cyrilzakka/clinical-trials huggingface dataset:
The Female Sexual Functions With Progestogen-only Contraception

Female sexual dysfunction is age-related, progressive, and very common condition. The physiology of the female sexual function is a complex condition affected by emotional, medical and hormonal elements.

Progestogen-only contraception relies on progestogens alone to achieve contraception. There are several progestogen only contraceptive methods include progestogen only pill (minipill), subdermal implants, Depo-Provera (DMPA) and levonorgestrel intrauterine system. Many studies in literature reported the negative effect of combined oral contraceptive pills (COCs) on female sexual function due to decrease in bioavailability of testosterone and increase level of sex hormone binding globulin (SHBG) which leads to decrease in free testosterone level contributes to dysfunction.

However, the progesterone only methods contains no estrogen, so it has less effect on sex hormone binding globulin and therefore less effect on free testosterone. DMPA (injectable progestins) is an injectable progestin is a highly reliable form of contraception. Nelson in 1996 found that about 6% of women using DMPA reported either lost or decreased libido. More recent study by Fortenberry in 2011 reported that DMPA had no effect on sexual interest compared with nonusers of any hormonal method of contraception in an adolescent population. The etonogestrel implant (Implanon) is a single rod that is inserted into the medial side of non dominant upper arm. Although in general, it is very effective and has relatively low side effect, a decreased libido has been noted.

Cerazette is a progestogen-only contraceptive pill containing 75 micrograms of desogestrel. It acts mainly by inhibiting ovulation. Cerazette users also may complain of decreased libido.

The estrogen is the main hormone which responsible for vitality of the pelvic organ especially the vagina. The main mechanism of action of the DMPA, Implanon and Cerazette is inhibition of ovulation, which leads to decrease in the estrogen level, which causes a drop in blood flow in uterine artery and accordingly the vagina artery. That can affect vaginal lubrication, causing the vagina to be too dry for comfortable sex.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 20-45 years old.
* Sexually active women with regular marital life.
* Using DMPA, Implanon or Cerazette for at least 6 months and no more than 12 months.
* Using the above method only for pregnancy prevention.
* Have not any medical or gynaecologic problem.

Exclusion Criteria:

* Lactating women
* Women have abnormal uterine bleeding with contraception
The Efficacy and Safety of ALIC/NAcc-DBS for Treatment-refractory OCD

The present study aims to explore the efficacy and safety of DBS targeted the combination of the anterior limb of internal capsule and nucleus accumbens (ALIC/NAcc-DBS) to refractory OCD, based on multicenter, randomized, double-blinded, sham-stimulation controlled design, that could help to obtain stronger evidence of the efficacy of multiple targets.

OCD is a chronic and disabled mental disorder, with one third of patients could hardly get recovery from the medication and psychotherapy. Deep brain stimulation (DBS) is a novel potential surgical treatment for refractory OCD, however, the choose of targets are still controversial. This study aims to investigate the therapeutic efficacy and safety of bilateral DBS of the anterior limb of internal capsule and nucleus accumbens (ALIC/NAcc-DBS) for treatment-refractory OCD. In this multicenter, prospective, and double-blinded study, 64 patients with OCD who met the eligibility criteria will be enrolled and randomized allocated to active and sham-stimulation group, followed up for three months after surgery. Then the blind will be uncover, the sham group switch to true stimulation, all patients will be followed up at six months after surgery. The primary outcome was to compare the treatment response rate between the active group and sham-controlled group at the end of three months after surgery. The secondary outcomes include changes in the Yale-brown obsessive-compulsive scale (Y-BOCS), Hamilton anxiety scale (HAMA), Hamilton depression scale (HAMD), and Clinical global impressions (CGI) scale of both groups.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years old;
* a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5);
* suffered from severe OCD symptoms over 5 years with substantial functional impairment;
* the Y-BOCS total score ≥ 25;
* met the criteria of treatment refractory. Treatment refractory is defined as failed 1) at least three adequate therapeutic trials of serotin reuptake inhibitors (SRIs), with clomipramine being one of the SRIs trials, 2) the use of at least two atypical antipsychotics as augmenting agents, 3) at least 20 sessions of therapist-guided cognitive-behavioral therapy while on a therapeutic dose of an SRIs. These patients have "failed" treatment by demonstrating \<25% reduction of Y-BOCS scores or, despite \>25% reduction in YBOCS score, by still experiencing significant impairment from their illness.

Exclusion Criteria:

* a history of current or past diagnosis of any psychosis according to DSM-5 except for OCD
* any clinical significant neurological disorder, traumatic brain injury, dementia, or medical illness
* any contradiction of neurosurgery
* any current or unstably remitted substance abuse or dependence
* women who are pregnant or preparing for pregnant
* severe suicide risk and tendency according to the investigators' judgements
* participate in any other clinical trials within three months (except for registered studies).
ACEs Referral From PED

Adverse childhood experiences (ACEs) are traumatic exposures that can cause many negative health impacts across life. ACEs are common in patients who seek out care in pediatric emergency departments (PEDs); this is an opportunity to connect families with mental health resources to mitigate the effects of ACEs and improve lifelong health. The goal of this study is to determine if children with high ACEs have better rates of follow-up with mental health resources when a telehealth option is provided, as previous research has shown that simply making an in-person follow-up appointment is not very helpful.

Children 12-17 years old who are receiving care in a PED and their legal guardians will fill out a tablet-based electronic consent/assent and survey that takes no longer than 10 minutes to complete while waiting for treatment once they are in a private patient room. The study team will review the responses to identify children with ACE scores 2 or higher and contact the family to help them arrange therapy services. Patients will be randomized to in-person versus telehealth therapy. A few months after enrollment, the study team will contact the family and mental health team to find out if the family was able to keep their appointment to start mental health treatment. This will aid future research to identify if and how mental health treatment impacts these patients over the following years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12-17 years seen in the PED who read and speak English

Exclusion Criteria:

* Patients already enrolled in outpatient therapy resources,
* Critically ill patients
* Patients with significant developmental delays impeding their ability to participate in therapy.
The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)

This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. These patients are usually not fully awake and need help with their breathing and with preventing them from choking on their secretions. This is done with a breathing tube inserted through the mouth into the lungs and connected to a breathing machine. As patients recover, It is often unclear when the best time is to remove the breathing tube. Doctors might decide to remove it relatively early, or they may wait until the patient is more fully awake, or they may perform a tracheostomy (neck surgery to insert a new tube directly into the windpipe (trachea), replacing the temporary breathing tube). Each of these approaches has risks and benefits. This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 16 years
2. Acute brain injury (subarachnoid hemorrhage, diffuse axonal injury, ischemic stroke, intracerebral hemorrhage, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis, cerebral abscess, epidural hematoma, subdural hematoma, seizure) that occurred within the previous 4 weeks
3. Receiving mechanical ventilation via endotracheal tube for ≥ 48 hours

Exclusion Criteria:

1. Quadriplegic
2. Neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to Guillain-Barre syndrome, cervical spinal cord injury, advanced multiple sclerosis
3. Do-Not-Reintubate order in place
4. Previously randomized in this trial
5. Underlying pre-existing condition with life expectancy less than 6-months
6. Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
Interim FDG PET/CT in Diffuse Large B Cell Lymphoma (DLBCL) Patients

Newly diagnosed diffuse large B cell lymphoma (DLBCL) patients who enter this study will receive baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) scan at the time of initial staging. The patients will be diagnosed and undergo initial staging according to The Catholic University Lymphoma Group (CULG) Protocol.

After 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) chemotherapy, early interim FDG PET/CT will be obtained after the patient recovers from nadir (usually 13 to 16 days after) following the administration of first cycle of R-CHOP,immediately before the second cycle of R-CHOP. The result of early interim FDG PET/CT study will not impact patient management, except in rare case where newly developed lesion is found and biopsy confirmed.

The same PET/CT system and analysis software will be used for all scans from baseline to surveillance for all patients enrolled in this study.

After 3 cycles of R-CHOP, a mid-therapy interim FDG PET/CT will be obtained. Patients with newly developed lesion will receive different chemotherapy regimen, while patients with stable disease, partial metabolic response or complete metabolic response will continue to receive 3 more cycles of R-CHOP.

After the completion of 6 cycles of R-CHOP, the patients will receive a FDG PET/CT scan for response assessment. Selected patients with persistent disease or very bulky tumor volume on initial staging images will receive additional radiation therapy.

The patients will be followed up every 3 months for 2 years from beginning of therapy. Physical examination and lab studies will be done usually every 3 months. Imaging studies will be performed every 3 months alternating between enhanced CT and FDG PET/CT and noted when different schedule is applied for surveillance.

The end points are changes in FDG uptake measurements between the baseline and early interim FDG PET/CT, and between baseline and mid-therapy interim FDG PET/CT scans; response assessment following completion of 6 cycles of R-CHOP with or without radiation therapy assessed by International Workshop Criteria (IWC)+PET and PET Response Criteria in Solid Tumors (PERCIST) guideline; and the 2 year disease free survival.


Eligibility Criteria:
Inclusion Criteria:

* CD20+ diffuse large B cell lymphoma confirmed
* Therapy naïve for lymphoma
* 19 years or older
* Written informed consent

Exclusion Criteria:

* Cannot understand informed consent
* Age under 19 years old
* Previous chemotherapy or radiation therapy for lymphoma
* Known pregnancy or urine/serum hCG (+)
* Unable to lie down still on back for about 30 minutes
Resistant Maltodextrin Supplementation: Gastrointestinal Health

Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal bulk by enhancing growth of specific microbial populations; however the effect of RMD on bifidobacteria and total fecal weight is not clear. The purpose of this research study is to determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce beneficial changes in gastrointestinal function, the fecal microbiota profile (increased number of healthy bacteria in stool) and immune processes resulting in improved quality of life.

This is a randomized, double-blind, placebo-controlled study. After obtaining informed consent, participants will be randomized to either consume 0, 15 or 25 grams of resistant maltodextrin (RMD) during the first arm of the study. During the first intervention period, participants will consume the RMD everyday for 3 weeks. After a 2-week post intervention period, participants will be crossed to one of the other treatments for 3 weeks, followed by a 2-week post intervention and then receive the final intervention for 3 weeks.

Participants will complete daily questionnaires and weekly gastrointestinal symptom questionnaires during the intervention and post-intervention periods. Stool samples will be collected at the baseline and final time points of each intervention. Dietary intake will also be assessed weekly during each intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.5 to \<30 kg/m2
* Usual fiber intake of \<19 g/d for males and 13 g/d for females based on Food Frequency Questionnaire (FFQ) such as the NutritionQuest Fruit/Vegetable/Fiber Screener.
* Willing to complete daily and weekly questionnaires, 20 dietary recalls, and 15 stool collection days over approximately 18 weeks
* Willing to drink the study supplements for 3 weeks for each of the three intervention periods
* Willing to discontinue any prebiotic, fiber, or probiotic supplements or foods containing probiotics (e.g., yogurts with live, active cultures)
* Internet access for the duration of the protocol to complete online questionnaires
* On average you have 6 or more stools but fewer than 12

Exclusion Criteria:

* Does not meet above criteria
* Dietary fiber intake greater than half the adequate intake (AI) based on Automated Self-Administered Diet History (ASA24) (http://riskfactor.cancer.gov/tools/instruments/asa24/) dietary intake data collected during run-in period:

  * Females with a dietary fiber ≥13 g/d
  * Males with a dietary fiber ≥19 g/d
* Antibiotic use within 2 months from providing the screening stool sample
* Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than Gastroesophageal Reflux Disease (GERD), constipation, or diverticular disease
* Purposeful strenuous exercise of \>300 minutes per week on average
* Women who are lactating or know they are pregnant
Role of Gut Microbiome in the Health Benefits

Beneficial effects of moderate chronic consumption of beer have been extensively reported, however, the mechanisms have not been elucidated yet. Gut microbiota is an important mediator in the homeostasis of the host. Polyphenols act as bacterial substrates and modulators of the gut microbiota. Indeed, the investigators have previously observed that the chronic moderate consumption of red wine by metabolic syndrome patients triggered in an amelioration of the metabolic syndrome variables, and this effect was mediated, at least partially, by the interaction of the gut microbiota with the polyphenols of the red wine. In this manner, beer has a medium content of polyphenols. Thus, the investigators propose that the beneficial effects of moderate chronic consumption of beer could be because of the action of the gut microbiota with the beer polyphenols. The investigators are going to perform an intervention study in which normal volunteers will consume three different beer types with different content in polyphenols and it will be analyzed the gut microbiota profile (Metagenomics), metabolites (Metabolomics) and metabolic syndrome markers (gene expression, ELISA) to establish the correspondent relationships, trying to decipher the implication of the gut microbiota in the beneficial effects of moderate chronic consumption of beer.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Usual consumer of Beer

Exclusion Criteria:

* being a non usual beer-consumer,
* body mass index (BMI) \> 40 kg m2.
* acute or chronic infection, inflammatory disease or endocrine disorders; history of cancer; leukocytosis; anti-inflammatory, corticosteroid or hormone treatment.
* history of alcohol abuse or drug dependence.
* under a restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
* antibiotic therapy, prebiotics, probiotics, synbiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.
First-in-Human Single Ascending and Multiple Dose of GLPG0634

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 40-60 years
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

* any condition that might interfere with the procedures or tests in the study
* smoking
* drug or alcohol abuse
The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans

The main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin \[IMD\], partially digestible maltodextrin) and RS4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice porridge). The primary outcome of the study is the effect of fibers on postprandial blood glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (18.5 kg/m² ≤ BMI ≤ 29.9 kg/m²)
* No history of abnormal glucose metabolism
* No ongoing use of drugs affecting blood glucose levels
* Fasting blood glucose between 90-110 mg/dL
* Low dietary fiber intake (less than 15 g per day)

Exclusion Criteria:

* Diabetic individuals
* Individuals with history of gastrointestinal disease
* Pregnant or nursing women
Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation

This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation.

PRIMARY OBJECTIVE:

I. To examine the feasibility, adoption, extent of implementation, acceptability and fidelity of chaplain-delivered compassion-centered spiritual health (CCSH).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive chaplain-led compassionate centered spiritual health sessions over 30 minutes, twice per week for up to 2 weeks.

ARM II: Patients receive a traditional chaplain consultation and care upon request, per standard of care.

After completion of study treatment, patients are followed up at 80-100 days and 6 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT: Within 6 weeks of scheduled hematopoietic stem cell transplant (HSCT)
* PATIENT: \> 18 years of age
* PATIENT: Speak and read English
* CHAPLAIN: Emory Healthcare chaplain

Exclusion Criteria:

* PATIENT: Patients will be excluded if they are cognitively impaired, on a ventilator, or are in a room requiring enteric precautions or airborne precautions (e.g., use of an N-95 mask requiring fit-testing) to enter
* CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis

Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital.

Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital during follow-up

Eligibility Criteria:
Inclusion Criteria:

* phase 1: experts in the field of haemochromatosis (hepatologists, hematologists, endocrinologists, general practitioner, nurses, ...)
* phase 2: patients with hereditary haemochromatosis, treatment with phlebotomy since 3 months, Dutch/English speaking

Exclusion Criteria:

* patients with secondary iron overload
* phlebotomy treatment less than 3 months
* language: no Dutch or English
Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet

The kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension occurs when this balance is altered or abnormal. We hypothesized that this balance is influenced by salt intake: therefore dietary salt affects the natriuretic response to the renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor, Enalapril.

In this trial we study normal salt balance mechanisms in salt resistant adults with normal blood pressure.

Eight adults of both genders and all races were studied in this double blind placebo controlled cross over study with randomization of the order of interventions. After 5 days each on low salt (about 1 gram/day) and high salt (about 6 grams/day)diet, with a washout period of at least four weeks in between, every subject was treated with Enalapril and Placebo on two consecutive days, followed by a Fenoldopam infusion for three hours, during which natriuresis and renal function testing were performed.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers
* Healthy
* Normal Blood Pressure

Exclusion Criteria:

* Renal Impairment
* Obesity
* Salt sensitive increase in blood pressure