cyrilzakka/clinical-trials huggingface dataset:
Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache

Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes of the brain, the autonomic nervous system and pain processing systems.

Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes in the functional connectivity, spectroscopy, iron deposition and perfusion of the brain. In addition, we plan to investigate circadian changes in the pain threshold of the brain using quantitative sensory testing (QST). Finally, we will investigate changes in the autonomic nervous system measuring the pupillary response.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cluster headache (CH) may enter the patient group, patients not suffering from CH may enter the control group.
* knowledge of the german language suffices to understand the information sheet and consent form
* having read, understood and signed the consent form

Exclusion Criteria:

* Pregnancy
* contraindications for the MRI scan (particularly metal splinters, ferromagnetic devices and implants)
* claustrophobia
* obesity (MRI \> 35 kg/m2)
* shift working (last night shift must date back more than one week)
* jet lag (last travel over more than two time zones must date back more than one week)
Social Media-based Active Self-report on Incidence and Outcomes of Adverse Events in NK/TCL Patients

The purpose of this study is to collect data from patients by social media and self-report on the adverse events and outcomes happened with patients with extranodal natural killer/T-cell lymphoma, nasal type, who are treated outside of clinical trials in China.

Extranodal natural killer/T-cell lymphoma, nasal type, is a rare subtype of non-Hodgkin lymphoma with relatively high incidence in China. L-asparaginase based chemotherapy are widely used with Chinese patients and has been reported to improve overall response and prolonged the long-term survival in some clinical trials with very limited patients. However, most patients were treated out of clinical trials in China. Therefore the real incidence of adverse events and treatment outcomes are largely unknown. This study is designed to evaluate the incidence of adverse events and treatment outcomes by social media-based (www.house086.com, www.wechat.com) self-report from patients who are treated out of clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
* Treated with at least one cycle of L-asparaginas or Pegaspargase based chemotherapy.
* Signed Informed consent.

Exclusion Criteria:

* patients who are enrolled in any other clinical trials.
* Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.
Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris

The purpose of the study is to testify the efficacy of treating moderate-to-severe acne vulgaris with Single Microneedle Radiofrequency, and provide evidence for the hypothesis that "whether Single Microneedle Radiofrequency therapy could be an alternative to photodynamic therapy for moderate to severe acne vulgaris."

The purpose of the study is to testify whether Single Microneedle Radiofrequency is effective for moderate-to-severe acne vulgaris, through treating moderate-to-severe acne vulgaris patient for 1 month, using photodynamic therapy as controlled group, and try to provide clinical evidence for the hypothesis that "whether Single Microneedle Radiofrequency therapy could be an alternative to photodynamic therapy for moderate to severe acne vulgaris."

Eligibility Criteria:
Inclusion Criteria:

1. Consistent with the diagnostic criteria of moderate-to-severe acne vulgaris (IGA3-4) .
2. Age of a subject is older than 14 and is younger than 45.（including 14 and 45）.
3. Did not take any anti-acne treatment in the last 1 month, and did not take part in any clinical trial.
4. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. systemic acne treatment with oral isotretinoin within 6 months or oral antibiotics in the past 1 month;
2. history of facial procedures like dermabrasion, chemical, or laser peels;
3. history of photosensitive diseases, porphyria, or porphyrin sensitivity.
4. With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
5. Pregnant women or women in lactation.
Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).

The purpose of this study is to compare the efficacy and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).

Eligibility Criteria:
Inclusion Criteria:

* Patient has primary Type II hyperlipidemia or mixed dyslipidemia
* If the patient is currently taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications
* Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
* LDL-C levels and/or Non HDL-C levels above normal for patients

This study will be conducted both in the USA and internationally.

Exclusion Criteria:

* Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives
* HbA1c ≥ 9% in diabetic patients
Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.

Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL).

Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hCG administration.

Eligibility Criteria:
Inclusion Criteria:

* to be at risk of OHSS were invited to participate in the study

Exclusion Criteria:

* age \> 40 years
Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.

The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Presenting with atopic dermatitis, dry skin, objective SCORAD \< 15,
* With xerosis on the body and a xerosis score \> = 2 (SCORAD sub-score) on the anterior part of lower limbs,

Exclusion Criteria:

* Acute phase of atopic dermatitis
* Severe form of atopic dermatitis
1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

The purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.

Toenail fungus (onychomycosis) is a common fungal infection of the nail that affects roughly 10% of Americans. Onychomycosis may be a precursor to many complications like ulcers, or skin infections, which may rarely result in amputation. Current treatment options have relatively limited long-term success and recurrence is common.

The researcher can determine that the laser therapy can heat the nail and destroy and decrease the fungus infecting the nail to improving the appearance of the nail.

Eligibility Criteria:
Inclusion Criteria:

* Adult Male/ female has been diagnose with fungal nail infection on both great toenails.

Exclusion Criteria:

* Any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator.
* Excessively thick or hypertrophic nails.
* Subjects with diabetes.
* Subjects that are pregnant
* Receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment.
* Subjects with impaired immune systems including, but not limited to HIV, transplant patients on immunosuppression, etc.
* Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
* History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.
Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artificial Childbirth Induction

The labor induction concerns 22% of births in France. In the event of labor induction, in almost two thirds of cases, a cervical ripening method is used and the use of mechanical methods is observed for 8% of cervical ripening. Intra-cervical balloon placement is generally well tolerated but is frequently associated with pain and acute anxiety. There are few options for pain relief. Virtual reality, a relatively new intervention, has been studied as a distraction technique for pain relief, but never in the context of the induction of childbirth.

It's prospective single-center, randomized, single-blind, prospective study (1:1, 2 group randomization) comparing a group of patients who benefited from the use of the virtual reality headset to a group of patients who received standard care during balloon insertion. Two groups of patients will be formed: a "standard care" group and a "standard care + virtual reality" group.

The study will take place at the Saint-Etienne University Hospital Center in the gynecology-obstetrics department.

The principal objective is to evaluate the effectiveness of the use of a virtual reality helmet on the reduction of pain during the insertion of an intra-cervical balloon for childbirth induction versus the use of standard care.

Eligibility Criteria:
Inclusion Criteria:

* Any pregnant woman presenting to the Gynecology-Obstetrics Department of the Saint-Etienne University Hospital for an induction by Cook's balloon.
* Patients affiliated or entitled to a social security system
* Patients having given their agreement to participate and after signing the consent form

Exclusion Criteria:

* Woman refusing to participate in the study (lack of consent)
* Non French-speaking woman (impossibility of carrying out a good quality interview of the pregnant woman)
* Women suffering from blindness, deafness or epilepsy against the use of the virtual reality helmet.
* Participation in another interventional study.
* Patient under guardianship or curatorship
* Patient subject to a legal protection measure or unable to express their consent
Neoadjuvant Treatment of Colon Cancer

This study will investigate

* the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
* the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
* Analysis of KRAS, BRAF, PIK3CA
* Age ≥18 år
* Performance status ≤ 2
* Hematology

  * ANC ≥ 1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l.
* Biochemistry

  * Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
* Consent to translational research
* Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
* Written and orally informed consent.

Exclusion Criteria:

* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
* Peripheral neuropathy NCI grade \>1
* Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
* Other investigational treatment within 30 days prior to treatment start
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
* Bleeding tumors
* Hypersensitivity to one or more of the substances
Study of the Participation of People With Aphasia Post Stroke and Their Caregivers in Valladolid Region (Spain)

The objective of this study is to determine the level of community participation of people with post-stroke aphasia and their caregivers, as well as the factors that facilitate or interfere with this participation in the Valladolid region (Spain).

The main questions that this study aims to answer are:

1. What is the retained activities of the people with aphasia post-stroke?
2. What is the retained activities of the caregivers of people with aphasia post-stroke?
3. What factors influence the community participation of people with aphasia post-stroke and their caregivers?


Eligibility Criteria:
Inclusion Criteria:

* Chronic Stroke (stroke onset above six months).
* Aphasia post stroke.
* Residents in Valladolid Region.
* Age over 18 years.
* Ability to walk equal to or greater than 3 according to the Functional Ambulation Category (FAC).
* Informed consent acceptance.

Exclusion Criteria:

* Stroke onset below of Six months
* Age under 18 years
* Both in the case of the person with aphasia and their caregiver, presence of other pathologies that affect functional independence
Mandibular Advancement Bite Block Efficacy Observational Study

The purpose of this study is to compare the effect of mandibular advancement bite block to standard bite block for prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.

During endoscopic examinations, especially upper gastrointestinal, bile duct, or bronchoscopic examinations, the endoscope need to be placed through the mouth. A bite block is used to protect vulnerable endoscope and protect patient's teeth. During sedative endoscopic exams, respiratory depression, apnea or upper airway obstruction will occur under the influence of the sedative medications. Serious adverse events may occur such as hypoxemia. A nasal airway, Larson's maneuver, jaw thrust or chin lift may be needed to open airways.

Mandibular advancement devices has been widely used in treating obstructive sleep apnea. A modified bite block that provides mandibular advancement could provide entry inlet of endoscope as well as provide mandibular advancement to provide patent airway during sedative endoscopy. In this study, we group the patients into test group using mandibular advancement bite block and a control group using standard bite block. After anesthetic induction, gastric endoscopy was performed. Degree of upper airway obstruction will be evaluated and recorded. Differences between the two groups will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist class I or II
* Patients undergoing routine upper gastrointestinal endoscopy under sedation

Exclusion Criteria:

* Baseline oxygen saturation \< 90%
* Known difficult airway
* Oral or facial surgery history
* BMI \> 35
* patients with gastroparesis or gastrointestinal bleeding
* anticipated exam time \> 30 minutes
Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)

COLLECT is a monocentric, prospective, observational study, which aims to assess the association between changes in the intestinal microbiota and the incidence of gastrointestinal graft-versus-host diseases (GvHD). Patients admitted for performance of an allogeneic hematopoietic stem cell transplantation (HSCT) or patients with a first diagnosis of an acute myeloid leukemia (AML) will be enrolled and stool samples will be analyzed using next-generation sequencing. In addition to stool, blood and urine samples will be collected for cytokine and 3-indoxylsulfate analysis.

Exposure to drugs will not be influenced and remains at the discretion of the treating physician.

Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.

The following data items of patients with a written informed consent are prospectively documented into our database:

* Demographics
* Chemotherapeutic agents
* Other immunosuppressives
* Radiation treatment
* Antibiotic prophylaxis and treatment
* Bowel movement abnormalities
* HSCT Donor and recipient information
* Status of hematological disease
* Days with neutropenia
* Fever and infectious complications

The following samples of patients with a written informed consent are prospectively collected, stored and analyzed:

* Stool samples (16S rRNA analysis)
* Urine (3-IS analysis)
* Ethylenediaminetetraacetic acid (EDTA) blood samples (PBMCs Fluorescence-activated cell sorting (FACS) analysis)
* Citrate blood samples (cytokine analysis)

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Patients admitted for performance of an allogeneic HSCT OR
* Patients with a first diagnosis of an acute myeloid leukemia
* No contraindication for an allogeneic stem cell transplantation
* Subject is not legally incapacitated
* Written informed consent from the study subject has been obtained

Exclusion Criteria:

* Active inflammatory bowel disease
* Ongoing gastroenteritis at the time of inclusion
* Patient has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the patient participating in the study, would make it unlikely for the patient to complete the study, or would confound the results of the study
* Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
* Persons held in an institution by legal or official order
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.

Eligibility Criteria:
Inclusion Criteria:

* Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial
* ECOG performance status ≤2
* Life expectancy of \>4 months at time of screening
* If woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)
* Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period
* Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol
* Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded
* Has an active, uncontrolled infection
* Has known or symptomatic brain metastases
* Receiving strong CYP3A4 inhibitors
* Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration
* Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation
* Patients actively receiving a concurrent investigational agent, other than Anamorelin HCl