this prospective cohort study of COVID-19 in adolescents is to study the long-term effects, with particular emphasis on post-infectious chronic fatigue. A total of 500 individuals with a SARS-CoV-2 positive test will be enrolled in the acute phase of COVID-19 and followed for 6 months. A total of 100 individuals with SARS-CoV-2 negative test will be included during the same time period as a control group. Investigations include autonomic, pulmonary and cognitive assessement; a questionnaire charting symptoms, emotionality, personality, loneliness, life events and demographics; and extensive biobanking including genetic markers, viable PBMC, urine, feces and hair. A subgroup of 40 SARS-CoV-2 positive and 20 SARS-CoV-2 negative individuals will also undergo detailed cardiological examination by echocardiography. Primary endpoints are fatigue at 6 months as assessed by the Chalder Fatigue Scale and post-COVID-19 syndrome cases at 6 months according to the WHO definition


Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 test/negative SARS-CoV-2 test
* Age 12 - 25 years
* Living in the counties of Oslo or Viken, Norway
* \< 28 days since onset of first symptom

Exclusion Criteria:

* Hospitalised due to COVID-19
* Pregnancy
* Lack of consent
Adherence in Clinical Trials-Induction Strategies

To examine the effects of two strategies of inducing enhanced adherence to medication in the context of a clinical trial: habit training versus habit training plus problem solving.

BACKGROUND:

The success of any therapeutic intervention, whether preventive or curative, is ultimately dependent on the individual's adherence to treatment. Unfortunately, the failure of a large percentage of patients to adhere to prescribed medical regimens is a widely recognized and well documented phenomenon. It has been estimated that as many as 50 percent of patients do not take their prescribed medications, and of those remaining, less than two-thirds take their medication as prescribed.

The interventions, implemented at the outset of pharmacologic intervention within the clinical trial, were timed to yield maximum effectiveness. Such randomized induction studies had not yet been undertaken. By capitalizing on a new unobtrusive assessment technique that generated the time of medication intake over prolonged periods, the study produced a unique set of data suitable for the study of recurring cycles in medication intake patterns.

The study was part of a two grant initiative entitled "Evaluation of Adherence Interventions in Clinical Trials". The initiative was developed by the Behavioral Medicine Branch staff and Clinical Trials Branch staff as well as members of the Clinical Applications and Prevention Advisory Committee Behavioral Medicine and Prevention Working Groups. The initiative was released in September, 1991 and awarded in September, 1992.

DESIGN NARRATIVE:

Randomized, double-blind, two-group design. Within each of the groups, half of the subjects were on lovastatin and half on placebo. The main outcome measure was medication intake monitored daily and unobtrusively with the MEMS electronic monitor. For each subject, event time series of six months duration were obtained. The effect of these interventions were determined on average adherence at two and six months; and variability of adherence. In addition, the relative cost effectiveness of each intervention was examined by a recalculation of sample size needs based upon increased adherence and related cholesterol lowering. Ancillary goals of the study included: determining the components of variability of medication intake using statistical modeling techniques; and covariates of treatment effects, including baseline daily hassles, problem solving skills, and generalized expectancy for success.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Reduction of Postherpetic Neuralgia in Herpes Zoster

The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of 50 years of age and older.
* Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within the first 72 hours of vesicles.
* Patients who are willing and able to comply with the requirements of the study.
* Patients who are willing and able to give written informed consent.
* Average pain score pre-therapy greater or equal than 4 on 10-point Likert scale.

Exclusion Criteria:

* Sexually-active women of childbearing potential, including postmenopausal women less than 1 year since last menses, not employing adequate contraception (approved oral contraceptive, intrauterine device, barrier methods or total abstinence).
* Pregnant females and nursing mothers.
* Patients with immune dysfunction including congenital immune deficiency, active malignancy of any type, collagen vascular diseases, organ or bone marrow transplantations, known infection with HIV or severe atopic dermatitis.
* Patients who have received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within the previous 3 months.
* Patients with evidence of cutaneous or visceral dissemination of herpes zoster infection (cutaneous dissemination is defined as \> 20 discrete lesions outside adjacent dermatomes).
* Patients who have received systemic anti-VZV medications or immunomodulatory medications (including interferon) within the previous 4 weeks.
* Patients currently receiving probenecid.
* Patients with impaired renal function: calculated creatinine clearance of \<30 mL/min using Cockcroft and Gault formula.
* Patients with abnormal liver function (alanine transaminase (ALT) or aspartate;transaminase (AST) levels greater than five times the upper limit of the normal range).
* Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, famciclovir or gabapentin.
* Patients currently receiving therapy with gabapentin or tricyclic antidepressants.
* Patients with clinical evidence of ocular involvement of herpes zoster. Patients with herpes zoster of the ophthalmic branch of the trigeminal nerve without evidence of ocular involvement will be included.
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Histologically confirmed hormone receptor positive (HR+) \[(estrogen receptor (ER+) and/or progesterone receptors(PgR+)\] breast cancer according to immunohistochemistry (IHC)
* Measureable or evaluable-only disease
* human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer
* Males and females ≥18 years of age
* Females are post menopausal or surgically sterile
* Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)

Exclusion Criteria:

* Pregnant or breast feeding
* \>1 chemotherapy regimen for advanced disease
* Pleural or pericardial effusion
* Serious cardiac condition