cyrilzakka/clinical-trials huggingface dataset:
Intervention Study for Individuals With Compulsive Sexual Behavior

The purpose of this study is compare three interventions (short-term psychodynamic psychotherapeutic group and relapse prevention group therapy vs. treatment as usual, namely, psychiatric follow up including prescription of medication vs. both interventions combined) to individuals presenting compulsive sexual behavior.

We will compare three groups of patients under the three interventions, namely, (1) Short-Term Psychodynamic Group Psychotherapy (STPGP) followed by Relapse Prevention Group Therapy (RPGT) (n = 48) vs. (2) Treatment as Usual (TAU) (n = 42) vs. (3) both previous interventions combined (n = 45).

The STPGP is a 16 weekly session's group psychotherapy. Each session lasts 90 minutes. Each group will consist of around 10 participants. All the groups of STPGP will be conducted by the same psychotherapist.

The RPGT is an eight weekly therapy group. The sessions are structured and will last 90 minutes.

The medication used by those who are under TAU will be introduced through psychiatric care. Initially three visits will occur at intervals of 30 days and the followings will occur with an interval of 60 days. The medication protocol includes serotonin reuptake inhibitors (fluoxetine, paroxetine, sertraline) or mood stabilizers (topiramate, divalproex sodium, oxcarbazepine) or both type of medications combined.

All patients will be assessed on the outcomes and independent variables in the baseline (time 0); in the 25th week (time 1); and 34th week (time 2) of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. meeting the criteria for "excessive sexual drive" (ICD-10 F52.7) which corresponds to complain of an excessive sexual drive that often leads to out of control sexual behaviors AND meeting the criteria for "sex addiction" by Goodman (2001), which is characterized as a maladaptive pattern of sexual behavior leading to clinically impairment or distress as manifested in the same 12-month period by three or more of the following: tolerance (process of engaging in increasingly sexual behavior, in terms of intensity and frequency to obtain the same satisfaction than before); withdrawal (experience of abstinence, characterized by the presence of physical and/or psychological symptoms, when the behavior is diminished or discontinued); frequent sexual behavior; unsuccessful efforts to control it; many time spent in preparation for it; social or occupational activities are diminished because of it; it goes on despite negative outcomes;
2. being literate in Portuguese;
3. cognitive ability to answer self-responsive measures.

Exclusion Criteria: - individuals who met criteria for:

1. sexual preference disorders (ICD-10 F65);
2. manic or hypomanic state of bipolar disorder (ICD-10 F30.0, F31.0, 31.1, and 31.2);
3. schizophrenia, schizotypal, and delusional disorders (ICD-10 F20 - F29);
4. other mental disorders due to brain dysfunction, injury or physical disease (ICD-10 F06);
5. gender identity disorder (ICD-10 F64).
The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)

To investigate whether increasing water intake has renal protective effect on PA patients after surgical treatment.

This is a single-center randomized controlled trial study to verify the effect of drinking water on renal function after PA surgery treatment and to follow up the clinical outcomes. We will take short-term follow-up on whether increasing water intake can improve eGFR decline in the early stage of PA patients after surgical treatment and further long-term follow-up to investigate whether increasing drinking water has long-term memory effect to slow down renal function deterioration and improve clinical outcomes. This study will be completed in 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Able to provide informed consent and willing to complete follow-up visits.
* Estimated glomerular filtration(eGFR) rate over 60 ml/min/1•73 m²
* According to the Guideline of Primary Aldosteronism, unilateral PA has been diagnosed and unilateral adrenalectomy has been completed
* Urine volume can be recorded consciously, and daily drinking water volume is less than 2L/d

Exclusion Criteria:

* Pregnant or breastfeeding
* Diagnosed with other types of chronic kidney diseases, such as IgA nephropathy, lupus nephritis, etc.
* History of malignant tumor
* History of kidney stones in past 5 years
* Kidney transplant within past six months (or on waiting list)
* Less than two years life expectancy
* Serum sodium \<130 mEq/L without suitable explanation or Serum calcium \>2.6 mmol/L without suitable explanation
* Currently taking hydrochlorothiazide \>25 mg/d, indapamide \>1.25 mg/d, furosemide \>40 mg, or metolazone \>2.5 mg/d
* Poor blood pressure control (systolic pressure\>180mmHg or diastolic pressure\> 110mmHg)
* Alcoholics, drug addicts, and people with mental disorders who cannot cooperate
* Patient is under fluid restriction (\<1.5 L a day) for kidney disease, heart failure, or liver disease, AND meets any of the following criteria: i) end stage of the disease (heart left ventricular ejection fraction \<40%, NYHA class 3 or 4, or end stage cirrhosis) , ii) hospitalization secondary to ACS,heart failure, stroke,ascites and/or anasarca ,iii)Severe anemia (Hb\<60g/L)
An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications

This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects completing 12 weeks treatment in Study M12-921 who would benefit from long-term treatment from ABT-SLV187. Alternatively, subjects who (i) participated in the Phase 2 Study M12-925 (ii) would, in the opinion of the Investigator, benefit from ABT-SLV187 treatment in the Study M12-923, (iii) did not discontinue the M12-925 Study due to safety reason, and (iv) meet all entry requirements. Lastly, subjects who completed another ABT-SLV187 study (e.g., Study M12-927) in South Korea.
2. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
3. The subject must be willing to continue on treatment.

Exclusion Criteria:

1. Subject is enrolled in another clinical trial.
2. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant and in the opinion of the PI, would be a contraindication to continued levodopa therapy.
4. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.
5. Subject has current significant suicidal ideation as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale completed at the Week 12 Visit of Study M12-921 or at the Baseline Visit of the current study for M12-925 or M12-927 study subjects.
6. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-SLV187.
Promoting Caregiver Implementation of an Effective Early Learning Intervention

The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:

* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.
* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.

Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.

Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions.


Eligibility Criteria:
Inclusion Criteria:

* receiving or on waitlist for speech services
* primary complaint of impaired language skills
* receptive, expressive, or mixed language disorder
* primarily communicates in English

Exclusion Criteria:

1. No known additional diagnoses causal of developmental language disorder including

   1. autism spectrum disorder
   2. hearing loss
   3. severe intellectual disability
2. Is not attending or has completed Kindergarten
A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)

The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Type 2 Diabetes Mellitus that is poorly controlled
Benefits of Eggs in Combination With a Plant-based Diet

The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids.

Results from studies involving cells, animal models and clinical trials have demonstrated that lutein and zeaxanthin potentially protect against chronic diseases, including age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma concentrations of lutein and zeaxanthin are closely associated with their antioxidant properties and with their protection against reactive oxygen species (ROS).

Choline is recognized as an essential nutrient for health because of its many functions in growth and development, as well as neurological function and formation of membrane phospholipids, including phosphatidylcholine (PC) and sphingomyelin.

Therefore the objective of this study is to demonstrate that inclusion of eggs in a plant-based diet will potentiate the benefits of this healthy diet by increasing plasma concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically increase the antioxidant and anti-inflammatory actions of these components. This would be potentially more important in those individuals with metabolic syndrome, which is the target population of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* All genders
* 35-70 years
* Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference. 88 cm for women and \> 102 cm for men; plasma triglycerides \> 150 mg/dL, blood pressure \> 135/85 mm Hg, fasting glucose \> 100 mg/dL and HDL \< 40 mg/dL for men and \< 50 mg/dL for women)
* Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each
* Willing to follow a plant-based diet for 13 weeks
* Not have cardiovascular disease, high cholesterol, diabetes, cancer, liver or renal disease
* Proficient in English

Exclusion Criteria:

* Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer
* Taking glucose lowering medications
* Triglycerides \> 500 mg/dL
* Cholesterol \> 240 mg/dL
* Blood pressure \> 145/100 mm Hg
* Allergic to eggs or spinach
Imaging During Subliminal Perception

Subliminal perception of visual stimuli can be studied with functional brain imaging, e.g. with functional magnetic resonance imaging (fMRI). However, it is unclear how subliminal perception affects connectivity in the brain.

Further, it is not known if real-time (rt) fMRI neurofeedback of brain areas involved in subliminal perception can lead to supra-threshold perception.

For attention tasks, the investigators hypothesize that functional connectivity strength is mediated by the insular cortex during both supra-threshold and subliminal perception.

Additionally, the investigators hypothesize that rt-fMRI neurofeedback training should alter neuronal and behavioral responses.

In this project, using healthy adults, the investigators have 2 aims:

1. Apply electroencephalography (EEG) and fMRI before and after rt-fMRI neurofeedback during attention tasks to identify brain regions involved in subliminal and supraliminal perception.
2. Apply functional connectivity analyses during these tasks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (\> 18 \< 80 years), which can read and sign the informed consent form
* Male and female
* Right-handed

Exclusion Criteria:

* metallic items in the body (i.e. eye splinter, MR incompatible implants)
* pacemaker
* claustrophobia
* pregnant participants
* participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease and with major psychiatric disorders such as schizophrenia, depression, or anxiety disorder
* Drug intake (psychopharmaca)
First Study in Humans With GSK424887

This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 18-45 years, limited to 25-40 years for PET section

Exclusion Criteria:

* The subject has a positive: drug/alcohol, Hepatitis, HIV screen
* The subject has a history of psychiatric illness suicidal attempts or behaviour.
* Abuse of alcohol.
* Clinically significant laboratory, ECG abnormality;
* The subject has recently received an investigational.
* Use of prescription or non-prescription drugs,
* History or presence of allergy to the study drug or drugs of this class,.
* Donation of more than 500 mL blood within the 90 days before dosing.
* An unwillingness of male subjects to comply with contraceptive requirements
* Average daily caffeine intake exceeding Protocol requirements.
Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion

Placental borders and mapping by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively . bladder peritoneal dissection till the level of internal Os Uterus is incised away from the placenta

* Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding . Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped . Then we proceed to systemically devascularize the uterus with the placenta in site After control of both superior vesical vessels Finding a fresh noninvaded plan between isthmocervical junction and posterior bladder wall aided by filling the bladder 150 cc saline Then cervical stump control sutures and severing the specimen above the clamps

Now the placenta is only attached to the bladder , apply intestinal clamp or foley cath on the bladder below the level of invasion if feasible to reduce bleeding

* cut through the placenta, heavy back flow bleeding of old blood stored in the placenta will be noticed , but there is no hemodynamic change since the cervical stump is already severed

  , dissect the bladder with a large safety margin cutting through the placenta.. Then in cases with hematuria saline irrigation of the bladder is usually enough to clear the hematuria 15 out of 20 In cases with larger blood clots in the bladder cystoscope is done avoiding the need for cystotomy
* lastly removal of excessive placental tissues from the bladder wall by gentle swabbing or trimming, then individual control of bleeders and plication of the invaded area with seromuscular purse string sutures around said area , in cases of large areas , bladder mobilization is imperative to increase bladder capacity


Eligibility Criteria:
Inclusion Criteria:

* Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
* patient's informed consent about the future risks of conservative management
* pregnancy \> 20 weeks

Exclusion Criteria:

* \* deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm

  * cases with total invasion in which the area of invasion is more than 20 min diameter
  * patient refusing conservative management and opting for hysterectomy
  * medical comorbidities making massive hemorrhage more likely such as coagulopathies
  * patient is in active antepartum hemorrhage
Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) promotes oxytocin release and the potential biomarkers of tVNS based on eye-tracking data

A randomized, single-blinded, sham-controlled, within-subject, crossover design will be employed in this study. In a randomized order, a total of 54 healthy subjects will receive transcutaneous vagus nerve stimulation via tragus and sham stimulation vis earlobe in the left ear (interval between these two stimulations will be 1 week). Eye-tracking and behavioral data will be collected before and after 30 minutes of stimulation, saliva samples will be collected before and after 30 minutes of stimulation, and the end of the experiment.

Some personal traits will be assessed using different kinds of questionnaires, such as the Autism Spectrum Quotient(ASQ), Social Responsiveness Scale(SRS), State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), and Toronto Alexithymia Scale (TAS-20).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant, menstruating, taking oral contraceptives;
* medical or psychiatric illness.
Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease

This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with idiopathic Parkinson Syndrome
* 18 to 85 years
* Nocturnal Pollakisuria \> 2 mictions /night (documented in Screening phase )
* Na+ i.S \> 135 mmol/l
* Patient is able to understand all aspects and individual consequences of the clinical trial
* An informed consent signed and dated by the patient is available prior to any study specific treatment
* The study is consistent with the patients´ request for an appropriate treatment

Exclusion Criteria:

* Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
* Central Diabetes insipidus
* Known heart insufficiency (NYHA Stad. III und IV)
* clinical relevant kidney insufficiency
* Habitual and psychogenic Polydipsia
* Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication
* Participation in another clinical trial during or within 6 months prior to this clinical trial
* Medical or psychological condition, which might endanger the proper conduction of the clinical trial
* Known drug or alcohol abuse
Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

A multicentre two-group parallel single-blind (outcome assessor) randomized controlled trial (RCT). A cost effectiveness study alongside a clinical trial using a payer and societal perspective to study the cost-effectiveness of geriatric assessment and management compared to usual care will be conducted.

Participants allocated to the control group will receive usual oncology care. Participants allocated to the intervention group will receive a comprehensive geriatric assessment and management in addition to their usual oncology care. The intervention will take 6 months to be completed. Total study follow-up will be 12 months for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70+ with any solid tumor (excluding pancreatic) or lymphoma/myeloma referred for first/second line adjuvant/curative or palliative chemotherapy (cannot have received more than 1 cycle),
* Able to speak English/French,
* Have a physician-estimated life expectancy \>6 months,
* Have an ECOG Performance Score 0-2 (indicating participants are ambulatory and able to complete all self-care activities),
* Able to give informed consent.

Exclusion Criteria:

* Receiving palliative care services upon recruitment
* Already participating in another psychosocial/educational intervention study (new treatment study is allowed if the participants would like to participate in 2 studies)
Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are at least 18 years old.
* Have a viral load of 5,000 copies/ml or greater.
* Have a CD4 count of at least 50 cells/mm3.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken any antiretroviral (anti-HIV) agent.
* Are pregnant.