cyrilzakka/clinical-trials huggingface dataset:
PINS Stimulator System to Treat Severe Anorexia Nervosa

Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. The study will help patients with severe AN using DBS. Individuals with severe intractable AN will be eligible to take part in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male patients aged 20-60 years.
2. Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).
3. Chronicity or treatment resistance shown by some or all of:

   * A pattern of 3 years' duration of relentless unresponsiveness to repeated voluntary hospital admissions, characterised by failure to complete treatment or immediate weight relapse after treatment.
   * A pattern of increasing medical instability, accompanied by refusal to participate in or a pattern of poor response to intensive expert treatment and increasing medical acuity, lasting at least 2 years and including at least two episodes of involuntary feeding.
   * A pattern of chronic stable anorexia nervosa that has lasted at least 10 years.
   * Able to provide informed consent.
4. Able to comply with all testing, follow-ups, and study appointments and protocols.

Exclusion Criteria:

1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
3. Patients with serious infectious disease.
4. Patients with history of serious neurological or psychiatrical diseases.
5. Person with history of HIV infection or serious malnutrition.
6. Dependent upon and addicted to multiple drugs.
7. Any contraindication to MRI or PET scanning.
8. Body-mass index less than 13.
9. Attended some other trials within one year.
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.

This study is designed to compare the safety, pharmacokinetics, and efficacy of weekly and daily formulations of setmelanotide in participants with obesity associated with biallelic or heterozygous POMC (pro-opiomelanocortin), PCSK1 (proprotein convertase subtilisin/kexin Type 1), LEPR (leptin receptor) genetic variants, and participants with Bardet-Biedl Syndrome (BBS).

Eligibility Criteria:
Key Inclusion Criteria:

* Biallelic or heterozygous POMC/PCSK1 or LEPR (PPL) genetic variants or Bardet-Biedl syndrome (BBS), for which they are being treated with QD setmelanotide.
* 6 years or older at screening.
* Taking the setmelanotide QD formulation for at least 6 months in the RM-493-022 (NCT03013543) study with acceptable safety and tolerability, and dose level.
* Participant and/or parent or guardian is able to communicate well with the Investigator, to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent.
* Use of a highly effective form of contraception throughout the study and for 90 days following the study.

Key Exclusion Criteria:

* Glycosylated hemoglobin (HbA1C) \>9.0% at screening.
* Anti-obesity medications within 3 months prior to starting the Run-in Period.
* History of significant liver disease or liver injury.
* Glomerular filtration rate \<30 milliliter per minute (mL/min).
* Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions.
* Major psychiatric disorders.
* Any suicidal ideation or behavior, or any lifetime history of a suicide attempt.
* Significant hypersensitivity to any excipient in the study drug.
* Inability to comply with the QW and QD injection regimens.
* Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing, with the exception of a setmelanotide clinical trial.

Other protocol defined Inclusion/Exclusion criteria may apply.
Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis

The aim of this study was to determine the effect of Clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation. This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of Clobetasol, nitroglycerin, and control. The data collection tools included demographic information, information about intravenous treatment and phlebitis measurement scale. In the intervention groups, after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.

Aim: The aim of this study was to determine the effect of clobetasol ointment with nitroglycerin ointment on the prevention of superficial phlebitis caused by cannulation.

Background: Today, more than 80 to 90% of hospitalized patients receive intravenous treatment during their treatment, and more than 500 million peripheral venous catheters are placed annually, although cannulation provide numerous benefits in clinical setting, but because of its invasive feature, it can end in unpleasant outcomes such as phlebitis Method: This clinical trial was conducted on 110 patients admitted to the surgical ward, in three groups of clobetasol, nitroglycerin, and control. The data collection tools included demographic information, information about intravenous treatment and phlebitis measurement scale. In the intervention groups, after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.

Eligibility Criteria:
Inclusion Criteria:

* must be older than 18 years old
* must be in need of hospitalization at least 72 hours
* does not state any previous allergic reaction to the ointments
* does not use any types of drug that can hurts veins (chemotherapy drugs, diazepam. amiodarone, and....)

Exclusion Criteria:

* active infection
* discharge from hospital sooner than 72 hours
* displacement of cannula before 72 hours
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers

The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.

This study is a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single-dose and multiple-ascending-dose study of 5-MeO-DMT administered by intramuscular injection in 54 healthy subjects (adult male and/or females, 18-65 years of age). Subjects will be randomized 6:1 to receive 5-MeO-DMT or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female.
* Aged at least 18 years but not older than 65 years, inclusive.
* Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2, inclusive.

Exclusion Criteria:

* History of significant hypersensitivity to the IP or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, or endocrine disorders, as determined by the investigator (or designee).
* Participants who, in the opinion of the investigator (or designee), should not participate in this study.
* Participant is participating in another study with a medical device or IP within the last 30 days prior to first study drug administration.
Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)

The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.

Data regarding the use under routine practice of abdominal aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from July 13, 2010, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve at least 150 patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.

In France, The Endurant™ Stent Graft System is registered on the LPPR for a period of 3 years since September 13, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Endurant stent graft.

Eligibility Criteria:
Inclusion Criteria:

* Patient with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release.
* Any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm.
* Patient not opposed to the collection and release of his/her personal information
* Intention of physician to implant electively the Endurant™ Stent Graft System

Exclusion Criteria:

* Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)
Post Radiotherapy MRI Based AI System to Predict Radiation Proctitis for Pelvic Cancers

In this study, investigators utilize a Artificial Intelligence (AI) supportive system to predict radiation proctitis for patients with pelvic cancers underwent radiotherapy. By the system, whether the participants achieve the radiation proctitis will be identified based on the radiomics features extracted from the post radiotherapy Magnetic Resonance Imaging (MRI) . The predictive power to discriminate the radiation proctitis individuals from non-radiation proctitis patients, will be validated in this multicenter, prospective clinical study.

This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the radiation proctitis in patients with pelvic cancers based on the post-radiotherapy Magnetic Resonance Imaging (MRI) data. Patients who have been pathologically diagnosed as pelvic cancers will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital and the Third Affiliated Hospital of Kunming Medical College. Patients with pelvic cancers who received radiotherapy will be enrolled and their post-radiotherapy MRI images will be used to predict their radiation proctitis or not. The clinical symptoms, endoscopic findings, imaging and histopathology as a standard. The predictive efficacy will be tested in this multicenter, prospective clinical study.

Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed as pelvic tumours
* intending to receive or undergoing radiotherapy
* MRI (high-solution T2-weighted imaging, contrast-enhanced T1-weighted imaging, and diffusion-weighted imaging are required) examination is completed after radiotherapy

Exclusion Criteria:

* insufficient imaging quality of MRI (e.g., lack of sequence, motion artifacts)
* incomplete radiotherapy
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI)

The purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* non-dialyzed patients with CKD
* indication for Ketosteril according to Summary of Product Characteristics (SmPC), including a glomerular filtration rate (GFR) \< 25 mL/min
* accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)
* adult patients ≥ 18 years

Exclusion Criteria:

* active cancer diseases
* pregnancy or breast feeding
* hypersensitivity to active substances or to any of the excipients in Ketosteril
* hypercalcaemia
* major disorder of amino acid metabolism, e.g., hereditary diseases
* participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study
* illiteracy or incapability to read or write
Rehabilitation of Type 2 Diabetes Patients.

The aim of this study is to investigate the effect of a new rehabilitation program of type 2 diabetes patients in a primary care center versus standard care in the outpatient Hospital Clinic.

Type 2 diabetes is major and growing health care problem and is associated with premature mortality and increased morbidity. At the time of diagnosis half of the patients have cardiovascular, renal, ophthalmic or neurological disease. A recent Danish intervention study found a marked reduction in cardiovascular events and microvascular complications in a group of patients with type 2 diabetes and microalbuminuria using an intensive multifactorial pharmacologic intervention and lifestyle intervention (3). The achieved changes in lifestyle seems however to vanish after a short period. Lack of information, unawareness of the seriousness of the disease and lack of supervised training and insufficient follow-up may be of importance of the long-term outcome in these patients.

A total number of 180 patients with type 2 diabetes, will be randomized to the intervention group or to standard care.

This study tests an intensive intervention of lifestyle by a newly developed program of rehabilitation compared with routine standards in a randomized controlled design. Provided that a significant positive outcome is found, the non-pharmacologic treatment of type 2 diabetes could be optimized and inpatient hospitalization due to complications could be avoided.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 diabetes mellitus
* HgbA1c between 6,8 - 10,0%
* With or without one or more micro- and macrovascular or neurological complications.

Exclusion Criteria:

* HgbA1c \< 6,8 and \> 10,0 %
* Patients who have attended lifestyle intervention in the past year
* Patients who is planned to start treatment with insulin during intervention period
* Lack of motivation
* Patients with severe heart-, liver or kidney disease or incurable cancer
CYP2B6 Polymorphisms in Ketamine

This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.


Eligibility Criteria:
Inclusion Criteria:

1. 18-50 yr old
2. CYP2B6\*1/\*1, CYP2B6\*1/\*6 or CYP2B6\*6/\*6 genotype (see table) (Note: subjects of other rare genotype but with one or more 516G\>T, 785A\>G, 983T\>C or 1459C\>T polymorphism may be enrolled at PI's discretion)
3. Good general health with no remarkable medical conditions
4. BMI \<33
5. Provided informed consent

Exclusion Criteria:

1. Known history of liver or kidney disease
2. Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6
3. Females who are pregnant or nursing
4. Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
5. Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)
Fasting-Associated Immune-metabolic Remission of Diabetes

People with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last 4 years had a remission (HbA1c \<6.5% without medication) of diabetes in over 80% upon weight loss of 15 kg. Longer duration of diabetes reduced the chance of remission. The investigators will test whether there is a difference in remission upon weight loss of 15 kg using formula low calorie diets between subjects with a diabetes duration of \<4 years vs. \>8 years and oral treatment as primary end points. The immune metabolic programming of circulating monocytes will be investigated in detail regarding trained innate immunity and the endocrine responses will be determined using meal challenge tests.

A remission of type 2 diabetes can be achieved in over 80% of people with a diagnosis within the last 4 years and overweight or obesity by weight loss of 15 kg. The mechanisms involve an improvement of insulin sensitivity and thereby insulin requirements and a regain of the function of insulin secreting beta cells. Longer duration of type 2 diabetes appears to impair the capacity of beta cell to regenerate. At present it is not possibe to predict success of the weight loss at an early time point. The investigators therefore aim to identify early markers of responders. It is unclear how the weight loss induces the remission in responders. Immune cells are known to contribute to insulin resistance by regulating adipose tissue function and hepatic and skeletal muscle metabolism by releasing cytokines. The inborn immune system is known to adapt to external stimuli by the process of trained immunity and is thought to contribute to insulin resistance and the dysfunction of beta-cells. The investigation will analyze the programming state of innate immune cells in detail in the course of diabetes remission. In addition, islet hormone responses to challenge tests will be performed to assess their function in detail.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed less than 4 or over 8 years, before study,
* BMI \> 28 kg/m²,
* willingness to follow weight loss diet,

Exclusion Criteria:

* consuming disease,
* intolerance for very low calorie formula diet,
* known severe hepatic disease or liver cirrhosis,
* type 1 diabetes,
* severe disease of kidney or heart,
* advanced diabetic retinopathy,
* intake of glucocorticoids,
* drug or alcohol abuse,
* weight loss of \>5 kg in the last 3 month,
* eating disorder
Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization

Participants with limited neck rotation are recruited to determine if manual therapy (joint stretching) techniques applied in a bio-mechanically correct sequence will improve neck motion, function and pain better than if the manual therapy is applied in the opposite direction. Each participant will receive both the correct and the incorrect applications in randomized order with each treatment separated by 2-3 days. Improvement in neck motion, function and pain will be assessed after each session.

Participants are recruited consecutively through referral from provider clinics or through self referral to physical therapy in the outpatient rehabilitation clinic at Indiana University Health West Hospital in Avon Indiana. After obtaining informed consent and meeting study criteria, participants will be randomized into either first receiving atlanto-axial joint mobilizations in a bio-mechanically correct or incorrect direction with respect to their loss of cervical rotation. Outcome measures will be completed both pre and post treatment. The participants will then be given self stretches at home to mimic the same intervention performed in the clinic three times per day. The participants will then return to the clinic in two or three days to receive the opposite treatment and opposite home program. Outcome data will again be collected both pre and post treatment. Participants will return for a final visit in two or three days and final outcome data will be collected and the participant will be offered continuation of physical therapy if neck symptoms still persist.

Planned Statistical Analysis:

* Descriptive statistics of subjects: age, gender, date of onset, Neck Disability Index, cervical active range of motion rotation, initial numeric pain rating at rest and rotating to the limited side
* Repeated measures ANOVA effect sizes for comparing differences between:

  1. Pre and post treatment comparing with-in treatment change for cervical range of motion rotation and numeric pain ratings on 1st and 2nd visits. Also comparing post treatment in cervical range of motion rotation and numeric pain ratings between 2nd and 3rd visits.
  2. Neck disability index change between 1st and 2nd visits and 2nd and 3rd visits
* Power calculation (actual achieved power)

Eligibility Criteria:
Inclusion Criteria:

* males or females between 18 and 80 years of age
* 25 percent or greater asymmetry of active cervical range of motion rotation limited by pain and/or stiffness

Exclusion Criteria:

* cervical surgeries or injections in the past one year
* current manual or exercise treatment by another provider for neck pain
* cervical manipulation/mobilization/trauma in past 3 months
* cervical radicular or referred pain distal to the acromion
* upper extremity neurologic myotome weakness or constant dermatomal numbness
* pending litigation
* signs of cervical myelopathy or vertebrobasilar artery insufficiency
* use of prescribed anticoagulants or documented blood clotting disorder
* alar or transverse ligament instability
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-50 years
* Willing and able to provide written informed consent
* HIV-uninfected and otherwise healthy
* Willing to abstain from sexual activity and from use of vaginal products while participating in the study
* Currently using oral contraceptives for pregnancy prevention
* Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study

Exclusion Criteria:

* History of allergy to TMC120 or to the constituents of the vaginal ring
* History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months
* History of genital tract surgery within the last month
* Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
* Currently or within one month of participating in any other clinical research study
* Current vulvar or vaginal symptoms / abnormalities that could influence the study results
* Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
* Current diagnosis of any genital infection
* Smoking more than 10 cigarettes / day