cyrilzakka/clinical-trials huggingface dataset:
Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program

The investigators know that treatment for prostate cancer and erectile dysfunction can impact sexual health and quality of life. They want to learn how the treatment affects one's emotional and social well-being.

They have developed a new type of counseling. Cancer patients seek counseling for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. They hope that this counseling will teach patients skills that they can use to comply with erectile treatment programs, improve their sexual health and quality of life. These skills may also improve physical and emotional well-being. As part of this study they will ask the patient to provide feedback on the proposed counseling.


Eligibility Criteria:
Inclusion Criteria:

Part A

* Men who are 1 to 3 years post radical prostatectomy for early stage prostate cancer
* Participated in penile injection program
* Are able to speak, read, write and understand English well enough to complete study assessment and communicate with an English speaking therapist

Part B

* Men who are up to 9 months post radical prostatectomy.
* Had good erectile functioning pre-surgery (i.e., 24 or greater on the IIEF Erectile Function Domain (EFD) score), graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale) or have a score of 7 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment)
* Seen at MSKCC"s Sexual Medicine Rehabilitation Program (SMRP)
* Advised by the clinical staff of the SMRP to start penile injections.

Exclusion Criteria:

Part A

* Recurrence or progression of disease,
* Specific injection phobia (self report)
* A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review)
* Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a focus group

Part B

* Specific injection phobia (self report)
* A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review)
* Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a therapeutic session.
Assessment of the Burden Within the Dyad Patient/Caregiver

This study is about the patients life ending and their caregiver, when a return to home is planned.

This is a behavioral sciences study (= interventional study for french law)


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old
* Cancer for which no curative treatment is envisaged
* Palliative treatment only
* For the caregiver: designated by the patient like the referring individual
A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.

The objective of this phase IIb study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms and impairment of symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the study participants by at lest two menstrual cycles of prospective DRSP ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The Total symptom score of the DRSP will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used.

The study will also include a follow-up (no treatment) cycle before patients final visit.

The study is conducted in four European countries (Sweden, Germany, Poland and United Kingdom) and will include up to 225 patients.

Eligibility Criteria:
Main Inclusion Criteria:

* have PMDD according to DSM-5 verified in two menstrual cycles
* have a regular menstrual cycle of 24-35 days cycle,
* use double barrier contraception, non-hormonal IUD, be truly sexually abstinent, or subject or her partner has been surgically sterilized,

Main Exclusion Criteria:

* steroid hormonal treatment or treatment with psychopharmaceuticals during previous three months
* treatments for premenstrual syndrome (PMS) or PMDD
* history of or significant medical condition ongoing
* be pregnant or plan a pregnancy within the study period
Combined Treatment of Resistant Hypertension and Atrial Fibrillation

The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic drug-refractory AF (with history of failure of ≥2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
* PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
* Office-based systolic blood pressure of ≥160 mm Hg, despite treatment with ≥3 antihypertensive drugs (including 1 diuretic)
* A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

* Previous atrial fibrillation ablation
* Type 1 of diabetes mellitus
* Structural heart disease
* Secondary cause of atrial hypertension
* Severe renal artery stenosis or renal arteries abnormalities
* Previous operations on renal arteries
* Pregnancy
* Previous heart, kidney, liver, or lung transplantation
* Unwillingness of participant
An Extension Study of JR-141-BR21 in Patients With Mucopolysaccharidosis II

A Phase II open-label, parallel group, 2 sites (Brazil), designed to evaluate the long term safety and efficacy of study drug for the treatment of the MPS II.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will have completed clinical trial JR-141-BR21.
* Capable of providing written consent by himself, unless the patient is under the age of 18 years at the time of informed consent process, or it is not possible to obtain consent from the patient himself due to his intellectual disabilities associated with MPS II.
* In the case of a patient who is under the age of 18 years or from whom it is not possible to obtain consent due to his intellectual disabilities associated with MSP II, he may be included if written consent can be provided by legal representative; however written consent should be obtained from the patient himself too, wherever possible.

Exclusion Criteria:

* Refusal to sign the informed consent form.
* Unable to perform the study procedures, except for neurocognitive testing.
* Previous engrafted BMT/HSCT.
* Judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking a position for lumber puncture due to joint contracture or those who are likely to experience difficulty breathing during the lumbar puncture process.
* Judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of a serious drug allergy or sensitivity.
* Otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study out of consideration for the subject safety.
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study

The purpose of this study is to explore the benefit of the prasugrel monotherapy without aspirin as compared with the 1-month dual therapy with aspirin and prasugrel in terms of reducing bleeding events after percutaneous coronary intervention (PCI) using cobalt-chromium everolimus-eluting stents (CoCr-EES, XienceTM) in patients with high bleeding risk or under the acute coronary syndrome patients.

In the previous trial, 1-month dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy provided a net clinical benefit for the cardiovascular and bleeding events over 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. However, even with very short DAPT, the rate of bleeding at 1-year remained very high in other trials that enrolled the patients with high bleeding risk (HBR). Notably, the risk of bleeding in patients with high bleeding risk (HBR) was particularly high within 1-month after percutaneous coronary intervention (PCI) in previous cohort data, when DAPT is implemented even in very short DAPT regimen. More recently, in another trial, prasugrel monotherapy without aspirin immediately after successful stent implantation was associated with no stent thrombosis in selected patients with low risk stable coronary artery disease. Aspirin-free strategy might be particularly beneficial in reducing bleeding in HBR patients. Patients with acute coronary syndrome (ACS) are also reported to be associated with higher risk for bleeding.

Therefore, we have planned a study to compare the cardiovascular and bleeding events at 1-month after PCI using CoCr-EES between no DAPT strategy and 1-month DAPT strategy in patients with HBR or ACS.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned to have percutaneous coronary intervention with exclusive use of everolimus-eluting stent (XienceTM series).
* Patients with high bleeding risk defined by Academic Research Consortium or acute coronary syndrome
* Patients who could take dual antiplatelet therapy with aspirin and P2Y12 inhibitors for 1-month

Exclusion Criteria:

* Patients who are judged to be unsuitable for participation by the principal investigator and co-investigator
* Patients with a known allergy to the study drugs
* Patients enrolled in the ongoing prospective interventional studies
Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer

The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.


Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer Stage T1-3, N1, M0
* Suitable candidate for anthracycline-containing adjuvant chemotherapy

Exclusion Criteria:

* Evidence of residual tumor following surgery, or metastatic disease
* Received prior therapy for breast cancer
A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects

This is a phase Ⅰ study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-45 years.
2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2.
3. Subjects not with clinically significant vital signs and laboratory tests.
4. Take contraception measures.

Exclusion Criteria:

1. Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug.
2. Severe infection, severe trauma or major surgery.
3. Any medications in the two weeks before screening or baseline period.
4. History of blood donation or severe blood loss.
5. Have been vaccinated within 2 weeks before the screening or baseline period.
6. History of smoking or excessive alcohol or drug abuse.
7. Other situations that the researcher judges to be unsuitable.
Activating Older People After a Hip Fracture

The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture.

The second aim is to determine if the ActiveHip intervention reduce the anxiety, stress and burden of the caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Have hip fracture surgery
* Age equal to or greater than 65 years
* Are allowed weight-bearing at 48 hours after surgery
* Had a high pre-fracture functional level the week before the fracture (Functional Independence Measure \[FIM\] index scored more than 90 points)
* Have an informal or family caregiver who has the ability to access the Internet to use the app ActiveHip+
* Basic management of the mobile phone
* Have signed an informed consent.

Exclusion Criteria:

* Presence of low cognitive level (Pfeiffer test score lower than 4 points)
* Being dependent on the activities of daily living before the hip (Functional Independence Measure \[FIM\] index scored less than 60 points)
* Being institutionalized
* Post-surgery complications
* Terminal disease
* Age under 65 years
The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer

Helical tomotherapy is being used to treat the prostate gland, local rates of spread and regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging (MRSI) is incorporated into pre- and post-treatment evaluation.


Eligibility Criteria:
Inclusion Criteria:

* High risk localized prostate cancer

Exclusion Criteria:

* Low/intermediate risk, metastatic cancer
* Patient refusal
Sensorial Discrimination in Chronic Low Back Pain

In this study, the effect of sensory discrimination training on cortical reorganization, pain and functionality in chronic nonspecific low back pain in which central sensitization is dominant will be investigated.

Patients who agree to participate in the study will be assigned to Group I (core stabilization) or Group II (core stabilization+sensorial discrimination training) after being screened and randomized according to the inclusion criteria on day one. On the first day, all evaluations will be carried out by taking informed consent form from the participants. With the participants in Group I, progressive core stabilization exercises will be practiced for 20-30 minutes a day, 2 days a week for 10 weeks. In Group II, sensorial discrimination training will be studied for 20 minutes before core stabilization exercises. Core stabilization exercise will be performed in accompany with a physiotherapist who has a I. Level mat exercises certificate. At the end of each week, participants will be questioned about the use of an adjunctive intervention to treatment, including changes in medication use, or the presence of an unexpected reaction to treatment, and their responses recorded. All assessments will be repeated before treatment, at the end of the 6th week, and at the end of the 10th week. The primary outcome is cortical reorganisation which will be assessed with tactile localization, two point discrimination, pressure pain threshold. Also, proprioception of the lumbal region, lumbopelvic control, pain intensity, functionality, central sensitization, pain catastrophizing, kinesiophobia, and quality of life of the participants will be assessed. Power and Sample Size Program was used to calculate the sample size. Minimal clinically important difference (MCID) and standard deviation (SD) values were used during the calculation. For the Numerical Rating Scale, the MCID value was 4.15 and the Standard Deviation value was 3. It was calculated that a total of 15 participants, 15 participants in both groups, should be included in the study. A total of 36 participants will be included in the study by calculating a 20% probability due to the possibility of the participants being excluded from treatment or dropped out.

Eligibility Criteria:
Inclusion Criteria:

* To be between 30 and 60 years old
* To have pain lasting longer than 3 months
* To have pain intensity greater than 4 out of 10
* To have pain that is not compatible with anatomical structures and is widespread
* To get score of 40 or more from the Central Sensitization Inventory

Exclusion Criteria:

* Inability to perceive the sense of touch in the waist
* Being pregnant
* Using a pacemaker or being diagnosed with heart disease
* Having an open wound in the waist
* Using drugs that affect the central system (dopamine, etc.)
* Having a history of surgery related to the spine
* Presence of a neurological injury or disease
* Having a Body Mass Index of 30 or more
* To have a diagnosis of fibromyalgia
Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report

Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum)

Case presentation: A 25-year-old male patient presented to the emergency department with generalized peritonitis caused by a perforated jejunal mass. The patient underwent an emergency exploratory laparotomy. There was 800 ml of thin pus in the peritoneal cavity and 5 cm by 6 cm perforated mass over the jejunum, 30cm from the ligament of the treitz, which extends to the mesentery. Palpable jejunal mesenteric lymphadenopathies were found. There were palpable intraluminal polyps with an inverted serosal surface for some of them, which were identified as 10cm proximal and 20cm distal to the mass. The pus was sucked out, and the mass was resected with its mesenteric lymph nodes and segments containing polyps, a total of 40cm of jejunum. Subsequently, end-to-end hand-sewn anastomosis was performed, and the abdomen was closed. The histopathology report showed poorly differentiated adenocarcinoma, stage IIIC (PT3, PN2), and Peutz-Jeghers polyps, suggesting Peutz-Jeghers syndrome. Lympho-vascular invasion was also noted. The tumor has affected seven of the 12 lymph nodes that have been identified. After 6weeks of uneventful follow-up at the surgical referral clinic, the patient was referred to the oncology department for adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* not necessary

Exclusion Criteria:

* not necessary
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery

Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading cause of perinatal morbidity and mortality in economically developed countries. Despite the development of therapeutics and paraclinic examinations, this rate of preterm delivery remains stable or even increases. The use of medically assisted procreation techniques alone can not explain this rate.

The analysis of the electrical activity of the uterus (electrohysterograms) is a promising technique for early diagnosis of the risk of premature delivery, allowing better management of the patients. This study is part of a European theme to study risk factors for the prevention of prematurity.


Eligibility Criteria:
Inclusion Criteria:

* Patients arriving at maternity emergency for threat of premature birth between 26 SA and 35 SA defined by uterine contractions and a cervical modification
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient minor,
* Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM)
* Patient under tutelage or curatorship or deprived of public law
A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.


Eligibility Criteria:
Key Inclusion Criteria:

* Is willing and able to provide written informed consent to participate in the study.
* Has an identified reliable informant.
* Is, in the investigator's opinion, suitable for initiating a washout from the subject's current antipsychotic regimen, if applicable, and is willing to abstain from prohibited psychotropic medications in accordance with study requirements.

  * Subjects must meet screening eligibility criteria and be in an inpatient setting prior to discontinuing antipsychotic medications.
  * Subject must be able, in the investigator's opinion, to safely discontinue prohibited psychotropic medications prior to Baseline without increased suicidality.
* Has a primary diagnosis of schizophrenia based on the Diagnostic and Statistical Manual 5th edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders Studies.
* Is experiencing an acute exacerbation or relapse of symptoms.
* Is in generally good physical health, in the investigator's opinion, based on Screening medical history, physical examination, vital signs, and clinical laboratory values.
* Has a body mass index (BMI) between 18 and 40 kg/m2, inclusive.
* For women of reproductive potential: has a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
* For women of reproductive potential and men with female partners of reproductive potential: agrees to remain abstinent from sexual intercourse or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug.

Key Exclusion Criteria:

* Is a woman who is pregnant, breastfeeding, or less than 6 months postpartum at Screening.
* Has any primary DSM-5 disorder other than schizophrenia, as confirmed by the MINI.
* Fails to discontinue prohibited psychotropic medications.
* Has, in the investigator's opinion, a significant risk of violent or destructive behavior.
* Is currently hospitalized involuntarily or incarcerated.
* Has a history or presence of any clinically significant medical condition, disease, or surgical history that could, in the investigator's opinion, jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug.
* Is, in the investigator's opinion, not a suitable candidate for the study.