cyrilzakka/clinical-trials huggingface dataset:
Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis

* Objective: To determine if the tele-rehabilitation program for chronic pelvic pain associated with endometriosis composed of pain education, therapeutic exercise and respiratory control decreases pain according to the Visual Numerical Scale (EVN), catastrophizing with the Pain Catastrophizing Scale (PCS), kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), improves sexual function according to the Female Sexual Function Index (FSFI) and QoL compared to the Control Group with the Health Status Questionnaire (SF-12).
* Follow-up: four evaluated questionnaires: preintervention; postintervention, 3 months postintervention, 6 months postintervention
* Participants: 66 women diagnosed with endometriosis with chronic pelvic pain in different Spanish endometriosis associations.
* Randomization: women will be randomly assigned to two groups using the EpiData 3.1 software
* Interventions: Experimental Group: therapeutic exercise + conscious breathing (16 sessions) and pain education (4 sessions) through the TRAK platform.

Control Group: They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease.


Eligibility Criteria:
Inclusion Criteria:

* Women with a medical diagnosis of endometriosis.
* Age equal to or older than 18 years and up to 55 years.
* Who are or have received medical and/or surgical treatment and with controlled disease.
* Persistent pelvic pain for at least 3 months.
* Pain greater than 4 on the EVN.
* No cognitive limitation to understand the information sheet, instructions and freely sign the informed consent
* Have any electronic device available (tablet, computer, cell phone).
* Have a current email address.
* Have a valid e-mail address.

Exclusion Criteria:

* Peri- and postmenopausal women.
* Women pregnant or desiring gestation during the study.
* Women with a history of gynecologic cancer and/or undergoing any systemic and/or localized oncologic treatment in the pelviperineal region
* Women with a diagnosis of chronic fatigue or fibromyalgia▪.
* Women concomitantly participating in another intervention study.
* Women undergoing surgery during the study.
Effects of Exercise on Cervical Pain Through Educational Videos

Due to the increased prevalence of neck pain in studied adolescents and young adults, this intervention is carried out, which mainly seeks to compare and verify the effectiveness of therapeutic exercise with education, compared to education alone.

It is also necessary to mention the high levels of stress levels reported in students, which can affect the increase in pain and the perception of these at times when stress increases. The intervention has been decreed in the weeks before and during the exam period at the University of Valencia, to see if the neck pain experienced by students at similar stages of their academic life is prevented or reduced.

It is decided to use education above all to give the participants a tool that allows the participants to find out what happens and why it happens when the participants suffer from neck pain, as well as an explanation of the pathology and the risk factors and how to avoid -the bear. In addition, knowledge about the condition in question can lead to a reconceptualization of pain, changing the approach and exposing a different approach, when treating the pathology.

It must be said that in the structure and layout of the informative document, the investigators think of an instrument that can serve the participants for the future.

Another reason for carrying out the study is the few tests on neck pain carried out with new technologies. The use of videos, therefore, seeks to facilitate access to the information provided, being a useful and practical tool for students, familiar with the use of new technologies.

In addition, the training is intended to be as didactic as possible, the chosen exercises are carefully explained and the fact that they are found in videos and not in a practical class, favors access to the content in these, for that the participants use the videos at their disposal. Finally, treating neck pain with training and education and taking into account the stress of students, brings to conventional treatment an interesting perspective of coping, focused on the biopsychosocial field.


Eligibility Criteria:
Inclusion Criteria:

* Students of first curse of physiotherapy.
* That they have had an episode of neck pain at exam time.

Exclusion Criteria:

* They do not want to sign the informed consent.
* That they present some pathology that causes chronic cervical pain.
Emergency Treatment of Coral Snake Envenomation With Antivenom

The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and death from the bite of a coral snake.

Funding Source - FDA OOPD.

Coral snake bites may be trivial in effect, or they may cause profound and life-threatening respiratory paralysis, depending on the severity of the envenomation. Venom toxins target the neuromuscular junction, where effects typically become apparent hours following the bite, by which time the clinical syndrome may be irreversible. Unless neurotoxicity is prevented, ventilatory paralysis may cause death or require intensive care for weeks after the bite. Prevention of paralysis, historically, has involved treating all bite victims with antivenom.

This protocol will enable the therapeutic use of a new F(ab')2 antivenom in the management of coral snake envenomation.

Following a coral snake bite, patients who meet inclusion/exclusion criteria and who provide informed consent will receive 5 vials of antivenom intravenously over no less than 30 minutes. Blood assays for venom levels and clinical assessments of neurologic status before and after treatment will be conducted and patients will be followed for 22 days for safety and survival endpoints.

The primary endpoint of this Phase 3 trial will be survival, for comparison with a historical mortality rate of 15%.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any age. Presenting for emergency treatment of coral snake bite.

Exclusion Criteria:

* Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
A Study of Imlunestrant (LY3484356) in Healthy Women

The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when administered orally on the levels of midazolam in the blood stream in healthy women of non-childbearing potential. The study will also evaluate the safety and tolerability of imlunestrant in healthy women of non-childbearing potential. This study will last up to approximately 6 weeks for each participant including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Women not of childbearing potential
* Participants who are overtly healthy as determined by medical assessment
* Participants with body mass index (BMI) of 18.0 and 35.0 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

* Have known allergies to imlunestrant, related compounds or any components of the formulation or midazolam
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Use or intend to use medications that are substrate drugs of P-glycoprotein
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea

The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
* Korean male or female subjects who are eligible for the primary and/or booster doses of Infanrix-IPV according to the Korean Prescribing Information.
* Written or signed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. Where parent(s)/ legally acceptable representatives are illiterate, the consent form will be countersigned by an impartial witness. Prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. And prior to obtaining informed consent form, the investigator will check whether the subject is eligible for vaccination.

Exclusion Criteria:

* At the time of post-marketing surveillance (PMS) entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
* Subjects who receive any investigational or non-licensed DTPa-IPV vaccine within 30 days prior to study start will not be enrolled.
* Child in care.
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* 6 months or more post-stroke
* upper extremity Fugl-Meyer score between 10 and 50
* no longer participating in upper-extremity physical or occupational therapy
* sufficient comprehension ability to understand instructions

Exclusion Criteria:

* previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
* dementia
Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial

Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as causes of post-operative morbidity. This prospective, double-blind, randomized controlled trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by implementing a simple intra-operative technique.

Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be randomized to either the current standard (control group) or to receive an intervention to remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the end of the operation, by placing the patient in the Trendelenburg position and utilising a pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of 60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of the procedure by passive decompression via the open operative ports.

This trial recruited 76 randomly assigned patients, 37 in the intervention group and 39 in the control group. The overall post-surgery pain scores, as analysed by two-way ANOVA, were significantly lower in the intervention group (P=0.0019). On Bonferroni post-tests both 12 hour (P\<0.01) and 24-hour (P\<0.01) pain scores were significantly lower in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* All patients were recruited from a single Consultant's surgical clinic at the same District General Hospital between August 2010 and February 2012. This study was approved by the local ethics committee (National Research Ethics Service REC ref: 09/H0405/65) and informed consent was obtained from all patients after they had the opportunity to study information leaflets that were also given to them. The trial was designed as a prospectively randomized and double blind trial with a 1:1 (control:intervention) allocation.

The inclusion criteria was all adults with an American Society of Anesthesiologists (ASA) physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal preperitoneal procedure (TAP). All procedures and data collection occurred at a District General Hospital.

Exclusion Criteria:

The pre-operative exclusion criteria included patients younger than 18 years, those who refused to give consent, those that had an inability to understand the research questionnaire and pregnancy. Patients who were found to require additional procedures, for example a conversion to open surgery, were excluded from the study prior to randomization.

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A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production

To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.


Eligibility Criteria:
Inclusion criteria

1. Male subjects \>18 years of age and \<25 years of age.
2. Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter
3. Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)
4. Willingness to participate in the study
5. Willingness to receive EXPERIMENTAL treatment
6. Informed consent agreement signed by the subject
7. Willingness to follow the treatment schedule and post treatment care requirements
8. Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment

Exclusion criteria

1. Subject has a history of isotretinoin use
2. Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
3. Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria
4. Presence of suntan in the area to be treated
5. Subject is immunosuppressed
6. Subject is unable to comply with treatment, home care or follow-up visits
7. Subject has a history of vitiligo
8. Subject has a history of keloid formation
9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Cognitive Function and Emotional Possessing in Bilateral Facial Palsy

Based on recent findings that botulinum toxin injections in the cranial muscles might reduce emotional processing (Havas 2011), an increasing number of popular newspaper tabloids are suggesting a negative effect on cognition. The underlying research articles address the "facial feedback hypothesis". The hypothesis indicates that expressive behaviour, including facial mimic expressions influences the subject's brain via feedback. (Alam 2008) Other systemic neurological diseases, e.g of inflammatory origin, may lead to temporary bilateral facial nerve palsy (BF). During recovery process, the palsy usually remits completely.

The effect of bilateral facial muscle palsy on cognition and emotional possessing has never been evaluated.

The results of this pilot study might provide new information about the effect bilateral facial palsy on emotional processing and cognition and the facial feedback hypothesis.

The aim of this controlled pilot study is to assess cognitive function and emotional processing in patients with bilateral facial palsy. In addition, differences in cognitive function and emotional processing in patients with different manifestations of dystonia should be evaluated.

According to the facial feedback theory, paralysed mimic muscles might alter emotional processing. Therefore, investigators compare patients with bilateral facial muscle palsy and healthy controls. Investigators expect no influence of facial muscle palsy on cognitive functions in any of the tested groups; the investigators expect a mild impairment of emotional processing only in the patients group with bilateral facial muscle palsy (BEB and BF). In addition, the investigators expect no difference in emotional processing in patients with different manifestations of dystonia (BEB and CD) at remission. There might be a slight difference of emotional processing in patients with different manifestations of dystonia (BEB and CD) at time of prominent facial palsy.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* willing to participate in this pilot trial
* bilateral facial palsy
* age 18-80 years

Control:

* willing to participate in this pilot trial
* age,
* gender and
* education (duration of school attendance) matched
* and/or cervical dystonia

Exclusion Criteria:

* neurological or psychiatric comorbidity
* psychotropic drugs
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)

Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or sickle-β0 thalassemia).

This is a proof-of-concept study in adult SCA participants, ages 18 to 55 years old, to examine the safety, tolerability, and pharmacokinetic (PK), as well as the potential pharmacodynamic (PD) effects and clinical efficacy, of IMR-687 across a range of doses.

IMR-687 was administered in 2 populations of participants with SCA: those who were not receiving hydroxyurea (HU) and those who were receiving a stable dose of HU according to standard of care.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female participants with confirmed SCA
* Age 18 to 55 years, inclusive
* For participants on HU, must have been on a stable dose for at least 60 days prior to screening

Key Exclusion Criteria:

* Total hemoglobin \>12.5 or \<6 grams/deciliter
* Red blood cell transfusion within 60 days of baseline
* \>7 hospitalizations for vaso-occlusive crises (VOCs) within the last year
* Estimated glomerular filtration rate \<50 milliliter/minute
* Aspartate aminotransferase/alanine aminotransferase \>3x the upper limit of normal
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.


Eligibility Criteria:
Inclusion Criteria:

* 30 years of age or older.
* UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
* PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
* On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
* Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization
* Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
* Documented end-of-dose wearing-off and levodopa-induced dyskinesia
* Have an average of two hours of OFF time per day

Exclusion Criteria:

* Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
* Subject who have had neurosurgical operation for PD
* Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers
* Subjects who smoke \> 5 cigarettes/day
A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
* Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications: lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (PANSS) no worse than moderate in severity throughout screening period of at least 4 weeks.
* Has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit.
* Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit.
* Has an identified contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.

Exclusion Criteria:

* In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
* Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
* Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
* Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
* Has any risk factors for Torsades de Pointes (TdP)